Probing the safety of medications in the frail elderly: Evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents
Probing the safety of medications in the frail elderly: Evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents
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DOI：
10.4088/jcp.v64n0804
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发表时间：
2003-08-01
影响因子：
5.3
通讯作者：
Katz, IR
中科院分区：
文献类型：
--
作者：
Oslin, DW;Ten Have, TR;Katz, IR
背景资料。在养老院居民和其他虚弱的老年患者中，老年和潜在的药物-药物和药物-疾病相互作用可能会影响药物的相对安全性和有效性。本研究的目的是观察文拉法辛和舍曲林治疗养老院居民抑郁的疗效和耐受性。这项研究是一项为期10周的随机、双盲、对照试验，研究对象为52名患有DSM-IV抑郁障碍、至多患有中度痴呆症的老年养老院居民，分别服用文拉法辛(剂量不超过150毫克/天)和舍曲林(剂量不超过100毫克/天)。结果的主要衡量标准是汉密尔顿抑郁量表(HAM-D)。结果：12例受试者因严重不良事件(SAE)停药，5例因其他严重不良反应停药，2例撤回同意。在严重不良事件(对数等级统计=5.28，p=.022)、严重不良事件或副作用(对数等级统计=8.08，p=.005)或严重不良事件、副作用或撤回同意(对数等级统计=10.04，p=.002)方面，文拉法辛的耐受性低于舍曲林。基线时平均(SD)HAM-D评分舍曲林为20.2(3.4)，文拉法辛为20.3(3.7)；意向治疗终点HAM-D评分为12.2(5.1)和15.7(6.2)(F=3.45；p=.069)。在意向治疗样本或合并物的分类反应上没有差异。结论：在这一虚弱的老年人群中，文拉法辛的耐受性较差，安全性可能低于舍曲林，但没有证据表明疗效有所提高。这一意想不到的发现表明，需要对虚弱老年人的药物安全性进行系统研究。
Background. In nursing home residents and other frail elderly patients, old age and potential drug-drug and drug-disease interactions may affect the relative safety and efficacy of medications. The purpose of this study was to examine the efficacy and tolerability of venlafaxine and sertraline for the treatment of depression among nursing home residents.Method. The study was a 10-week randomized, double-blind, controlled trial of venlafaxine (doses up to 150 mg/day) versus sertraline (doses up to 100 mg/day) among 52 elderly nursing home residents with a DSM-IV depressive disorder and, at most, moderate dementia. The primary measure of outcome was the Hamilton Rating Scale for Depression (HAM-D). Adverse events were monitored and recorded systematically during the trial.Results: Twelve subjects were discontinued due to serious adverse events (SAE), 5 were discontinued due to other significant side effects, and 2 withdrew consent. Tolerability estimated by the time to termination was lower for venlafaxine than sertraline for serious adverse events (log rank statistic = 5.28, p = .022), for serious adverse events or side effects (log rank statistic = 8.08, p = .005), or for serious adverse events, side effects, or withdrawal of consent (log rank statistic = 10.04, p = .002). Mean (SD) HAM-D scores at baseline were 20.2 (3.4) for sertraline and 20.3 (3.7) for venlafaxine; intent-to-treat endpoint HAM-D scores were 12.2 (5.1) and 15.7 (6.2) (F = 3.45; p = .069). There were no differences in categorical responses for the intent-to-treat sample or completers.Conclusion: In this frail elderly population, venlafaxine was less well tolerated and, possibly, less safe than sertraline without evidence for an increase in efficacy. This unexpected finding demonstrates the need for systematic research on the safety of drugs in the frail elderly.