title: Effects of High Density Lipoprotein Raising Therapies on Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus, with or without Renal Impairment: The Action to Control Cardiovascular Risk in Diabetes Study.
abstract: BACKGROUND
  The role of high density lipoprotein-raising interventions in addition to statin therapy in patients with diabetes remains controversial. Chronic kidney disease (CKD) is a strong modifier of cardiovascular (CV) outcomes. We therefore investigated the impact of CKD status at baseline on outcomes in patients with diabetes randomized to standard statin or statin plus fenofibrate treatment in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial.
  
  
  METHODS
  Among 5,464 participants in the ACCORD lipid trial, 3,554 (65%) were free of CKD at baseline, while 1,910 (35%) had mild to moderate CKD. Differences in CV outcomes during follow-up between CKD and non-CKD subgroups were examined. In addition, the effect of fenofibrate as compared to placebo on CV outcomes was examined for both subgroups.
  
  
  RESULTS
  All CV outcomes were 1.4-3 times higher among patients with CKD as compared to non-CKD patients. In patients with CKD, the addition of fenofibrate had no effect on any of the primary or secondary outcomes. In patients without CKD, however, the addition of fenofibrate was associated with a significant 36% reduction of CV mortality (hazards ratio [HR] 0.64; 95% CI 0.42-0.97; p value for treatment interaction <0.05) and 44% lower rate of fatal or non-fatal congestive heart failure (CHF; HR 0.56; 95% CI 0.37-0.84; p value treatment interaction <0.03).
  
  
  CONCLUSIONS
  For patients with type 2 diabetes at high CV risk but no CKD, fenofibrate therapy added to statin reduced the CV mortality and the rate of fatal and non-fatal CHF.
authors.affiliation: Veteran Affairs Medical Center and Georgetown University, Washington, DC, USA.
authors.forename: Vasilios
authors.initials: V
authors.lastname: Papademetriou
authors.forename: Laura
authors.initials: L
authors.lastname: Lovato
authors.forename: Costas
authors.initials: C
authors.lastname: Tsioufis
authors.forename: William
authors.initials: W
authors.lastname: Cushman
authors.forename: William B
authors.initials: WB
authors.lastname: Applegate
authors.forename: Amy
authors.initials: A
authors.lastname: Mottle
authors.forename: Zubin
authors.initials: Z
authors.lastname: Punthakee
authors.forename: Eric
authors.initials: E
authors.lastname: Nylen
authors.forename: Michael
authors.initials: M
authors.lastname: Doumas
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008075:Lipoproteins, HDL / Q000097:blood / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000960:Hypolipidemic Agents; D008075:Lipoproteins, HDL; D011345:Fenofibrate