VERALIPRIDE FOR HOT FLUSHES INDUCED BY A GONADOTROPIN-RELEASING-HORMONE AGONIST - A CONTROLLED-STUDY

Objectives: To evaluate the efficacy of veralipride, a benzamide deriv ative, in the treatment of hot flushes induced by GnRH agonists (GnRH- a) and to study peripheral blood mononuclear cell beta-endorphin conce ntrations during drug administration. Design: Randomized, placebo-cont rolled, double-blind trial. Setting: Academic department of obstetrics and gynecology. Patients: Forty women of mean age 43 +/- 5 years who experienced disturbing hot flushes during a 4-month course of tryptore lin depot for myoma-associated menorrhagia. Interventions: Treatment w ith oral veralipride 100 mg/d (20 subjects) or matching placebo (20 su bjects) during the third month of GnRH-a administration. Main Outcome Measures: Modifications of frequency and severity of hot flushes as sh own by a 0 to 6-point vasomotor scoring system and variations of beta- endorphin levels in peripheral blood mononuclear cells. Results: Two s ubjects in each group dropped out of the study. The median (range) vas omotor score at the end of the second month of treatment was 4 (3 to 6 ) in both the veralipride and placebo group. At the end of the third a nd fourth months the median (range) scores were, respectively, 2 (0 to 6) versus 4 (1 to 6) and 2 (0 to 5) versus 4 (1 to 6). No significant variations in mononuclear cell beta-endorphin concentrations were rec orded. Serum PRL levels rose from 11.7 +/- 5.7 to 132.3 +/- 65.0 ng/mL (conversion factor to SI unit, 1.0) during veralipride administration and returned to 10.6 +/- 3.7 ng/mL after drug withdrawal. Conclusion: Veralipride reduced vasomotor symptoms induced by a GnRH-a. Transient hyperprolactinemia was the main side effect observed. The mode of act ion of the drug in GnRH-a-treated patients and possible interactions w ith endogenous opioid peptides need further elucidation.