COMPARING CARDIOVASCULAR EVENT RATES OF STATIN PLUS FIBRATE COMBINATION THERAPY WITH STATIN MONOTHERAPY IN SUBJECTS WITH TYPE-2 DIABETES MELLITUS

Author(s)

Hae Sun Suh, BPharm, MS, MA, Ph.D. Candidate, Jason N Doctor, PhD, Associate ProfessorUniversity of Southern California, Los Angeles, CA, USA

OBJECTIVES To compare cardiovascular-event (CV) rates in subjects with type-2 diabetes who were on statin+fibrate combination-therapy with those on statin-monotherapy in a managed care setting. METHODS “Combo-group” (defined as subjects who used statin+fibrate combination-therapy) and “mono-group” (defined as subjects who used statin-monotherapy) were identified among subjects with type-2 diabetes having six-months washout-period without using any lipid-modifying agents, 2-years intake-period (July 1, 2002-June 30, 2004), 3-years follow-up, and treatment duration for more than 6-months using administrative claims from a Westcoast-based health plan in US covering 4 million lives. Outcomes measure was any occurrence of CV including ischemic heart disease, cerebrovascular disease, and peripheral vascular disease. A multivariate logistic model was developed to evaluate adjusted CV-risk. Multicollinearity test and Hosemer-Lemeshow test were performed. RESULTS Mean(+/-SD) age was 57(+/-8) years in combo-group(N=53) and 57(+/-11) years in mono-group(N=5670). In combo-group, mean(+/-SD) treatment-duration was 779(+/-424) days for statin+fibrate combination-therapy. In mono-group, mean(+/-SD) treatment-duration was 987(+/-588) days for statin-monotherapy. Unadjusted CV-rates of combo-group versus mono-group were not significantly different (odds ratio [OR]=1.39, P=0.2313). Although adjusting for age, gender, prior CV, CV related pharmacy-costs, total medical-costs, diabetes with complication, and Elixhauser-comorbidity, CV-rates of combo-group versus mono-group were not significantly different (OR=1.186, P=0.5929). All covariates were significantly associated with CV-rates. The model did not suffer from multicollinearity and the model goodness-of-fit was satisfactory (P=0.5575). CONCLUSIONS In a managed care population with type-II diabetes after adjusting for known baseline differences, CV-risks among subjects who used statin+fibrate combination-therapy compared to those who used statin-monotherapy did not significantly differ. This is different from what people expected for the combination-therapy, due to low power resulting from small sample size for combo-group. We hope this result will be useful in health policy to find treatment strategies to reduce CV-risk in diabetics. Future research is in progress to address the causality behind this association.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PCV8

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Cardiovascular Disorders, Diabetes/Endocrine/Metabolic Disorders, Multiple Diseases

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