ROLE OF PIVAGABINE IN THE TREATMENT OF CLIMACTERIC SYNDROME

A multicenter, double-blind, controlled study of pivagabine (4-[(2,2-d imethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg(R)) wa s conducted in 186 female patients (age: 33-79 years) suffering from c limacteric syndrome. In these patients, climacteric syndrome was mainl y constitued by symptoms of anxiety, often with mild symptoms of depre ssion and sometimes with mild symptoms of cardiac somatization. The en rolled patients were randomized to two treatment groups: the first gro up was administered pivagabine, 900 mg/d, fcr 90 days in succession; t he second group was administered placebo for the same period. The effi cacy of the treatments was assessed by the Hamilton Depression Rating Scale (HDRS) and the Zung's Self-rating Anxiety Scale (SAS) before the start of treatment, after one month and at the end of treatment. At t he end of the study, the physicians and the patients were also request ed to evaluate the efficacy of the two treatments. Tolerability was ev aluated by recording side effects and by assessing the course of arter ial blood pressure, of heart rate and of selected laboratory parameter s. The study showed that pivagabine was able to reduce symptoms of anx iety and depression. As a consequence, when asked to evalulate the eff icacy, the physicians and the patients consistently stated that pivaga bine was effective in controlling the symptoms of anxiety, often assoc iated with mild symptoms of depression, that may arise during the clim acterium. Furthermore, these results were obtained with a high safety margin, since the few side effects recorded were mild and transient an d the laboratory results were normal as well as the physical examinati on findings.