Effect of pravastatin on coronary disease events in subgroups defined by coronary risk factors - The prospective pravastatin pooling project

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 characteristic s. Methods and Results-The data from 3 large randomized trials with pravastati n 40 mg were pooled and analyzed with the use of a prospectively defined pr otocol. Included were 19 768 patients, 102 559 person-years of follow-up, 2 194 primary end points (coronary death or nonfatal myocardial infarction), and 3717 expanded end points (primary end point, CABG, or PTCA). Pravastati n significantly reduced relative risk in younger (<65 years) and older (gre ater than or equal to 65 years) patients, men and women, smokers and nonsmo kers, and patients with or without diabetes or hypertension. The relative e ffect was smaller, but absolute risk reduction was similar in patients with hypertension compared with those without hypertension. Relative risk reduc tion was significant in predefined categories of baseline lipid concentrati ons. Tests for interaction were not significant between relative risk reduc tion 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 tr iglyceride (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 0.01 9 for the expanded end point. Relative risk reduction was similar throughou t 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 d isease events in patients with high or low risk factor status and across a wide range of pretreatment lipid concentrations.