November 9th, 2010
Intensive Statin Therapy Examined in Meta-Analysis and SEARCH Trial
A new meta-analysis and a large clinical trial shed new light on the additive effects of intensive statin therapy over standard therapy. The meta-analysis from the Cholesterol Treatment Trialists’ Collaboration and the results from SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) are published online in the Lancet.
The meta-analysis examined individual patient data from nearly 40,000 patients enrolled in five trials comparing intensive versus standard statin therapy and nearly 130,000 patients enrolled in 21 trials of statin therapy versus controls. Major vascular events were reduced by 15% in the intensive versus standard therapy arm. When all trials were combined, the authors observed a 20% reduction in deaths due to coronary heart disease associated with each 1.0 mmol/L reduction in LDL. The authors report that they found no significant evidence “that further lowering of LDL cholesterol … produced any adverse effects”, thereby “suggesting that reduction of LDL cholesterol by 2-3 mmol/L would reduce risk by about 40-50%.”
The SEARCH trial, which was originally presented in 2008 at the AHA, compared the effects of 80 mg versus 20 mg simvastatin in 12,000 patients with a history of MI. The SEARCH Collaborative Group reported a nonsignificant 6% reduction in major vascular events from 25.7% in the 20-mg arm to 24.5% in the 80-mg arm. Myopathy occurred in 0.03% in the 20-mg group compared with 0.9% in the 80-mg group. The authors conclude that “for patients deemed to be at sufficient risk of major vascular events, a more appropriate strategy (by contrast with current guidance) could be to consider regimens involving newer, more potent, statins… or the combination of standard doses of generic statins… with other agents that can lower LDL cholesterol substantially without producing such increases in the risk of myopathy.”
In an accompanying editorial, Bernard Cheung and Karen Lam write: “People with substantial cardiovascular risk should have intensive lipid-lowering therapy. A low baseline LDL concentration is not a reason to withhold statin therapy if the patient is at a definite risk of cardiovascular events (eg, secondary prevention or diabetes). In this setting, the absolute risk reduction, number needed to treat, and risk–benefit and cost–benefit ratios are favourable. These numbers will be less persuasive for people at low cardiovascular risk, such as young people with no risk factors.”
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