Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial.
Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial.
复制标题
DOI：
10.1016/j.jacc.2010.03.068
复制
发表时间：
2010-08-24
影响因子：
24
通讯作者：
Krishnan, Ranga
中科院分区：
文献类型：
--
作者：
O'Connor, Christopher M.;Jiang, Wei;Kuchibhatla, Maragatha;Silva, Susan G.;Cuffe, Michael S.;Callwood, Dwayne D.;Zakhary, Bosh;Stough, Wendy Gattis;Arias, Rebekka M.;Rivelli, Sarah K.;Krishnan, Ranga
目的是验证与安慰剂相比，接受舍曲林治疗的心力衰竭（HF）患者抑郁评分较低，心血管事件较少的假设。心衰患者常见抑郁。它与住院率和死亡率增加有关。SADHART-CHF是一项随机、双盲、安慰剂对照试验，服用舍曲林50 - 200mg /天，对照安慰剂12周。所有参与者均接受护士辅助支持。符合条件的患者为年龄≥45岁，伴有HF （LVEF≤45%，NYHA II-IV级）和临床抑郁（DSM-IV当前重度抑郁障碍标准）。排除了显著的认知障碍、精神病、最近的酒精或药物依赖、双相情感障碍或严重的人格障碍、积极的自杀意念和目前的抗精神病或抗抑郁药物。主要终点是12周时抑郁严重程度（汉密尔顿抑郁评定量表[HDRS]总分）和复合心血管状态的变化。随机选取469例患者（舍曲林234例，安慰剂235例）。基线至12周HDRS总分的平均±SE变化为-7.1±0.5（舍曲林组）和-6.8±0.5（安慰剂组）（与基线相比P< 0.001，组间P= 0.89，组间平均变化-0.4,95% CI -1.7, 0.92）。舍曲林组心血管综合评分恶化、改善或保持不变的比例分别为29.9%、40.6%、29.5%，安慰剂组为31.1%、43.8%、25.1% （P=0.78）。舍曲林对明显心衰患者是安全的。然而，与安慰剂相比，舍曲林治疗并没有在心衰合并抑郁症患者中提供更大的抑郁减少或心血管状态的改善。
The objective was to test the hypothesis that heart failure (HF) patients treated with sertraline will have lower depression scores and fewer cardiovascular events compared to placebo. Depression is common among HF patients. It is associated with increased hospitalization and mortality. SADHART-CHF was a randomized, double-blind, placebo-controlled trial of sertraline 50 to 200 mg/day versus matching placebo for 12 weeks. All participants also received nurse facilitated support. Eligible patients were age ≥45 years with HF (LVEF ≤45%, NYHA class II-IV) and clinical depression (DSM-IV criteria for current major depressive disorder). Significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medications were exclusions. Primary endpoints were change in depression severity (Hamilton Depression Rating Scale [HDRS] total score) and composite cardiovascular status at12-weeks. 469 patients were randomized (N=234 sertraline, N=235 placebo). The mean ± SE change from baseline to 12-weeks in the HDRS total score was -7.1 ± 0.5 (sertraline) and -6.8 ± 0.5 (placebo) (P<.001 from baseline, P=.89 between groups, mean change between groups -0.4, 95% CI -1.7, 0.92). The proportion whose composite cardiovascular score worsened, improved, or was unchanged was 29.9%, 40.6%, and 29.5% in the sertraline group and 31.1%, 43.8%, and 25.1% in the placebo group (P=0.78). Sertraline was safe in patients with significant HF. However, treatment with sertraline compared with placebo did not provide greater reduction in depression or improved cardiovascular status among patients with HF and depression.
登录
查看更多内容
影响因子：
4.8
作者：
Jiang, Wei;O'Connor, Christopher;Silva, Susan G.;Kuchibhatla, Maragatha;Cuffe, Michael S.;Callwood, Dwayne D.;Zakhary, Bosh;Henke, Elizabeth;Arias, Rebekka M.;Krishnan, Ranga
通讯作者：
Krishnan, Ranga
影响因子：
18.2
作者：
Serebruany, VL;Glassman, AH;O'Connor, CM
通讯作者：
O'Connor, CM
影响因子：
18.2
作者：
Angermann, Christiane E.;Gelbrich, Goetz;Ertl, Georg
通讯作者：
Ertl, Georg
影响因子：
6
作者：
Mueller-Tasch, Thomas;Peters-Klimm, Frank;Herzog, Wolfgang
通讯作者：
Herzog, Wolfgang
影响因子：
4.8
作者：
Gurbel, PA;Gattis, WA;O'Connor, CM
通讯作者：
O'Connor, CM