Abstract

Objective: Statins and gemfibrozil as individual monotherapy have shown to reduce major cardiovascular events with statins alone reducing all cause mortality. However, it is uncertain whether the combination of statins with gemfibrozil is associated with further reduction in all cause mortality compared to mortality reduction by statins alone. We will examine the hypothesis that combination of gemfibrozil with statin is associated with greater reduction in all cause mortality compared to statin alone. Methods: We performed a retrospective cohort chart review of the VistA database between January 1, 2003 and January 1, 2013 at the Veterans Affairs Healthcare System in Fargo, North Dakota. All veterans greater than or equal to 18 years of age taking either the combination of statin and gemfibrozil or statin alone for a minimum of 12 months were included in the study. The subjects in either group were selected randomly from the pharmacy database, which divided the subjects into statin or combination group. The total sample size was 1800 with 900 subjects in each group. Our primary outcome variable was all cause mortality. The Kaplan Meier Survival curve was drawn for the combination group versus statin alone group. The adjustment for mortality covariates was by the Cox proportional hazard regression. Findings: Statin versus the combination group differed demographically by age (73 ± 11.5 vs 68 ± 11.8), BMI (29.9 ± 50 vs 31.7 ± 5.4), hypertension (72.1% vs 80.9%), diabetes mellitus (33.0% vs 47%), smoking (22% vs 28.2%) and stroke (8.3% vs 5.2%); all P<0.01. The two groups were similar for myocardial infarction, transient ischemic attack, peripheral vascular disease, coronary artery disease, and coronary artery bypass graft outcomes. The all cause mortality difference was 10.2% between statin and the combination group at 10 years (25% vs 14.8%, P<0.0001). The unadjusted Kaplan-Meier analysis over 10 years subsequent to lipid therapy initiation showed a highly significant group difference. Cox proportional hazard adjustment for age, BMI, hypertension, and diabetes revealed persistence of the group difference (P <0.0001). Conclusion: Combination of gemfibrozil with statin is associated with greater reduction in all cause mortality compared to statins alone. Keywords: gemfibrozil, mortality

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