"Fenofibrate and Simvastatin Not Beneficial in Reducing Cardiovascular Events in Patients with Type 2 Diabetes".The New England Journal of Medicine. 2010.
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1Clinical Question 2Bottom Line 3Major Points 4Guidelines 5Design 6Population 6.1Inclusion Criteria 6.2Exclusion Criteria 6.3Baseline Characteristics 7Interventions 8Outcomes 8.1Primary Outcome 8.2Secondary Outcomes 9Criticisms 10Funding 11Further Reading
In high-risk patients with type 2 diabetes mellitus already on statin therapy, does additional fenofibrate therapy reduce the risk of cardiovascular events?
In high-risk patients with type 2 diabetes on simvastatin therapy, addition of fenofibrate did not reduce cardiovascular events compared to placebo. Routine use of this combination therapy is not supported for reducing cardiovascular risk in the majority of patients with type 2 diabetes.
Type 2 diabetes patients are at an elevated risk for cardiovascular disease, partly due to dyslipidemia characterized by elevated triglycerides, low HDL cholesterol, and small, dense LDL particles. This study tested whether the addition of fenofibrate to statin therapy in such patients would further reduce cardiovascular events.
Modern guidelines do not currently support the use of combination fibrate-statin therapy over statin therapy alone for the majority of patients with type 2 diabetes at high cardiovascular risk.
Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial.
Patients with type 2 diabetes at high risk for cardiovascular disease, on statin therapy.
Inclusion Criteria LDL cholesterol 60-180 mg/dL, low HDL cholesterol, triglycerides <750 mg/dL without lipid therapy or <400 mg/dL with lipid therapy.
Exclusion Criteria Not provided.
Baseline Characteristics Mean age was 62 years, 31% female, 37% with history of cardiovascular event.
Patients on open-label simvastatin were randomly assigned to either fenofibrate or placebo on top of their statin therapy.
Primary Outcome First occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes.
Rates of death, secondary efficacy endpoints like revascularization and hospitalization for congestive heart failure.
Despite broad inclusion criteria and adequate power, no significant benefit was found. Selection criteria and event rates suggest possible benefit for certain subgroups with severe dyslipidemia.
National Heart, Lung, and Blood Institute, other NIH institutes, CDC, and General Clinical Research Centers, with study medications donated by various pharmaceutical companies.
For further information on this study, please refer to the full text article available at NEJM.org.