Replies

E. Pluribus et al......

Not taking a statin is bad advice if you have diabetes:

London — June 13, 2003 — Most adults with diabetes should be taking statins (cholesterol-lowering drugs see below) even if they have normal cholesterol levels and no evidence of heart disease, a major new study has concluded. The study found that statin drugs cut the risk of heart attacks, strokes and the need for angioplasty or bypass surgery in people with diabetes by one-third. Experts say the findings, published in The Lancet, demand a change in current recommendations, which do not advise statin therapy unless cholesterol levels are elevated.

From the article:

Findings

Both among the participants who presented with diabetes and among those who did not, there were highly significant reductions of about a quarter in the first event rate for major coronary events, for strokes, and for revascularisations. For the first occurrence of any of these major vascular events among participants with diabetes, there was a definite 22% (95% CI 13-30) reduction in the event rate (601 [20·2%] simvastatin-allocated vs 748 [25·1%] placebo-allocated, p<0·0001), which was similar to that among the other high-risk individuals studied. There were also highly significant reductions of 33% (95% CI 17-46, p=0·0003) among the 2912 diabetic participants who did not have any diagnosed occlusive arterial disease at entry, and of 27% (95% CI 13-40, p=0·0007) among the 2426 diabetic participants whose pretreatment LDL cholesterol concentration was below 3·0 mmol/L (116 mg/dL). The proportional reduction in risk was also about a quarter among various other subcategories of diabetic patient studied, including: those with different duration, type, or control of diabetes; those aged over 65 years at entry or with hypertension; and those with total cholesterol below 5·0 mmol/L (193 mg/dL). In addition, among participants who had a first major vascular event following randomisation, allocation to simvastatin reduced the rate of subsequent events during the scheduled treatment period.

Interpretation

The present study provides direct evidence that cholesterol-lowering therapy is beneficial for people with diabetes even if they do not already have manifest coronary disease or high cholesterol concentrations. Allocation to 40 mg simvastatin daily reduced the rate of first major vascular events by about a quarter in a wide range of diabetic patients studied. After making allowance for non-compliance, actual use of this statin regimen would probably reduce these rates by about a third. For example, among the type of diabetic patient studied without occlusive arterial disease, 5 years of treatment would be expected to prevent about 45 people per 1000 from having at least one major vascular event (and, among these 45 people, to prevent about 70 first or subsequent events during this treatment period). Statin therapy should now be considered routinely for all diabetic patients at sufficiently high risk of major vascular events, irrespective of their initial cholesterol concentrations.

Reference: Lancet 2003; 361: 2005-16

Should these recommendations be applied now, or after further study?
At the 2003 meeting of the Endocrine Society, there was lots of discussion about the study. Most of the endocrinologists seemed to "believe" the results, and there seems to be a developing consensus that a "statin" (not necessarily simvastatin, the one in this study) would become a routine recommendation for adults with diabetes, as is the recommendation for use of aspirin.