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Statin therapy benefited those with low 5-year risk for major vascular events

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Results of a meta-analysis of 27 trials comprising 175,000 participants suggest that statin therapy can be safely used to prevent the development of vascular disease in patients with a lower than 10% 5-year risk for major vascular events.

For the meta-analysis, the Cholesterol Treatment Trialists’ Collaborators grouped study participants into one of five baseline categories of 5-year major vascular event risk: <5%; ≥5% to <10%; ≥10% to <20%; ≥20% to <30%; ≥30%. Outcomes were studied in trials comparing statin with no statin treatment and trials of more vs. less intensive statin regimens.

The researchers found that statins reduced the risk for major vascular events by 21% for each 1-mmol/L reduction in LDL in each of the five baseline risk groups, including those with the lowest risk for vascular disease (RR=0.79; 95% CI, 0.77-0.81). This finding was irrespective of age, sex, baseline LDL, history of previous vascular disease and mortality.

According to the researchers, “The proportional reduction in major vascular events was at least as big in the two lowest risk categories as in the higher risk categories.” Results showed:

• <5%: RR per 1-mmol/L reduction=0.62; 99% CI, 0.47-0.81.
• ≥5% to ,10%: RR=0.69; 99% CI, 0.60-0.79.
• ≥10% to ,20%: RR=0.79; 99% CI, 0.74-0.85.
• ≥20% to ,30%: RR=0.81; 99% CI, 0.77-0.86.
• ≥30%: RR=0.79; 99% CI, 0.74-0.84.

The proportional reduction in vascular events between the risk groups reflected significant reductions in these two lowest-risk categories in major coronary events (RR=0.57; 99% CI, 0.36-0.89 and RR=0.61; 99% CI, 0.50-0.74) and coronary revascularizations (RR=0.52; 99% CI, 0.35-0.75 and RR=0.63; 99% CI, 0.51-0.79).

For stroke, the reduction for those with 5-year risk for major vascular events ,10% (RR=0.76; 99% CI, 0.61-0.95) was similar to reductions found in higher-risk categories. Statin therapy was also associated with reduced risks for vascular mortality (RR=0.85; 99% CI, 0.77-0.95) and all-cause mortality (RR=0.91; 99% CI, 0.85-0.97) in those without a history of vascular disease. These proportional reductions were similar by baseline risk, the researchers said.

The meta-analysis yielded no evidence that reducing LDL with statin therapy increased cancer incidence, cancer mortality or other nonvascular mortality.

For those with low (<10%) 5-year risk for major vascular events, each 1-mmol/L reduction in LDL was associated with an absolute reduction in events of about 11 per 1,000 over 5 years, according to the abstract. “This benefit greatly exceeds any known hazards of statin therapy,” the researchers said.

“Under present guidelines, such individuals would not typically be regarded as suitable for LDL-lowering statin therapy. The present report suggests, therefore, that these guidelines might need to be reconsidered,” the researchers wrote.

For more information:

Cholesterol Treatment Trialists’ Collaborators. Lancet. 2012;doi:10.1016/S0140-6736(12)60367-5.

Disclosure: The researchers report support from the pharmaceutical industry and Solvay.