Abstract
Background: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them. Objective: To determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes. Design: Observational, propensity score–matched, new-user cohort study. Setting: Linked electronic data from medical and pharmacy claims. Participants: Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008. Intervention: Initiation of a generic or brand-name statin. Measurements: Adherence to statin therapy (measured as the proportion of days covered [PDC] up to 1 year) and a composite outcome comprising hospitalization for an acute coronary syndrome or stroke and all-cause mortality. Hazard ratios (HRs) and absolute rate differences were estimated. Results: A total of 90 111 patients who initiated a statin during the study was identified; 83 731 (93%) initiated a generic drug, and 6380 (7%) initiated a brand-name drug. The mean age of patients was 75.6 years, and most (61%) were female. The average PDC was 77% for patients in the generic group and 71% for those in the brand-name group (P < 0.001). An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99]). The absolute difference was −1.53 events per 100 person-years (CI, −2.69 to −0.19 events per 100 person-years). Limitation: Results may not be generalizable to other populations with different incomes or drug benefit structures. Conclusion: Compared with those initiating brand-name statins, patients initiating generic statins were more likely to adhere and had a lower rate of a composite clinical outcome. Primary Funding Source: Teva Pharmaceuticals.
Highlights
Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them
An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99])
Randomized, controlled trials have found that statins reduce the relative risk for major vascular events by 21% for each 1.0-mmol/L (39-mg/dL) reduction in lowdensity lipoprotein (LDL) cholesterol level in patients at low risk for vascular disease [3]
Summary
Study Cohort The study cohort comprised Medicare beneficiaries (aged Ն65 years) who had prescription drug coverage through either a stand-alone Medicare Part D plan or a retiree drug plan administered by CVS Caremark, a large national pharmacy benefits manager. We linked claims for filled prescriptions to diagnostic, health. Original Research Comparative Effectiveness of Generic and Brand-Name Statins care utilization, and demographic data from Medicare Parts A and B files and enrollment files. The cohort included patients who initiated a statin (lovastatin, pravastatin, or simvastatin) between 2006 and 2008 and had continuous Medicare and CVS Caremark eligibility in the 6 months before initiation. We restricted the cohort to patients initiating these drugs because they were the only statins for which generic versions were available in the United States during the study. To maximize the generalizability of this comparative effectiveness study, we did not impose any other exclusion criteria
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