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Adverse events of sitagliptin compared with oral hypoglycemic agents (continued) 35a 51 38 Seck 50mg cytoxan with visa medications without doctors prescription, 2010 Vilsboll purchase cytoxan 50mg online treatment 2014, 2010 Aschner buy cytoxan 50 mg visa medications 44 175, 2010 Glip/ P/insulin Adverse event S/ MET MET S/insulin+ MET +MET S100 M2 Treatment- emergent adverse events (%) Hypoglycemia 5 cytoxan 50 mg low cost symptoms ms women. Meta-analysis comparing adverse events of sitagliptin 100 mg to placebo Heterogeneity 2 Outcome N Measure Estimate 95% CI P value I a Total 7 RR 0. Adverse events of sitagliptin compared with placebo Aschner, Rosenstock, Charbonnel, Hermansen, 42 43 44 50 48 47 49 2006 Raz, 2006 Nonaka, 2008 Raz, 2008 2006 2006 2007 Adverse event S100 PBO S100 PBO P/Pio S/MET P/MET S/Glim S/ Pio P/Pio S/ MET P/MET S/Glim P/Glim Hypoglycemia 1. Adverse events of sitagliptin compared with placebo (continued) 45 46 Mohan, 2009 Hanefeld, 2007 Adverse event S100 PBO S25 S50 S100 S50BID PBO Hypoglycemia 0 0 0. Changes in lipid parameters (mean change from baseline, mg/dL) 46 36 47 45a Hanefeld, 2007 Scott, 2008 Charbonnel, 2006 Mohan, 2009 S100 PBO S100/MET Rosi/MET PBO S100 PBO S100 PBO Total cholesterol +6. Changes in lipid parameters (mean change from baseline, mg/dL) (continued) 30 31a 32 33b Scott, 2007 Goldstein, 2007 Williams-Herman, 2009 Williams-Herman, 2010 S100 PBO Glip S100 M1 M2 S/M1 S/M2 PBO S100 M1 M2 S/M1 S/M2 S100 M1 M2 S/M1 S/M2 Total 4. Changes in lipid parameters (mean change from baseline, mg/dL) (continued) Nauck, 42a 43a 34a 37a 49a Study Aschner, 2006 Raz, 2006 2007 Chan, 2008 Hermansen, 2007 Intervention S100 PBO S100 PBO S100 Glip S25/50 PBO/Glip S100 PBO/Pio Total NR NR NR NR NR NR -4. Detailed Assessment for Saxagliptin: Harms In the 5 identified placebo-controlled trials (see Key Question 1 saxagliptin section for study characteristics), total withdrawals were higher in the placebo groups compared to either the saxagliptin 2. Withdrawals due to adverse effects were similar between placebo and saxagliptin 2. Similar rates of withdrawal due to adverse effects were seen regardless of saxagliptin being used as add-on therapy or monotherapy. Results of our meta-analyses are summarized in Table 57 and results from individual saxagliptin trials for adverse events are summarized in Table 58 and in Evidence Table 8. The most common adverse effects seen were headache, upper respiratory infections, nasopharyngitis, and urinary tract infections. Gastrointestinal adverse effects were rarely reported and were most commonly seen when saxagliptin was used in combination with metformin. Hypoglycemia Hypoglycemia was reported in all 5 trials. The incidence of confirmed hypoglycemia (≤50 mg/dL) was low ranging from 0 to 2. The trials that reported any confirmed hypoglycemia were those using saxagliptin in combination with either glyburide, 55-57 metformin, or a TZD. Overall, there was no difference in the incidence of confirmed hypoglycemia in saxagliptin 2. Infections Infection related adverse events were reported in all 5 trials. Pooled relative risk showed no significant difference between saxagliptin 2. Similarly, no difference was seen between saxagliptin 5 mg daily and placebo in incidence of upper respiratory tract infections (relative risk 0. Three of the 5 studies reported small numerical decreases in absolute lymphocyte counts in higher dose of saxagliptin (≥10 mg daily), however minimal to no decrease in either 53-55 saxagliptin 2. Lipids 56 Changes in lipid parameters were only reported in 1 trial. When compared to placebo in addition to a TZD, there was a numerically greater increase in LDL cholesterol in subjects treated with saxagliptin in addition to a TZD (compared with a small decrease in LDL cholesterol with placebo), however there were no statistical comparisons reported. In addition, placebo-treated subjects total cholesterol decreased more than saxagliptin 2. There was a greater numerical reduction seen in triglycerides in patients receiving saxagliptin as add-on therapy compared to placebo (P=NR) (Table 59). Meta-Analysis results comparing saxagliptin to placebo as both monotherapy and add-on therapy Heterogeneity a 2 Dose Outcome N Measure Estimate 95% CI P value I Total 5 RR 0. Adverse events in trials of saxagliptin Rosenstock, Rosenstock, Chacra, 2009 2008 DeFronzo, 2009 2009 Hollander, 2009 Adverse event S2. Changes in lipid parameters (mean change from baseline, mg/dL) Hollander, 2009 S2. Summary of Findings for GLP-1 Agonists: Harms Exenatide compared with liraglutide • In the 1 head-to-head randomized-control trial, withdrawal rates were similar between groups. The incidence of nausea was similar between the groups initially, but was more persistent over time in the exenatide group. The proportion of patients who reported minor hypoglycemia was less in the liraglutide group than the exenatide group (26% compared with 34%, 1. There was no significant difference in change in total cholesterol, LDL cholesterol, or HDL cholesterol between the exenatide and the liraglutide treatment arms. Reduction in triglycerides was significantly greater in the liraglutide group than the exenatide group (−15. Exenatide • The longest duration of an included study was 52 weeks. Nausea declined after the first 8 weeks of therapy (moderate strength of evidence). A majority of affected patients (90%) in those reports had other risk factors for pancreatitis. Liraglutide • The longest duration of an included study was 52 weeks. Studies comparing liraglutide with glimepiride could not exclude a weak association between treatment with liraglutide and the development of pancreatitis (1 case compared with 1 case in LEAD-2 study; 2 cases compared with 0 in LEAD-3); there were no reports of pancreatitis in the active-control trial with insulin glargine; only 1 of the included placebo-controlled trials reported any cases of pancreatitis (1 case compared with 1 case) (insufficient strength of evidence). Nausea was more common in the liraglutide groups compared to rosiglitazone (low strength of evidence). Gastrointestinal complaints, particularly nausea, were more common in the liraglutide arms of the study than in the sitagliptin arm (low strength of evidence). Rates of hypoglycemia were not significantly different between liraglutide 0. The risk increased with higher doses (relative risk 1. Detailed Assessment of GLP-1 Agonists: Harms Characteristics of trials included in this section were described in the Key Question 1 section for GLP-1 agonists. In this section, we focus on the results of those trials related to harms. For observational studies, we provide a table summarizing study characteristics (Table 61). Detailed Assessment of Exenatide Compared with Liraglutide: Harms In the one 26-week randomized-controlled trial (N=464) of liraglutide compared with exenatide, 61 withdrawal rates were not significantly different between groups. In the liraglutide arm of the study, 14% of participants withdrew from the study, and 10% withdrew due to adverse events. In the exenatide arm of the study, 19% of participants withdrew from the study, and 13% withdrew due to adverse events. Overall, participants in the liraglutide group reported fewer adverse events than in the exenatide group (74. The incidence of nausea was similar between the groups initially, but was more persistent over time in the exenatide group. Otherwise, the distribution of adverse events was similar between the study arms. There were 2 major episodes of hypoglycemia in patients in the exenatide arm of the study who were also on a sulfonylurea.

The study was rated poor quality primarily for attrition of almost 26% buy cytoxan 50mg fast delivery treatment stye. This study was funded by makers of a PEG 3350 formulation buy cytoxan 50 mg low price medications j tube. There were no significant differences in adverse events between the groups generic 50 mg cytoxan otc medicine 5658. The most common adverse events in the PEG 3350 group were dizziness (5%) and fatigue (3 order cytoxan 50 mg line treatment quad strain. Constipation Drugs Page 51 of 141 Final Report Drug Effectiveness Review Project Table 23. Summary of trials assessing the comparative harms of constipation drugs Author, year Study N; Study Comparisons Population, % Results Quality design duration female, rating setting LACTULOSE VS. French and No significant Poor (No 43 1999 single- weeks PEG 3350 Scottish differences in median ITT blind, patients with daily scores for analysis) open-label chronic diarrhea, abdominal constipation, pain, flatulence, or 82% female, bloating. Fewer days general and with flatulence in the geriatric PEG group (3. Mean number of liquid stools was higher in the PEG group (2. Adults with No significant Poor 66 1991 open-label weeks lactulose chronic differences for (High constipation, abdominal pain or for attrition) % female straining (P NR). Evidence profile ofth e generaltolerability and h arm s ofconstipationdrugs inadults Evidence Profile:G eneraltolerability and h arm s ofconstipationdrugs inadults N o. Evidence profile ofth e com parative tolerability and h arm s ofconstipationdrugs inadults Evidence Profile:C om parative tolerability and h arm s ofconstipationdrugs inadults N o. Summary of findings General tolerability and safety in children The evidence is very poor quality and sparse. We found no studies on the general tolerability and safety of docusate calcium, docusate sodium, lactulose, lubiprostone, and psyllium that met our expanded eligibility criteria. All of the studies we found were rated poor quality for the assessment of adverse events and results should be interpreted with caution. We found three poor quality studies that reported safety or tolerability information for PEG 3350 without a comparison group. The most common adverse events reported were diarrhea in 10-13%, bloating/flatulence in 6-18%, and pain/cramping in 2-5%. They found no significant laboratory abnormalities and reported that PEG 3350 was well tolerated by children. We found one RCT that reported on the tolerability and harms of tegaserod for the treatment of postpubertal adolescents with constipation predominant IBS. The study reported that no adverse events were observed in any patient and there were no dropouts. Comparative tolerability and safety in children The evidence was limited to one poor quality RCT comparing PEG 3350 with lactulose in children. This study reported more abdominal pain, pain at defecation, and straining at defecation in those treated with lactulose and worse palatability with PEG. The results should be interpreted cautiously due to the poor quality of the study. Detailed assessment General risk of harms Table 26 summarizes the trials assessing the general harms of constipation drugs in children; Table 29 summarizes the evidence profile for the general tolerability and safety of individual drugs. Docusate calcium, Docusate sodium, Lactulose, Lubiprostone, and Psyllium We did not find any studies on the general harms of these medications in children that met our eligibility criteria. Constipation Drugs Page 55 of 141 Final Report Drug Effectiveness Review Project Polyethylene glycol We found no studies reporting the general safety of PEG that included a placebo comparison group. The other study did not report a source of funding or any conflicts of interest, but was by the same group of authors as the prospective cohort study. The most common adverse events reported were diarrhea in 10-13%, bloating/flatulence in 6-18%, and pain/cramping in 2-5%. Results of these studies should be interpreted with caution due to the poor quality. Previous therapies for constipation had been attempted in 82% of subjects prior to enrollment. For safety and adverse events, the study reported diarrhea in 10%, abdominal pain in 2%, bloating or flatulence in 6%, elevated alanine aminotransferase (ALT) in 11%, and elevated aspartate transaminase (AST) in 4%. Of the 9 patients with abnormal ALTs during treatment, 8 had repeat values 8 weeks later. Seven of the 8 had normal repeat values; one subject had a level 1. The duration and dose of PEG was not different between those with elevated liver function tests (LFTs) and those with normal labs. All children (n = 68, 82%) who had used other therapies in the past preferred PEG to other laxatives. Although they were not required to have chronic constipation, the mean duration of constipation was 10 months (range 0. Diarrhea was reported in 7% of 71 subjects followed for up to 4 months and in an additional 2% of 47 subjects followed for over 6 months. Parents did not report increased flatus, abdominal distention, vomiting, or new onset abdominal pain in any subjects. Lab tests (CBC, electrolytes, and LFTs) were occasionally done in some subjects and all those checked were normal. The study was rated poor quality for several reasons including: no comparison group, adverse events were not defined, adverse events were not clearly pre-specified, and high attrition. Constipation Drugs Page 56 of 141 Final Report Drug Effectiveness Review Project 69 One dose response study was a prospective, double-blind, parallel trial that randomized children aged 3 to 18 years with chronic constipation to 4 doses of PEG 3350 without electrolytes (Miralax, 0. All groups were treated for 3 days and evaluated 5 days after beginning treatment. They enrolled forty-one subjects referred to a pediatric gastroenterology clinic for evaluation of chronic constipation with evidence of fecal impaction. For all subjects, the following adverse events were reported: diarrhea (13%), nausea (5%), vomiting (5%), bloating/flatulence (18%), and pain/cramping (5%). Diarrhea was more prevalent in the high dose groups than the low dose groups (25% vs. No patients had clinically significant abnormal laboratory values after the use of PEG 3350. For tolerability, 95% of children took the medication on the first attempt. In addition, all children said that they would repeat a 3-day regimen of PEG 3350 to help treat a future fecal impaction. The results of the study should be interpreted with caution due to poor quality (no control group). Tegaserod As described in the tegaserod section for general harms in adults (see above), the FDA issued a public health advisory to inform patients and health care professionals that the sponsor of tegaserod agreed to 12 stop selling the medication because of cardiovascular adverse events. We found one RCT that reported on the safety and harms of tegaserod for the treatment of postpubertal adolescents with constipation 53 predominant IBS.

Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (% cheap cytoxan 50 mg without prescription symptoms quotes, adverse Country Adverse effects reported n/enrolled n) Comments Bisoprolol Anonymous NR quality 50mg cytoxan medicine, except NR 1994 Bis: 2 sinus bradycardia buy cheap cytoxan 50mg on-line treatment of scabies, 2 atrioventricular blockade Non CV events: The Cardiac Bis: 44/320 (13 discount cytoxan 50mg without prescription medicine abuse. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Anonymous 27. CV therapy unchanged past 2 Insufficiency IV: 17% weeks. Mandatory medication diuretic and ACE inhibitor or other Bisoprolol Study vasodilator if ACEI intolerant. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Anonymous Uncontrolled hypertension, MI or unstoppable angina pectoris in past 3 Bisoprolol (bis) 10 mg. No treatment with beta blockers weekly for 3 weeks to 5 mg (13%), (CIBIS II) (also eye drops), calcium antagonists, inotropic agents except digitalis, then 4-week intervals to 7. Beta blockers Page 181 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Anonymous Diuretic: 99% Vasodilator: Primary: Total mortality. Mean age 61 CHF etiology: 1999 -ACE inhibitors: 96% - Primary dilated -Calcium antagonists: Secondary: All-cause hospital 80. Beta blockers Page 182 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Anonymous Total screened & eligible: NR Total: 69/2647 (2. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Anonymous NR NR 1999 The Cardiac Insufficiency Bisoprolol Study (CIBIS II) Good quality Beta blockers Page 184 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Carvedilol Bristow 23% Age 18-85, ejection fraction < 35%, symptomatic ischemic or dilated 1996 cardiomyopathy heart failure, symptoms present > 3 months, walk NYHA class test 150-450 m, stability (no change in NYHA class and absence of II: 46% hospitalization) > past 1 month, any digoxin use started > 2 months Multicenter Oral II: 52% prior and stable dose > past 1 month, resting heart rate > 68 bpm. Carvedilol Heart IV: 2% Failure Assessment (MOCHA) Fair quality Beta blockers Page 185 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Carvedilol Bristow Uncorrected valvular disease, hypertrophic or postpartum Carvedilol (car) 12. Failure Assessment exercise testing, sitting systolic blood pressure <85 mm Hg or >160 2-week run-in with open-label car. Fair quality other selected disorders and sensitivities. Excluded drugs: alcohol intake >100 g/day, use of investigational drug within 30 days, CCBs, amiodarone within 3 months, and others. Beta blockers Page 186 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Carvedilol Bristow ACE inhibitors: 94% Primary: Mean age 59. Beta blockers Page 187 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Carvedilol Bristow Screened: NR Total: 52/345 (15%) No effect on exercise duration. NR 1996 Eligible for run-in: 376 Enrolled: 345 Lost to QOL assessment: No effect on NYHA class. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Carvedilol Bristow Dizziness: Withdrawals due to any adverse events: 1996 All car: 83/261 (31. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Packer 22% Chronic heart failure (dyspnea or fatigue >3 months), LVEF <35% 1996 despite >2 months treatment with diuretics and ACEI. NYHA class PRECISE II: 40% III: 56% Fair quality IV: 4% Beta blockers Page 190 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Packer Uncorrected primary valvular disease, active myocarditis or obstructive Carvedilol (car) 50 mg daily vs. Patients receiving CCBs, alpha- or beta-adrenergic agonist or antagonists or specific antiarrhythmic drugs. Beta blockers Page 191 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Packer Digitalis: 90% Primary: Mean age 60. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Packer Screened: NR 49/278 (18%) withdrawn Primary: NR 1996 Eligible for run-in: 301 6-minute exercise test increase: Enrolled: 278 Lost to follow-up for NYHA class car: 17 m PRECISE and global assessment: 9% pla: 6 m (NS) car (n= 133) No difference in 9-minute treadmill test. Fair quality pla (n= 145) Lost to follow-up for AE report: 10/278 (4%) Secondary: NYHA class III/IV improvement: Analyzed: 278 car: 28/130 (21. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Packer Dizziness: Withdrawals due to any adverse event: car=7(5. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Colucci Mild Age 18-85 with chronic symptomatic heart failure (dyspnea or 1996 23% fatigue) >3 months), LVEF <35% despite >2 months treatment with diuretics and ACEI. Carvedilol Heart NYHA class Failure Study Group II: 85% (Mild) III: 15% Fair quality Beta blockers Page 195 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Colucci Uncorrected primary valvular disease, nondilated or hypertrophic Carvedilol (car) 50 mg daily vs. Carvedilol Heart antiarrhythmic drugs or implantable defibrillator within 3 months; Failure Study Group likelihood of revascularization or transplantation within 12 months; sick Begin 12. Fair quality pressure >160 or <85 mm Hg or diastolic blood pressure >100 mm Hg; clinically significant hepatic or renal disease, or any condition that could Terminated early with significant limit survival. Patients receiving amiodarone within 3 months before screening. Beta blockers Page 196 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Colucci Background therapy held Primary: Mean age 55 Cause of heart failure: 1996 constant if possible, adjusted for progression of heart failure. Carvedilol Heart Secondary: Failure Study Group LVEF, NYHA class, heart failure Race NR (Mild) score, global assessments, quality of life, 9-minute self-powered Fair quality treadmill test, and heart size Beta blockers Page 197 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Beta blockers Page 198 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Colucci dizziness: nr 1996 car: 81/232 (34. Carvedilol Heart Failure Study Group cardiac failure: (Mild) car: 26/232 (11. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Cohn 22% Age 22-85; symptoms of heart failure (dyspnea or fatigue) >3 1997 months); LVEF <35% despite >2 months treatment with diuretics and NYHA class ACEI; able to walk less than 150 m on 6-minute corridor walk test U. Carvedilol Heart II: 1% assigned to severe protocol (relaxed to <350 m due to slow Failure Study Group III: 86% enrollment). IV: 14% Poor quality Beta blockers Page 200 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9.

Similarly 50 mg cytoxan visa anima sound medicine, valproate was found to have superior efficacy compared with lithium for patients experiencing mixed manic episodes discount 50mg cytoxan free shipping symptoms nausea headache, while in a systematic review of valproate in Antiepileptic drugs Page 53 of 117 Final Report Update 2 Drug Effectiveness Review Project 15 bipolar disorder cytoxan 50 mg otc medications venlafaxine er 75mg, response to the drugs was similar in patients with mania alone discount cytoxan 50mg on line treatment variance. These authors also found that irritability was more responsive to valproate than lithium or carbamazepine. Subgroup analyses by bipolar subtype were performed in a trial that compared lamotrigine with placebo maintenance therapy in patients who had bipolar I or II disorder with rapid cycling. The bipolar II subgroup consistently responded better to lamotrigine than placebo on time to premature discontinuation for any reason, proportion of patients who were stable 162 without relapse for 6 months, and GAS score. However, while time to relapse (the primary efficacy measure) was also longer with lamotrigine than placebo in the bipolar II subgroup (17 weeks compared with 7 weeks), this difference between treatments was not statistically significant (P=0. The bipolar I subgroup showed no significant difference between lamotrigine and placebo for any outcome. According to the authors, this finding was unexpected, since lamotrigine had previously been shown to be effective in bipolar I disorder. A high rate of response to placebo was observed in bipolar I patients and may be a confounder or an indication of other possible confounders. The factors accounting for different responses between the 2 bipolar subtypes need further clarification. Age We found 2 reports on the effect of antiepileptic drugs on symptoms of bipolar disorder in older 14, 164 patients. A pooled analysis evaluated data on 98 patients ≥ 55 years who had been randomized to lamotrigine, lithium, or placebo in these 2 studies of lamotrigine maintenance 164 therapy for which the primary outcome measure was time to intervention for a mood episode. Because the subgroups were small and not stratified at randomization, differences at baseline were present, such as mean lifetime hospitalizations, which were 11. Similar to the findings of the results across all ages, compared with placebo lamotrigine delayed the time to intervention for any mood disorder (manic, mixed manic, or depressive episode), while lithium delayed time to intervention for manic and mixed episodes only. The mean age in these subgroups was 61 years, older than the typical bipolar population but not elderly. Because these are post hoc subgroup analyses, they should be interpreted with caution. In a 2006 systematic review of evidence on antiepileptic drugs for bipolar disorder in patients > 60 years, Aziz and colleagues reported that there were no “published, controlled 14 studies with these medications that focus on late-life bipolar disorder. Comorbidity A small placebo-controlled trial in patients with both bipolar disorder and alcoholism found that valproate as adjunct treatment to lithium was no different from placebo in treating manic or depressive symptoms. Valproate did reduce the number of heavy drinking days; the number of 61 drinks per day on heavy drinking days was about the same as with placebo. Fibromyalgia Typically, trial populations were about 90% women. Pregabalin at 450 mg/d was statistically more efficacious than placebo in the primary analyses that included both men and women, as 105 well as a secondary analysis including only women. Antiepileptic drugs Page 54 of 117 Final Report Update 2 Drug Effectiveness Review Project 165 In a companion paper Arnold and colleagues studied the effect of anxiety and depression on improvement in pain in the pregabalin trial. Significantly more patients reported symptoms of anxiety (71%) than depression (56%; P<0. The pain treatment did not depend on baseline HAM-D score, suggesting that pregabalin improves pain in patients with or without symptoms of depression and anxiety. These analyses indicate that much (75%) of the pain reduction appears to be independent of improvements in anxiety or mood symptoms. Similarly the pregabalin trial might have excluded the most severely affected patients and patients with psychiatric comorbidity. Migraine prophylaxis Included trials did not provide sufficient evidence to determine comparative efficacy or safety in patients with migraine. Chronic pain Included trials did not provide sufficient evidence to determine comparative efficacy or safety in patients with chronic pain. Antiepileptic drugs Page 55 of 117 Final Report Update 2 Drug Effectiveness Review Project REFERENCES 1. Snow V, Weiss K, Wall EM, Mottur-Pilson C, American Academy of Family P, American College of Physicians-American Society of Internal M. Pharmacologic management of acute attacks of migraine and prevention of migraine headache. Prevalence and economic implications of chronic pain. Current methods of the US Preventive Services Task Force: a review of the process. Methods for Meta-Analysis in Medical Research: John Wiley & Sons, Inc. Vasudev A, MacRitchie K, Rao SNK, Geddes JR, Young AH. Tiagabine in the treatment of acute affective episodes in bipolar disorder: efficacy and acceptability. Vasudev A, MacRitchie K, Rao SNK, Geddes JR, Young AH. Tiagabine in the maintenance treatment of bipolar disorders. Macritchie K, Geddes JR, Scott J, Haslam D, de Lima M, Goodwin G. Valproate for acute mood episodes in bipolar disorder. Macritchie KA, Geddes JR, Scott J, Haslam DR, Goodwin GM. Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder. Effectiveness of mood stabilizers and antipsychotics in the maintenance phase of bipolar disorder: a systematic review of randomized controlled trials. Antiepileptic drugs Page 56 of 117 Final Report Update 2 Drug Effectiveness Review Project 19. Smith LA, Cornelius V, Warnock A, Tacchi MJ, Taylor D. Pharmacological interventions for acute bipolar mania: a systematic review of randomized placebo- controlled trials. A systematic review and economic model of the clinical effectiveness and cost-effectiveness of interventions for preventing relapse in people with bipolar disorder. Vasudev A, Macritchie K, Watson S, Geddes JR, Young AH. Oxcarbazepine in the maintenance treatment of bipolar disorder. Vasudev K, Macritchie K, Geddes JR, Watson S, Young AH.

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