REAL-WORLD EVIDENCE ON THE EFFECTS OF STATIN-FIBRATE COMBINATION THERAPY IN TYPE-2 DIABETES- THE ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD) TRIAL REDUX
Author(s)
Borah BJ, Shah N, Reinalda M, Montori VMayo Clinic, Rochester, MN, USA
OBJECTIVES: The famed ACCORD-Lipid Trial found that simvastatin/fenofibrate combination therapy (CT) provides no incremental cardiovascular risk reduction in type 2 diabetese (T2D) over statin monotherapy (MT). Yet, with sales over $1 billion, fibrate use in the US does not appear to have slowed down. The inconsistency between scientific evidence and clinical practice raises concern. There is dearth of longitudinal studies with longer follow-up evaluating the efficacy of CT over MT. This study replicates the ACCORD-Lipid trial using a 16-year longitudinal claims database from a large US health plan. METHODS: This retrospective study included patients enrolled between 1995 and 2010. ACCORD inclusion/exclusion criteria were adopted, that required, among other things, T2D patients on statin with baseline A1C≥7.5 and aged 40 to 79. The two study cohorts, MT and CT, were identified from pharmacy claims. At a minimum, patients must have 1-year baseline and 90-day follow-up periods. Cox proportional hazard models were used on propensity-score-matched sample to estimate the hazard of major adverse cardiac event (MACE). Secondary ACCORD outcomes, described below, were also assessed. RESULTS: The study included 9711 patients (MT=8383; CT=1328) with average follow-up of 3.2 years. An average patient in the sample was a White male aged 57 years from the South with annual household income of $40-49K. The two study cohorts differed in demographics (female, ethnicity, income), baseline lipid panel (HDL/LDL/triglyceride/HbA1c), and comorbid conditions. CT and MT patients did not differ in MACE rate (hazard rate or HR=1.19), and in all-cause death (HR=1.09), macrovascular event(HR=0.89), cardiovascular death(HR=0.87), coronary disease event(HR=1.22), non-fatal stroke(HR=1.09) and CHF event(HR=1.04), all with non-significant p-values. CONCLUSIONS: We found that, compared to MT, CT may not provide any additional cardiovascular risk reduction in T2D. Given that our database represents a large commercially-insured US population, our findings appear to genearalize ACCORD-Lipid trial results to real-world population.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
RM1
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Cardiovascular Disorders, Diabetes/Endocrine/Metabolic Disorders, Respiratory-Related Disorders