小剂量帕罗西汀获准用于治疗潮热

美国食品药品管理局(FDA)在6月28日批准帕罗西汀(Brisdelle)用于治疗中重度潮热，但用药剂量必须低于治疗抑郁症、强迫症及其他精神疾病的帕罗西汀制剂。

FDA药物评价与研究中心骨、生殖及泌尿系统产品部主任Hylton Joffe博士在一则声明中指出，有相当多的女性承受着与绝经有关的潮热的困扰，并且不想使用激素疗法。此批准令为这些女性提供了首个经FDA批准的非激素治疗选择，这种疗法有助于减轻绝经期常见的潮热症状。其他所有获准的治疗药物均含有雌二醇或雌二醇+孕酮。

Brisdell的用法将为：7.5 mg，每日1次，睡前服用。FDA是根据2项随机、双盲、安慰剂对照研究的结果下达此批准令的，这2项研究涉及1,175例每天潮热至少发作7~8次或每周至少发作50~60次的绝经后女性。其中一项研究的疗程为12周，另一项研究的疗程为24周。在疗程为24周的研究中，在第4周时，治疗组女性每周潮热的发作次数减少28.9次，而安慰剂对照组减少19次；在第12周时，治疗组减少37.2次，而安慰剂对照组减少27.6次。在第24周时差异仍然存在，并且具有统计学意义。疗程为12周的试验得出了相似的结果。

服用该药最常见的副作用为头痛、疲乏及恶心或呕吐。

FDA表示，“所有获准用于治疗抑郁的药物，其中包括Paxil和Pexeva，均带有一个关于儿童和青年人服药后自杀风险增加的黑框警告。由于Brisdelle含有与Paxil和Pexeva相同的有效成分，故其说明书中也有一个与自杀有关的黑框警告。”

Brisdelle的说明书中还警告，如果与他莫昔芬同服，其有效性可能会降低，出血风险增加，并且还有发生5-羟色胺综合征的风险。该药将带有一份患者用药指导。

Brisdelle和Pexeva由Noven制药公司上市销售。Paxil由葛兰素史克公司销售。

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By: M. ALEXANDER OTTO, Internal Medicine News Digital Network

The Food and Drug Administration June 28 approved paroxetine (Brisdelle) for moderate to severe hot flashes, but in a dose lower than paroxetine formulations indicated for depression, obsessive-compulsive disorder, and other psychiatric problems.

"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments. Today’s approval provides women with the first FDA-approved, nonhormonal therapeutic option to help ease the hot flashes that are so common in menopause," Dr. Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products in the agency’s Center for Drug Evaluation and Research, said in a statement. All other approved treatments contain estrogen or estrogen plus a progestin.

Brisdelle is to be taken in a 7.5-mg dose once daily at bedtime. Approval came after two randomized, double-blind, placebo-controlled studies in 1,175 postmenopausal women with at least seven to eight hot flashes per day, or 50-60 per week. Treatment lasted 12 weeks in one study and 24 weeks in the other. At week 4 in the 24 week study, treated women had 28.9 fewer hot flashes per week, vs. 19 fewer on placebo; at week 12, they had 37.2 fewer, vs. 27.6 fewer on placebo. Differences persisted at 24 weeks and were statistically significant. Results were similar in the 12 week trial.

Headache, fatigue, and nausea/vomiting were the most common side effects.

"All medications that are approved for treating depression, including Paxil and Pexeva, have a boxed warning about an increased risk of suicide in children and young adults. Because Brisdelle contains the same active ingredient as Paxil and Pexeva, a boxed warning about suicidality is included in the Brisdelle label," the agency noted.

Brisdelle’s label also warns of a possible reduction in the effectiveness of tamoxifen if both medications are used together, an increased risk of bleeding; and a risk of developing serotonin syndrome. The drug will come with a Medication Guide for patients.

Brisdelle and Pexeva are marketed by Noven Therapeutics. GlaxoSmithKline markets Paxil.

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