Role of pivagabine in the treatment of climacteric syndrome.

A multicenter, double-blind, controlled study of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg) was conducted in 186 female patients (age: 33-79 years) suffering from climacteric syndrome. In these patients, climacteric syndrome was mainly constituted by symptoms of anxiety, often with mild symptoms of depression and sometimes with mild symptoms of cardiac somatization. The enrolled patients were randomized to two treatment groups: the first group was administered pivagabine, 900 mg/d, for 90 days in succession; the second group was administered placebo for the same period. The efficacy 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 the end of the study, the physicians and the patients were also requested to evaluate the efficacy of the two treatments. Tolerability was evaluated by recording side effects and by assessing the course of arterial blood pressure, of heart rate and of selected laboratory parameters. The study showed that pivagabine was able to reduce symptoms of anxiety and depression. As a consequence, when asked to evaluate the efficacy, the physicians and the patients consistently stated that pivagabine was effective in controlling the symptoms of anxiety, often associated with mild symptoms of depression, that may arise during the climacterium. Furthermore, these results were obtained with a high safety margin, since the few side effects recorded were mild and transient and the laboratory results were normal as well as the physical examination findings.

RCT Entities:   Population Interventions Outcomes