title: Meta-analysis of the safety and tolerability of two dose regimens of buspirone in patients with persistent anxiety.
abstract: Buspirone is an azapirone with 5-HT1A 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.
authors.affiliation: California Clinical Trials, Beverly Hills 90211, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Sramek
authors.forename: W W
authors.initials: WW
authors.lastname: Hong
authors.forename: S
authors.initials: S
authors.lastname: Hamid
authors.forename: B
authors.initials: B
authors.lastname: Nape
authors.forename: N R
authors.initials: NR
authors.lastname: Cutler
mesh_terms: D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects; D001008:Anxiety Disorders / Q000188:drug therapy*; D002065:Buspirone / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans
chemical_list: D014151:Anti-Anxiety Agents; D002065:Buspirone