Lancet：他汀长期使用安全有效

11月23日，《柳叶刀》（Lancet）杂志在线刊登了英国心脏保护研究（HPS）的学者的研究成果"Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20 536 high-risk individuals: a randomised controlled trial"。
研究者发现，对于血管疾病高风险患者，用他汀进行降低低密度脂蛋白胆固醇（LDL-C）的治疗时间越长，血管事件发生的绝对次数就越少。此外，在受试者终止他汀治疗后，该药益处仍存在至少5年且无其他风险。

研究者将20536例血管事件高风险但尚无血管事件的患者随机分入辛伐他汀组（40 mg）和对照组，在研究阶段平均随访5.3年后发现，辛伐他汀组患者LDL-C平均降低1.0 mmol/L，主要血管事件发生率降低23%。为观察他汀的长期效应，研究者在结束上一研究后，对生存的受试者平均继续随访11.0年，结果显示，该药益处持续存在且基本无改变，患者的主要血管事件发生率及死亡率均未进一步增高。此外，无论研究阶段还是研究后阶段，两组患者癌症发病率、癌症死亡率及非血管事件死亡率均无显著差异。

Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20 536 high-risk individuals: a randomised controlled trial

Heart Protection Study Collaborative Group

Background：Findings of large randomised trials have shown that lowering LDL cholesterol with statins reduces vascular morbidity and mortality rapidly, but limited evidence exists about the long-term efficacy and safety of statin treatment. The aim of the extended follow-up of the Heart Protection Study (HPS) is to assess long-term efficacy and safety of lowering LDL cholesterol with statins, and here we report cause-specific mortality and major morbidity in the in-trial and post-trial periods.Methods：20 536 patients at high risk of vascular and non-vascular outcomes were allocated either 40 mg simvastatin daily or placebo, using minimised randomisation. Mean in-trial follow-up was 5·3 years (SD 1·2), and post-trial follow-up of surviving patients yielded a mean total duration of 11·0 years (SD 0·6). The primary outcome of the long-term follow-up of HPS was first post-randomisation major vascular event, and analysis was by intention to treat. This trial is registered with ISRCTN, number 48489393.Findings：During the in-trial period, allocation to simvastatin yielded an average reduction in LDL cholesterol of 1·0 mmol/L and a proportional decrease in major vascular events of 23% (95% CI 19—28; p<0·0001), with significant divergence each year after the first. During the post-trial period (when statin use and lipid concentrations were similar in both groups), no further significant reductions were noted in either major vascular events (risk ratio [RR] 0·95 [0·89—1·02]) or vascular mortality (0·98 [0·90—1·07]). During the combined in-trial and post-trial periods, no significant differences were recorded in cancer incidence at all sites (0·98 [0·92—1·05]) or any particular site, or in mortality attributed to cancer (1·01 [0·92—1·11]) or to non-vascular causes (0·96 [0·89—1·03]).

only effect,never talk about safety

lijinshen73 发表于 2011-12-6  08:02
only effect,never talk about safety

" with significant divergence each year after the first. During the post-trial period (when statin use and lipid concentrations were similar in both groups), no further significant reductions were noted in either major vascular events (risk ratio [RR] 0·95 [0·89—1·02]) or vascular mortality (0·98 [0·90—1·07]). During the combined in-trial and post-trial periods, no significant differences were recorded in cancer incidence at all sites (0·98 [0·92—1·05]) or any particular site, or in mortality attributed to cancer (1·01 [0·92—1·11]) or to non-vascular causes (0·96 [0·89—1·03])."

学习了。。