title: Use of Fibrates Monotherapy in People with Diabetes and High Cardiovascular Risk in Primary Care: A French Nationwide Cohort Study Based on National Administrative Databases.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy.
authors.affiliation: INSERM, UMR 872, Centre de Recherche des Cordeliers, 15 rue de l'école de médecine, 75006 Paris, France; Université Paris 7, Faculté de Médecine, 16 rue Huchard, 75018 Paris, France; Hôpital Bichat, AP-HP, Diabetology Endocrinology Nutrition, 46 rue Huchard, 75018 Paris, France.
authors.forename: Ronan
authors.initials: R
authors.lastname: Roussel
authors.affiliation: Strategy and Research Department, National Health Insurance, CNAMTS 50, avenue du Professeur André Lemierre 75986 Paris Cedex 20, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Chaignot
authors.affiliation: Strategy and Research Department, National Health Insurance, CNAMTS 50, avenue du Professeur André Lemierre 75986 Paris Cedex 20, Paris, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Weill
authors.affiliation: INSERM, UMR 872, Centre de Recherche des Cordeliers, 15 rue de l'école de médecine, 75006 Paris, France; Université Paris 7, Faculté de Médecine, 16 rue Huchard, 75018 Paris, France; Hôpital Bichat, AP-HP, Diabetology Endocrinology Nutrition, 46 rue Huchard, 75018 Paris, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Travert
authors.affiliation: INSERM, UMR 872, Centre de Recherche des Cordeliers, 15 rue de l'école de médecine, 75006 Paris, France; Université Paris 7, Faculté de Médecine, 16 rue Huchard, 75018 Paris, France; Hôpital Bichat, AP-HP, Diabetology Endocrinology Nutrition, 46 rue Huchard, 75018 Paris, France.
authors.forename: Boris
authors.initials: B
authors.lastname: Hansel
authors.affiliation: INSERM, UMR 872, Centre de Recherche des Cordeliers, 15 rue de l'école de médecine, 75006 Paris, France; Université Paris 7, Faculté de Médecine, 16 rue Huchard, 75018 Paris, France; Hôpital Bichat, AP-HP, Diabetology Endocrinology Nutrition, 46 rue Huchard, 75018 Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Marre
authors.affiliation: Strategy and Research Department, National Health Insurance, CNAMTS 50, avenue du Professeur André Lemierre 75986 Paris Cedex 20, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ricordeau
authors.affiliation: General division, National Health Insurance, CNAMTS 50, avenue du Professeur André Lemierre 75986 Paris Cedex 20, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Alla
authors.affiliation: General division, National Health Insurance, CNAMTS 50, avenue du Professeur André Lemierre 75986 Paris Cedex 20, Paris, France.
authors.forename: Hubert
authors.initials: H
authors.lastname: Allemand
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000150:complications* / Q000188:drug therapy*; D015331:Cohort Studies; D019992:Databases as Topic; D003920:Diabetes Mellitus / Q000188:drug therapy*; D005260:Female; D058607:Fibric Acids / Q000627:therapeutic use*; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D016016:Proportional Hazards Models; D012307:Risk Factors; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D058607:Fibric Acids