WOSCOPS analysis supports LDL-C lowering for primary prevention at high LDL-c without risk assessment
LDL-Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men with Primary Elevations of LDL-Cholesterol Levels of 190 mg/dL or Above: Analyses from the WOSCOPS 5-year Randomised Trial and 20-year Observational Follow-UpLiterature - Vallejo-Vaz AJ, Robertson M, Catapano AL, et al. - Circulation 2017; 136:1878-91
- At 4.9 years, in individuals with LDL-C ≥190 mg/dL, pravastatin significantly reduced the risk of CHD by 27% (P=0.033) with a 25% lower risk of MACE (P=0.037) compared with placebo.
- Amongst all subjects initially allocated to pravastatin, CHD death, CV death and all-cause mortality were significantly reduced by 22%, 17% and 12% respectively during a total of 20-years of follow-up.
- The long-term risk of CHD death, CV death and all-cause mortality were significantly reduced by 28%, 25% and 18%, respectively, among those with LDL-C ≥190 mg/dL originally randomised to pravastatin.
- The ARR of death at 20 years from CHD, CV causes and from any-cause was at least two-fold greater among patients with LDL-C ≥190 mg/dL (ARR: 2.34%, 3.25% and 5.39%, respectively) compared with those with LDL-C <190 mg/dL.
- Among individuals with LDL-C ≥190 mg/dL, a reduction in LDL-C of greater than 30% or 39 mg/dL (1 mmol/L) on pravastatin was associated with a lower risk of CHD and MACE compared to placebo, whereas those individuals allocated to pravastatin whose LDL-C reduction was less than 30% or 39 mg/dL were not significantly different from placebo.
- For participants with a predicted 10-year atherosclerotic CVD risk below 7.5% and no DM, MACE was significantly reduced to 4.8% among those allocated to pravastatin in contrast to a rate of 7.5% among placebo, representing a 38% reduction in risk (HR: 0.62; 95% CI: 0.42 - 0.92; P = 0.018) during the 5-year trial period. During the 20-year extended follow up the corresponding rates were 18.76% vs 24.18%, representing a risk reduction of 27% (HR: 0.73; 95% CI: 0.60 - 0.90; P = 0.003).
Men with LDL-C levels ≥190 mg/dL without atherosclerotic CVD, have a 2-fold higher risk of major CV events than would be predicted with a risk calculator. These results provide evidence for the benefits of LDL-C lowering for the primary prevention of individuals with primary elevations of LDL-C ≥190 mg/dL, which may help reinforce current recommendations for this group of patients.