Long-Standing Statin Therapy and the Risk of New-Onset Diabetes in the Elderly
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COMMENTARY
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Long-Standing Statin Therapy and the Risk of New-Onset Diabetes in the Elderly Collateral Damage Caused by Preventive Medicine? Luca Mascitelli1 and Mark R. Goldstein2 1 Comando Brigata Alpina ‘‘Julia’’, Medical Service, Udine, Italy 2 NCH Healthcare Group, Naples, FL, USA
It is widely believed that the connection between cholesterol elevation and atherosclerotic plaques is clear and well established, with the consequent assumption that ‘‘atherosclerosis is a cholesterol problem’’,[1] and that ‘‘[HMG-CoA reductase inhibitor] statin drugs are to atherosclerosis what penicillin was to infectious disease’’.[2] However, controversy continues to surround the aetiology and pathogenesis of atherosclerosis, particularly with respect to cholesterol and lipids.[3] It has also been suggested that hypercholesterolaemia does not represent a causa sine qua non for the development of atherosclerosis, and that the beneficial effects of statins are overstated and do not resolve the cholesterol controversy.[4] Preventive medicine aims to delay the onset of illness and disease and to prevent untimely and premature deaths. Although it has long been considered ‘common knowledge’ that interventions aimed at preventing cardiovascular disease should be related to their control of serum cholesterol levels, statin therapy has been found to reduce the risk of coronary heart disease events in men, but not in women, without prior cardiovascular disease; total mortality was not reduced for either men or women.[5] Furthermore, there appears to be no upper age limit for assessing cardiovascular risk, and it is common to use evidence from younger populations and extrapolate this to the elderly. In the geriatric population, the likelihood of many compounding diseases increases, and the absolute risk of dying is higher because the elderly are nearer to the end of their life; this
may magnify the apparent effect of a single intervention for a specific condition while overall survival is only minimally affected.[6] The PROSPER (PROspective Study of Pravastatin in the Elderly at Risk)[7] is the only statin trial that was specifically designed for elderly subjects. PROSPER was 3.2 years in duration and randomized subjects (mean age at entry: 75 years) to pravastatin or placebo. Half of the patients had known vascular disease and the remainder had risk factors for vascular disease. In subjects randomized to pravastatin during the trial, there was an increase in cancer death that was equal in magnitude to a decrease in coronary heart disease death, which resulted in unchanged all-cause mortality. Unpublished data from the same PROSPER trial revealed a significant 18% decrease in all-cause mortality in subjects with known vascular disease randomized to pravastatin.[8] This implies that the other half of the subjects, without vascular disease and randomized to pravastatin, had a significant increase in all-cause mortality, leaving all-cause mortality of the entire cohort of pravastatin-tre
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