Exner D V, Dries D L, Domanski M J, Cohn J N
Cardiovascular Research Group, University of Calgary, Alta, Canada.
N Engl J Med. 2001 May 3;344(18):1351-7. doi: 10.1056/NEJM200105033441802.
Black patients with heart failure have a poorer prognosis than white patients, a difference that has not been adequately explained. Whether racial differences in the response to drug treatment contribute to differences in outcome is unclear. To address this issue, we pooled and analyzed data from the Studies of Left Ventricular Dysfunction (SOLVD) prevention and treatment trials, two large, randomized trials comparing enalapril with placebo in patients with left ventricular dysfunction.
We used a matched-cohort design in which up to four white patients were matched with each black patient according to trial, treatment assignment, sex, left ventricular ejection fraction, and age. A total of 1196 white patients (580 from the prevention trial and 616 from the treatment trial) were matched with 800 black patients (404 from the prevention trial and 396 from the treatment trial). The average duration of follow-up was 35 months in the prevention trial and 33 months in the treatment trial.
The black patients and the matched white patients had similar demographic and clinical characteristics, but the black patients had higher rates of death from any cause (12.2 vs. 9.7 per 100 person-years) and of hospitalization for heart failure (13.2 vs. 7.7 per 100 person-years). Despite similar doses of drug in the two groups, enalapril therapy, as compared with placebo, was associated with a 44 percent reduction (95 percent confidence interval, 27 to 57 percent) in the risk of hospitalization for heart failure among the white patients (P<0.001) but with no significant reduction among black patients (P=0.74). At one year, enalapril therapy was associated with significant reductions from base line in systolic blood pressure (by a mean [+/-SD] of 5.0+/-17.1 mm Hg) and diastolic blood pressure (3.6+/-10.6 mm Hg) among the white patients, but not among the black patients. No significant change in the risk of death was observed in association with enalapril therapy in either group.
Enalapril therapy is associated with a significant reduction in the risk of hospitalization for heart failure among white patients with left ventricular dysfunction, but not among similar black patients. This finding underscores the need for additional research on the efficacy of therapies for heart failure in black patients.
心力衰竭的黑人患者比白人患者预后更差,这一差异尚未得到充分解释。药物治疗反应中的种族差异是否导致了预后差异尚不清楚。为解决这一问题,我们汇总并分析了左心室功能障碍研究(SOLVD)预防和治疗试验的数据,这两项大型随机试验比较了依那普利与安慰剂对左心室功能障碍患者的疗效。
我们采用匹配队列设计,根据试验、治疗分配、性别、左心室射血分数和年龄,每例黑人患者最多与4例白人患者匹配。共有1196例白人患者(580例来自预防试验,616例来自治疗试验)与800例黑人患者(404例来自预防试验,396例来自治疗试验)匹配。预防试验的平均随访时间为35个月,治疗试验为33个月。
黑人患者与匹配的白人患者具有相似的人口统计学和临床特征,但黑人患者的全因死亡率(每100人年12.2例 vs. 9.7例)和心力衰竭住院率(每100人年13.2例 vs. 7.7例)更高。尽管两组药物剂量相似,但与安慰剂相比,依那普利治疗使白人患者心力衰竭住院风险降低了44%(95%置信区间为27%至57%)(P<0.001),而黑人患者中无显著降低(P=0.74)。在1年时,依那普利治疗使白人患者的收缩压(平均[±标准差]降低5.0±17.1 mmHg)和舒张压(降低3.6±10.6 mmHg)较基线有显著降低,而黑人患者则无。两组中依那普利治疗均未观察到死亡风险有显著变化。
依那普利治疗可使左心室功能障碍的白人患者心力衰竭住院风险显著降低,但类似的黑人患者中未观察到这一效果。这一发现强调了对黑人患者心力衰竭治疗疗效进行更多研究的必要性。