To analyse the effects of simvastatin in patients at risk of death from coronary artery disease (CAD) having low to average LDL cholesterol levels
HPS (Heart Protection Study)
18 Mar, 14
Aim
Design
Randomized, placebo-controlled study
Patients
20,356 patients with total cholesterol>135 mg/dl and who met one of the following criteria: prior myocardial infarction, any other CAD, occlusive disease of noncoronary arteries (peripheral vascular disease or stroke), diabetes mellitus or treated hypertension
Follow-up
5 years
Treatment Regimen
Simvastatin 40 mg vs. Antioxidant therapy with vitamin E (600 mg), vitamin C (250 mg) and beta carotene (20 mg) vs. Placebo
Additional Therapy
American Heart Association phase I and II diet.
Results
- Simvastatin caused a significant reduction in vascular and all-cause mortality
- Simvastatin reduced stroke by 27%
- Simvastatin reduced major vascular events (MI, stroke and revascularisation) by 24%
- Benefit was observed even in patients with baseline LDL level lower than the recommended target level of 100 mg/dl
- Benefits of statin therapy increased with each year of therapy and were irrespective of age, gender, or baseline total cholesterol or LDL levels
- Simvastatin was well tolerated; there was no significant increase in liver or muscle enzymes
- Antioxidant vitamin therapy did not have any benefit on all-cause mortality, vascular or non-vascular mortality
Conclusion
- Simvastatin 40 mg/day reduced risk of heart attack, stroke and revascularisation procedures by at least one third
- This benefit was totally independent of initial lipid values, including levels that are lower than published target goal levels
- Even in diabetic patients without any evidence of vascular disease, simvastatin demonstrated benefit
- The study confirmed the benefit of statin treatment in the prevention of stroke
- It is never too late to initiate treatment - even patients older than 75 years of age exhibited a sustained benefit from this treatment
-
There may no longer be a need to check a lipid profile prior to initiation of a statin.
Lancet 2004;363:757-67






