Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group.
Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group.
复制标题
低剂量和高剂量的血管紧张素转换酶抑制剂赖诺普利对慢性心力衰竭发病率和死亡率的影响比较。
作者：
M. Packer;P. Poole‐Wilson;P. Armstrong;J. Cleland;J. Horowitz;B. Massie;L. Rydén;K. Thygesen;B. Uretsky
背景
血管紧张素转换酶(ACE)抑制剂通常由医生以低于大剂量的剂量开出，大剂量已被证明可降低心力衰竭患者的发病率和死亡率。然而，目前还不清楚低剂量和高剂量的血管紧张素转换酶抑制剂是否有类似的益处。
方法和结果
我们随机将3164名患有纽约心脏协会II级至IV级心力衰竭、射血分数<lt；或=30%的患者随机分成两组，分别用低剂量(每天2.5至5.0毫克，n=1596)或大剂量(每天32.5至35 mg，n=1568)的ACE抑制剂赖诺普利治疗39至58个月，同时继续进行心力衰竭的背景治疗。与低剂量组相比，高剂量组患者的死亡风险降低了8%(P=0.128)，但死亡或因任何原因住院的风险降低了12%(P=0.002)，因心力衰竭住院的风险减少了24%(P=0.002)。头晕和肾功能不全在高剂量组中更常见，但两组需要停止研究药物的患者数量相似。结论--这些发现表明，心力衰竭患者一般不应该服用非常低剂量的ACE抑制剂(除非这是唯一可以耐受的剂量)，并表明中剂量和高剂量ACE抑制剂(如果有的话)之间的疗效差异可能非常小。
BACKGROUND
Angiotensin-converting enzyme (ACE) inhibitors are generally prescribed by physicians in doses lower than the large doses that have been shown to reduce morbidity and mortality in patients with heart failure. It is unclear, however, if low doses and high doses of ACE inhibitors have similar benefits.
METHODS AND RESULTS
We randomly assigned 3164 patients with New York Heart Association class II to IV heart failure and an ejection fraction < or = 30% to double-blind treatment with either low doses (2.5 to 5.0 mg daily, n=1596) or high doses (32.5 to 35 mg daily, n=1568) of the ACE inhibitor, lisinopril, for 39 to 58 months, while background therapy for heart failure was continued. When compared with the low-dose group, patients in the high-dose group had a nonsignificant 8% lower risk of death (P=0.128) but a significant 12% lower risk of death or hospitalization for any reason (P=0.002) and 24% fewer hospitalizations for heart failure (P=0.002). Dizziness and renal insufficiency was observed more frequently in the high-dose group, but the 2 groups were similar in the number of patients requiring discontinuation of the study medication. Conclusions-These findings indicate that patients with heart failure should not generally be maintained on very low doses of an ACE inhibitor (unless these are the only doses that can be tolerated) and suggest that the difference in efficacy between intermediate and high doses of an ACE inhibitor (if any) is likely to be very small.