COMPARISON OF CARDIOVASCULAR EVENT RATES IN SUBJECTS WITH TYPE-2 DIABETES MELLITUS WHO AUGMENTED FROM STATIN MONOTHERAPY TO STATIN PLUS FIBRATE COMBINATION THERAPY WITH THOSE WHO REMAINED ON STATIN MONOTHERAPY

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 II-diabetes who augmented from short-term statin-monotherapy to statin+fibrate combination-therapy with those who remained on statin-monotherapy in a managed care setting. METHODS “Combo-group” (defined as subjects who used statin less than six-months and augmented to statin plus fibrate for more than six-months) and “mono-group” (defined as subjects who used statin less than six-months and remained on statin for more than six-months) were identified among subjects with type-2 diabetes with 2-years intake-period (July 1, 2002-June 30, 2004) and three-years follow-up using administrative claims from a Westcoast-based health plan in U.S. covering 4million 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, model sensitivity, and specificity analyses were performed. RESULTS Mean(+/-SD) age was 58(+/-11) years in combo-group(N=322) and 61(+/-11) years in mono-group(N=9955). In combo-group, mean(+/-SD) treatment-duration was 909(+/-409) days for statin plus fibrate following 118(+/-52) days for statin-monotherapy. In mono-group, mean(+/-SD) treatment-duration was 1339(+/-451) days for statin-monotherapy following 115(+/-51) days for statin-monotherapy. Unadjusted CV-rates between groups were not significantly different (odds ratio [OR]=0.93, P=0.496). Adjusting for age, gender, prior CV, CV related pharmacy-costs, Elixhauser-comorbidity, and diabetes with complication, combo-group experienced 23% risk reduction in CV compared with mono-group (OR=0.67, P=0.006). All covariates were significantly associated with CV-rates. The model did not suffer from multicollinearity and model sensitivity (71.8%) and specificity (76.6%) were satisfactory. CONCLUSIONS In a managed care population with type-2 diabetes after adjusting for known baseline differences, CV-risk was significantly lower among subjects who augmented from short-term statin use to statin+fibrate combination-therapy compared with those remained on statin-monotherapy. We hope this result will be useful in health policy 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

CV2

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

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

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