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Effects on 11-Year Mortality and Morbidity of Lowering LDL Cholesterol with Simvastatin (Zocor, Merck)



Findings of large randomized trials have shown that lowering LDL cholesterol with statins reduces vascular morbidity and mortality rapidly. However, only limited evidence exists about the long-term efficacy and safety of statin treatment. As a result, an article published in The Lancet, Early Online Publication (23 November 2011), was performed to assess long-term efficacy and safety of lowering LDL cholesterol with statins. The study used data from the extended follow-up of the Heart Protection Study (HPS), to report cause-specific mortality and major morbidity in the in-trial and post-trial periods.


For the trial, 20,536 patients at high risk of vascular and non-vascular outcomes were allocated either 40 mg simvastatin daily or placebo, using minimized randomization. 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 years (SD 0.6). The primary outcome of the long-term follow-up was first post-randomization major vascular event. Analysis was by intention to treat.


Results showed that 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% (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. However, during the combined in-trial and post-trial periods, no significant differences were recorded in cancer incidence at all sites (0.98 or any particular site, or in mortality attributed to cancer (1.01) or to non-vascular causes (0.96).


According to the authors, more prolonged LDL-lowering statin treatment produces larger absolute reductions in vascular events. Moreover, even after study treatment, benefits persisted for at least 5 years without any evidence of emerging hazards. The authors emphasized that these findings provide further support for the prompt initiation and long-term continuation of statin treatment.


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