The efficacy and safety of a new enteric-coated formulation of fluoxetine given once weekly during the continuation treatment of major depressive disorder
The efficacy and safety of a new enteric-coated formulation of fluoxetine given once weekly during the continuation treatment of major depressive disorder
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DOI：
10.4088/jcp.v61n1107
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发表时间：
2000-11-01
影响因子：
5.3
通讯作者：
Judge, R
中科院分区：
文献类型：
--
作者：
Schmidt, ME;Fava, M;Judge, R
背景：一个简单的，每周一次的给药方案可能是一个方便的选择，许多患者在长期治疗抑郁症。这样的策略也可能是有效的，以提高药物的依从性和继续治疗的结果。在持续治疗重性抑郁症期间，测试了每周一次给予肠溶氟西汀（90 mg）新制剂的安全性和有效性。方法：使用改良的17项汉密尔顿抑郁量表，符合DSM-IV重度抑郁障碍标准的患者（HAM-D-17）评分大于或等于18且临床总体印象-疾病严重程度量表（CGI-S）评分大于或等于4的患者接受开放标签20 mg/kg治疗13周。一项多中心美国研究中氟西汀的治疗日。应答者（N = 501）被随机分配接受每日20 mg氟西汀、安慰剂或每周90 mg肠溶氟西汀，持续25周的双盲持续治疗。主要疗效指标是复发患者的百分比。使用Kaplan-Meier复发率估计值的对数秩分析，在25周持续期内检验至复发时间。其他疗效分析包括按末次观察值结转法（LOCF）比较HAM-D-17、CGI-S和HAM-D-28子量表从基线至终点的变化。安全性措施包括比较治疗后出现的不良事件，自发和征集（使用协会的文件在精神病学-模块5的方法），生命体征，和实验室measures.Results：复发率分配给氟西汀的患者，无论是20毫克每天或90毫克每周，显着低于安慰剂的对数秩分析和LOCF分析的次要疗效措施。根据这些指标，2个活性药物组之间的疗效无显著差异。肠溶氟西汀在一个每周一次的剂量为90毫克耐受性良好，其安全性是类似的，每天20毫克的fluoxetine.Conclusion：肠溶氟西汀的配方采取每周一次是有效的，安全的，耐受性良好的持续治疗抑郁症的患者谁回应急性治疗与20毫克/天的氟西汀。无论给药方案如何，在长期治疗期间监测持续缓解的证据都很重要。
Background: A simple, once-weekly dosing regimen could be a convenient alternative for many patients during long-term treatment of depression. Such a strategy might also be effective for improving medication compliance and the outcome of continuation treatment. The safety and effectiveness of a new formulation of enteric-coated fluoxetine (90 mg) given once weekly was tested during the continuation treatment of major depressive disorder.Method: Patients meeting DSM-IV criteria for major depressive disorder with modified 17-item Hamilton Rating Scale for Depression (HAM-D-17) scores greater than or equal to 18 and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores greater than or equal to 4 were treated 13 weeks with open-label 20 mg/day of fluoxetine in a multicenter U.S. study. Responders (N = 501) were randomly assigned to receive 20 mg of fluoxetine daily, placebo, or 90 mg of enteric-coated fluoxetine weekly for 25 weeks of double-blind continuation treatment. The primary efficacy measure was the percentage of patients who relapsed. Time to relapse was tested over the 25-week continuation period using log-rank analyses of the Kaplan-Meier estimates of relapse rates. Additional analyses of efficacy included comparison of change from baseline to endpoint for the HAM-D-17, CGI-S, and HAM-D-28 subscales by last observation carried forward (LOCF). Safety measures included comparison of treatment-emergent adverse events, both spontaneous and solicited (using the Association for Methodology of Documentation in Psychiatry-Module 5), vital signs, and laboratory measures.Results: Relapse rates for patients assigned to fluoxetine, either 20 mg daily or 90 mg weekly, were significantly lower than for placebo by log-rank analysis and LOCF analyses of secondary efficacy measures. Efficacy did not significantly differ between the 2 active drug groups by these measures. Enteric-coated fluoxetine at a once-weekly dose of 90 mg was well tolerated, and its safety profile was similar to that of daily 20 mg of fluoxetine.Conclusion: The formulation of enteric-coated fluoxetine taken once weekly is effective, safe, and well tolerated for continuation treatment of depression in patients who responded to acute treatment with 20 mg/day of fluoxetine. Monitoring during long-term treatment fur evidence of sustained remission is important regardless of dosing regimen.