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Current methods of the US Preventive Services Task Force: a review of the process best super levitra 80mg. Antihistamines Page 61 of 72 Final Report Update 2 Drug Effectiveness Review Project Appendix D generic super levitra 80 mg. Excluded studies in Update 2 The following full-text publications were considered for inclusion but failed to meet the criteria for this report buy super levitra 80 mg without a prescription. See previous versions of the report on the DERP website for studies excluded previously. Exclusion Excluded studies code # Head-to-head trials Day J, Briscoe M, Rafeiro E, et al. Comparative efficacy of cetirizine and fexofenadine for 6 seasonal allergic rhinitis, 5-12 hours postdose, in the environmental exposure unit. Day JH, Briscoe MP, Rafeiro E, Hewlett D, Chapman D, Kramer B. Randomized double- 6 blind comparison of cetirizine and fexofenadine after pollen challenge in the Environmental Exposure Unit: duration of effect in subjects with seasonal allergic rhinitis. Loratadine provides early symptom control in seasonal 6 allergic rhinitis. Comparative study of sensory attributes of two 2 antihistamine nasal sprays: olopatadine 0. The effects of the nasal antihistamines 6 olopatadine and azelastine in nasal allergen provocation. Single center, randomized, double-blind, crossover study comparing the effects 4 of single-dose fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on cognitive performance in naval flight personnel [completed]. Five parallel groups, exploratory clinical trial to compare the efficacy of single dose 7 levocetirizine 2. Active- control trials Day JH, Briscoe M, Widlitz MD. Cetirizine, loratadine, or placebo in subjects with 6 seasonal allergic rhinitis: effects after controlled ragweed pollen challenge in an environmental exposure unit. Onset of action and efficacy of 6 terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis. Horak F, Zieglmayer PU, Zieglmayer R, Kavina A, Lemell P. Levocetirizine has a longer 6 duration of action on improving total nasal symptoms score than fexofenadine after single administration. Comparative outdoor study of the efficacy, onset and 6 duration of action, and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis. Comparison of the effects in the nose and 6 skin of a single dose of desloratadine and levocetirizine over 24 hours. Antihistamines Page 62 of 72 Final Report Update 2 Drug Effectiveness Review Project Exclusion Excluded studies code # Weiler JM, Bloomfield JR, Woodworth GG, et al. Effects of fexofenadine, 6 diphenhydramine, and alcohol on driving performance. A randomized, placebo-controlled trial in the Iowa driving simulator. Single-center, double-blind, randomized , parallel study comparing onset of 6 action, efficacy & safety of a single-dose of fexofenadine HCl 180 mg vs montelukast Na 10 mg & placebo in treating seasonal allergic rhinitis subjects in an allergen exposure unit (study I) [completed]. Efficacy of azelastine nasal spray 4 in the treatment of vasomotor (perennial nonallergic) rhinitis. Montelukast for treating fall allergic rhinitis: effect 3 of pollen exposure in 3 studies. Gehanno P, Deschamps E, Garay E, Baehre M, Garay RP. Vasomotor rhinitis: clinical 5 efficacy of azelastine nasal spray in comparison with placebo. Orl; Journal of Oto-Rhino- Laryngology & its Related Specialties. A randomized, double blind, placebo controlled study for evaluation of 7 the efficacy and safety of cetirizine dry syrup (CTZ DS) (2. The efficacy of short-term 6 administration of 3 antihistamines vs placebo under natural exposure to Japanese cedar pollen. Placebo controlled pilot study on the efficacy of 7 levocetirizine 5 mg in reducing symptoms, airway resistance, and sleep impairment in patients with persistent allergic rhinitis [completed]. Cintinuous intake of levocetirizine for 6 months has no relevant effect on 5 laboratory values: the XPERT trial. A placebo-controlled evaluation of 6 butterbur and fexofenadine on objective and subjective outcomes in perennial allergic rhinitis. Meltzer E, Banov C, Halverson P, Weiler J, Woehler T, Hemsworth G. Comparison of 4 azelastine, clemastine fumarate and placebo for treatment of perennial allergic rhinitis. Randomized, double-blind, placebo-controlled study of 3 montelukast for treating perennial allergic rhinitis. Histamine skin test reactivity following single and 2 multiple doses of azelastine nasal spray in patients with seasonal allergic rhinitis. A single-center, randomized, double-blind, placebo-controlled, two-way 7 crossover study designed to evaluate the efficacy of fexofenadine HCl 180 mg for preventing and controlling cat allergy symptoms [completed]. Improvements in simulated real-world relevant 6 performance for patients with seasonal allergic rhinitis: impact of desloratadine. Schering Plough, Double-blind, randomized, placebo-controlled, parallel-group, 6 multicenter/multinational, efficacy and safety study of desloratadine 5 mg in the treatment of subjects with allergic rhinitis who meet the criteria for intermittent allergic rhinitis (IAR) [completed]. High-dose desloratadine 6 decreases wheal volume and improves cold provocation thresholds compared with standard-dose treatment in patients with acquired cold urticaria: a randomized, placebo- controlled, crossover study. Clinical pharmacology of the H1-receptor antagonists 6 cetirizine and loratadine in children. Torkildsen GL, Gomes P, Welch D, Gopalan G, Srinivasan S. Evaluation of desloratadine 4 on conjunctival allergen challenge-induced ocular symptoms. A multi-center, randomized, double-blind, placebo-controlled, parallel-A multi-center, 5 randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg once daily given for 2 weeks in subjects 18 yr of age and older with seasonal allergic rhinitis [completed]. A multi-center, randomized, double-blind, placebo-controlled, parallel-group study 5 evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg once daily given for 2 weeks in subjects 18 yr of age and older with seasonal allergic rhinitis [completed]. A multi-center, randomized, double blind, placebo controlled parallel group study of 5 the safety of levocetirizine dihydrochloride oral liquid formulation b. Antihistamines Page 64 of 72 Final Report Update 2 Drug Effectiveness Review Project Appendix E. Reporting of adverse events a Adverse events from head-to-head and active control trials in adults (Original Report) Author Withdrawals from Year Adverse events Total withdrawals AEs Head-to-head trials 29 Ciprandi 1997 No significant AEs reported Total: 0 0 L: loratadine 10 mg qd C: cetirizine 10 mg qd Total AEs: 16. L: loratadine 10 mg qd NR NR Considered treatment related F: fexofenadine 120 mg in F 8. A2: 4% chest pain, D: desloratadine 5 mg D: Headache 3%, pharyngitis A1: 2% lightheadedness) A1: azelastine nasal 4% D: 1% D: 1% (headache A2: azelastine nasal + P: headache 7% P: 1% and nausea) loratadine Somnolence: P: 1% (rash) P: placebo A1: 2%; A2: 1%; D: 1%; P: 1% More AEs (considered probably or possibly 56 Dockhorn 1987 treatment-related) in C C: 37% L: loratadine 10 mg L: 21% NR NR C: clemastine 2 mg P: 20% (p<0. Abbreviations: bid, twice daily; mg, milligrams; NSD, no significant difference; NR, not reported; qd, once daily; tid, 3 times daily. Adverse events from studies in adults (includes only studies from update 2003- a 2005) Adverse Type of AE event Cetirizine Fexofenadine Loratadine NEUROLOGICAL MAJOR 6. Abdominal MINOR fexofenadine cetirizine 0%, pain 75 75 2. MINOR Cough fexofenadine fexofenadine, 55 75 75 rupatadine 20 mg 5. Feet fexofenadine, cetirizine 0%, swelling 75 75 NSD NSD OR of hypospadias with loratadine 167 exposure: 1. Abbreviations: mg, milligrams; NR, not reported; NSD, no significant difference; OR, odds ratio QT, cardiac output; QTc, corrected QT interval for heart rate. There were no data on desloratadine identified in update 1.

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O r lactating Race included NCS Page 108 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a super levitra 80 mg line. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR InternalValidity Rep o rtingo f attritio n 80 mg super levitra sale, Lo s s to Au tho r generic 80mg super levitra, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR External Validity Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care Ratne r ye s no fair NR/NR/726 Clinic allysignific c antabnorm allabte st1we e k no ye s 2006a re sultsor physic alfind ingsof nasal base line run-in U S polypsor nasaltrac tm alform ations; e vid e nc e of oc ular he rpe ssim ple xor c atarac tsor historyof glauc om a; e vid e nc e of abronc hial,pulm onaryor RT Ior d iord e rsothe r than ARor asthm aw. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance Ratne r ALT ANAPharm a ye s 2006a U S NCS Page 111 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care Ratne r ye s no fair 419/NR/327 Nasalpathologyinc lud ing nasalpolyps7-10d ay no ye s 2006b within 60d aysof stud ye ntry;c linic ally base line run-in U S re le vantre spiratorytrac t m alform ations;re c e ntnasalbiopsy; nasaltraum a;nasalsurge ry;atrophic rhinitis;rhinitism e d ic am e ntosa;ac tive asthm are quiring tre atm e ntwith inhale d or syste m tic c ortic oste roid s; routine use of be taagonists;known hype rse nsitivityto c ortic oste roid s; historyof RT Ior d isord e r within 14 d aysof sc re e ning;tre atm e ntwith syste m ic c ortic oste roid swithin 2 m onthsof stud y;tre atm e ntwith >1% topic alste roid swithin 1m onth of stud y NCS Page 113 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance Ratne r ALT ANAPharm a ye s 2006b U S NCS Page 114 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care K aise r ye s no fair 428/NR/299 Signific antc onc om itantm e d ic al 5-21d ay no ye s 2007 c ond ition,inc lud ing unc ontrolle d base line run-in U S d ise ase of anybod ysyste m ;se ve re physic alnasalobstruc tion or injury; asthm a;rhinitism e d ic am e ntosa; bac te rialor viralinfe c tion within 2 we e ksof sud ye ntry;ac ute of c hronic sinusitis;glauc om a;c atarac ts;oc ular he rpe ssim ple x;c and id ainfe c tion of the nose ;psyc hiatric d isord e r;ad re nal insuffic ie nc y;use of syste m ic of inhale d c ortic oste roid within 8we e ks of stud ye ntry;use of inhale d NCS within 4we e ksof stud ye ntry;use of othe r m e d ic ationsthatc ould affe c tAR or the e ffe c tive ne ssof the stud yd rug NCS Page 116 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance K aise r GlaxoSm ithK line ye s 2007 R&D U S NCS Page 117 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care Martin ye s ye s;1/642 fair NR/NR/642 Se ve re physic alobstruc tion of the 5-21d ay no ye s 2007 nose ;re c e ntnasalse ptalsurge ryor base line run-in U S pe rforation;asthm a;rhinitis m e d ic am e ntosa;uppe r RT I;c hronic use of m e d ic ationsthatwould affe c t alle rgic rhinitisor asse ssm e ntsof e ffic ac yof stud ym e d ic ation;c urre nt tobac c o use ;use of subc utane ous om alizum abwithin 5m onthsof stud y; c ortic oste roid s;antihistam ine s; d e c onge stants;intranasal antic holine rgic s;oralantile ukotrie ne s within 3d aysof stud y;intranasalor oc ular c rom olyn within 14d aysof stud y Fokke ns ye s no fair 425/NR/285 Se ve re physic alnasalinjuryor 5-21d ay no ye s 2007 obstruc tion;asthm a;rhinitis base line run-in Europe m e d ic am e ntosa;or anyothe r c hronic m e d ic alc ond ition thatc ould inte rfe re with the c ourse of the stud y;use of INS within 4we e ksof stud y;othe r c ortic oste roid within 8we e ks;any m e d ic ation thatc ould affe c tSAR sym ptom sor e ffe c tive ne ssof stud y m e d ic ation NCS Page 119 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance Martin GlaxoSm ithK line ye s 2007 U S Fokke ns GlaxoSm ithK line ye s 2007 Europe NCS Page 120 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s Ko b a ya shi R a n do m ized, Children a ged 5-13 b eclo m etha so n e Deco n gesta n ts24ho urs R escue m edica tio n : 1989 do ub le-b lin d, yea rs,with sea so n a l dipro pio n a te a queo us b efo re study chlo rhen ira m in e m a lea te 4m g pla ceb o -co n tro lled,a llergic rhin itis n a sa lspra y,42m cg pa ra llel Exclusio n :U se o f twice da ilyvspla ceb o Multicen ter system ic Studydura tio n :3weeks co rtico stero ids, b egin n in g hypo sen sitiza tio n trea tm en t,un derlyin g n a sa lpa tho lo gy,histo ry o fa dverse rea ctio n sto in ha led o rsystem a tic co rtico stero ids, co n curren tvira lin fectio n Strem 1978 R a n do m ized, Children a ged 6-15 flun iso lide n a sa lspra y, NR /NR NR do ub le-b lin d, yea rswith sea so n a l 50m cg three tim esda ily pla ceb o -co n tro lled a llergic rhin itis vspla ceb o Studydura tio n :4weeks NCS Page 121 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed Ko b a ya shi Eva lua ted a tclin ic o n studyda ys4, Mea n a ge:8. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s G a le 1980 R a n do m ized, Children a ged 5-14 flun iso lide 50m cg fo ur NR /NR NR do ub le-b lin d, yea rswith sea so n a l tim esda ilyvspla ceb o pla ceb o -co n tro lled,a llergic rhin itis Studydura tio n :6weeks pa ra llel Sin gle-cen ter Mun k,1994 R a n do m ized, Children a ged 12-17 In tra n a sa lflutica so n e NR /NR chlo rphen ira m in e m a lea te do ub le-b lin d, yea rswith sea so n a l pro pio n a te 200m cg pla ceb o -co n tro lled,a llergic rhin itis,n a ive to o n ce da ilyvs100m cg pa ra llel in tra n a sa lflutica so n e twice da ilyvspla ceb o Multi-cen ter pro pio n a te,a n d/o rfa iled Studydura tio n :2weeks thera pywith o ther m edica tio n s NCS Page 124 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed G a le 1980 P a tien tda ilydia ry Mea n a ge:9. Placebo-con trolledtrialsin children withSAR Author Year Totalwithdrawals; Coun try Methodofadverse Adverseeffects withdrawalsdueto TrialName Outcomes effectsassessmen t reported adverseeven ts G a le 1980 P ercen ta ge o fpa tien tsrepo rted to ta lo r P a tien tself-repo rt Num b ero fa dverse even ts NR ;0 sub sta n tia lco n tro lo fha yfeversym pto m s: repo rted: F:64% vspla ceb o :33%;P <0. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s Bo n er1995 Do ub le-b lin d, Children with sea so n a l flutica so n e pro pio n a te NR /NR NR pla ceb o -co n tro lled,a llergic rhin itisfo ra t a queo usn a sa lspra y pa ra llel lea sto n e sea so n 100m cg vs200m cg vs m ulti-cen ter Exclusio n :peren n ia l pla ceb o a rthritis,im m un o thera py Studydura tio n :4weeks trea tm en t,use o f in tra n a sa l,in ha led system ic co rtico stero ids,in ha led, in tra n a sa lso dium cro m o glyca te o r n eo cro m ilso dium within o n e m o n th b efo re study Schen kel1997 R a n do m ized, Children a ged 6-11 tria m cin o lo n e a ceto n ide NR /NR NR do ub le-b lin d, yea rswith sprin g gra ss a queo usn a sa lin ha ler, pla ceb o -co n tro lled sea so n a la llergic rhin itis110m cg da ilyvs Multicen ter 220m cg da ilyvs pla ceb o Studydura tio n :2weeks NCS Page 127 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed Bo n er1995 P hysica lexa m in a tio n , Mea n a ge:8. Placebo-con trolledtrialsin children withSAR Author Year Totalwithdrawals; Coun try Methodofadverse Adverseeffects withdrawalsdueto TrialName Outcomes effectsassessmen t reported adverseeven ts Bo n er1995 Media n percen ta ge o fsym pto m s-free da ys:p- P a tien tself-repo rt No. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s Ba n o v,1996 R a n do m ized, Children a ged 6-11 tria m cin o lo n e a ceto n ide NR /NR NR do ub le-b lin d, yea rs,with sea so n a l a ero so ln a sa lin ha ler, pla ceb o -co n tro lled,a llergic rhin itis 220m cg da ily,vs pa ra llel Exclusio n :An yclin ica lly pla ceb o Multicen ter releva n tdevia tio n fro m Studydura tio n :2weeks m edica lla b tests, histo ryo f hypersen sitivityto co rtico stero ids, trea tm en twith n a sa l, in ha led o rsystem ic co rtico stero idswithin 42 da yso fstudy G a la n t,1994 R a n do m ized, Children a ged 4-11 in tra n a sa lflutica so n e NR /NR NR do ub le-b lin d, yea rs,with histo ry pro pio n a te,100m cg o r pla ceb o -co n tro lled,o fsea so n a la llergic 200m cg,o n ce da ilyvs pa ra llel rhin itis,severe pla ceb o Multicen ter sym pto m s,a n d Studydura tio n :4weeks po sitive skin test rea ctio n to a lo ca l a utum n a llergin NCS Page 130 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed Ba n o v,1996 P a tien tdia rysym pto m sco res Mea n a ge:9yea rsNR NR /NR /116 1/0/115 Ma le:63. Placebo-con trolledtrialsin children withSAR Author Year Totalwithdrawals; Coun try Methodofadverse Adverseeffects withdrawalsdueto TrialName Outcomes effectsassessmen t reported adverseeven ts Ba n o v,1996 Sym pto m sco resa t1a n d 2weeks: P a tien tself-repo rt Adverse even tsrepo rted: 1;0 Na sa lstuffin ess: TAA:31 W eek 1:TAA:-0. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s G ro ssm a n 1993 R a n do m ized, Children a ged 4-11 flutica so n e pro pio n a te NR /NR chlo rphen ira m in e m a lea te do ub le-b lin d, yea rs,with sea so n a l a queo usn a sa lspra y, pla ceb o -co n tro lled,a llergic rhin itis, 100m cg vs200m cg pa ra llel po sitive skin test o n ce da ilyvspla ceb o Multicen ter rea ctio n to la te- Studydura tio n :2weeks sum m er,a utum n a llergin ,m o dera te to severe n a sa l sym pto m s NCS Page 133 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed G ro ssm a n 1993 Na sa la n d o cula rsym pto m sa ssessed Mea n a ge:8. Placebo-con trolledtrialsin children withSAR Author Year Totalwithdrawals; Coun try Methodofadverse Adverseeffects withdrawalsdueto TrialName Outcomes effectsassessmen t reported adverseeven ts G ro ssm a n 1993 Clin icia n -ra ted m ea n sym pto m sco resa t22 P a tien tself-repo rt Adverse even tsrepo rted: NR ;NR da ys: An yeven t:F100:12% vs R hin o rrhea :F100:43vsF200:46vspla ceb o : F200:5% vspla ceb o :8% 48 Na sa lb urn in g:F100:4% vs Sn eezin g:F100:22vsF200:22vspla ceb o :21 F200:1% vspla ceb o :0% Na sa litchin g:F100:33vsF200:39vspla ceb o : Epista xis:F100:4% vs 37 F200:2% vspla ceb o :4% Ocula rsym pto m s:F100:22vsF200:29vs Hea da che:F100:0% vs pla ceb o :26 F200:1% vspla ceb o :2% NCS Page 135 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable4. Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR InternalValidity Rep orting of attrition, Au thor, Allocation Elig ibility Ou tcome Care crossov ers, Losstofollow - Year, Randomization concealment Grou p ssimilarcriteria assessors p rov ider Patient adherence,and u p :differential/ Cou ntry adeq u ate? Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR External Validity Nu mber Au thor, screened/ Year, Intention-to-treat Post-randomization elig ible/ Cou ntry (ITT)analysis exclu sions Qu alityrating enrolled Exclu sioncriteria Ba n ov n o -1pa tien tra n NR fa ir NR/ An yclin ica llyreleva n tdevia tion from n orm a l m edica l or 1996 outofm edica tion NR/ la bora toryva lues,existin g n a sa l ca n didia sis ora cute US(5sites) priorto en dof 116 sin usitis,h istoryofh ypersen sitivityto corticosteroids, trea tm en tperiod,2 trea tm en tw ith n a sa l,in h a ledorsystem ic pa tien ts didn ot corticosteroids w ith in 42da ys ofstudyin itia tion , h a veusa bleda ta trea tm en tw ith n a sa l crom olyn sodium w ith in 14da ys of studyin itia tion ,useofa n yin vestig a tion a l drug w ith in 90 da ys,useofa n ym edica tion th a tcouldeffect sig n s/sym ptom s ofa llerg icrh in itis,im m un oth era py w ith in 30da ys ofen rollm en t,previous pa rticipa tion in T AAa erosol n a sa l in h a lerstudy Bon er yes NR fa ir NR/ Peren n ia l rh in itis,im m un oth era py(tim efra m en ot 1995 NR/ specified),useofin tra n a sa l,in h a ledorsystem ic Europe(18sites, 143 corticosteroids w ith in 1m o ofstudy,useofin tra n a sa l or specificcoun tries in h a ledsodium crom og lyca teorn edocrom il sodium n otlisted) w ith in 1m o ofstudy,useofa stem iz olew ith in 6w k s of study Ga la n t n o -7w ith dra w a ls NR poor NR/ Exposureto in tra n a sa l,in h a ledorsystem ic 1994 (4un rela tedAEs,2 NR/ corticosteroids w ith in 1m o ofen rollm en t,orw ith in 3 US(10sites) protocol viola tion s, 249 m os ofen rollm en tforpa tien ts requirin g th eequiva len t sa m eda ta 1con sen t ofpredn ison e20m g /da y>2m os),in tra n a sa l crom olyn reportedin w ith dra w a l) sodium th era pyw ith in 2w k s ofen rollm en t,n a sa l An on ym ous, sym ptom scoreofa tlea st200pts (selfreported)fora t 1994a n d lea st4of7da ys precedin g en tryin to study Grossm a n ,1993 NCS Page 137 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable4. Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR Class Au thor, naïv e Controlg rou p Year, p atients standardof Cou ntry Ru n-in/w ashou t only care Fu nding Relev ance Ba n ov NR NR yes Rh on e-Poulem c yes 1996 Rorer US(5sites) Bon er run -in n otreported/2w k NR yes NR yes 1995 w a sh out Europe(18sites, specificcoun tries n otlisted) Ga la n t 4-14da yrun -in /w a sh outn ot NR NR Gla xo yes 1994 reported US(10sites) sa m eda ta reportedin An on ym ous, 1994a n d Grossm a n ,1993 NCS Page 138 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable4. Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR InternalValidity Rep orting of attrition, Au thor, Allocation Elig ibility Ou tcome Care crossov ers, Losstofollow - Year, Randomization concealment Grou p ssimilarcriteria assessors p rov ider Patient adherence,and u p :differential/ Cou ntry adeq u ate? Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR External Validity Nu mber Au thor, screened/ Year, Intention-to-treat Post-randomization elig ible/ Cou ntry (ITT)analysis exclu sions Qu alityrating enrolled Exclu sioncriteria Ga le yes NR fa ir NR/ Allerg en in jection s fora tlea st2yrs,un derlyin g 1980 NR/ sym ptom s ofn a sa l pa th olog y,useofm edica tion s Austra lia 35 w h ich couldpoten tia llym a sk sym ptom s ofa llerg ic rh in itis ora ffecta dren ocorticol fun ction Koba ya sh i n o w ith dra w a ls NR fa ir NR/ Useofsystem iccorticosteroids,beg in n in g 1989 NR/ h yposen sitiz a tion trea tm en t,un derlyin g n a sa l US(2sites) 101 pa th olog y,h istoryofa dverserea ction s to in h a ledor system iccorticosteroids,con curren tvira l orba cteria l in fection Mun k yes forsa fety, NR fa ir NR/ Useofin tra n a sa l crom olyn sodium 2w k s precedin g 1994 un clea rforeffica cy NR/ study,useofin tra n a sa l,in h a ledorsystem icsteroids for US(12sites) 243 1m o priorto en rollm en t NCS Page 140 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable4. Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR Class Au thor, naïv e Controlg rou p Year, p atients standardof Cou ntry Ru n-in/w ashou t only care Fu nding Relev ance Ga le 2w k run -in */w a sh outn ot NR yes NR yes 1980 reported Austra lia (*textin dica tes "2-w eek pretrea tm en tba selin e period... Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR InternalValidity Rep orting of attrition, Au thor, Allocation Elig ibility Ou tcome Care crossov ers, Losstofollow - Year, Randomization concealment Grou p ssimilarcriteria assessors p rov ider Patient adherence,and u p :differential/ Cou ntry adeq u ate? Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR External Validity Nu mber Au thor, screened/ Year, Intention-to-treat Post-randomization elig ible/ Cou ntry (ITT)analysis exclu sions Qu alityrating enrolled Exclu sioncriteria Sch en k el yes forsa fety, NR fa ir NR/ An ym edica l con dition s th a tm ig h tin terferew ith th e 1997 un clea rforeffica cy NR/ studysig n ifica n tly,clin ica llyreleva n tdevia tion s from US(n um berof 223 n orm a l m edica l orla bora torypa ra m eters,n a sa l sites un clea r) ca n didia sis,a cuteorch ron icsin usitis,sig n ifica n tn a sa l polyposis oroth erg ross n a sa l deform itysufficien tto im pa irin g n a sa l brea th in g ,useofsystem ic corticosteroids w ith in 42da ys,useofn a sa l crom olyn sodium w ith in 28da ys,useofn a sa l orin h a led corticosteroids w ith in 30da ys,a stem iz olew ith in 60 da ys,im m un oth era pyw ith in 6m os,useof in vestig a tion a l drug w ith in 90da ys Strem yes NR fa ir NR/ NR 1978 NR/ US 48 NCS Page 143 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable4. Qu alityassessment ofp lacebo-controlledtrialsinchildrenw ithSAR Class Au thor, naïv e Controlg rou p Year, p atients standardof Cou ntry Ru n-in/w ashou t only care Fu nding Relev ance Sch en k el 6da yrun -in ,n o rh in itis relief n o yes Rh on e-Poulem c yes 1997 m edica tion s;w a sh outn ot Rorer US(n um berof reported sites un clea r) Strem 2w k run -in /w a sh outn ot NR yes NR yes 1978 reported US NCS Page 144 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable5. Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry TrialName Stu dy design, Interv entions(totaldaily (Qu ality Score) Setting Eligibility criteria dose) Ru n-in/w ashou tp eriod Fairqualitystudies! Head-to-headtrialsinp atientsw ithPAR Au thor Year Age Nu mber Cou ntry Allow edother Methodof ou tcome Gender (% screened/ Nu mber TrialName medications/ assessmentandtimingof female) Other p op u lation eligible/ w ithdraw n/ (Qu ality Score) interv entions assessment Ethnicity characteristics enrolled losttofu /analy zed Fairqualitystudies! B NCS Page 146 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable5. Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry TrialName Methodof adv erseeffects (Qu ality Score) Resu lts assessment Adv erseEffectsRep orted Fairqualitystudies! Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry Totalw ithdraw als; TrialName w ithdraw alsdu etoadv erse (Qu ality Score) ev ents Comments Fairqualitystudies! Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry Totalw ithdraw als; TrialName w ithdraw alsdu etoadv erse (Qu ality Score) ev ents Comments N - 910; # ,# $9# B T 5. Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry Totalw ithdraw als; TrialName w ithdraw alsdu etoadv erse (Qu ality Score) ev ents Comments >10; # ,# $9# B LCP ())X d "- - = - 2E0%"4 h - 8# H % 2E0%"4 NCS Page 184 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable5. Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry TrialName Stu dy design, Interv entions(totaldaily (Qu ality Score) Setting Eligibility criteria dose) Ru n-in/w ashou tp eriod Q$&&0? Head-to-headtrialsinp atientsw ithPAR Au thor Year Age Nu mber Cou ntry Allow edother Methodof ou tcome Gender (% screened/ Nu mber TrialName medications/ assessmentandtimingof female) Other p op u lation eligible/ w ithdraw n/ (Qu ality Score) interv entions assessment Ethnicity characteristics enrolled losttofu /analy zed Q$&&0? Head-to-headtrialsinp atientsw ithPAR Au thor Year Cou ntry TrialName Methodof adv erseeffects (Qu ality Score) Resu lts assessment Adv erseEffectsRep orted Q$&&0?

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Frequent hepatitis B virus rebound among HIV-hepatitis B virus-coinfected patients following antiretroviral therapy interruption buy super levitra 80 mg free shipping. Mutation takes no vacation: can structured treatment interrup- tions increase the risk of drug-resistant HIV-1? Short-cycle structured intermittent treatment of chronic HIV infection with highly active antiretroviral therapy: effects on virologic discount super levitra 80 mg fast delivery, immunologic order super levitra 80 mg fast delivery, and toxicity parameters. Long-cycle structured intermittent versus continuous HAART for the treatment of chronic infection with HIV: effects on drug toxicity and on immunologic and virologic parameters. A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection. Re-initiation of ART in the CD4-guided ART interruption group in the SMART study lowers risk of opportunistic disease or death. CD4+ count-guided interruption of antiretroviral treatment. Biphasic decline of CD4 cell count during scheduled treatment interruptions. Long-term follow-up of asymptomatic HIV-infected patients who discon- tinued antiretroviral therapy. Strategies to decrease viral load rebound, and prevent loss of CD4 and onset of resistance during structured treatment interruptions. Is the interruption of antiretroviral treatment during pregnancy an additional major risk factor for mother-to-child transmission of HIV type 1? Effect of mycophenolate mofetil on immune response and plasma and lym- phatic tissue viral load during and after interruption of HAART for patients with chronic HIV infection: a ran- domized pilot study. The virological and immunological consequences of structured treatment inter- ruptions in chronic HIV-1 infection. Dynamics of viral load rebound and immunological changes after stopping effec- tive antiretroviral therapy. AIDS 1999, 13: F79-86 Ghosn J, Wirden M, Ktorza N, et al. No benefit of a structured treatment interruption based on genotypic resist- ance in heavily pretreated HIV-infected patients. Continuous antiretroviral therapy decreases bone mineral density. Long-term persistence of HIV with drug resistance after CD4 cell count-guided structured treatment interruption. Therapeutic vaccination of HIV-1-infected patients on HAART with a recom- binant HIV-1 nef-expressing MVA: safety, immunogenicity and influence on viral load during treatment inter- ruption. Antivir Ther 2005; 10:285-300 Harrer T, Jaeger H, Helm M, et al. Immunogenicity and efficacy of an MVA-nef vaccine in a randomized con- trolled phase-II-study in HIV-1-infected patients with CD4 counts >250/µl followed by structured treatment inter- ruption. Abstract 716, 15th CROI 2008, Boston Harrigan PR, Whaley M, Montaner JS. Rate of HIV-1 RNA rebound upon stopping antiretroviral therapy. Strong HIV-specific CD4+ T cell responses in a cohort of chronically infected patients are associated with interruptions in anti-HIV chemotherapy. Metabolic and anthropometric consequences of interruption of HAART. Pre-HAART HIV burden approximates post-HAART viral levels following inter- ruption of therapy in patients with sustained viral suppression. A pilot study evaluating time to CD4 T-cell count <350 cells/mm(3) after treatment interruption following antiretroviral therapy +/- interleukin 2: results of ACTG A5102. Results of Antiretroviral Treatment Interruption and Intensification in Advanced Multi-Drug Resistant HIV Infection from the OPTIMA Trial. HIV type 1 quasi species that rebound after discontinuation of HAART are similar to the viral quasi species present before initiation of therapy. Shift in HIV resistance genotype after treatment interruption and short-term antiviral effect following a new salvage regimen. Evidence that intermittent structured treatment interruption, but not immunization with ALVAC-HIV vCP1452, promotes host control of HIV replication: the results of AIDS Clinical Trials Group 5068. Benefit of treatment interruption in HIV-infected patients with mul- tiple therapeutic failures: a randomized controlled trial (ANRS 097). A randomized, partially blinded phase 2 trial of antiretroviral therapy, HIV- specific immunizations, and interleukin-2 cycles to promote efficient control of viral replication (ACTG A5024). A 6-month interruption of antiretroviral therapy improves adipose tissue func- tion in HIV-infected patients: the ANRS EP29 Lipostop Study. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. Changes in lipids and lipoprotein particle concentrations after interrup- tion of antiretroviral therapy. Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: final results of the CPCRA 064 study. Structured treatment interruption in patients with multidrug-resistant HIV. Control of HIV despite the discontinuation of antiretroviral therapy. Control of SIV rebound through structured treatment interruptions during early infection. CD4 cell-guided scheduled treatment interruptions in HIV-infected patients with sustained immunologic response to HAART. Maggiolo F, Ripamonti D, Gregis G, Quinzan G, et al. Effect of prolonged discontinuation of successful anti- retroviral therapy on CD4 T cells: a controlled, prospective trial. The effects of intermittent, CD4-guided antiretroviral therapy on body composition and metabolic parameters. Martinez-Picado J, Morales-Lopetegi K, Wrin T, et al. Selection of drug-resistant HIV-1 mutants in response to repeated structured treatment interruptions. When to stop ART 245 Miller V, Sabin C, Hertogs K, et al. Virological and immunological effects of treatment interruptions in HIV-1 infected patients with treatment failure. AIDS 2000, 14: 2857-67 Mocroft A, Wyatt C, Szczech L, et al. Interruption of antiretroviral therapy is associated with increased plasma cystatin C. Thymic volume predicts CD4 T-cell decline in HIV-infected adults under prolonged treatment interruption. CD4 cell-monitored treatment interruption in patients with a CD4 cell count > 500 x 106 cells/l. Effect of treatment interruption monitored by CD4 cell count on mito- chondrial DNA content in HIV-infected patients: a prospective study. Effect of prolonged interruption of ART on mitochondrial toxic- ity. HIV-1 rebound during interruption of HAART has no deleterious effect on reinitiated treatment. Impact of antiretroviral therapy interruption on plasma bio- markers of cardiovascular risk and lipids: 144-week final data from the STOPAR study. HIV-1-specific immune responses in subjects who temporarily contain virus replication after discontinuation of HAART. Stimulation of HIV-specific cellular immunity by structured treatment interruption fails to enhance viral control in chronic HIV infection. Determinants of virologic and immunologic outcomes in chroni- cally HIV-infected subjects undergoing repeated treatment interruptions: the ISS-PART study. A high HIV DNA level in PBMCs at antiretroviral treatment interruption predicts a shorter time to treatment resumption, independently of the CD4 nadir. Antiretroviral therapy interruption guided by CD4 cell counts and plasma HIV- 1 RNA levels in chronically HIV-1-infected patients. Role of structured treatment interruption before a five-drug salvage antiretro- viral regimen: the Retrogene Study.

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Numerically similar rates of dizziness and hyperkalemia for combination therapy and monotherapy with enalapril; numerically slightly fewer events for losartan monotherapy order 80 mg super levitra mastercard. No differential effects between groups for changes in creatinine clearance cheap super levitra 80 mg on-line. No significant change in creatinine clearance was seen between groups buy cheap super levitra 80 mg line. The incidence of hyperkalemia was statistically less likely in the candesartan group compared with the combination arm. In the latter study blood pressure control was not equivalent between groups. One trial noted increase in glomerular filtration rate for combination therapy greater than for monotherapy, but creatinine clearance changes were not different between treatment groups. One trial noted no hyperkalemic events in either group. No difference was seen in changes in creatinine clearance between groups. Numerically more participants experienced dizziness in combination arm compared with either monotherapy arm; numerically more participants experienced hyperkalemia in combination arm compared with irbesartan arm. Combination of ACE-I and AIIRA compared with monotherapy with either ACE-I or AIIRA • Combination therapy of an ACE-I and an AIIRA compared with an ACE-I alone (4 trials) o Losartan and lisinopril compared with lisinopril alone (1 trial; fair quality): No differential effects found between groups for proteinuria reduction. Markers for change in renal function were inconsistent; glomerular filtration rate was lower for those on combination therapy but there was no difference between groups in creatinine clearance. Creatinine clearance was stable in both groups, both trials. Harms were not delineated by treatment groups or were only delineated for an AIIRA. One dizziness/hypotension event occurred with ramipril monotherapy compared with zero with combination therapy; no hyperkalemia events occurred in either group. Harms were reportedly only for the combination therapy group. Changes in creatinine were numerically similar between groups. A numerical higher percent rate of hyperkalemia was seen in those on maximum dose combination therapy compared with lower dose combination therapy or monotherapy. Detailed assessment Monotherapy: Inter-class comparison of effectiveness, efficacy, and harms between AIIRA and ACE-I Proteinuric chronic kidney disease 83-95 We identified 17 trials that compared monotherapy with an angiotensin II receptor antagonist (AIIRA) to monotherapy with an angiotensin converting enzyme inhibitor (ACE-I). Trials rated as poor will not be discussed in detail, but additional information can be found in Evidence Table 10. Those trials that were rated poorly were heterogeneous in their flaws. Very high withdrawal rate was evident in 2 studies, 1 for a 99 98 withdrawal rate of 22%, and 1 with a withdrawal rate of 47%. The very high withdrawal rate in the latter, coupled with an overall small sample size (N=19, nine of which were withdrawn), 99 was the primary reason for its poor rating. In the former study, the poor rating stemmed from the lack of statistical analysis of any outcomes of interest and the lack of reporting of any adverse events in addition to the noted small sample size. A third study was rated as poor because the treatment arm groups were different at baseline in terms of both blood pressure and 97 proteinuria, and no adverse events were reported. The fourth trial that was rated poor quality 96 92 was the COOPERATE study, as was one of its sub-studies. This trial has been a point of much consternation and debate in the medical community; 1 correspondence raised concerns about statistical methods as well as better than expected level of similarity among treatment 100 groups at baseline. Recently, a formal retraction of the COOPERATE study was published by 101 the The Lancet. Per this retraction statement, a formal investigation of this trial conducted by the original university hospital revealed that this trial was not double blind, that the presence of a statistician during the data analysis was unclear, and that the patient specific data (on a sample chart review) could not be verified to be authentic. For this reason, the COOPERATE trial and its ambulatory blood pressure sub-study were rated as poor and were not included in this report. Valsartan was compared with lisinopril in 1 trial, to benazepril in 2 trials, and to 85, 95 87 ramipril in 2 trials. Telmisartan was compared with enalapril in 1 trial and irbesartan was 86 compared with fosinopril in 1 trial. We did not find any trials involving comparisons of either eprosartan or olmesartan to an ACE-I, or any trials involving comparisons of captopril, cilazapril, moexipril, or quinapril to an AIIRA. One trial reported a renal survival outcome, including time to end stage renal disease or 88 doubling of serum creatinine. All but 2 trials compared the change in level or percent of proteinuria experienced; the 2 trials that did not report changes in proteinuria did report changes 83, 94 in renal function and were included for the benefit of those analyses. Of note, while blood pressure control was not a primary outcome of interest in this analysis, blood pressure control is DRIs, AIIRAs, and ACE-Is Page 49 of 144 Final Report Drug Effectiveness Review Project known to impact proteinuria (with higher blood pressure leading to more proteinuria compared 106 with lower blood pressure). For that reason, if blood pressure control was reported as statistically not equivalent between groups, effects on proteinuria within that trial will not be considered to be independent of blood pressure control. No quality-of-life results were examined by any of these trials. Of the 12 studies rated good or fair, only 1 showed that ACE-I was superior to AIIRA in 89 its ability to reduce proteinuria independent of blood pressure control. Four studies did not report a statistical analysis comparing changes 86, 90, 91, 102 in proteinuria between groups, but 2 of those did provide overlapping confidence 86, 90 intervals, suggesting no statistically significant difference. The remaining 6 studies did provide statistical analysis comparing change in proteinuria between ACE-I and AIIRA groups and noted no statistically significant difference. In total, these data would suggest no additional benefit of ACE-I compared with AIIRA as monotherapy for the reduction of proteinuria in patients with proteinuric non-diabetic chronic kidney disease. Losartan Losartan compared with lisinopril One trial compared the use of monotherapy with losartan compared with lisinopril for reduction 89 of proteinuria (N=10). This prospective open-label crossover study included 10 participants and provided 78 weeks of follow-up. We rated this study as fair based on small sample size and exclusion of 10% (1 of 10) of participants from final analysis. Participants had a range of different types of chronic kidney disease, including focal segmental glomerulosclerosis, membranous nephropathy, IgA nephropathy, and some with non-conclusive biopsies. All included participants were proteinuric (greater than 2 grams per day required with a median value of 4. Escalating doses of each drug were used to determine the optimal antiproteinuric dose for each individual. Percent change in proteinuria based on use of that optimal antiproteinuric dose was compared. Percent change in proteinuria was noted to be –75% (95% CI, –85 to –43) for lisinopril and –46% (95% CI, –60 to –24) for losartan. The notably broad confidence intervals likely stem from the very small sample size. This study did note a statistically greater decline in proteinuria for those on lisinopril compared with losartan (P<0. No statistically significant differences in changes in creatinine clearance were noted between groups. No outcomes involving mortality, hospitalization, cardiovascular events, or end stage renal disease were reported. No differences in blood pressure control between monotherapy groups were reported. The rates of adverse events were similar for each therapy, with 10% (1 of 9) experiencing a potassium level of greater than 5. Similarly, 10% in each group (1 of 9) experienced dizziness while on therapy. No withdrawals due to adverse events were reported; the only withdrawal was related to non-adherence (specifically, inability to keep scheduled study appointments). Losartan compared with enalapril Losartan was compared with enalapril in 3 trials (N=145), all of which were conducted in Poland 93, 102, 103 by the same group. Losartan dose was 25 mg per day and enalapril dose was 10 mg per day in each trial. The trials ranged in duration from 3 DRIs, AIIRAs, and ACE-Is Page 50 of 144 Final Report Drug Effectiveness Review Project 103 102 93 months to 12 months with 1 intermediate range of 9 months. All 3 trials had a homogenous mix of participants including participants with mesangial glomerulonephritis, mesangiocapillary nephritis, and membranous nephropathy; 1 of these 3 trials also enrolled 103 participants with focal segmental glomerulosclerosis. Two trials specifically excluded 102, 103 participants with IgA nephropathy.

Followed by 8-week washout period buy super levitra 80mg with visa, then (50% to simvastatin and switched to alternate drug in corresponding 50% to atorvastatin) Mean baseline LDL-c: dose for 3 months effective 80mg super levitra. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Praagh et al super levitra 80mg for sale, 2004 % LDL-c reduced from baseline after 3 months: No serious adverse events reported nor discussed in detail. Atorva) % Trig level decreased from baseline after 3 months: Simva 20 mg/d: -15. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Praagh et al, 2004 Industry role, if any, not R, OL, crossover, ITT not specified stated 49 patients randomized (50% to simvastatin and 50% to atorvastatin) 10 months (3 mos. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Recto et al. Followed by 1-week washout period, then switched to alternate drug in corresponding dose for 6 weeks. Statins Page 48 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Recto et al. R, OL, MC, crossover, LDL-c reduction from baseline at 6 weeks: not ITT aorta 10 mg: 36. Atorva 10 mg reduction 22% Atorva 20 mg reduction 25% Simva 20 mg reduction 21. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Recto et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Van Dam et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Van Dam et al. Atorva 20 mg: 14+ 14% 378 patients randomized Simva 20 mg: 3. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Van Dam et al. One 378 patients randomized author employed by (n= 185 atorvastatin, 193 Parke-Davis. VGHKS 91-41 and 8 months Veterans General Hospital, Tsin-Hua, Yang-Ming Research Program, Grant no. VTY92-G3-03 Statins Page 53 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Atorvastatin vs. Randomization to: R (4:1:1:1:1), OL, MC, elevated cholesterol, with or without Only 3,262 patients completed study. Patients with active liver Atorva 10 mg qd not ITT CHD. Lova 20 mg qd 3,916 patients Mean baseline LDL-c Prava 20 mg qd randomized 176-179 mg/dl or Simva 10 mg qd 54 weeks for 54 weeks. Doses were doubled until LDL-c goal or maximum doses were reached. Statins Page 54 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Andrews et al. Serious treatment related ADEs HDL increase from baseline at 54 weeks (NS): occurred in 2 aorta patients (elevated CK , muscle cramps and rash) and 1 aorta 5% patient in simva (gastroenteritis). No details on dose for withdrawals or serious fulva 6% ADEs. Trigs reduction from baseline at 54 weeks: aorta 19% (p<0. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Andrews et al. One Pfizer not ITT employee acknowledged for 3,916 patients analysis and randomized interpretation of data. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Brown et al. Optional 8-week dietary phase, 4-week R, OL, MC, not ITT documented CHD and LDL-c 130- Pregnancy or breast-feeding, secondary hyperlipoproteinemia, dietary run-in, then randomization to: aorta 250 mg/dl. No intervals until LDL-c goal or maximum 81 lova, 77 simva) numbers provided for exclusion at each step. If goal not reached with statin, colestipol added (aorta 8%, fulva 76%, lova 15%, simva 33%). Calza L, et al 2008 Stable PI-based antiretroviral Drug or alcohol abuse; genetic hyperlipidemia, diabetes, rosuvastatin (10 mg once daily), therapy at least 12 months, and hypothyroidism, Cushings, acute or chronic myopathy, kidney pravastatin (20 mg once daily) or RCT (1:1:1), OL, SC, presenting hypercholesterolemia disease, acute hepatitis, liver cirrhosis, treatment with corticosteroids, atorvastatin (10 mg once daily) not ITT (total cholesterol level >250 mg/dL) androgens, estrogens, growth hormones, thiazide diuretics, beta- of at least 3-month duration and blockers, thyroid preparations or other hypolipidemic drugs 94 patients randomized unresponsive to a hypolipidemic (n=28 rosuva, 34 parva, diet and physical exercise 32 aorta) 85 analyzed 1 year LDL-C at baseline mg/dL Rosuva 177 parva 173 aorta 180 Statins Page 57 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Brown et al. ADEs similar across treatment groups at 54 weeks, except fluvastatin where R, OL, MC, not ITT LDL reduction from baseline at 54 weeks: patients also receiving colestipol experienced a 2-fold increase in GI ADEs. Two fulva (n= 80 aorta, 80 fulva, simva 40 mg: 37% patients had elevations in either ALT or AST >3x ULN. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Brown et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Gentile et al. Secondary causes of hyperlipidemia, type 1 DM, elevated randomization to: >160 mg/dl CK, BMI >32 kg/m, uncontrolled HTN, MI, CABG, PTCA or aorta 10 mg qd 412 patients randomized established CAD, sensitivity to statins, or taking drugs with the lova 20 mg qd 24 weeks Mean baseline LDL-c potential for interaction with statins. Hadjibabaie M, et al Men and women 18-70 years old Hepatic or renal dysfunction, uncontrolled hypothyroidism, type 1 DM, atorvastatin 10 mg, simvastatin 20 mg, 2006 with T2DM and a LDL-c 100 mg/dl pregnancy, current use of lipid lowering drugs, hormone replacement lovastatin 20 mg once daily for 12 weeks RCT (1:1:1), OL, SC, or more therapy, uncontrolled hypertension. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Gentile et al. Withdrawal for ADEs: 1 aorta, 1 lova and 1 parva R, OL, MC, not ITT LDL-c reduction from baseline: patient. No clinically important elevation in ALT, AST or CK observed in any aorta 37% (*p<0. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Gentile et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Hunninghake et al. Men or women 18-80 years at risk 344 patients randomized, efficacy analysis performed on 337 8-week optional dietary phase, 4-week 1998 for CHD and elevated cholesterol. Pregnancy or breast-feeding, secondary dietary run-in followed by randomization to R, OL, MC, not ITT hyperlipoproteinemia, uncontrolled endocrine disorders, hepatic or aorta 10 mg, fulva 20 mg, lova 20 mg or Mean baseline LDL-c renal impairment, MI, CABG, PTCA, unstable angina 1 month prior to simva 10 mg qd. Doses titrated at 12-week 344 patients Atorva 205 mg/dl screening, participation in another study, uncontrolled type 2 DM, type intervals until LDL-c goal achieved or randomized Fluva 201 mg/dl 1 DM, taking a drug with the potential for interaction with statins. No maximum dosage reached (aorta 80 mg, (n= 85 aorta, 82 fulva, Lova 206 mg/dl numbers provided for exclusion at each step. Colestipol added = aorta 2%, fulva 67%, lova 24%, simva 24%. Statins Page 63 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Hunninghake et al. Efficacy analysis for 337 patients (median dose/day). ADEs similar across treatment groups prior to addition of colestipol to statin 1998 LDL reduction from baseline at 54 weeks : therapy at 24 weeks. At 54 weeks there were more ADEs in the fulva and lova R, OL, MC, not ITT aorta 10 mg: 36% groups than in the aorta or simva groups primarily GI in nature. One randomized simva 20 mg: 33% lova-treated patient experienced an elevation in ALT >3x ULN. Other clinically (n= 85 aorta, 82 fulva, HDL increase at 54 weeks: insignificant elevations in ALT or AST occurred in all groups.

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Liver toxicity occurs usually early during ART (within 18 weeks of starting) and may progress to liver failure despite laboratory monitoring cheap super levitra 80mg fast delivery. Readministration must be discussed carefully and should generic super levitra 80mg line, whenever possible proven super levitra 80 mg, be avoided. In patients treated with efavirenz or rilpivirine, minor enzyme elevations are generally safe and usually resolve so that a treatment change may not be necessary (Gutierrez 2008, Kontorinis 2003, Cohen 2011, Molina 2011). Protease inhibitors and INSTIs Atazanavir (as well as indinavir) inhibit the hepatic enzyme UDP glucuronosyl-trans- ferase, inducing non-dangerous hyperbilirubinemia in up to 50% of patients (Torti 2009). UGT1A1*28 variant allele seems to be a predictor of severe hyperbilirubine- mia (Turatti 2012). Atazanavir was safe in end-stage liver disease patients, hepatitis coinfected patients and those with liver fibrosis (Guaraldi 2009, Pineda 2008). While darunavir and atazanavir were not associated with increased liver morbiditiy, other PIs such as tipranavir/r are associated with a higher risk of transaminase elevations (Hicks 2006). In all cases of unknown liver enzyme increase, hepatitis diagnostics (including HAV, HBV, HCV, HEV), syphilis testing (EBV and CMV) and abdominal ultrasound is recommended. In case of a more chronic enzyme elevation other metabolic diseases, such as Wilson disease, hemochromatosis, alpha-1-antitrypsin deficiency, 284 ART autoimmune hepatitis or (non-alcoholic) fatty liver disease must be excluded. In case of acute liver failure or increase in transaminases, more frequent testing is necessary. ART discontinuation may not be necessary, unless acute >5-fold increase of transam- inases. Ultimately a liver biopsy can reveal macro- and microvesicular steatosis and mitochondrial alterations in NRTI-induced steatosis and is therefore helpful to distinguish NRTI-induced hepatopathy from other causes. Moderate liver enzyme elevation has also been reported in several INSTI studies. Dolutegravir, elvitegravir and raltegravir can lead to mild to moderate increase in liver enzymes. Rates of elevated liver enzymes in patients with elvitegravir were comparable to those treated with efavirenz or boosted atazanavir (DeJesus 2012, Sax 2012). Dolutegravir-associated increase in liver enzymes was mostly seen during immune reconstitution and coinfection with viral hepatitis (Curtis, 2014). In any case, transaminase elevation due to INSTI leads only in a very rare number of cases to discontinuation. Renal problems Renal complications are mostly seen with tenofovir disoproxil fumarate (TDF) or less likely with atazanavir (see HIV and Renal Function). Rilpivirine, cobicistat, and dolute- gravir reduce the tubular secretion of creatinine by different mechanisms, inducing a decrease of estimated glomerular filtration rate. Calculated eGFR results might decrease after beginning a new treatment and will establish a plateau quickly (Sax 2012, Curtis 2014). Clinicians should carefully monitor renal function in order to identify possible alterations suggestive of a true renal functional impairment. Additional renal monitoring (urine dipstick, alpha-1- microglobulin, cystatin C-GFR or the albumin/creatinine ratio) should be used for renal safety monitoring or screening of tubular injury. Besides renal problems, rhabdomyolysis is a rare but dangerous event. Rhabdo- myolysis has been reported during abacavir HSR (Fontaine 2005), statin and boosted PI use as a consequence of CYP450 interactions and in rare cases after raltegravir exposure (Dori 2010). Immediate action should be taken if patients complain about muscle pain and/or otherwise unexplained elevated creatine kinase levels, to avoid more severe kidney injury. Tenofovir disoproxil fumarate (TDF) In ART-naïve patients tenofovir is associated with a greater decline in renal function and a higher risk of proximal tubular dysfunction: 4. A meta-analysis of 17 studies confirmed an association with a statistically significant loss of renal function with TDF, although the clinical magnitude of this effect was modest (Cooper 2010). Severe cases have been reported with acute renal failure, prox- imal tubulopathy with Fanconi’s syndrome and nephrogenic diabetes insipidus and rarely hypophosphatemic osteomalacia (Rollot 2003, Saumoy 2004). Renal toxicity occurs after some months, rarely at the beginning of therapy. Risk factors include high TDF exposure due to pre-existing renal impairment, low body weight (Nishijima 2012) or coadministration of nephrotoxic drugs (Nelson 2007). Boosted PIs can interact with the renal transport of organic anions, leading to proximal tubular intracellular accumulation of tenofovir (Izzedine 2004+2007, Rollot 2003). The combination of atazanavir/r plus TDF caused greater GFR decreases compared with EFV (Albini 2012). This was confirmed by another study showing that TDF with a boosted PI leads to a greater initial decline in eGFR than TDF plus Management of Side Effects 285 efavirenz; this decline may be worse with atazanavir/r compared to lopinavir/r (Young 2012). Extensive pretreatment with NRTIs might be a risk factor (Saumoy 2004). However, even in patients without any predisposing factors, nephrotoxicity may occur (Barrios 2004). In cases of renal dysfunction, especially in patients with low body weight, TDF should be avoided, or the dosing interval should be adjusted (see Drugs). In case of severe renal dysfunction (creatinine clearance <30 ml/min) TDF should not be adminis- tered. As normal creatinine levels may be misleading especially in subjects with low body weight, creatinine clearance needs to be measured before initiating TDF. Renal function tests including urine protein/creatinine ratio (UPC), urine albumin/creati- nine ratio (UPA), creatinine clearance, proteinuria, glycosuria, urine dipstick and urine phosphate should be monitored closely. Another tool to analyze the renal function is the measurement of cystatin C and cystatin C-eGFR, to measure the decreased renal function more accurately (Lucas 2014 Driver 2013). The majority of renal dysfunction in TDF patients is related to pre-existing renal disorders (Brennan 2011). Therefore it is not recommended for use in patients with preexisting renal insufficiency. It should also be avoided with concomitant or recent use of nephrotoxic agents such as aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2. Usually, abnorm- alities resolve upon discontinuation (Izzedine 2004, Roling 2006). Neurological side effects The most important neurological side effects are peripheral polyneuropathy caused by NRTIs and CNS side effects caused by efavirenz (for other problems see neuro- logical chapters). Peripheral polyneuropathy Peripheral polyneuropathy (PNP) is mainly caused by d-NRTIs (ddI, d4T) or AZT and are much less frequent today. Because of their continued use in resource-limited areas, we will review the symptoms and possibilities for palliation. PNP usually presents with a distal symmetrical distribution and sensorimotor paralysis. Patients complain of paresthesia and pain (“tingling”) in hands and feet and perioral dysesthesia. The symptoms often begin gradually after several months of therapy. HIV infection itself can lead to PNP, but the drug-induced form becomes apparent much earlier and may develop within a shorter period of time. Patients must be informed that they should consult their treating physician as soon as possible if these complaints develop. Additional risk factors for polyneuropathy, such as vitamin B12 deficiency, alcohol abuse, diabetes mellitus, malnutrition or treatment with other neurotoxic drugs, e. Symptoms frequently improve within the first two months following discontinua- tion of the drugs responsible, but may initially increase in intensity and are not always fully reversible. Because treatment is difficult and because there is no specific therapy, it is important that PNP is recognized early by the doctor, resulting in a rapid change of treatment. An easy test in practice is to test vibration with a tuning fork. A 64 Hz tuning fork (Rydel-Seiffer) is applied to the appropriate bony surface (e. The patient is asked to report the percep- tion of both, the start of the vibration sensation and the cessation of vibration on dampening.

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