Efficacy and Tolerability of Desvenlafaxine Succinate Treatment for Menopausal Vasomotor Symptoms: A Randomized Controlled Trial
Efficacy and Tolerability of Desvenlafaxine Succinate Treatment for Menopausal Vasomotor Symptoms: A Randomized Controlled Trial
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琥珀酸去甲文拉法辛治疗更年期血管舒缩症状的疗效和耐受性：随机对照试验
DOI：
10.1097/01.aog.0000297371.89129.b3
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发表时间：
2008
影响因子：
7.2
通讯作者：
S. Olivier
中科院分区：
文献类型：
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作者：
L. Speroff;M. Gass;G. Constantine;S. Olivier
目的：比较琥珀酸去甲文拉法辛（去甲文拉法辛）与安慰剂治疗血管痉挛症状的有效性和安全性。方法：采用正交设计法这项随机、双盲、安慰剂对照试验纳入了707名健康的绝经后妇女，她们每周有50次或更多的中度至重度潮热。参与者每天随机接受50、100、150或200 mg去甲文拉法辛或安慰剂。试验持续时间为52周。主要结果是第4周和第12周时中重度潮热的平均每日次数和每日潮热严重程度评分较基线的变化。研究结果：基线时平均每天有11次中度至重度潮热的620名女性完成了至少一次主要疗效终点的治疗评价; 519名参与者完成了12周的治疗，368名完成了研究。第4周时，与安慰剂相比，地文拉法辛100 mg/d显著降低了每日平均潮热次数（P= 0.013）和12（P= 0.005），在第12周较基线下降64%，与安慰剂相比，去甲文拉法辛100 mg组的75%应答率（50%）显著较高（29%; P= 0.003;需要治疗的人数=4.7）。在第12周，与安慰剂组相比，去甲文拉法辛100 mg组每日平均潮热严重程度显著降低（P= 0.020）。仅在治疗的第一周，接受地文拉法辛治疗的女性报告的治疗后出现的不良事件明显多于安慰剂治疗的女性。结论：地文拉法辛是一种有效的非激素治疗绝经后妇女血管痉挛症状。其耐受性特征与其他阿托宁-去甲肾上腺素再摄取抑制剂一致。临床试验注册：ClinicalTrials.gov，www.clinicaltrials.gov，NCT 00421031证据等级：I
OBJECTIVE: To compare efficacy and safety of desvenlafaxine succinate (desvenlafaxine) with placebo for the treatment of vasomotor symptoms. METHODS: This randomized, double-blind, placebo-controlled trial enrolled 707 healthy, postmenopausal women experiencing 50 or more moderate-to-severe hot flushes per week. Participants randomly received desvenlafaxine 50, 100, 150, or 200 mg or placebo daily. Trial duration was 52 weeks. Primary outcomes were change from baseline in average daily number of moderate-to-severe hot flushes and in daily hot flush severity score at weeks 4 and 12. RESULTS: Six hundred twenty women with an average of 11 moderate-to-severe hot flushes per day at baseline completed at least one on-therapy evaluation for primary efficacy end points; 519 participants completed 12 weeks of treatment, and 368 completed the study. Desvenlafaxine 100 mg/d achieved a significantly greater reduction compared with placebo in average daily number of hot flushes at weeks 4 (P=.013) and 12 (P=.005), reaching a 64% decrease from baseline at week 12, and the 75% responder rate was significantly higher for desvenlafaxine 100 mg (50%) compared with placebo (29%; P=.003; number needed to treat=4.7) at week 12. Average daily severity of hot flushes was significantly lower in the desvenlafaxine 100-mg group compared with placebo at week 12 (P=.020). Desvenlafaxine-treated women reported significantly more treatment-emergent adverse events than placebo-treated women during the first week of therapy only. CONCLUSION: Desvenlafaxine is an effective nonhormonal treatment for vasomotor symptoms in postmenopausal women. Its tolerability profile is consistent with that of other serotonin-norepinephrine reuptake inhibitors. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00421031 LEVEL OF EVIDENCE: I
DOI：
--
发表时间：
1997-12
期刊：
The Journal of pharmacology and experimental therapeutics
影响因子：
--
作者：
M. Owens;W. N. Morgan;S. Plott;C. Nemeroff
通讯作者：
M. Owens;W. N. Morgan;S. Plott;C. Nemeroff
DOI：
10.1016/j.amjmed.2005.09.057
发表时间：
2005-12-19
期刊：
The American journal of medicine
影响因子：
--
作者：
Avis, Nancy E;Brockwell, Sarah;Colvin, Alicia
通讯作者：
Colvin, Alicia