Holman R R, Paul S, Farmer A, Tucker L, Stratton I M, Neil H A W
Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology & Metabolism, Churchill Hospital, Headington, Oxford, UK.
Diabetologia. 2009 Jan;52(1):50-9. doi: 10.1007/s00125-008-1179-5. Epub 2008 Nov 11.
AIMS/HYPOTHESIS: The aim of the study was to examine the impact of statin or omega-3-acid ethyl esters 90 (omega-3 EE90; omega-3-acid ethyl esters 90 refers to a mixture of ethyl esters of n-3 fatty acids) on estimated cardiovascular disease (CVD) risk in community-based people with type 2 diabetes but without known CVD and not taking lipid-lowering therapy.
A central computer randomised 800 patients in 59 UK general practices to atorvastatin (n = 401, 20 mg/day) or placebo (n = 399) and omega-3 EE90 (n = 397, 2 g/day) or placebo (n = 403) in a concealed factorial manner. Participants with LDL-cholesterol <2.6 mmol/l, triacylglycerol <1.5 mmol/l and estimated 10-year CVD risk <20% were compared at 4 months.
Mean (SD) age was 63.5 (11.7) years, HbA(1c) 6.9 (1.1) % and known diabetes duration (median [interquartile range]) was 4 (2-8) years. Fifty-seven per cent were men, 90% white and 74% had an estimated 10-year CVD risk >or=20%. Of 732 patients with 4-month data, more allocated atorvastatin (n = 371) compared with placebo (n = 361) achieved LDL-cholesterol <2.6 mmol/l (91% vs 24%, p < 0.001) and had estimated 10-year CVD risks <20% (38% vs 26%, p < 0.001). No differences were seen between those allocated omega-3 EE90 (n = 371) compared with placebo (n = 361) for participants achieving triacylglycerol <1.5 mmol/l (65% vs 60%, p = 0.18) or estimated 10-year CVD risks <20% (34% vs 30%, p = 0.18). There were no side effects of note.
CONCLUSIONS/INTERPRETATION: Many community-based diabetic patients without known CVD remain at high CVD risk despite statin treatment and require additional risk-reduction strategies. The impact of omega-3 EE90 on CVD risk will remain uncertain until clinical endpoint trial results are available.
ISRCT no. 76737502.
目的/假设：本研究旨在探讨他汀类药物或ω-3-酸乙酯90（ω-3 EE90；ω-3-酸乙酯90是指n-3脂肪酸乙酯的混合物）对社区中2型糖尿病但无已知心血管疾病（CVD）且未接受降脂治疗的人群估计的心血管疾病（CVD）风险的影响。
一台中央计算机以隐蔽的析因方式将英国59家全科诊所的800名患者随机分为阿托伐他汀组（n = 401，20毫克/天）或安慰剂组（n = 399）以及ω-3 EE90组（n = 397，2克/天）或安慰剂组（n = 403）。对低密度脂蛋白胆固醇<2.6毫摩尔/升、甘油三酯<1.5毫摩尔/升且估计10年CVD风险<20%的参与者在4个月时进行比较。
平均（标准差）年龄为63.5（11.7）岁，糖化血红蛋白（HbA1c）为6.9（1.1）%，已知糖尿病病程（中位数[四分位间距]）为4（2 - 8）年。57%为男性，90%为白人，74%的人估计10年CVD风险≥20%。在732例有4个月数据的患者中，与安慰剂组（n = 361）相比，更多分配到阿托伐他汀组（n = 371）的患者实现了低密度脂蛋白胆固醇<2.6毫摩尔/升（91%对24%，p < 0.001）且估计10年CVD风险<20%（38%对26%，p < 0.001）。对于甘油三酯<1.5毫摩尔/升（65%对60%，p = 0.18）或估计10年CVD风险<20%（34%对30%，p = 0.18）的参与者，分配到ω-3 EE90组（n = 371）与安慰剂组（n = 361）之间未观察到差异。未发现明显的副作用。
结论/解读：许多社区中无已知CVD的糖尿病患者尽管接受了他汀类药物治疗，但CVD风险仍很高，需要额外的风险降低策略。在获得临床终点试验结果之前，ω-3 EE90对CVD风险的影响仍不确定。
国际标准随机对照试验编号76737502。
