Veralipride versus conjugated oestrogens: A double-blind study in the management of menopausal hot flushes

Abstract

A double-blind, randomized study was carried out in 43 women, who had undergone spontaneous menopause at least 6 months earlier, to compare the effectiveness and tolerance of veralipride with that of a conjugated oestrogens preparation in the control of hot flushes. Twenty-one women received 100 mg veralipride per day and 22 were due to receive 1.25 mg per day of the hormone preparation over a period of 20 days but 3 women in the oestrogen group discontinued the trial without giving any reason. The number, duration and severity of hot flushes were assessed and scored at the start of the trial and during treatment. Statistical analysis of the results showed marked relief with both preparations but no significant difference between them in terms of effectiveness or tolerance. Veralipride, however, appeared to provide better control in patients who had complained of severe hot flushes initially.

Hot Flashes: The Old and the New, What Is Really True?

“…Veralipride is a first cousin of cisapride, which has been approved for the treatment of hot flashes in several countries, and compared favorably with estrogen. 15 However, the occurrence of central nervous system adverse effects such as tremor and pseudoparkinsonian symptoms has limited the use of this agent.…”

Actual status of veralipride use

“…The schedules in use have different rates of effectiveness (Table 2) and secondary effects and are:7,36,39–41 Classic schedule, 100 mg/day for 20 days, with 10 days drug free for no more than 6 months;100 mg/day for 7 days, followed by 100 mg every 48 hours for 1 month, followed by 100 mg/day twice a week for 3–6 months;100 mg/day from Monday to Friday with Saturday and Sunday free of treatment;100 mg/day for 2 days, and 2 days without treatment, and then repeat;100 mg every 48 hours for 3–6 months.…”

“…One of the main secondary effects of veralipride use is hyperprolactinemia, which may or may not be accompanied by galactorrhea, and can disappear at 48 hours of treatment withdrawal,39 other studies indicate that the normalization of prolactin levels can take 2 or 3 weeks 45. Reported prolactin levels after 2 cycles have been 106.2 ± 41.5 ng/mL;39 others have reported levels 10 times higher than those at baseline 46.…”

“…Reported prolactin levels after 2 cycles have been 106.2 ± 41.5 ng/mL;39 others have reported levels 10 times higher than those at baseline 46. A clinical study reported that after veralipride administration at a dose of 100 mg/day for 6 months on alternate days or months, the prolactin levels were not higher than 21 ng/mL 7.…”

Menopause and Hot Flashes: No Easy Answers to a Complex Problem

“…In a double-blind, randomized study, veralipride was compared to a high dose of conjugated estrogens (1.25 mg); efficacy for hot flashes was equal. 24 The adverse effects of galactorrhea, elevated prolactin levels, and weight gain of 5 kg limit use of veralipride in clinical practice. The α 2 -adrenergic agonists reduce hot flashes due to alteration of hypothalamic neurotransmitters and stabilization of the thermoregulatory center.…”