A systematic review of placebo-controlled trials of XXXX : How useful is a multiple-indications review for evaluating the adverse events of an antiepileptic drug?

@entity1 @entity1296 @entity1183 @entity132 @entity3180 @entity73 @entity22717 @entity2147 @entity2704 @entity1771 @entity302 @entity8408 @entity2414 @entity2342 @entity2055
OBJECTIVE: @entity1771 ( @entity22717 ) is an antiepileptic drug that is also used for other indications (e.g., @entity2704 ). Adverse event (AE) data from @entity302 trials could be supplemented by data from trials in other indications. Combining data across trials and indications is a novel method for evaluating AEs. We conducted a multiple-indications review by systematically reviewing randomized placebo-controlled trials of @entity22717 , to compare the nervous system AEs of @entity22717 in @entity302 with those in other indications. METHODS: Randomized placebo-controlled trials of @entity22717 including @entity1 with any indication were included. We searched Cochrane Central Register of Controlled Trials (Issue 2, 2012) and MEDLINE (1966-February 2012). Two authors assessed eligibility and risk of bias, and extracted data. For each reported nervous system AE, we extracted event rates, applied random-effects inverse-variance meta-analysis (pooling within-indications then across-indications), and assessed within- and across-indication heterogeneity. RESULTS: Ninety trials, including 16 @entity302 trials, were included. A difference was detected between @entity22717 and placebo for three events (i.e., drooling, @entity2342 , and @entity1183 ) that were not reported in @entity302 trials but were reported by other trials. A difference between @entity22717 and placebo was detected for @entity8408 using @entity302 trials but not when combining all trials. For two events (i.e., @entity73 and " @entity3180 "), no difference was detected between @entity22717 and placebo when using @entity302 trials alone, but a difference was identified using all trials. A difference was detected between @entity22717 and placebo for six events (i.e., @entity2055 , @entity132 in attention, @entity1296 , @entity2414 , paraesthesia, and @entity2147 ) when using @entity302 trials alone, and using all trials. SIGNIFICANCE: Including trials of any indication enabled detection of differences that would have been missed using @entity302 trials alone. Multiple-indications reviews can improve the synthesis of AEs for antiepileptic drugs.
