University of Texas School of Public Health, Houston, TX 77030, USA.
Circulation. 2011 Oct 25;124(17):1811-8. doi: 10.1161/CIRCULATIONAHA.110.012575. Epub 2011 Oct 3.
In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind, practice-based, active-control, comparative effectiveness trial in high-risk hypertensive participants, risk of new-onset heart failure (HF) was higher in the amlodipine (2.5-10 mg/d) and lisinopril (10-40 mg/d) arms compared with the chlorthalidone (12.5-25 mg/d) arm. Similar to other studies, mortality rates following new-onset HF were very high (≥50% at 5 years), and were similar across randomized treatment arms. After the randomized phase of the trial ended in 2002, outcomes were determined from administrative databases.
With the use of national databases, posttrial follow-up mortality through 2006 was obtained on participants who developed new-onset HF during the randomized (in-trial) phase of ALLHAT. Mean follow-up for the entire period was 8.9 years. Of 1761 participants with incident HF in-trial, 1348 died. Post-HF all-cause mortality was similar across treatment groups, with adjusted hazard ratios (95% confidence intervals) of 0.95 (0.81-1.12) and 1.05 (0.89-1.25), respectively, for amlodipine and lisinopril compared with chlorthalidone, and 10-year adjusted rates of 86%, 87%, and 83%, respectively. All-cause mortality rates were also similar among those with reduced ejection fractions (84%) and preserved ejection fractions (81%), with no significant differences by randomized treatment arm.
Once HF develops, risk of death is high and consistent across randomized treatment groups. Measures to prevent the development of HF, especially blood pressure control, must be a priority if mortality associated with the development of HF is to be addressed. Clinical Trial Registration- http://www.clinicaltrials.gov. Unique identifier: NCT00000542.
在高血压防治和降低血脂以预防心脏病发作试验（ALLHAT）中，一项在高危高血压参与者中进行的随机、双盲、基于实践、活性对照、比较疗效试验中，与氯噻酮（12.5-25mg/d）组相比，氨氯地平（2.5-10mg/d）和赖诺普利（10-40mg/d）组的新发心力衰竭（HF）风险更高。与其他研究类似，新发 HF 后的死亡率非常高（≥50%，5 年内），且在随机治疗组之间相似。在 2002 年试验的随机阶段结束后，从行政数据库中确定了结果。
使用国家数据库，获得了 ALLHAT 试验随机（试验内）阶段发生新发 HF 的参与者的试验后随访死亡率，直至 2006 年。整个时期的平均随访时间为 8.9 年。在 1761 名试验内发生 HF 的参与者中，有 1348 人死亡。HF 后全因死亡率在各组之间相似，氨氯地平与氯噻酮相比，调整后的危险比（95%置信区间）分别为 0.95（0.81-1.12）和 1.05（0.89-1.25），赖诺普利与氯噻酮相比，调整后的危险比分别为 0.95（0.81-1.12）和 1.05（0.89-1.25），10 年调整后的死亡率分别为 86%、87%和 83%。射血分数降低（84%）和射血分数保留（81%）者的全因死亡率也相似，随机治疗组之间无显著差异。
一旦 HF 发生，死亡风险很高，且在随机治疗组之间一致。如果要解决与 HF 发生相关的死亡率，预防 HF 发生的措施，尤其是血压控制，必须是优先事项。临床试验注册-http://www.clinicaltrials.gov。独特标识符：NCT00000542。
