EVALUATING CLINICAL OUTCOMES FOR SUBJECTS THAT ARE NEWLY INITIATED ON HMG-COA REDUCTASE INHIBITORS IN A NATURALISTIC ENVIRONMENT USING LONGITUDINAL DESIGN

Author(s)

Al-Zakwani I1, Bullano MF1, Willey VJ1, Cziraky MJ1, Hoffman L2, 1Health Core, Inc, Newark, DE, USA; 2Blue Cross and Blue Shield of Florida, Jacksonville, FL, USA

OBJECTIVES: To evaluate lipid level changes, NCEP-ATPIII LDL-C goal attainment and time to goal in a managed care setting. METHODS: Patients were included if they began atorvastatin, fluvastatin, pravastatin, or simvastatin therapy between July 1, 1999 and June 30, 2001, and had no dyslipidemic therapy in the previous 6 months, continuous health plan enrollment, 6 months pre-index and 12 months post-index, and post-index lipid measurements. Goal attainment status was assessed at each LDL-C lab result utilizing NCEP-ATPIII guidelines. Descriptive statistics, generalized estimating equations (GEE), and Cox proportional hazard with multiple-failure data were employed for analysis. Model covariates included age, gender, coronary artery disease, diabetes mellitus, hypertension, duration of statin therapy, medication possession ratio (MPR), and baseline lipid profile. RESULTS: A total of 16,979 patients were identified for this study (fluvastatin = 1,251; pravastatin = 2,302; simvastatin = 5,603; atorvastatin = 7,823). The mean overall age of the cohort was 62 ± 13 years, 49% were male, and 58% of patients were defined as secondary prevention by NCEP-ATPIII risk criteria. The overall mean duration of therapy (persistence) was 16 ± 9 months and adherence to therapy (MPR) was 79%. The mean/median doses were as follows: atorvastatin = 14mg/10mg, fluvastatin=35mg/40mg, pravastatin=28mg/20mg and simvastatin = 24mg/20mg. Changes in lipid levels for atorvastatin, fluvastatin, pravastatin, and simvastatin were as follows: total cholesterol (-21%, -15%, -16%, -20%), LDL-C (-28%, -21%, -23%, -28%), HDL-C (0.1%, 1.0%, 1.0%, 1.5%), and triglycerides (-8%, -1%, -3%, -5%), respectively. The probabilities of achieving LDL-C goal and median times to goal were: atorvastatin (0.51, 236 days); fluvastatin (0.30, 379 days); pravastatin (0.35, 377 days); simvastatin (0.47, 246 days). CONCLUSIONS: Patients who were prescribed atorvastatin had significantly greater improvements in total cholesterol and triglycerides and attained LDL-C goal significantly more often evaluating each lab result independently. Changes in LDL-C and HDL-C were similar between atorvastatin and simvastatin.

Conference/Value in Health Info

2004-05, ISPOR 2004, Arlington, VA, USA

Value in Health, Vol. 7, No. 3 (May/June 2004)

Code

PCV11

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Cardiovascular Disorders

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