糖尿病或空腹血糖受损患者长期使用普伐他汀进行心血管事件的二级预防：来自LIPID试验的结果。

Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial.

作者信息

Keech Anthony, Colquhoun David, Best James, Kirby Adrienne, Simes R John, Hunt David, Hague Wendy, Beller Elaine, Arulchelvam Manjula, Baker Jennifer, Tonkin Andrew

机构信息

National Health Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.

出版信息

Diabetes Care. 2003 Oct;26(10):2713-21. doi: 10.2337/diacare.26.10.2713.

DOI:10.2337/diacare.26.10.2713

PMID:14514569

Abstract

OBJECTIVE

Diabetes, a major health problem worldwide, increases the risk of cardiovascular disease and its associated mortality: The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) trial showed that cholesterol-lowering treatment with pravastatin reduced mortality and coronary heart disease (CHD) events in 9014 patients aged 31-75 years with CHD and total cholesterol 4.0-7.0 mmol/l. We measured the effects of pravastatin therapy, 40 mg/day over 6.0 years, on the risk of CHD death or nonfatal myocardial infarction and other cardiovascular outcomes in 1,077 LIPID patients with diabetes and 940 patients with impaired fasting glucose (IFG).

RESULTS

In patients allocated to placebo, the risk of a major CHD event was 61% higher in patients with diabetes and 23% higher in the IFG group than in patients with normal fasting glucose, and the risk of any cardiovascular event was 37% higher in the diabetic group and 19% higher in the IFG group. Pravastatin therapy reduced the risk of a major CHD event overall from 15.9 to 12.3% (relative risk reduction [RRR] 24%, P < 0.001) and from 23.4 to 19.6% in the diabetic group (19%, P = 0.11); in the diabetic group, the reduction was not significantly different from the reductions in the other groups. Pravastatin reduced the risk of any cardiovascular event from 52.7 to 45.2% (21%, P < 0.008) in patients with diabetes and from 45.7 to 37.1% (26%, P = 0.003) in the IFG group. Pravastatin reduced the risk of stroke from 9.9 to 6.3% in the diabetic group (RRR 39%, CI 7-61%, P = 0.02) and from 5.4 to 3.4% in the IFG group (RRR 42%, CI -9 to 69%, P = 0.09). Pravastatin did not reduce the incidence of diabetes. Over 6 years, pravastatin therapy prevented one major CHD event (CHD death or nonfatal myocardial infarction) in 23 patients with IFG and 18 patients with diabetes. A meta-analysis of other major trials confirmed the high absolute risks of diabetes and IFG and the absolute benefits of statin therapy in these patients.

CONCLUSIONS

Cholesterol-lowering treatment with pravastatin therapy prevents cardiovascular events, including stroke, in patients with diabetes or IFG and established CHD.

摘要

目的

糖尿病是全球主要的健康问题，会增加心血管疾病风险及其相关死亡率：普伐他汀缺血性疾病长期干预研究（LIPID）表明，对于9014名年龄在31 - 75岁、患有冠心病且总胆固醇水平在4.0 - 7.0 mmol/L的患者，使用普伐他汀进行降胆固醇治疗可降低死亡率和冠心病（CHD）事件发生率。我们评估了在6.0年中每日服用40 mg普伐他汀对1077例LIPID研究中的糖尿病患者和940例空腹血糖受损（IFG）患者发生CHD死亡或非致命性心肌梗死风险以及其他心血管结局的影响。

结果

在分配至安慰剂组的患者中，糖尿病患者发生主要CHD事件的风险比空腹血糖正常的患者高61%，IFG组高23%；糖尿病组发生任何心血管事件的风险比空腹血糖正常患者高37%，IFG组高19%。普伐他汀治疗总体上使主要CHD事件风险从15.9%降至12.3%（相对风险降低[RRR]24%，P < 0.001），糖尿病组从23.4%降至19.6%（19%，P = 0.11）；糖尿病组的降低幅度与其他组相比无显著差异。普伐他汀使糖尿病患者发生任何心血管事件的风险从52.7%降至45.2%（21%，P < 0.008），IFG组从45.7%降至37.1%（26%，P = 0.003）。普伐他汀使糖尿病组中风风险从9.9%降至6.3%（RRR 39%，CI 7 - 61%，P = 0.02），IFG组从5.4%降至3.4%（RRR 42%，CI -9至69%，P = 0.09）。普伐他汀未降低糖尿病发病率。在6年期间，普伐他汀治疗可预防23例IFG患者和18例糖尿病患者发生一次主要CHD事件（CHD死亡或非致命性心肌梗死）。对其他主要试验的荟萃分析证实了糖尿病和IFG患者的高绝对风险以及他汀类药物治疗对这些患者的绝对益处。