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美托洛尔缓释片/控释片在糖尿病合并慢性心力衰竭患者中的疗效、安全性及耐受性:来自美托洛尔治疗慢性心力衰竭随机干预试验(MERIT-HF)的经验

Efficacy, safety and tolerability of metoprolol CR/XL in patients with diabetes and chronic heart failure: experiences from MERIT-HF.

作者信息

Deedwania Prakash C, Giles Thomas D, Klibaner Michael, Ghali Jalal K, Herlitz Johan, Hildebrandt Per, Kjekshus John, Spinar Jindrich, Vitovec Jiri, Stanbrook Hilary, Wikstrand John

机构信息

Department of Veterans Affairs Medical Center, Fresno, Calif, USA.

出版信息

Am Heart J. 2005 Jan;149(1):159-67. doi: 10.1016/j.ahj.2004.05.056.

Abstract

BACKGROUND

The objective of the current study was to examine the efficacy and tolerability of the beta-blocker metoprolol succinate controlled release/extended release (CR/XL) in patients with diabetes in the Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure (MERIT-HF).

METHODS

The Cox proportional hazards model was used to calculate hazard ratios (HR) for convenience expressed as relative risks (risk reduction = 1-HR), and 95% confidence intervals (CI).

RESULTS

The risk of hospitalization for heart failure was 76% higher in diabetics compared to non-diabetics (95% CI 38% to 123%). Metoprolol CR/XL was well tolerated and reduced the risk of hospitalization for heart failure by 37% in the diabetic group (95% CI 53% to 15%), and by 35% in the non-diabetic group (95% CI 48% to 19%). Pooling of mortality data from the Cardiac Insufficiency Bisoprolol Study II (CIBIS II), MERIT-HF, and the Carvedilol Prospective Randomized Cumulative Survival Study (COPERNICUS) showed similar survival benefits in patients with diabetes (25%; 95% CI 40% to 4%) and without diabetes (36%; 95% CI 44% to 27%); test of diabetes by treatment interaction was non-significant. Adverse events were reported more often on placebo than on metoprolol CR/XL.

CONCLUSIONS

Patients with heart failure and diabetes have a much higher risk of hospitalization than patients without diabetes. Regardless of diabetic status, a highly significant reduction in hospitalizations for heart failure was observed with metoprolol CR/XL therapy, which was very well tolerated also by patients with diabetes. Furthermore, the pooled data showed a statistically significant survival benefit in patients with diabetes.

摘要

背景

在美托洛尔控释/缓释片(CR/XL)慢性心力衰竭随机干预试验(MERIT-HF)中,本研究的目的是检验β受体阻滞剂美托洛尔琥珀酸盐控释/缓释片(CR/XL)对糖尿病患者的疗效和耐受性。

方法

采用Cox比例风险模型计算风险比(HR),为方便起见以相对风险表示(风险降低=1-HR),以及95%置信区间(CI)。

结果

与非糖尿病患者相比,糖尿病患者因心力衰竭住院的风险高76%(95%CI 38%至123%)。美托洛尔CR/XL耐受性良好,糖尿病组因心力衰竭住院的风险降低了37%(95%CI 53%至15%),非糖尿病组降低了35%(95%CI 48%至19%)。汇总心脏 insufficiency Bisoprolol研究II(CIBIS II)、MERIT-HF和卡维地洛前瞻性随机累积生存研究(COPERNICUS)的死亡率数据显示,糖尿病患者(25%;95%CI 40%至4%)和非糖尿病患者(36%;95%CI 44%至27%)的生存获益相似;治疗交互作用对糖尿病的检验无统计学意义。安慰剂组报告的不良事件比美托洛尔CR/XL组更频繁。

结论

心力衰竭合并糖尿病的患者比无糖尿病的患者住院风险高得多。无论糖尿病状态如何,美托洛尔CR/XL治疗均能显著降低心力衰竭住院率,糖尿病患者对其耐受性也很好。此外,汇总数据显示糖尿病患者有统计学意义的生存获益。

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