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Any significant pooled odds ratio greater than 1 indicated that the odds of the adverse event associated with an antiepileptic drug (the intervention group) was larger than the odds associated with the comparison (placebo buy procardia 30 mg lowest price, lithium buy procardia 30 mg with amex, or other antiepileptic drug) buy procardia 30mg free shipping. If no events were observed in the comparison group, but events were observed in the intervention group, the odds ratio was infinity and the associated confidence interval was bounded from below only. We report the lower bound of this confidence interval. If no events were observed in either group, the odds ratio was undefined, which we denote as “Not calculated” (NC) in the results tables. We did not observe any subgroups of studies for which no events were reported for the intervention group but events were observed in the comparison group. Since only 1 bipolar disorder trial directly compared adverse events between antiepileptic drugs, for bipolar disorder we assessed only 2 comparisons, antiepileptic drug compared with placebo and antiepileptic drug compared with lithium. We looked for overlap between the confidence intervals of the pooled odds ratios (or single study odds ratio if only 1 trial was available) for each antiepileptic drug. If the confidence intervals overlapped, then we could not conclude that the odds between antiepileptic drugs were significantly different. Antiepileptic drugs Page 15 of 117 Final Report Update 2 Drug Effectiveness Review Project Peer and Public Review The Original report underwent a review process that involved solicited peer review from 3 clinical experts. Their comments were reviewed and, where possible, incorporated into the final document. The comments received and the author’s proposed actions were reviewed by the representatives of the participating organizations of the Drug Effectiveness Review Project prior to finalization of the report. Names of peer reviewers for Drug Effectiveness Review Project reports are listed at www. Antiepileptic drugs Page 16 of 117 Final Report Update 2 Drug Effectiveness Review Project RESULTS Overview Our literature searches identified 2308 new citations for Update 2: 540 from the Cochrane Central Register of Controlled Trials, 25 from the Cochrane Database of Systematic Reviews, 1254 from Medline, 441 from PsychINFO, and 48 from hand-searching. We received no new pharmaceutical company dossier submissions for Update 2. Figure 1 shows results of our study selection process for Update 2. Results of literature search (Update 2) Citations screened in Update 2: 2308 Citations excluded at title/abstract Level: 2023 Full-text articles retrieved for more detailed evaluation: 285 Articles excluded at full-text level: 157 1 foreign language 11 outcome not included 20 intervention not included 27 population not included 79 wrong publication type (letter, editorial, non systematic review, etc) 17 study design not included 2 study duration did not meet eligibility Included studies: 128 7 head-to-head trials 34 active-control trials 47 placebo-controlled trials 19 observational studies 16 systematic reviews 5 other (pooled analyses and medical reviews) Antiepileptic drugs Page 17 of 117 Final Report Update 2 Drug Effectiveness Review Project Summary of Findings Bipolar Disorder Stabilization of acute manic/mixed episodes • Evidence supports the use of immediate- and extended-release forms of carbamazepine and valproate for stabilization of acute manic/mixed episodes. Maintenance treatment of manic/mixed episodes • Evidence supports the use of lamotrigine and older forms of carbamazepine and valproate as maintenance treatment in patients whose most recent episode was manic/mixed. Differences between lamotrigine and lithium did not reach statistical significance (P=0. Rapid cycling • Both valproate and lithium prevented relapse for 20 months in just over half of 60 patients with rapid cycling bipolar disorder. Bipolar depression • Evidence supports a benefit of lamotrigine monotherapy in treating acute bipolar depression over 7 to 10 weeks. The mean response rate based on the MADRS was 51% Antiepileptic drugs Page 18 of 117 Final Report Update 2 Drug Effectiveness Review Project for lamotrigine and 41% for placebo, with a pooled number needed to treat of 13. Benefit was also found based on the mean change in depression scale score. Across the 3 studies, response rates with lamotrigine ranged from 45% with adjunctive treatment to 67. The combination of olanzapine/fluoxetine was found superior on some other measures, but not all. Limited evidence suggests valproate was not superior to placebo in preventing relapse of depressive symptoms. Fibromyalgia • Using a definition of 30% or more reduction in pain, pregabalin showed statistically significantly greater rates of response compared with placebo for 300, 450 and 600 mg per day (pooled estimate of relative risk 1. Gabapentin also showed a greater response rate than placebo (51% compared with 31%; P=0. Pregabalin 600 mg/d recorded the highest responder rate compared with placebo (30% versus 15%; P=0. The mean pain scores for gabapentin 1800 mg/d and pregabalin 450/d and 600 mg/d were statistically significantly greater than placebo at endpoint.. Migraine Prophylaxis • There is evidence to support the use of topiramate or valproate for migraine prophylaxis, in that these drugs reduce migraine frequency compared with placebo. Direct comparisons between the drugs are insufficient to make conclusions. Antiepileptic drugs Page 19 of 117 Final Report Update 2 Drug Effectiveness Review Project • The evidence supporting the use of carbamazepine or gabapentin for migraine prophylaxis is weaker than the evidence base for topiramate and valproate but indicates that these drugs also may be superior to placebo in reducing headache frequency. These drugs were not found to be superior to placebo in reducing headache frequency. Chronic Pain • Limited evidence supports the short-term efficacy of topiramate and gabapentin compared with placebo for treatment of chronic pain. Harms Associated with Antiepileptic Drugs • Antiepileptic drugs may be associated with an increased risk of suicidal ideation or behaviors; however, the risk associated with specific drugs, patient populations, and treatment regimens is unclear. Carbamazepine has a significantly increased risk of suicide attempts resulting in hospitalization compared with lithium. Adjusted odds ratios for any fracture in patients who used antiepileptic drugs were significantly increased with exposure to carbamazepine (1. The odds ratios were nonsignificant but increased for lamotrigine (1. The numbers for lamotrigine were too small for meaningful analysis. In both studies the risk with phenytoin was low and not statistically significant, and in 1 study the risk associated with valproate was 18. With both drugs the numbers of cases were too low for precise estimates. Antiepileptic drugs Page 20 of 117 Final Report Update 2 Drug Effectiveness Review Project o Antiepileptic drug monotherapy is associated with somewhat lower risk compared with antiepileptic drug polytherapy. Lamotrigine doses larger than 200 mg/d were associated with risk approaching that of valproate 1000 mg/d in one study, but no association was found in another study. Valproate and topiramate had higher rates of withdrawal than placebo. No difference was found between topiramate and valproate. Topiramate was not directly compared with carbamazepine. Valproate (1 trial), but not lamotrigine (1 trial), was associated with significantly higher odds of tremor than placebo (odds ratio 4. Lamotrigine was associated with weight loss (mean change from baseline to 6 weeks, –0. There were no significant differences between lamotrigine and placebo or between gabapentin and placebo. Antiepileptic drugs Page 21 of 117 Final Report Update 2 Drug Effectiveness Review Project Weight change data should be interpreted with caution, since it was not based on randomized patients. Subgroups • In bipolar disorder o Demographic factors were not found to be associated with response to valproate or lithium. Analysis of data on females did not find this difference to be significant. The drugs were similar in patients with mania alone. This difference was not seen in the subgroup with bipolar I disorder. Detailed Assessment Key Question 1 For adult outpatients with bipolar disorder, fibromyalgia, migraine, or chronic pain, do antiepileptic drugs differ in effectiveness? Bipolar disorder 12, 13 We found no trials of ethotoin, levetiracetam, pregabalin, tiagabine or zonisamide in patients with bipolar disorders. A large proportion of included trials in patients with bipolar disorder were 12-22 previously evaluated in a number of prior systematic reviews. However, findings from only 16, 17, 20 the most recent and comprehensive systematic reviews are discussed in detail here.

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A 12-month purchase 30mg procardia with mastercard, open-label discount 30mg procardia amex, comparative study of quetiapine and risperidone in the acute and long-term treatment of schizophrenia buy procardia 30 mg with mastercard. Peuskens J, Gillain B, De Graeve D, Van Vleymen B, Albert A. Belgian schizophrenia outcome survey --Results of a 2-year naturalistic study in patients stabilised on monotherapy with olanzapine, risperidone or haloperidol. Atypical antipsychotic drugs and the risk of sudden cardiac death. Comparing the effectiveness of aripiprazole and quetiapine in schizophrenia and related psychoses: a naturalistic, retrospective chart review study. Atypical antipsychotic drugs Page 170 of 230 Final Report Update 3 Drug Effectiveness Review Project 211. Weight gain due to long term antipsychotic treatment of persistent mental disorders. Taylor DM, Douglas-Hall P, Olofinjana B, Whiskey E, Thomas A. Reasons for discontinuing clozapine: matched, case-control comparison with risperidone long-acting injection. Comparing the use and discontinuation of antipsychotics in clinical practice: an observational study. Major changes in glucose metabolism, including new-onset diabetes, within 3 months after initiation of or switch to atypical antipsychotic medication in patients with schizophrenia and schizoaffective disorder. Yu AP, Atanasov P, Ben-Hamadi R, Birnbaum H, Stensland MD, Philips G. Resource utilization and costs of schizophrenia patients treated with olanzapine versus quetiapine in a Medicaid population. Serum BDNF levels and weight gain in schizophrenic patients on long-term treatment with antipsychotics. Response and relapse in patients with schizophrenia treated with olanzapine, risperidone, quetiapine or haloperidol: 12-month follow-up of the Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO) study. Effectiveness of antipsychotic treatment for schizophrenia: 6-month results of the Pan- European Schizophrenia Outpatient Health Outcomes (SOHO) study. Patterns of concomitant psychotropic medication use during a 2-year study comparing clozapine and olanzapine for the prevention of suicidal behavior. A 1-year, double-blind, placebo-controlled trial of ziprasidone 40, 80 and 160 mg/day in chronic schizophrenia: the Ziprasidone Extended Use in Schizophrenia (ZEUS) study. Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients. Reviewing CATIE for clinicians: balancing benefit and risk using evidence-based medicine tools. Hospitalisation risks in the treatment of schizophrenia in a Medicaid population: comparison of antipsychotic medications. Atypical antipsychotic drugs Page 171 of 230 Final Report Update 3 Drug Effectiveness Review Project 226. Ritsner M, Gibel A, Perelroyzen G, Kurs R, Jabarin M, Ratner Y. Quality of life outcomes of risperidone, olanzapine, and typical antipsychotics among schizophrenia patients treated in routine clinical practice: a naturalistic comparative study. Effects of antipsychotic medications on psychosocial functioning in patients with chronic schizophrenia: findings from the NIMH CATIE study. Does switching to a new antipsychotic improve outcomes? Pharmacological treatment and other predictors of treatment outcomes in previously untreated patients with schizophrenia: results from the European Schizophrenia Outpatient Health Outcomes (SOHO) study. Silva de Lima M, de Jesus Mari J, Breier A, Maria Costa A, Ponde de Sena E, Hotopf M. Quality of life in schizophrenia: a multicenter, randomized, naturalistic, controlled trial comparing olanzapine to first-generation antipsychotics. Mahmoud R, Engelhart L, Janagap C, Oster G, Ollendorf D. Risperidone versus conventional antipsychotics for schizophrenia and schizoaffective disorder: symptoms, quality of life and resource use under customary clinical care. Revicki DA, Genduso LA, Hamilton SH, Ganoczy D, Beasley CM, Jr. Olanzapine versus haloperidol in the treatment of schizophrenia and other psychotic disorders: quality of life and clinical outcomes of a randomized clinical trial. Effectiveness and Cost of Olanzapine and Haloperidol in the Treatment of Schizophrenia: A Randomized Controlled Trial. Nasrallah HA, Duchesne I, Mehnert A, Janagap C, Eerdekens M. Health-related quality of life in patients with schizophrenia during treatment with long-acting, injectable risperidone. Kane JM, Eerdekens M, Lindenmayer JP, Keith SJ, Lesem M, Karcher K. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Ciudad A, Olivares JM, Bousono M, Gomez JC, Alvarez E. Improvement in social functioning in outpatients with schizophrenia with prominent negative symptoms treated with olanzapine or risperidone in a 1 year randomized, open-label trial. Harvey PD, Patterson TL, Potter LS, Zhong K, Brecher M. Improvement in social competence with short-term atypical antipsychotic treatment: a randomized, double-blind comparison of quetiapine versus risperidone for social competence, social cognition, and neuropsychological functioning. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. Atypical antipsychotic drugs Page 172 of 230 Final Report Update 3 Drug Effectiveness Review Project 239. Employment outcomes in a randomized trial of second-generation antipsychotics and perphenazine in the treatment of individuals with schizophrenia. The Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO) study: Baseline clinical and functional characteristics and antipsychotic use of patterns in the Central and Eastern Europe (CEE) region. Recovery in the outpatient setting: 36- month results from the Schizophrenia Outpatients Health Outcomes (SOHO) study. Kinon BJ, Noordsy DL, Liu-Seifert H, Gulliver AH, Ascher-Svanum H, Kollack-Walker S. Randomized, double-blind 6-month comparison of olanzapine and quetiapine in patients with schizophrenia or schizoaffective disorder with prominent negative symptoms and poor functioning. The safety of olanzapine compared with other antipsychotic drugs: results of an observational prospective study in patients with schizophrenia (EFESO Study). Pharmacoepidemiologic Study of Olanzapine in Schizophrenia. Effectiveness of clozapine, olanzapine, quetiapine, risperidone, and haloperidol monotherapy in reducing hostile and aggressive behavior in outpatients treated for schizophrenia: A prospective naturalistic study (IC- SOHO). Comparison of antipsychotic medication effects on reducing violence in people with schizophrenia. Schizophrenia, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and number needed to treat: how can CATIE inform clinicians? Antipsychotic type and correlates of antipsychotic treatment discontinuation in the outpatient treatment of schizophrenia. Chen C-H, Chiu C-C, Huang M-C, Wu T-H, Liu H-C, Lu M-L. Metformin for metabolic dysregulation in schizophrenic patients treated with olanzapine. Gianfrancesco FD, Rajagopalan K, Sajatovic M, Wang R-H. Treatment adherence among patients with schizophrenia treated with atypical and typical antipsychotics. Risperidone versus clozapine in the treatment of schizophrenic patients with acute symptoms: a double-blind, randomised trial. Mori K, Nagao M, Yamashita H, Morinobu S, Yamawaki S.

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Safety of desloratadine syrup in children 6 months to younger than 2 years of age: A randomized cheap procardia 30 mg free shipping, double-blinded procardia 30mg sale, placebo-controlled study cheap procardia 30 mg overnight delivery. Simons FER, Early Prevention of Asthma in Atopic Children Study G. Safety of levocetirizine treatment in young atopic children: An 18-month study. Evaluation of the drug monitoring programme of azelastine hydrochloride nasal spray in the treatment of allergic rhinitis in children under 13 years of age. Rossi GA, Tosca MA, Passalacqua G, Bianchi B, Le Grazie C, Canonica GW. Evidence of desloratadine syrup efficacy and tolerability in children with pollen-induced allergic rhinitis. Evaluation of the potential cardiotoxicity of the antihistamines terfenadine, astemizole, loratadine, and cetirizine in atopic children. Prophylactic management of children at risk for recurrent upper respiratory infections: the Preventia I Study. Long-term treatment with cetirizine of infants with atopic dermatitis: A multi-country, double-blind, randomized, placebo-controlled trial (the ETAC trial) over 18 months. Antihistamines Page 45 of 72 Final Report Update 2 Drug Effectiveness Review Project 158. Long-term evaluation of the impact of the H1- receptor antagonist cetirizine on the behavioral, cognitive, and psychomotor development of very young children with atopic dermatitis. Cetirizine in patients with seasonal rhinitis and concomitant asthma: prospective, randomized, placebo-controlled trial. Evaluation of cetirizine in patients with allergic rhinitis and perennial asthma. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study. Einarson A, Bailey B, Jung G, Spizzirri D, Baillie M, Koren G. Prospective controlled study of hydroxyzine and cetirizine in pregnancy. Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study. Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Pregnancy outcome following first trimester exposure to antihistamines: Meta-analysis. Evaluation of an association between loratadine and hypospadias--United States, 1997-2001. Treatment with intranasal fluticasone propionate significantly improves ocular symptoms in patients with seasonal allergic rhinitis. Salmun LM, Herron JM, Banfield C, Padhi D, Lorber R, Affrime MB. The pharmacokinetics, electrocardiographic effects, and tolerability of loratadine syrup in children aged 2 to 5 years. Antihistamines Page 46 of 72 Final Report Update 2 Drug Effectiveness Review Project Appendix A. Glossary This glossary defines terms as they are used in reports produced by the Drug Effectiveness Review Project. Some definitions may vary slightly from other published definitions. Absolute risk: The probability or chance that a person will have a medical event. It is the ratio of the number of people who have a medical event divided by all of the people who could have the event because of their medical condition. Add-on therapy: An additional treatment used in conjunction with the primary or initial treatment. Adherence: Following the course of treatment proscribed by a study protocol. Adverse drug reaction: An adverse effect specifically associated with a drug. Adverse event: A harmful or undesirable outcome that occurs during or after the use of a drug or intervention but is not necessarily caused by it. Adverse effect: An adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility. Active-control trial: A trial comparing a drug in a particular class or group with a drug outside of that class or group. Allocation concealment: The process by which the person determining randomization is blinded to a study participant’s group allocation. Applicability: see External Validity Before-after study: A type nonrandomized study where data are collected before and after patients receive an intervention. Before-after studies can have a single arm or can include a control group. Bias: A systematic error or deviation in results or inferences from the truth. Several types of bias can appear in published trials, including selection bias, performance bias, detection bias, and reporting bias. Bioequivalence: Drug products that contain the same compound in the same amount that meet current official standards, that, when administered to the same person in the same dosage regimen result in equivalent concentrations of drug in blood and tissue. Black box warning: A type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning. A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The US Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. Blinding: A way of making sure that the people involved in a research study — participants, clinicians, or researchers —do not know which participants are assigned to each study group. Blinding usually is used in research studies that compare two or more types of treatment for an illness. Antihistamines Page 47 of 72 Final Report Update 2 Drug Effectiveness Review Project Case series: A study reporting observations on a series of patients receiving the same intervention with no control group. Case study: A study reporting observations on a single patient. Case-control study: A study that compares people with a specific disease or outcome of interest (cases) to people from the same population without that disease or outcome (controls). Clinical diversity: Differences between studies in key characteristics of the participants, interventions or outcome measures. Clinically significant: A result that is large enough to affect a patient’s disease state in a manner that is noticeable to the patient and/or a caregiver. Cohort study: An observational study in which a defined group of people (the cohort) is followed over time and compared with a group of people who were exposed or not exposed to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective cohort study identifies subjects from past records and follows them from the time of those records to the present. Combination Therapy: The use of two or more therapies and especially drugs to treat a disease or condition. Confidence interval: The range of values calculated from the data such that there is a level of confidence, or certainty, that it contains the true value. The 95% confidence interval is generally used in Drug Effectiveness Review Project reports.

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