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Triptan compared with placebo: Characteristics and outcomes Author Year Country Allowed other Method of Outcome Age Trial Name medications/ Assessment and Timing of Gender (Quality Score) interventions Assessment Ethnicity Other population characteristics Winner Rescue medication Primary efficacy endpoints: Study 1 Migraines without aura 2006 was permitted % pain-free at 2 hours; % Mean age Study 1: S6: 59%; Pla: 62% USA migraine free at 2 hours; % (years): S6: 40 cardura 4mg low price. Triptan compared with placebo: Characteristics and outcomes Results Author Year Country Number screened/ Trial Name eligible/ Number withdrawn/ (Quality Score) enrolled lost to fu/analyzed Relief at various times Winner Study 1 Study 1 NR 2006 NR/NR/357 1/NR/297 USA Study 2 Study 2 NR/NR/351 1/NR/287 *p<0 order 1mg cardura. Triptan compared with placebo: Characteristics and outcomes Author Year Country Trial Name Pain Free at various times (% Presence of migraine-associated (Quality Score) patients) symptoms at 2 hours Other efficacy outcomes Winner At 2 Hours % with symptoms NR 2006 Study 1: S6: 48% vs Pla: 18% Nausea USA (p<0 discount cardura 4 mg on-line. Triptan compared with placebo: Characteristics and outcomes Author Year Country Trial Name Method of adverse effects (Quality Score) assessment Adverse Effects Reported Winner Patient report Nausea 2006 Study 1: S6: 6% vs Pla: 2% USA Study 2: S6: 4% vs Pla 2% Injection site reaction Study 1: S6: 5% vs Pla: 2% Study 2: S6: 5% vs Pla: 1% *p<0. Triptan compared with placebo: Characteristics and outcomes Author Year Country Trial Name (Quality Score) Comments Winner 2 studies 2006 USA Morning migraines *p<0. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Eletriptan Farkkila, 2003 40, 80mg N=446 Relief at 1 hour: Relief at 2 hours: 41 E40: 40% E40: 59% 87. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Eletriptan Farkkila, 2003 Recurrance of pain within 24 Hours: E40: 26% E80:32% Placebo: 50% Need for rescue medication at 1 Hr: E40: 24% E80: 14% Placebo: 63% Nausea at 1 hour: E40: 41% E80: 44% Placebo: 62% Sustained response: E40: 39% E80: 45% Placebo: 14% Triptans Page 130 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Frovatriptan Goldstein, 2002 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Frovatriptan Goldstein, 2002 Triptans Page 132 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Rapoport, 2002 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Rapoport, 2002 Triptans Page 134 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Sumatriptan Brandes, 2007 85mg N=1441 NR Headache relief Study 1 Mean age (years) SNS: 65% vs S: 55% vs NS: SNS:40. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Sumatriptan Brandes, 2007 NR Study 1 Brandes, 2007 NR Study 2 Triptans Page 136 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Nasal Formulations: Sumatripan Diamond, 1998 5, 10, 20 mg N=1086 Relief at 1 Hour: Relief at 2hrs: 41. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Nasal Formulations: Sumatripan Diamond, 1998 Clinical Disability scores at 2 hours: 5mg: 57%-No/Mild Impairment 10mg: 67%-No/Mild Impairment 20mg: 70%-No/Mild Impairment Placebo: 50%-No/Mild Impairment Triptans Page 138 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Peikert, 1999 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Peikert, 1999 Report of grade 0-1 for clinical disability: 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Salonen, 1994 1,5,10,20,40mg N=455 Results at Pain relief at 2 hrs: 41. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Salonen, 1994 Clinical Disability at 2 hrs: Grade 0=no disability 5-40mg Sumatriptan: 0. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Dowson, 2003 0. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Dowson, 2003 Resumption of Normal Activities at 1 Hour: 0-90 days: 40. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Nasal Formulations: Zolmitripan Dodick, 2005 5mg N=1868 Relief at 1 Hour: Relief at 2 Hours: 40. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Nasal Formulations: Zolmitripan Dodick, 2005 No recurrance/requirement for rescue meds: Zolmitriptan: 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Gawel, 2005 5mg Nasal N=1044 Relief at 1 Hour: Relief at 2 hours: 41. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Gawel, 2005 Relief at 10 minutes: Z5: 15. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Eletriptan Difference of 19 yes Fair Pfizer, Ltd. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Cady Yes Study 1 Good Merck 2006 35 (1%) and USA Study 2 45 (11%) withdrawn post- randomizatio n due to not being treated, withdrew consent, or lost to follow- up Brandes NR 23 (<1%) Fair Pfizer 2005 withdrawn USA & post- Canada randomizatio n for not having an attack and/or recording necessary information in diary Triptans Page 152 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 6. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Goldstein Yes 18 (<1%) Good BMS 2005 withdrawn USA post- randomizatio n for not taking study medication to treat an attack Jelinski Yes 4 (<1%) GSK 2006 withdrawn Canada post- randomizatio n for not treating a migraine attack Mathew No; excluded No Fair NR 2007 30/347 (9%) who USA did not have 2-hour pain intensity data Triptans Page 154 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 6. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Tepper Yes 73 (10%) Good GSK 2006 withdrawn USA post- randomizatio n for not treating a migraine attack Winner Yes Study 1 Good NR 2006 58 (16%) USA Study 2 63(17%) withdrawn post- randomizatoi n for not treating a migraine attack Wendt NR NR Fair GSK 2006 USA Triptans Page 156 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 6. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Diener Yes 23 (10%) Good Bayer 2005 withdrawn HealthCare Germany post- randomizatio Diener n for not 2005 treating a Germany migraine (companion attack paper) Silberstein Yes 183 (14%) Good Pozen, Inc 2008 withdrawn and US post- GlaxoSmit randomizatio hKline n for not treating a migraine attack Tfelt-Hansen Yes 49 (32. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Loder 2001 No; excluded No Fair Merck 88/472 (19%) who only treated 1 attack Pascual 2001 No; excluded No Fair Merck 32/481 (7%) for sumatriptan and 25/481 (5%) for rizatriptan in headache relief analysis Merck Yes No Good Merck Protocol 39- Unpublished Ahrens 1999 No; excluded 2/188 No Good Merck (1%) from rizatriptan and 5/185 (3%) from placebo groups that discontinued for "other" reasons Goadsby Yes No Fair NR 2008 Triptans Page 160 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Akpunonu 6mg Time to discharge: 60 NR NR NR 43 vs 66 1995 vs 96 min min Anonymous 1991 6mg, 8mg Relief: 51 vs 15 Relief: 73 vs 26 NR 30 Free: 45 vs 8 Bousser 6mg EARLY MORNING NR Relief: 71 vs 21 Relief: 78 vs 28 NR 1993 Free: 33 vs 10 Free: 44 vs 18 Cady 1991 (JAMA) 6mg Pooled results from 2 NR Relief: 70 vs 22 NR 10 studies Free: 49 vs 9 Cady 1993 6mg Relief: 54 vs 11 Relief: 80 vs 18 NR (Neurology) Cady 1998 6mg Sumatriptan naïve NR NR NR PRODUCTIVITY (any form); Only generalizable to patients that are working 8-hour shifts and have a migraine w/I the 1st 4 hours of a shift Cull 1997 S 6 mg Tx of recurrences NR NR NR Triptans Page 161 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Dahlof 1992 S 8 mg 8 mg NR NR NR 30 General well-being (MSEP): S>P Diener 1999 6mg NR NR Relief: 91. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Winner, 2006 S 6mg Morning migraines NR NR Free: 48 vs 18 10 (Study 1) Winner, 2006 S 6mg Morning migraines NR NR Free: 57 vs 19 10 (Study 2) Wendt, 2006 S 4mg Acute migraine attacks Relief: 43 vs 18 Relief: 67 vs 25 Relief: 70 vs 22 10 in clinic Free: 10 vs 3 Free: 34 vs 7 Free: 50 vs11 Triptans Page 165 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Almotriptan Freitag, 2008 Almotriptan N=378 Functional disability and A vs Pla 12. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Almotriptan Freitag, 2008 24 hour QOL social function domain p<0. Eletriptan Wells, 2000 Total Time Loss: Median Hours E40: 4. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Martin 2005 40mg N=160 Patients who failed on Normal functioning at 2 Hours 37 Fiorinal and/or Fioricet 69% of E40 85% Female Open label Silberstein, 2006 20, 40mg N=613 Work productivity outcomes Functional response based on FIS criteria Mean age (years) E40: 75% vs Pla: 45% (p<0. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Martin 2005 MSQ Scores Pre-treatment: 57. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Anonymous 1991 6mg, 8mg N=639 Normal function at 60: 45 vs 9; p<0. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Anonymous 1991 Bousser Duration of inability to work: 5 h 40 m vs. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Gross 1994 S 6 mg (novel N=86 Self-injected at home self-injector) 43. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Gross 1994 Ability to return to work within 2 hours: 61% vs 27%; p=0. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Russell, 1994 6mg N=230 Auto-injector Improvement of severity of headache: 44 S6 had 48% more success than Placebo at 82% Female both 1 and 2 hours; (p<0. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Russell, 1994 Headache: none/mild after treatment: S6: 29% vs Placebo: 9% Schulman, 2000 Productivity loss in min. Triptan compared with placebo: Summary of orally disintegrating drug results Sample Size Mean age (yrs) Author, Year Dose % Female Results at 1 Hour Results at 2 hours Functional/Return to Normal Zolmitriptan Loder, 2005 2. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Almotriptan Mathew, 2007 12. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Goadsby, 2008 Almotriptan 491 NR 1) A 12. Sustained pain-free (2- 24 hrs) 46% vs 30% vs 16% vs 11% Differences: 1 vs. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Frovatriptan Cady, 2004 2. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Cady 2006 10mg N=331 NR Pain Freedom at 2 Functional Disability at 2 Study 2 41 Hours Hours 88% Female R10: 59% vs Pla: R10: 34% vs Pla: 56% 31% (p<0. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Jelinski, 2006 50 & 100mg N=361 Pain-Free at 1 Hour Pain-Free at 2 Hours NR 40 S50: 24% Pla: 7% S50: 40% vs Pla: 16% 85 (p<0.

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IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event buy cardura 4 mg otc. The controlled high risk Avonex multiple sclerosis trial (CHAMPS Study) generic cardura 2 mg online. Journal of neuro-ophthalmology : the official journal of the North American Neuro- Ophthalmology Society buy cardura 1mg on line. Interferon beta-1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double- blind, placebo-controlled trial. Interferon beta-1a for optic neuritis patients at high risk for multiple sclerosis. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Effect of early interferon beta-1a therapy on conversion to multiple sclerosis in Iranian patients with a first demyelinating event. Disease-modifying drugs for multiple sclerosis Page 92 of 120 Final Report Update 1 Drug Effectiveness Review Project 131. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Interferon beta-1 a and depression in relapsing-remitting multiple sclerosis: an analysis of depression data from the PRISMS clinical trial. Interferon beta-1b treatment in patients with relapsing--remitting multiple sclerosis under a standardized protocol in Spain. Interferon beta-1b injection site reactions and necroses. An open-labelled assessment of adverse effects associated with interferon 1-beta in the treatment of multiple sclerosis. Side effect profile of interferon beta- 1b in MS: results of an open label trial. Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a or 1b. Interferon beta in secondary progressive multiple sclerosis : daily clinical practice. Clinical benefits of interferon beta-1a in relapsing-remitting MS: a phase IV study 942. Results of an on-going, open-label, safety- extension study of interferon beta-1a (Avonex) treatment in multiple sclerosis. Safety and immunogenicity of a new formulation of interferon beta-1a (Rebif New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Safety and tolerability in relapsing-remitting multiple sclerosis patients treated with high-dose subcutaneous interferon-beta by Rebiject autoinjection over a 1-year period: the CoSa study. Arnoldus JH, Killestein J, Pfennings LE, Jelles B, Uitdehaag BM, Polman CH. Quality of life during the first 6 months of interferon-beta treatment in patients with MS. A post-marketing study on immunomodulating treatments for relapsing-remitting multiple sclerosis in Lombardia: preliminary results. Interferon beta treatment in relapsing-remitting multiple sclerosis: a post-marketing study in Lombardia, Italy. Disease-modifying drugs for multiple sclerosis Page 93 of 120 Final Report Update 1 Drug Effectiveness Review Project 146. A post-marketing study on interferon beta 1b and 1a treatment in relapsing-remitting multiple sclerosis: different response in drop-outs and treated patients. Minagar A, Murray TJ, Investigators PS, Minagara A, Murray TJ. Efficacy and tolerability of intramuscular interferon beta-1a compared with subcutaneous interferon beta-1a in relapsing MS: results from PROOF. Interferon beta treatment of MS in the daily clinical setting: a 3-year post-marketing study. Relationship between MRI lesion activity and response to IFN-beta in relapsing-remitting multiple sclerosis patients. Portaccio E, Zipoli V, Siracusa G, Sorbi S, Amato MP. Long-term adherence to interferon beta therapy in relapsing-remitting multiple sclerosis. Long-term follow-up of 106 multiple sclerosis patients undergoing interferon-beta 1a or 1b therapy: predictive factors of thyroid disease development and duration. Thyroid function and autoimmunity during interferon beta-1b treatment: a multicenter prospective study. Autoimmune events during interferon beta-1b treatment for multiple sclerosis. Autoimmune hepatitis and interferon beta-1a for multiple sclerosis. Fulminant liver failure during interferon beta treatment of multiple sclerosis. Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis. Liver injury associated with the beta-interferons for MS: a comparison between the three products. Hepatic reactions during treatment of multiple sclerosis with interferon-beta-1a: incidence and clinical significance. Liver and thyroid function and autoimmunity during interferon-beta 1b treatment for MS. Disease-modifying drugs for multiple sclerosis Page 94 of 120 Final Report Update 1 Drug Effectiveness Review Project 162. Patten SB, Francis G, Metz LM, Lopez-Bresnahan M, Chang P, Curtin F. The relationship between depression and interferon beta-1a therapy in patients with multiple sclerosis. Multiple sclerosis and depression: influence of interferon beta therapy. Borras C, Rio J, Porcel J, Barrios M, Tintore M, Montalban X. Emotional state of patients with relapsing-remitting MS treated with interferon beta-1b. 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France purchase cardura 1 mg free shipping, Italy buy cardura 2mg lowest price, Spain order 1 mg cardura fast delivery, Sweden, Switzerland & UK FM DPI (24) Fair 75 RCT, open 1998 vs. AND 482 Age ≥ 18, moderate-severe, not controlled on ICS, 14-16% current SM DPI (100) Rutten-van Molken smokers 76 6 months et al. Symbol use: Drug X > Drug Y = statistically significant difference in outcomes favoring Drug X; Drug X > Drug Y trend = point estimate favors Drug X, but the difference is not statistically significant or tests of statistical significance were NR; No difference = no statistically significant difference or tests of statistical significance were not reported and outcomes are similar. Controller medications for asthma 55 of 369 Final Update 1 Report Drug Effectiveness Review Project D. Anti-IgE Therapy Summary of findings Omalizumab is the only available anti-IgE drug approved for the treatment of asthma; therefore, there are no studies of intra-class comparisons. We did not find any head-to-head studies directly comparing omalizumab to ICSs, LABAs, leukotriene modifiers, or combination products. We found eight RCTs (13 publications) and two 92, 93 systematic reviews with meta-analyses that met our eligibility criteria. Only two of the 83, 84, 90 RCTs enrolled children (6-12 years old). Five of the other RCTs included adolescents and 91 adults ≥ 12 years of age, and one included only adults 20-75 years old. Data from good and fair quality RCTs and systematic reviews consistently found that omalizumab-treated patients showed significant improvement in asthma-related health outcomes compared to placebo-treated 90 patients. Most trials were 28-32 weeks in duration with the exception being one 52 week trial. In addition, two trials conducted optional double-blind extensions providing data for up to 52 weeks. Our meta-analyses (Appendix I) and previously published systematic reviews with meta- analyses showed omalizumab to be statistically significantly superior to placebo for several outcome measures. Detailed Assessment Description of Studies 81, Six of the RCTs were 28 weeks in duration, with the others being 32 and 52 weeks in duration 90 (Table 11). Four trials had 16 weeks of stable ICS dose followed by a 12-16 week phase of 91 ICS tapering. One trial used only a 16 week stable ICS phase without subsequent tapering, and 90 another, longer trial included 24 weeks of stable ICS dose followed by 28 weeks of tapering. In all included RCTs, subjects continued ICS treatment throughout the study duration. In three trials, all patients were also taking either a LABA or other standard maintenance therapy at 82, 90, 91 92 constant doses throughout the study, In all eight RCTs and one systematic review, omalizumab was administered subcutaneously. One systematic review included studies where omalizumab was administered intravenously or by inhalation (modes that are not approved for 93 use in the US or Canada) as well as by subcutaneous injection. Study Populations The eight RCTs included a total of 3,480 patients. Five trials were conducted in adolescent and adult populations (ranging from 12 to 75 years of age) and one was conducted only in adults age 91 83, 90 20 to 75. Only two studies were conducted in pediatric populations (6-12 years of age). In addition, all patients had moderate to severe asthma with concurrent allergies and/or rhinitis. One trial was conducted in the US, one in the US and UK, and one in Japan; the remaining five trials were multinational. Current smoking status was not reported in either of the two studies that enrolled children 83, 90 82 (age 6-12). One study explicitly excluded smokers and one included both current and ex- 91 smokers; the remaining four studies had no current smokers enrolled but included previous smokers. Controller medications for asthma 56 of 369 Final Update 1 Report Drug Effectiveness Review Project Methodological Quality The RCTs and systematic reviews were of fair to good quality. Two efficacy studies that met our eligibility criteria were not included in our analysis because they were rated poor quality (Appendix F). Sponsorship Of the 8 included RCTs, 7 (88%) were funded by pharmaceutical companies; one did not report the source of funding but at least one author had a primary affiliation with a pharmaceutical 82 company. Head-to-head comparisons We found no head-to-head studies directly comparing the efficacy of omalizumab with another asthma treatment. Omalizumab is the only anti-IgE medication approved in the US or Canada for the treatment of asthma. Omalizumab compared with placebo The majority of trials assessed overall asthma symptom scores, exacerbations, use of rescue medication, quality of life, urgent care or ER visits, and hospitalization rates. All trials found greater improvements in omalizumab-treated patients (Evidence Tables A and B). One RCT 83 conducted in children reported nocturnal awakenings. One study reported no deaths in either 90 the omalizumab or placebo groups, but no other studies reported mortality or adherence. We conducted meta-analyes on these outcomes when sufficient data was reported by multiple studies (Appendix I). The five trials in adolescent and adult populations reported statistically significant differences favoring omalizumab in overall symptom scores. The study including only adult subjects also showed an improvement in asthma symptom score in the omalizumab group, but 91 the difference was not statistically significant. One of the pediatric studies reported “little 83 change” in scores and “minimal difference” between omalizumab and placebo (data NR). The other also noted no statistically significant difference between groups with respect to mean change from baseline in nocturnal symptom scores at 24 weeks (–0. Two trials reported the proportion of “low symptom days. Seven studies assessed the number of exacerbations per patient. The results of our meta- analysis show fewer exacerbations per patient with omalizumab compared to placebo (WMD = - 2 0. In addition, six studies reported the percentage of patients with one or more exacerbations. Our meta-analysis results show significantly fewer omalizumab- treated subjects with one or more exacerbations compared to placebo-treated subjects (OR = 2 0. There was no significant heterogeneity between studies. All RCTs assessing rescue medication use (seven trials) reported a greater decrease in use of rescue medication for omalizumab. Differences were statistically significant in five of the 82, 91 seven studies. The difference was not significant in two studies, and the P value was not 88 reported in one. We were not able to conduct meta-analyses for rescue medicine use outcomes because too few studies reported sufficient data. Controller medications for asthma 57 of 369 Final Update 1 Report Drug Effectiveness Review Project Six of the 8 RCTs that met our eligibility criteria utilized the AQLQ and demonstrated significantly higher scores in omalizumab-treated patients. Results of our meta-analyses show greater improvement in quality of life for those treated with omalizumab than for those treated with placebo. Subjects treated with omalizumab had a statistically significantly greater increase 2 in AQLQ scores than subjects treated with placebo (SMD = 0. Two systematic reviews with meta-analyses reported results consistent with our findings. One good quality systematic review included 14 RCTs (3143 subjects) comparing omalizumab 93 and placebo in children and adults with chronic asthma. This review included six RCTs that met our inclusion criteria and eight studies that did not meet our eligibility criteria (e. All patients had a diagnosis of allergic asthma (ranging from mild to severe). Another fair quality systematic review conducted a meta-analysis of asthma-related quality of 92 life from five RCTs.

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