MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience
Summary
This summary is machine-generated.This study investigated cholesterol-lowering therapy and antioxidant vitamins in high-risk patients. Results showed simvastatin significantly reduced cholesterol, but vitamin supplements had no significant impact on mortality or major events.
Area Of Science
- Cardiovascular Medicine
- Clinical Trials
- Nutritional Science
Background
- Observational studies link lower cholesterol and antioxidant vitamins to reduced coronary heart disease (CHD) risk.
- High-risk individuals may benefit from cholesterol-lowering therapy regardless of baseline levels.
- Antioxidant vitamin supplementation is also suggested to lower CHD risk.
Purpose Of The Study
- To reliably assess the effects of cholesterol-lowering therapy (simvastatin) and antioxidant vitamin supplementation on mortality and major morbidity.
- To evaluate these interventions in a diverse population of high-risk patients.
- To provide evidence on the benefit-risk balance of these treatments in uncertain cases.
Main Methods
- A randomized, 2x2 factorial trial involving 15,454 men and 5,082 women aged 40-80 years at high risk of CHD.
- Participants received simvastatin (40 mg) or placebo, and antioxidant vitamins (vitamins E, C, beta-carotene) or placebo.
- Follow-up for at least 5 years with assessments of mortality and major morbidity.
Main Results
- Simvastatin significantly reduced total and LDL cholesterol levels by approximately 1.5-1.6 mmol/L and 1.1-1.2 mmol/L, respectively.
- Antioxidant vitamin supplementation increased plasma vitamin E levels but showed no significant difference in muscle symptoms or elevated enzymes.
- Initial follow-up indicated annual rates of 2.4% for non-fatal MI/fatal CHD, 1.3% for stroke, and 2.2% for all-cause mortality.
Conclusions
- The Heart Protection Study is a large trial with well-tolerated regimens producing substantial lipid and vitamin level changes.
- The study is expected to provide reliable evidence on the efficacy of cholesterol-lowering therapy and antioxidant vitamins.
- Further analysis will clarify the effects on mortality and morbidity across various high-risk patient categories.
View abstract on PubMed