Long-Term Effectiveness and Safety of Pravastatin in Patients With Coronary Heart Disease: 16 Years of Follow-Up of the LIPID Study
Background—We aimed to assess the long-term effects of treatment with statin therapy on all-cause mortality, cause-specific mortality, and cancer incidence from extended follow-up of the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial.
Methods and Results—LIPID initially compared pravastatin and placebo over 6 years in 9014 patients with prior coronary heart disease (CHD). After the double-blind period, all patients were offered open-label statin therapy. Data were obtained over a further 10 years from 7721 patients, by direct contact for 2 years, questionnaires thereafter, and from mortality and cancer registries. During extended follow-up, 85% assigned pravastatin and 84% assigned placebo took statin therapy. Patients assigned pravastatin maintained a significantly lower risk of death from CHD (relative risk (RR) 0.89; 95% confidence interval (CI) 0.81−0.97; P=0.009), from cardiovascular disease (RR 0.88; 95% CI 0.81−0.95; P=0.002), and from any cause (RR 0.91; 95% CI 0.85−0.97; absolute risk reduction 2.6%; P=0.003).Cancer incidence was similar by original treatment group during the double-blind period (RR 0.94; 95% CI 0.82 to 1.08; P=0.41), later follow-up (RR 1.02; 95% CI 0.91 to 1.14; P= 0.74), and overall (RR 0.99; 95% CI 0.91 to 1.08; P=0.83). Nor were there significant differences in cancer mortality, or in the incidence of organspecific cancers. Cancer findings were confirmed in a meta-analysis with other large statin trials with extended follow-up.
Conclusions—In LIPID, the absolute survival benefit from 6 years pravastatin treatment appeared to be maintained for the next 10 years, with a similar risk of death among survivors in both groups after the initial period. Treatment with statins does not influence cancer or death from noncardiovascular causes during long-term follow-up.
- risk factors
- coronary heart disease risk
- cancer and stroke
- cardiovascular disease risk factors
- statin therapy
- Received July 20, 2015.
- Revision received March 7, 2016.
- Accepted March 16, 2016.