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Long-term efficacy and safety of statins
Although an overwhelming amount of evidence now points towards the beneficial effects of statins, most of the large statin studies have only had 5-year follow-up and there have been observational studies that have suggested a long-term increased risk of particular types of cancer and of other non-vascular morbidity and mortality.
The 20 536 patients in the Heart Protection Study were randomised to either simvastatin 40 mg once daily or placebo and were followed up within the trial for 5.3 years. Following this period, patients were asked to discuss with their family doctor whether non-trial statin treatment should be prescribed. The patients were then followed-up by mailing questionnaires biannually until a total of 11 years, with further details sought from family doctors or hospital records if required. The primary outcome during this period was major vascular-events, non-fatal myocardial infarction or coronary death, fatal or non-fatal stroke, and coronary or non-coronary revascularisation. Secondary outcomes were major vascular events, death from vascular and non-vascular causes, and cancers at all sites.
The previously reported reduction in major vascular events associated with low-density lipoprotein cholesterol reduction was seen in this patient population during the 5-year follow-up period. After the trial ended, statin use and lipid concentrations were similar in the two groups, and in the subsequent 6 years there was no further significant reduction in major …