• Ann. Intern. Med. · Sep 2014

    Comparative Study Observational Study

    Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study.

    • Joshua J Gagne, Niteesh K Choudhry, Aaron S Kesselheim, Jennifer M Polinski, David Hutchins, Olga S Matlin, Troyen A Brennan, Jerry Avorn, and William H Shrank.
    • Ann. Intern. Med. 2014 Sep 16; 161 (6): 400-7.

    BackgroundStatins are effective in preventing cardiovascular events, but patients do not fully adhere to them.ObjectiveTo determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes.DesignObservational, propensity score-matched, new-user cohort study.SettingLinked electronic data from medical and pharmacy claims.ParticipantsMedicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008.InterventionInitiation of a generic or brand-name statin.MeasurementsAdherence 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.ResultsA 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).LimitationResults may not be generalizable to other populations with different incomes or drug benefit structures.ConclusionCompared 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 SourceTeva Pharmaceuticals.

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