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Need for large scale randomised evidence about lowering LDL cholesterol in people with diabetes mellitus: MRC/BHF heart protection study and other major trials
  1. JANE ARMITAGE,
  2. RORY COLLINS
  1. MRC/BHF Heart Protection Study
  2. Clinical Trial Service Unit and Epidemiological Studies Unit
  3. Nuffield Department of Clinical Medicine
  4. Radcliffe Infirmary
  5. Oxford OX2 6HE, UK

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Diabetes mellitus contributes substantially to the global burden of disease, with an estimated 100 million people affected worldwide, and its prevalence is increasing rapidly.1 Macrovascular complications are among the chief causes of major morbidity in people with diabetes, and most of their deaths are attributed to cardiovascular causes.2 ,3 In type 2 (“non-insulin dependent”) diabetes, blood triglyceride concentrations tend to be raised and high density lipoprotein (HDL) cholesterol concentrations reduced even with good metabolic control, whereas a similar pattern tends to emerge in type 1 (“insulin dependent”) diabetes mellitus only when glycaemic control is poor.4 ,5 Typically in both type 1 and type 2 diabetes, however, blood concentrations of total and low density lipoprotein (LDL) cholesterol are similar to those in the general population. This may have contributed to the belief that LDL cholesterol is of little relevance to the risk of cardiovascular disease in diabetes4 ,6 and, apart from those with pronounced dyslipidaemia or pre-existing coronary heart disease (CHD), most people with diabetes do not receive cholesterol lowering treatment despite their increased risk.

Prospective epidemiological studies in the general population show that there is a positive association between CHD risk and blood total cholesterol concentration, which continues down at least to 3 mmol/l (that is, well below the range commonly seen in western populations)7 without any evidence of a “threshold” below which lower cholesterol is not associated with lower risk. In these observational studies, the continuous association is roughly linear between CHD risk plotted on a doubling scale and the concentration of total or LDL cholesterol. This implies that the proportional reduction in CHD risk associated with a particular prolonged absolute difference in cholesterol is similar throughout the range studied. Hence, the absolute size of the reduction in CHD produced by lowering …

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