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Safety and Efficacy of Statin Therapy to Lower LDL Cholesterol
Study Questions:
What is the long-term impact of statin therapy on mortality and cumulative morbidity in a high-risk cohort of middle-aged men?
Methods:
WOSCOPS (West of Scotland Coronary Prevention Study) was a primary prevention trial in 45- to 64-year-old men with high low-density lipoprotein cholesterol (LDL-C). A total of 6,595 men were randomized to receive pravastatin 40 mg once daily or placebo for an average of 4.9 years. Linkage to electronic health records permitted analysis of major incident events over 20 years. Post-trial statin use was about one third in both the pravastatin and placebo cohorts at 5 years, with no further data available for the next 10 years.
Results:
At a mean follow-up of 18 years, men with a mean age of 55 years and mean LDL-C of 192 mg/dl allocated to pravastatin had reduced all-cause mortality (hazard ratio [HR], 0.87; p = 0.0007), mainly attributable to a 21% decrease in cardiovascular death (HR, 0.79; p = 0.0004), but no reduction in stroke mortality. There was no difference in noncardiovascular or cancer death rates between groups. Cumulative hospitalization event rates were lower in the statin-treated arm: by 18% for any coronary event (p = 0.002), 24% for myocardial infarction (p = 0.01), and 35% for heart failure (p = 0.002), but there was no difference in stroke. There were no significant differences between groups in hospitalization for noncardiovascular causes and less in the pravastatin group were hospitalized for diabetic-related complications.
Conclusions:
Statin treatment for 5 years was associated with a legacy benefit with improved survival and a substantial reduction in cardiovascular disease outcomes over a 20-year period, supporting the wider adoption of primary prevention strategies.
Perspective:
This report provides the best evidence available from a clinical trial that there is a legacy benefit from statins and no incremental risk of noncardiovascular deaths or hospitalizations from a statin with intermediate potency. Considering that use of statins likely increased in the last 10 years of follow-up, the legacy benefits are even more impressive. The WOSCOPS results at 15 years provided data of cost savings in primary prevention of middle-aged men with severe hypercholesterolemia. Most interesting was the 25% reduction in hospitalizations for heart failure, which cannot be explained by hospitalizations for a myocardial infarction.
Keywords: Cholesterol, LDL, Diabetes Mellitus, Dyslipidemias, Electronic Health Records, Heart Failure, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Middle Aged, Morbidity, Mortality, Myocardial Infarction, Neoplasms, Pravastatin, Primary Prevention, Stroke
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