The safety of veralipride.

The perimenopausal period, from 1 to 4 years, is characterised by vasomotor symptoms, or hot flushes, and other effects due a deficit of estrogens. Approximately 85% of women have hot flushes for 1 year and 25 - 50% continue for up to 5 years. The cause of hot flushes has been linked to dysfunction of the thermoregulatory centre caused by estrogen withdrawal. One proposal for the aetiology of hot flushes is that the thermoregulatory zone is shifted downward in patients who experience hot flushes. Estrogen withdrawal creates a change of the central opioid system and a thermoregulatory instability. Estrogen and/or progestin replacement is the treatment of choice for this distressing symptom. However, steroid replacement may be associated with risks and complications, and is limited in some subjects by well-known contraindications. Veralipride, a synthetic benzamide derivative with antidopaminergic action, is effective in reducing the frequency and severity of hot flushes associated with menopausal hypoestrogenism, gaining interest as a non-hormonal treatment for climacteric flushing. In recent years, extrapyramidal disorders associated with veralipride therapy have been reported and are often due to drug misuse. Adverse effects include acute dyskinesia or Parkinsonism, which may occur after many months of treatment. An association between adverse effects and mistake of administration has been described. This article discusses available data on the benefits and risks of veralipride therapy for menopausal symptoms.

Effects of raloxifene therapy on plasma renin and aldosterone levels and blood pressure in postmenopausal women.

OBJECTIVE: Blood pressure, which generally increases after menopause, is one of the best tools to characterize cardiovascular disease. The renin-aldosterone system plays a role in determining cardiovascular risk and the role of estrogen in the regulation of angiotensinogen gene expression and serum levels is well known. Raloxifene can induce endothelium-dependent vasodilation without affecting endothelium-independent vasorelaxation. The aim of the study was to investigate the effects of raloxifene on the renin-aldosterone system and blood pressure in postmenopausal women. DESIGNS: Forty women, 54-59 years of age, in physiological menopause for 6 months to 4 years, were enrolled in the study and treated with raloxifene 60 mg/day for 6 months. All had blood pressure less than 130/85 mm Hg at the start of the study. The women were divided into two groups: the first (group A; 20 women) with normal blood pressure and the second (group B; 20 women) with previous high blood pressure treated with antihypertensive drugs, not angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. RESULTS: No significant changes in plasma renin activity (PRA) or plasma concentrations of aldosterone were observed between the two groups after 6 months of raloxifene use. There was a slight reduction in PRA (11+/-4% for group A and 13+/-5% for group B) and in plasma levels of aldosterone (3.6+/-0.5% and 4.6+/-0.5%, respectively) with respect to basal values, but neither change was statistically significant. CONCLUSIONS: The results of the present study show that raloxifene at 60 mg/day dose is well tolerated and has no clinical impact on blood pressure, PRA or aldosterone in postmenopausal women.