Prolonged LDL-Lowering Statin Treatment Beneficial, Safe

Benefits persist without increase in mortality, morbidity for at least five years after treatment

WEDNESDAY, Nov. 23 (HealthDay News) -- Prolonged statin treatment reduces low-density lipoprotein (LDL) cholesterol and is accompanied by a proportional decrease in vascular events, according to a study published online Nov. 23 in The Lancet.

Rory Collins, M.D., and colleagues from the Heart Protection Study Collaborative Group investigated the efficacy and safety of prolonged treatment with LDL-lowering statins in 20,536 participants at high risk for vascular and non-vascular outcomes, who were allocated to receive either 40 mg simvastatin daily or placebo. Cause-specific mortality and major morbidity were assessed in the in-trial (mean, 5.3 years) and post-trial (mean, 11.0 years) follow-up periods. The first post-randomization major vascular event was the primary outcome of long-term follow-up in the intention-to-treat analysis.

The investigators found that allocation to simvastatin was associated with an average reduction of 1.0 mm/L in LDL cholesterol, and a proportional decrease of 23 percent in major vascular events during the in-trial period; with significant divergence every year following the first year. No significant reductions were observed in major vascular events (risk ratio [RR], 0.95; 95 percent confidence interval [CI], 0.89 to 1.02) or vascular mortality (RR, 0.98; 95 percent CI, 0.90 to 1.07) during the post-trial period, when statin use and lipid concentrations were similar in both groups. There were no significant differences in cancer incidence at all sites or at any particular site, or in mortality related to cancer or to nonvascular causes, during the combined in-trial and post-trial periods.

"More prolonged LDL-lowering statin treatment produces larger absolute reductions in vascular events," the authors write. "Benefits persisted for at least five years without any evidence of emerging hazards."

The study was partially funded by Merck & Co. and Roche Vitamins.

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