老年单纯收缩期高血压患者的心血管事件。STOP-Hypertension-2研究中治疗策略的亚组分析。

Cardiovascular events in elderly patients with isolated systolic hypertension. A subgroup analysis of treatment strategies in STOP-Hypertension-2.

作者信息

Ekbom Tord, Linjer Erland, Hedner Thomas, Lanke Jan, De Faire Ulf, Wester P-O, Dahlöf Björn, Scherstén Bengt

机构信息

Department of Community Medicine, Malmö University Hospital, Malmö, Sweden.

出版信息

Blood Press. 2004;13(3):137-41. doi: 10.1080/08037050410014944.

Abstract

OBJECTIVE

To perform a subgroup analysis on those patients in STOP-Hypertension-2 who had isolated systolic hypertension.

DESIGN AND METHODS

The STOP-Hypertension-2 study evaluated cardiovascular mortality and morbidity in elderly hypertensives comparing treatment with conventional drugs (diuretics, beta-blockers) with that of newer ones [angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists]. In all, 6614 elderly patients with hypertension (mean age 76.0 years, range 70-84 years at baseline) were included in STOP-Hypertension-2. In the present subgroup analysis of STOP-Hypertension-2, isolated systolic hypertension was defined as systolic blood pressure at least 160 mmHg and diastolic blood pressure below 95 mmHg, in accordance with the Syst-Eur and Syst-China study criteria. In total, 2280 patients in STOP-Hypertension-2 met these criteria. In the study, patients were randomized to one of three treatment groups: "conventional" antihypertensive therapy with beta-blockers or diuretics (atenolol 50 mg, metoprolol 100 mg, pindolol 5 mg, or fixed-ratio hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily); ACE inhibitors (enalapril 10 mg or lisinopril 10 mg daily); or calcium antagonists (felodipine 2.5 mg or isradipine 2.5 mg daily). Analysis was by intention to treat.

RESULTS

The blood pressure lowering effect in patients with systolic hypertension was similar with all three therapeutic regimens: 35/13 mmHg in the conventional group (n=717), 34/12 mmHg in the ACE inhibitor group (n = 724), and 35/13 mmHg in the calcium antagonist group (n=708). Prevention of cardiovascular mortality, the primary endpoint of the study, did not differ between the three treatment groups. All stroke events, i.e. fatal and non-fatal stroke together, were significantly reduced by 25% in the newer-drugs group compared with the conventional group (95% CI 0.58-0.97; p=0.027). This difference was attributable to reduction of non-fatal stroke while fatal stroke events did not differ between groups. New cases of atrial fibrillation were significantly increased by 43% (95% CI 1.02-1.99; p=0.037) on "newer" drugs compared with "conventional" therapy, mainly attributable to the calcium antagonists. There were no significant differences between the three treatment groups with respect to the risks of myocardial infarction, sudden death or congestive heart failure.

CONCLUSIONS

The analysis demonstrated that "newer" therapy (ACE inhibitors/calcium antagonists) was significantly better (25%) than "conventional" (diuretics/beta-blockers) in preventing all stroke in elderly patients with isolated systolic hypertension.

摘要

目的

对收缩期高血压患者进行亚组分析,这些患者来自STOP - Hypertension - 2研究。

设计与方法

STOP - Hypertension - 2研究评估老年高血压患者的心血管死亡率和发病率,比较传统药物(利尿剂、β受体阻滞剂)与新型药物[血管紧张素转换酶(ACE)抑制剂、钙拮抗剂]的治疗效果。共有6614例老年高血压患者(基线时平均年龄76.0岁,范围70 - 84岁)纳入STOP - Hypertension - 2研究。在本次STOP - Hypertension - 2的亚组分析中,根据Syst - Eur和Syst - China研究标准,单纯收缩期高血压定义为收缩压至少160 mmHg且舒张压低于95 mmHg。总共有2280例STOP - Hypertension - 2研究中的患者符合这些标准。在该研究中,患者被随机分为三个治疗组之一:使用β受体阻滞剂或利尿剂的“传统”抗高血压治疗(阿替洛尔50 mg、美托洛尔100 mg、吲哚洛尔5 mg或固定比例的氢氯噻嗪25 mg加阿米洛利2.5 mg每日);ACE抑制剂(依那普利10 mg或赖诺普利10 mg每日);或钙拮抗剂(非洛地平2.5 mg或伊拉地平2.5 mg每日)。分析采用意向性治疗。

结果

三种治疗方案对收缩期高血压患者的降压效果相似:传统治疗组(n = 717)为35/13 mmHg,ACE抑制剂组(n = 724)为34/12 mmHg,钙拮抗剂组(n = 708)为每35/13 mmHg。预防心血管死亡作为研究的主要终点,在三个治疗组之间没有差异。与传统治疗组相比,新型药物组所有卒中事件(即致命性和非致命性卒中合计)显著降低了25%(95% CI 0.58 - 0.97;p = 0.027)。这种差异归因于非致命性卒中的减少,而致命性卒中事件在组间没有差异。与“传统”治疗相比,使用“新型”药物时房颤新发病例显著增加了43%(95% CI 1.02 - 1.99;p = 0.037),主要归因于钙拮抗剂。在心肌梗死、猝死或充血性心力衰竭风险方面,三个治疗组之间没有显著差异。

结论

分析表明,在预防单纯收缩期高血压老年患者的所有卒中方面,“新型”治疗(ACE抑制剂/钙拮抗剂)比“传统”治疗(利尿剂/β受体阻滞剂)显著好25%。

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