作者：Raikou M， McGuire A， Colhoun HM， Betteridge DJ， Durrington PN， Hitman GA， Neil HA， Livingstone SJ， Charlton-Menys V， Fuller JH; CARDS Investigators.

摘要：

目的/假说：应用来自阿托伐他汀糖尿病协作研究(CARDS)的资料评价2型糖尿病患者应用阿托伐他汀进行心血管疾病一级预防的效价比。对象与方法：来自英国和爱尔兰32个中心的、无心血管疾病记录史、无LDL胆固醇升高、年龄在40岁至75岁之间共2838例糖尿病患者，随机分配至阿托伐他汀 10mg/日组（n=1428）或安慰剂组（n=1410）。这些患者的平均随访时间为3.9年。分析直接治疗费用和疗效去评价就终末事件的其它定义而言的整个试验期间无终末事件年费用、寿命延长年费用及患者一生中生活质量调整后的寿命（QALY）延长年费用 。

结果：整个试验期间，估计增加的效价比（ICER）：无任何CARDS一级终点的为7608英镑/年，无心血管终点的为4896英镑/年，无任何研究终点的为4120英镑/年。整个一生中，寿命延长年增加费用为5107英镑，每OALY增加费用为6471英镑（费用与疗效均减少3.5%）。

结论/解释：2型糖尿病患者中阿托伐他汀一级预防心血管疾病是一项效价干预，在目前可接受的、国家健康与临床研究所指定的最高费用（20000英镑/QALY）范围内ICER随干预下降。

来源: Diabetologia. 2007 Apr;50(4):733-40.

原始摘要：

AIMS/HYPOTHESIS:  We estimated the cost-effectiveness of atorvastatin treatment in the primary prevention of cardiovascular disease in patients with type 2 diabetes using data from the Collaborative Atorvastatin Diabetes Study (CARDS).

SUBJECTS AND METHODS: A total of 2，838 patients， who were aged 40 to 75 years and had type 2 diabetes without a documented history of cardiovascular disease and without elevated LDL-cholesterol， were recruited from 32 centres in the UK and Ireland and randomly allocated to atorvastatin 10 mg daily (n = 1，428) or placebo (n = 1，410). These subjects were followed-up for a median period of 3.9 years. Direct treatment costs and effectiveness were analysed to provide estimates of cost per endpoint-free year over the trial period for alternative definitions of endpoint， and of cost per life-year gained and cost per quality-adjusted life-year (QALY) gained over a patient’s lifetime.

RESULTS: Over the trial period， the incremental cost-effectiveness ratio (ICER) was estimated to be pound7，608 per year free of any CARDS primary endpoint; the ICER was calculated to be pound4，896 per year free of any cardiovascular endpoint and pound4，120 per year free of any study endpoint. Over lifetime， the incremental cost per life-year gained was pound5，107 and the cost per QALY was pound6，471 (costs and benefits both discounted at 3.5%).

CONCLUSIONS/INTERPRETATION: Primary prevention of cardiovascular disease with atorvastatin is a cost-effective intervention in patients with type 2 diabetes， with the ICER for this intervention falling within the current acceptance threshold ( pound20，000 per QALY) specified by the National Institute for Health and Clinical Excellence (NICE).

附：

Title:Baseline characteristics in the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes.

Author:Thomason MJ， Colhoun HM， Livingstone SJ， Mackness MI， Betteridge DJ， Durrington PN， Hitman GA， Neil HA， Fuller JH; CARDS Investigators. EURODIAB， Department of Epidemiology and Public Health， Royal Free and University College Medical School， London， UK. m.thomason@ucl.ac.uk

Abstract:
AIM: To describe baseline characteristics of patients in the Collaborative AtoRvastatin Diabetes Study (CARDS)， a randomized， placebo-controlled trial of lipid lowering with atorvastatin 10 mg daily for the primary prevention of major cardiovascular events in patients with Type 2 diabetes.

METHODS: The main eligibility criteria were Type 2 diabetes， age 40-75 years， no previous history of coronary heart disease， stroke or other major cardiovascular events， a documented history of at least one of retinopathy， micro- or macroalbuminuria， hypertension or current smoking， LDL-cholesterol < or = 4.14 mmol/l and triglycerides < or = 6.78 mmol/l.

RESULTS: Randomization of 2838 persons (909 women) into CARDS was completed in June 2001. At entry， mean age was 62 years， 12% were over 70 years old and median duration of diabetes was 6 years. Median fasting lipid levels were total cholesterol 5.4 mmol/l， LDL-cholesterol 3.1 mmol/l， HDL-cholesterol 1.4 mmol/l and triglyceride 1.7 mmol/l. There was a documented history of retinopathy in 30% of patients， micro/macroalbuminuria in 11% (additionally 17% had micro/macroalbuminuria based on two elevated pretreatment measurements of albumin-creatinine ratios)， hypertension in 79% and 23% were current smokers.

CONCLUSION: CARDS will contribute importantly to the evidence for the macrovascular and microvascular benefits of lipid lowering with atorvastatin in patients with Type 2 diabetes. The results are likely to have important implications for the management of patients.
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Diabet Med. 2004 Aug;21(8):901-5.