Abstract 16290: Long-Term Safety and Effectiveness of Cholesterol Lowering with Pravastatin Treatment Over 11 Years: The Lipid Study Extension

Abstract

The effectiveness and safety of statin therapy in patients with or at high risk of cardiovascular disease (CVD) has been clearly established in many randomized trials. However, these trials were conducted over an average of 5 years. More recently, several (WOSCOPS, ASCOT-LLA, 4S, HPS) have provided further information on open-label follow-up over an additional 5 years or more, including evidence of longer-term effectiveness and safety. The LIPID trial now has 16 years of follow-up: the main trial compared 6 years of pravastatin treatment with placebo in 9014 patients with prior CHD and average baseline total cholesterol 4.0-7.0 mmol/L (155-271 mg/dL); the LIPID cohort has been followed since then for a further 10 years, with statin treatment recommended for all patients and on average taken by 84% of both groups over the extended period. Long-term mortality and cancer incidence data were available for 8750 patients (97%), with 3791 deaths and 2128 patients with new cancer.

Conclusions: Over the 16 years, the absolute effects of treatment were largely sustained (with slight attenuation of total mortality benefit) and remained highly significant for both CVD (P=0.002) and total mortality (P=0.009). There were no safety concerns about cancer deaths or other non-CVD deaths. There was no significant excess in the incidence of cancer overall (23.4% vs 23.8%, HR 0.99 (95% CI 0.91-1.08) or any specific cancer subtype for the whole period or during extended follow-up. These results confirm sustained survival benefits for initial pravastatin therapy with no legacy effects on cancer or nonvascular mortality after 16 years.