Krum Henry, Nolly Hector, Workman Diane, He Weizhong, Roniker Barbara, Krause Scott, Fakouhi Kaffa
Clinical Pharmacology Unit, Monash University, Alfred Hospital, Prahran, Victoria , Australia.
Hypertension. 2002 Aug;40(2):117-23. doi: 10.1161/01.hyp.0000025146.19104.fe.
The efficacy and tolerability of eplerenone, a selective aldosterone blocker, was assessed when added to existing antihypertensive therapy with an ACE inhibitor or an angiotensin II receptor blocker (ARB). Hypertensive patients (n=341) whose blood pressure (BP) was not controlled despite ACE inhibitor or ARB were randomized (double-blind) to receive 50 mg eplerenone (increasing to 100 mg if required) once daily or placebo for 8 weeks. Diastolic and systolic BP and adverse events were recorded. By study end (week 8), mean seated diastolic BP was significantly reduced from week 0 among patients receiving eplerenone/ARB (-12.7+/-0.81 mm Hg) compared with those receiving placebo/ARB (-9.3+/-0.83 mm Hg). The change in mean seated diastolic BP was -9.9+/-0.88 mm Hg in eplerenone/ACE inhibitor patients and -8.0+/-0.86 mm Hg in placebo/ACE inhibitor patients (P=NS). Systolic BP levels were also significantly lower at week 8 for eplerenone/ACE inhibitor (-13.4+/-1.35 mm Hg) and eplerenone/ARB (-16.0+/-1.37 mm Hg) patients, respectively, compared with placebo/ACE inhibitor (-7.5+/-1.31 mm Hg) and placebo/ARB patients (-9.2+/-1.41 mm Hg). Adverse events were generally nonsevere and not significantly different between eplerenone and placebo. This study demonstrated that in patients whose BP was not controlled with an ACE inhibitor or ARB, the addition of eplerenone over an 8-week period significantly lowered systolic BP in both groups and diastolic BP in ARB patients. Selective aldosterone blockade with eplerenone, therefore, may be useful add-on therapy in hypertensive patients inadequately controlled on ACE inhibitor or ARB alone.
在已使用血管紧张素转换酶抑制剂（ACE抑制剂）或血管紧张素II受体阻滞剂（ARB）进行抗高血压治疗的基础上，添加选择性醛固酮受体拮抗剂依普利酮，评估其疗效和耐受性。341例高血压患者，尽管使用了ACE抑制剂或ARB，但血压仍未得到控制，将其随机（双盲）分为两组，一组每天服用50mg依普利酮（必要时增至100mg），另一组服用安慰剂，为期8周。记录舒张压和收缩压以及不良事件。到研究结束时（第8周），与接受安慰剂/ARB的患者相比，接受依普利酮/ARB的患者从第0周起平均坐位舒张压显著降低（-12.7±0.81mmHg）。依普利酮/ACE抑制剂组患者平均坐位舒张压的变化为-9.9±0.88mmHg，安慰剂/ACE抑制剂组为-8.0±0.86mmHg（P=无显著性差异）。与安慰剂/ACE抑制剂组（-7.5±1.31mmHg）和安慰剂/ARB组（-9.2±1.41mmHg）相比，依普利酮/ACE抑制剂组（-13.4±1.35mmHg）和依普利酮/ARB组（-16.0±1.37mmHg）患者在第8周时收缩压水平也显著降低。不良事件一般不严重，依普利酮组和安慰剂组之间无显著差异。本研究表明，对于使用ACE抑制剂或ARB血压仍未得到控制的患者，在8周内添加依普利酮可显著降低两组患者的收缩压以及ARB组患者的舒张压。因此，依普利酮选择性阻断醛固酮可能是单独使用ACE抑制剂或ARB控制不佳的高血压患者的有用附加治疗方法。
