Clinical studies with the new anxiolytic alpidem in anxious patients: an overview of the European experiences.

Alpidem is a new imidazopyridine compound which has been selected in animal pharmacology for its anxiolytic and anticonvulsant activity, and for its high therapeutic index. In healthy volunteers, alpidem was well tolerated up to doses of 300 mg and appeared to be devoid of CNS toxic effects. An extensive clinical development plan has been carried out in Europe to test its efficacy and safety in anxious patients. In a series of 5 double-blind placebo controlled parallel group studies, alpidem was administered as a single dose in a situation of stress induced anxiety where the stress was represented by diagnostic investigations such as gastroscopy, cardiac catheterisation or minor surgical operations. In these studies, 188 patients received placebo and 188 received alpidem; their anxiety was assessed before and after the drug administration by means of visual analogue scales and state anxiety inventories. Alpidem at 50 and 75 mg was significantly better than placebo in reducing stress induced anxiety. Alpidem was then administered to patients suffering from severe generalized anxiety in doses from 50 to 150 mg/day for 3-4 weeks in 3 double-blind placebo controlled studies: 127 patients received alpidem and 80 received placebo. Patients were assessed by means of rating scales and visual analogue scales. Alpidem did show an anxiolytic activity in this patient population and was well tolerated especially with regard to CNS side-effects.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes