CHICAGO (EGMN) – An extended-release formulation of gabapentin for hot flashes showed the potential both to minimize peak adverse events and to allow for less frequent dosing in a randomized, controlled trial of 565 women, said Dr. Wulf Utian.

“The results of the Breeze 2 study suggest that gabapentin–extended release 1,800 mg/day may be effective and well tolerated for the treatment of moderate to severe hot flashes in postmenopausal women,” he noted at the annual meeting of the North American Menopause Society.

Gabapentin-ER releases over 8 hours, potentially minimizing peak adverse events and allowing once daily or twice daily dosing, said Dr. Utian, the Arthur H. Bill Professor Emeritus of Reproductive Biology and Obstetrics and Gynecology at Case Western Reserve University in Cleveland. Gabapentin is a novel anticonvulsant.

Breeze 2 is a prospective, multicenter, randomized, double-blind, placebo-controlled study in postmenopausal women aged 18-70 years at 45 sites across the United States. The study had two active arms: gabapentin-ER 1,200 mg given once daily, and 1,800 mg given as 600 mg in the morning and 1,200 in the evening. Efficacy was assessed at 4 and 12 weeks, and the treatment duration was 3 months. The primary efficacy end points were reductions in the mean frequency of moderate to severe hot flashes and the average severity of hot flashes.

The trial’s secondary end points were the proportion of patients who were categorized as “much improved” or “very much improved” at 12 weeks in the self-reported Patient Global Impression of Change scale. Investigators also recorded their impression of the results of the therapy using the Clinician Global Impression of Change scale.

Postmenopausal women who had been experiencing seven or more moderate to severe hot flashes per day (or at least 50 per week), accompanied by sweating during at least the previous 30 days, were the trial population.

Baseline characteristics were similar across the three groups. In the 1,800-mg group, for example, the average age was 54 years, the women were 71% white, and the average body mass index was less than 30 kg/m².

Data were subjected to both parametric and nonparametric analysis, said Dr. Utian, because parametric analyses can be influenced by outliers.

At 4 weeks and 12 weeks, change in the mean severity of moderate and severe hot flashes was –0.6 and –0.8 for 1,800-mg group vs. placebo. Change in frequency of these hot flashes was at the same statistical level at both time points for both dosing groups.

More than 60% of patients in both groups and more than 40% in the placebo group self-reported and were clinician reported as “very much improved” at 12 weeks. “This was a particularly high placebo response,” said Dr. Utian.

Nonparametric analysis revealed a statistically significant change in median frequency of moderate to severe hot flashes at 4 weeks and 12 weeks in both active groups, compared with the placebo group.

Dizziness was the most commonly reported adverse event in both the 1,800-mg and 1,200-mg groups, whereas headache was most commonly reported in the placebo group. Somnolence was the second most common complaint in the active treatment groups. A total of 48 patients across both active treatment groups discontinued because of adverse events.

“Essentially, this long-release product was well tolerated, adverse events were mild, the difference was a slight difference in dizziness and somnolence during the titration, and [there was] no real difference in the adverse events” between the 1,800-mg and the 1,200-mg dosing regimens, said Dr. Utian. “The incidence of the adverse events declined markedly after 2-4 weeks of study therapy,” he added.

Dr. Utian is a clinical consultant to Depomed Inc., the sponsor of the study. Some of the study investigators are Depomed employees.

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芝加哥(EGMN) ——根据一项涉及565名绝经后妇女的随机对照研究Breeze2研究结果，应用控释型加巴喷丁治疗潮热症状，既可减少严重不良反应，又能减少用药次数。

 

Breeze2研究是一项前瞻性、多中心、双盲的随机安慰剂对照研究，研究对象来自美国45个地点的18~70岁绝经女性。克利夫兰市凯斯西储大学生殖生物学、妇产科学Arthur H. Bill荣誉教授Wulf Utian博士在北美绝经期协会年会上发布了该研究成果。该研究显示，剂量为每日1,800 mg的控释型加巴喷丁，在治疗绝经妇女中、重度潮热症状方面具有很好的效果和耐受性。控释片每次用药释放药物时间可超过8 h，每日仅需用药1~2次。

 

该研究由Depomed公司提供资金支持，Wulf Utian博士是Depomed公司的临床顾问。

 

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