Lancet：服用他汀类药物降低心血管疾病的患病风险优于患糖尿病的风险

近日，刊登在国际著名医学杂志The Lancet上的一篇研究报告指出，对服用降胆固醇药物的病人进行实验发现，他汀类药物在降低心脏血管疾病风险上的效用优于患者增加糖尿病患病的风险。

研究者分析了来自朱庇特研究中心收集的数据，第一项对照研究组的数据揭示了服用他汀类药物可以导致糖尿病风险的增加，这项结果随后被很多类似研究证实了。

随后研究者继续分析了朱庇特研究中心收集的数据，旨在发现是否增加的糖尿病患病风险更优于其对心血管疾病的益处。他们发现发展为糖尿病可能性的标志性区别，这依赖于试验开始时，病人是否处于患糖尿病的风险之中。

至少有一项糖尿病患病风险因子的病人，当使用他汀类药物时，其患糖尿病的可能性仅为28%。试验开始时，没有任何糖尿病风险的病人在使用药物后完全没有患糖尿病的风险。

尽管使用他汀类药物可以增加病人患糖尿病的可能性，但是其同时也降低了患心血管疾病39%的可能性以及试验中17%的死亡可能性。没有糖尿病患病风险的病人，其使用他汀类药物后，心血管疾病的发病风险降低了52%，而且并不会有糖尿病风险。

编译自：Statins: cardiovascular benefits outweigh diabetes risk

doi:10.1016/S0140-6736(12)61190-8
PMC:
PMID:

Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial

Prof Paul M Ridker MD a b , Aruna Pradhan MD a, Jean G MacFadyen BA a, Prof Peter Libby MD b, Prof Robert J Glynn ScD a

Background In view of evidence that statin therapy increases risk of diabetes, the balance of benefit and risk of these drugs in primary prevention has become controversial. We undertook an analysis of participants from the JUPITER trial to address the balance of vascular benefits and diabetes hazard of statin use. Methods In the randomised, double-blind JUPITER trial, 17 603 men and women without previous cardiovascular disease or diabetes were randomly assigned to rosuvastatin 20 mg or placebo and followed up for up to 5 years for the primary endpoint (myocardial infarction, stroke, admission to hospital for unstable angina, arterial revascularisation, or cardiovascular death) and the protocol-prespecified secondary endpoints of venous thromboembolism, all-cause mortality, and incident physician-reported diabetes. In this analysis, participants were stratified on the basis of having none or at least one of four major risk factors for developing diabetes: metabolic syndrome, impaired fasting glucose, body-mass index 30 kg/m2 or higher, or glycated haemoglobin A1c greater than 6%. The trial is registered at ClinicalTrials.gov, NCT00239681. Findings Trial participants with one or more major diabetes risk factor (n=11 508) were at higher risk of developing diabetes than were those without a major risk factor (n=6095). In individuals with one or more risk factors, statin allocation was associated with a 39% reduction in the primary endpoint (hazard ratio [HR] 0·61, 95% CI 0·47—0·79, p=0·0001), a 36% reduction in venous thromboembolism (0·64, 0·39—1·06, p=0·08), a 17% reduction in total mortality (0·83, 0·64—1·07, p=0·15), and a 28% increase in diabetes (1·28, 1·07—1·54, p=0·01). Thus, for those with diabetes risk factors, a total of 134 vascular events or deaths were avoided for every 54 new cases of diabetes diagnosed. For trial participants with no major diabetes risk factors, statin allocation was associated with a 52% reduction in the primary endpoint (HR 0·48, 95% CI 0·33—0·68, p=0·0001), a 53% reduction in venous thromboembolism (0·47, 0·21—1·03, p=0·05), a 22% reduction in total mortality (0·78, 0·59—1·03, p=0·08), and no increase in diabetes (0·99, 0·45—2·21, p=0·99). For such individuals, a total of 86 vascular events or deaths were avoided with no new cases of diabetes diagnosed. In analysis limited to the 486 participants who developed diabetes during follow-up (270 on rosuvastatin vs 216 on placebo; HR 1·25, 95% CI 1·05—1·49, p=0·01), the point estimate of cardiovascular risk reduction associated with statin therapy (HR 0·63, 95% CI 0·25—1·60) was consistent with that for the trial as a whole (0·56, 0·46—0·69). By comparison with placebo, statins accelerated the average time to diagnosis of diabetes by 5·4 weeks (84·3 [SD 47·8] weeks on rosuvastatin vs 89·7 [50·4] weeks on placebo). Interpretation In the JUPITER primary prevention trial, the cardiovascular and mortality benefits of statin therapy exceed the diabetes hazard, including in participants at high risk of developing diabetes. Funding AstraZeneca.