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ABSTRACT: Background and aim
According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk.Design
Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health insurance systems (07/01/08-12/31/09) with a follow-up of up to 30 months.Methods
Lipid-lowering drug-naive diabetic patients initiating fibrate or statin monotherapy were identified. Patients at high cardiovascular risk were then selected: patients with a diagnosis of diabetes and hypertension, and > 50 (men) or 60 (women), but with no history of cardiovascular events. The composite endpoint comprised myocardial infarction, stroke, amputation, or death.Results
Of the 31,652 patients enrolled, 4,058 (12.8%) received a fibrate. Age- and gender-adjusted annual event rates were 2.42% (fibrates) and 2.21% (statins). The proportionality assumption required for the Cox model was not met for the fibrate/statin variable. A multivariate model including all predictors was therefore calculated by dividing data into two time periods, allowing Hazard Ratios to be calculated before (HR < 540) and after 540 days (HR > 540) of follow-up. Multivariate analyses showed that fibrates were associated with an increased risk for the endpoint after 540 days: HR < 540 = 0.95 (95% CI: 0.78-1.16) and HR > 540 = 1.73 (1.28-2.32).Conclusion
Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy.
SUBMITTER: Roussel R
PROVIDER: S-EPMC4580631 | biostudies-literature | 2015
REPOSITORIES: biostudies-literature
Roussel Ronan R Chaignot Christophe C Weill Alain A Travert Florence F Hansel Boris B Marre Michel M Ricordeau Philippe P Alla François F Allemand Hubert H
PloS one 20150923 9
<h4>Background and aim</h4>According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk.<h4>Design</h4>Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health in ...[more]