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Effect of pravastatin on coronary disease events in subgroups defined by coronary risk factors: the Prospective
F M Sacks1, A M Tonkin, J Shepherd
1Brigham and Women's Hospital, Harvard Medical School Boston, MA 02115, USA. fsacks@hsph.harvard.edu
Insights
Pravastatin significantly reduces coronary heart disease events across diverse patient groups and lipid levels. This lipid-modifying therapy proves effective for both high and low-risk individuals, demonstrating broad applicability.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Previous trials lacked sufficient power to definitively assess lipid-modifying therapy's impact on coronary heart disease (CHD) in specific patient subgroups.
- Understanding treatment effects across varying baseline characteristics is crucial for personalized cardiovascular risk management.
Purpose of the Study:
- To pool data from multiple pravastatin trials to evaluate its efficacy in reducing coronary events across diverse patient populations and lipid profiles.
- To determine if the benefits of pravastatin vary based on patient demographics, risk factors, and baseline lipid concentrations.
Main Methods:
- Pooled analysis of data from 3 large randomized trials involving 19,768 patients treated with pravastatin 40 mg.
- Analysis included 102,559 person-years of follow-up and 2,194 primary end points (coronary death or nonfatal myocardial infarction).
- Statistical methods assessed treatment effects across subgroups and tested for interactions with baseline characteristics and lipid levels.
Main Results:
- Pravastatin significantly reduced relative risk of CHD events in younger/older patients, men/women, smokers/nonsmokers, and those with/without diabetes or hypertension.
- Absolute risk reduction was similar in patients with and without hypertension.
- While relative risk reduction was generally consistent across baseline lipid concentrations, potential variations were observed at the lowest LDL cholesterol levels.
Conclusions:
- Pravastatin treatment is effective in reducing coronary heart disease events in patients with both high and low risk factor status.
- The therapy demonstrates efficacy across a wide range of pretreatment lipid concentrations, supporting its broad clinical utility.
Background:
Previous trials have had insufficient numbers of coronary events to address definitively the effect of lipid-modifying therapy on coronary heart disease in subgroups of patients with varying baseline characteristics.
Methods And Results:
The data from 3 large randomized trials with pravastatin 40 mg were pooled and analyzed with the use of a prospectively defined protocol. Included were 19 768 patients, 102 559 person-years of follow-up, 2194 primary end points (coronary death or nonfatal myocardial infarction), and 3717 expanded end points (primary end point, CABG, or PTCA). Pravastatin significantly reduced relative risk in younger (<65 years) and older (>/=65 years) patients, men and women, smokers and nonsmokers, and patients with or without diabetes or hypertension. The relative effect was smaller, but absolute risk reduction was similar in patients with hypertension compared with those without hypertension. Relative risk reduction was significant in predefined categories of baseline lipid concentrations. Tests for interaction were not significant between relative risk reduction and baseline total cholesterol (5% to 95% range 177 to 297 mg/dL, 4.6 to 7.7 mmol/L), HDL cholesterol (27 to 58 mg/dL, 0.7 to 1.5 mmol/L), and triglyceride (74 to 302 mg/dL, 0.8 to 3.4 mmol/L) concentrations, analyzed as continuous variables. However, for LDL cholesterol, the probability values for interaction were 0.068 for the prespecified primary end point and 0.019 for the expanded end point. Relative risk reduction was similar throughout most of the baseline LDL cholesterol range (125 to 212 mg/dL, 3.2 to 5.5 mmol/L) with the possible exception of the lowest quintile of CARE/LIPID (<125 mg/dL) (relative risk reduction 5%, 95% CI 19% to -12%).
Conclusions:
Pravastatin treatment is effective in reducing coronary heart disease events in patients with high or low risk factor status and across a wide range of pretreatment lipid concentrations.
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