摘要：据6月22/29日《美国医学会杂志》上的一则研究披露，与中等剂量他汀类药物疗法相比，他汀类药物的强化剂量治疗与新发糖尿病风险的增加有关。
与安慰剂相比，他汀类药物治疗在有和没有糖尿病史的人中可显著地降低其心血管疾病的发生率。根据文章的背景资料，最近，对强化剂量与中等剂量他汀疗法进行比较的数项试验的发现提示，那些接受他汀类药物强化治疗的人有着更高的新发糖尿病的风险。据文章的作者披露：“鉴于他汀类药物对心血管系统的益处，以及可能会出现的他汀类药物强化治疗的增加，对这种疗法的任何可能的长期风险进行量化分析，以帮助患者作出明智的选择是十分重要的。”
英国格拉斯哥大学的David Preiss, M.R.C.P.及其同事对强化剂量的他汀疗法相对于中等剂量的他汀疗法在服用者出现糖尿病以及发生重大心血管不良事件之间的相关性进行了检查。他们是应用相关的发表及未发表的临床试验数据所进行的一项荟萃分析来做这一相关性检查的。研究人员发现了5项符合该分析入选标准的他汀类试验。
这5项随机化临床试验提供了32752位无糖尿病的试验参与者在为期4.9年的加权平均跟踪随访期中的数据。在跟踪随访期间，有2749人（占8.4%）发生了糖尿病（其中1449人属于强化剂量治疗组，1300人属于中等剂量治疗组）；有6684人（占20.4%）经受了一次严重的心血管不良事件（其中3134人属于强化剂量治疗组，3550人属于中等剂量治疗组）。在分配到强化他汀治疗组的试验参与者中，其出现伴发性糖尿病者要比那些接受中等剂量组的人多出149例，但接受强化剂量治疗组的人发生心血管不良事件的病人也要少416例。
对这些数据进行的一项分析表明，与中等剂量疗法相比，使用他汀药物强化剂量疗法与新近起病的糖尿病发病率的增加有关。但是，强化剂量他汀疗法与较少的心血管不良事件发病率有关。与中等剂量他汀疗法相比，对强化剂量他汀疗法的人来说，每年造成新发糖尿病伤害的数字为498，而每年需要治疗心血管不良事件的数字为155。
文章的作者写道：“我们的发现表明，临床医生应该对接受强化他汀疗法的病人会发生糖尿病的可能性保持警觉。总之，这一荟萃分析通过提供他汀类治疗和糖尿病发病率的增加之间存在着剂量依赖性的证据而拓展了人们早先的发现。”
生物探索推荐英文原文
Intensive-dose statin therapy associated with increased risk of diabetes
CHICAGO – An analysis of data from previously published studies indicates that intensive-dose statin therapy is associated with an increased risk of new-onset diabetes compared with moderate-dose therapy, according to a study in the June 22/29 issue of JAMA.
Compared with placebo, statin therapy significantly reduces cardiovascular events among individuals with and without a history of diabetes mellitus. Recently, findings of several trials comparing intensive- to moderate-dose statin therapy suggested an excess risk of new diabetes among those treated with intensive statin regimens, according to background information in the article. According to the authors, “Given the cardiovascular benefits of statins and the likely increasing use of intensive statin regimens, it is important to quantify any potential long-term risks to enable physicians and patients to make informed choices.”
David Preiss, M.R.C.P., of the University of Glasgow, United Kingdom, and colleagues examined the associations of intensive-dose statin therapy vs. moderate-dose therapy with the development of diabetes and the occurrence of major cardiovascular events by conducting a meta-analysis of published and unpublished data from relevant clinical trials. The researchers identified 5 statin trials that met criteria for inclusion in the analysis.
The 5 randomized clinical trials provided data on 32,752 nondiabetic participants over a weighted average follow-up of 4.9 years. During follow-up, 2,749 participants (8.4 percent) developed diabetes (1,449 of whom were assigned intensive-dose therapy, 1,300 assigned moderate-dose therapy), and 6,684 (20.4 percent) experienced a major cardiovascular event (3,134 assigned intensive-dose therapy, 3,550 assigned moderate-dose therapy). There were 149 more cases of incident diabetes in participants assigned to intensive statin treatment than in those receiving moderate therapy and 416 fewer patients with cardiovascular events who received intensive-dose therapy.
An analysis of the data indicated that use of intensive-dose statin therapy compared with moderate-dose statin therapy was associated with a higher incidence of new-onset diabetes. However, intensive statin therapy was associated with fewer major cardiovascular events. As compared with moderate-dose statin therapy, the number needed to harm per year for intensive-dose statin therapy was 498 for new-onset diabetes while the number needed to treat per year for intensive-dose statin therapy was 155 for cardiovascular events.
“Our findings suggest that clinicians should be vigilant for the development of diabetes in patients receiving intensive statin therapy,” the authors write. “In conclusion, this meta-analysis extends earlier findings of an increased incidence of diabetes with statin therapy by providing evidence of a dose-dependent association.”
生物探索推荐英文论文摘要：
Risk of Incident Diabetes With Intensive-Dose Compared With Moderate-Dose Statin Therapy
ABSTRACT
Context A recent meta-analysis demonstrated that statin therapy is associated with excess risk of developing diabetes mellitus.
Objective To investigate whether intensive-dose statin therapy is associated with increased risk of new-onset diabetes compared with moderate-dose statin therapy.
Data Sources We identified relevant trials in a literature search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (January 1, 1996, through March 31, 2011). Unpublished data were obtained from investigators.
Study Selection We included randomized controlled end-point trials that compared intensive-dose statin therapy with moderate-dose statin therapy and included more than 1000 participants who were followed up for more than 1 year.
Data Extraction Tabular data provided for each trial described baseline characteristics and numbers of participants developing diabetes and experiencing major cardiovascular events (cardiovascular death, nonfatal myocardial infarction or stroke, coronary revascularization). We calculated trial-specific odds ratios (ORs) for new-onset diabetes and major cardiovascular events and combined these using random-effects model meta-analysis. Between-study heterogeneity was assessed using the I2 statistic.
Results In 5 statin trials with 32 752 participants without diabetes at baseline, 2749 developed diabetes (1449 assigned intensive-dose therapy, 1300 assigned moderate-dose therapy, representing 2.0 additional cases in the intensive-dose group per 1000 patient-years) and 6684 experienced cardiovascular events (3134 and 3550, respectively, representing 6.5 fewer cases in the intensive-dose group per 1000 patient-years) over a weighted mean (SD) follow-up of 4.9 (1.9) years. Odds ratios were 1.12 (95% confidence interval [CI], 1.04-1.22; I2 = 0%) for new-onset diabetes and 0.84 (95% CI, 0.75-0.94; I2 = 74%) for cardiovascular events for participants receiving intensive therapy compared with moderate-dose therapy. As compared with moderate-dose statin therapy, the number needed to harm per year for intensive-dose statin therapy was 498 for new-onset diabetes while the number needed to treat per year for intensive-dose statin therapy was 155 for cardiovascular events.
Conclusion In a pooled analysis of data from 5 statin trials, intensive-dose statin therapy was associated with an increased risk of new-onset diabetes compared with moderate-dose statin therapy.
KEYWORDS: cardiovascular diseases, clinician's corner, diabetes mellitus, drug reaction, adverse, drug therapy, hydroxymethylglutaryl-coa reductase inhibitors, meta-analysis, risk assessment.
