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Meta‐analysis of the safety and tolerability of two dose regimens of buspirone in patients with persistent anxiety
Author(s) -
Sramek John J.,
Hong Walter W.,
Hamid Suha,
Nape Barbara,
Cutler Neal R.
Publication year - 1999
Publication title -
depression and anxiety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.634
H-Index - 129
eISSN - 1520-6394
pISSN - 1091-4269
DOI - 10.1002/(sici)1520-6394(1999)9:3<131::aid-da5>3.0.co;2-h
Subject(s) - buspirone , tolerability , anxiety , medicine , adverse effect , nausea , placebo , regimen , anesthesia , psychiatry , agonist , receptor , alternative medicine , pathology
Buspirone is an azapirone with 5‐HT 1A partial agonist activity which has demonstrated efficacy in the treatment of generalized anxiety disorder, commonly referred to as persistent anxiety. In this meta‐analysis report, safety results from two studies comparing buspirone 15 mg twice daily (BID) with buspirone 10 mg three times daily (TID) in patients with persistent anxiety are presented. In the study protocols, qualified patients completed a 7‐day placebo lead‐in phase and were randomized to receive buspirone 30 mg per day, as either a BID or TID regimen, for 6‐8 weeks. A total of 289 patients received buspirone 15 mg BID (n=144) or 10 mg TID (n=145) at 15 sites. The incidence of adverse events was similar between the two treatment groups, except for a significantly greater incidence of palpitations in patients receiving buspirone BID (5%) compared to buspirone TID (1%). The most frequently reported adverse events for both buspirone BID‐ and TID‐treated patients were dizziness, headache, and nausea. No appreciable differences between treatments were observed for vital signs, physical exam, ECG, or clinical laboratory results. A change to BID dosing for buspirone may offer convenience and possibly higher compliance in patients with persistent anxiety without compromising the excellent safety and tolerability profile of the medication. Depression and Anxiety 9:131–134, 1999. © 1999 Wiley‐Liss, Inc.