[A pharmacovigilance study with bentazepam in a sample of 1046 psychiatric outpatients]

A pharmacovigilance study was performed upon 1,046 ambulatory patients that have been treated in external psychiatric consultation with bentazepam. The sample size made possible to detect with 99% of security the incidence higher to 5% secondary effects, as mouth dryness, somnolence, asthenia, gastralgias/dyspepsias, constipation and sickness. It has as well been possible to detect the most usual ways of coprescription, and the most frequent was with antidepressants drugs that undertook approximately 1/3 of the sample and that it was responsible for some of the secondary effects observed. The bentazepam treatment cut down significatively the score mean in Hamilton scale for the anxiety after 10-15 days of treatment. According to an intention analysis a therapeutic profit was got in the 76.7% of the sample depending on medical criteria and the 74.0% on patient criteria after 20-30 days of the treatment. The results obtained are discussed in terms of the sample characteristics.