The Pharmaceutical Journal
Vol 275 No 7376 p625
19 November 2005

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Intensive lowering of cholesterol of limited benefit

Intensive lipid lowering in patients with previous myocardial infarction does not result in a significant reduction in major coronary events but does reduce the risk of non-fatal acute MI and major cardiovascular events, including stroke, according to research published in JAMA this week (2005;294:2437).

Researchers conducted a prospective, open-label, blinded endpoint trial involving 8,888 patients, aged 80 years or younger, with a history of acute MI. The researchers compared the effects of aggressive with standard lipid lowering on risk of cardiovascular disease. Patients were randomised to received either atorvastatin 80mg daily or simvastatin 20mg daily and followed up for a median of 4.8 years. Mean low-density lipoprotein cholesterol levels during treatment were 2.7mmol/L in the simvastatin group and 2.1mmol/L in the atorvastatin group.

The primary endpoint of a major coronary event, including coronary heart disease death, admission to hospital for non-fatal acute MI or cardiac arrest with resuscitation, was not significantly different between the two groups. The composite secondary endpoint of major cardiovascular event, including stroke, was reduced in the atorvastatin group compared with the simvastatin group (13.7 per cent versus 12 per cent; hazard ratio 0.87, 95 per cent confidence interval 0.78–0.98, P=0.02). Risk of non-fatal MI was also reduced in the atorvastatin group (6 per cent versus 7.2 per cent; 0.83, 0.71–0.98, P=0.02). There was no difference between the two groups in all-cause or cardiovascular mortality.

The researchers report that no significant differences in non-cardiovascular deaths, including cancer, were observed between the two groups. In addition, the incidence of serious adverse events was similar. However, more patients in the atorvastatin group discontinued medication due to non-serious adverse events. Elevation of liver enzymes occurred more frequently in the atorvastatin group (P<0.001).

The researchers concluded that, although the primary endpoint was not met, their results indicate that more intensive lipid lowering in patients with previous MI might prevent 68 first cardiovascular events (95 per cent CI, 39–97) per 1,000 patients over five years.