Joshua J. Gagne, PharmD, ScD; Niteesh K. Choudhry, MD, PhD; Aaron S. Kesselheim, MD, JD, MPH; Jennifer M. Polinski, ScD, MPH; David Hutchins, MBA, MHSA; Olga S. Matlin, PhD; Troyen A. Brennan, MD; Jerry Avorn, MD; William H. Shrank, MD, MSHS
Note: Dr. Gagne had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Grant Support: By Teva Pharmaceuticals (2010A057139).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2942.
Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Gagne (e-mail, firstname.lastname@example.org). Data set: Not available.
Requests for Single Reprints: Joshua J. Gagne, PharmD, ScD, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, email@example.com.
Current Author Addresses: Drs. Gagne, Choudhry, Kesselheim, Polinski, and Avorn: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
Mr. Hutchins: CVS Caremark, 10001 North 92nd Street, Scottsdale, AZ 85258.
Dr. Matlin: CVS Caremark, 2211 Sanders Road, Northbrook, IL 60062.
Dr. Brennan: CVS Caremark, 1 CVS Drive, Woonsocket, RI 02895.
Dr. Shrank: CVS Caremark, 100 Scenic View Road, Cumberland, RI 02864.
Author Contributions: Conception and design: J.J. Gagne, A.S. Kesselheim, D. Hutchins, T.A. Brennan, W.H. Shrank.
Analysis and interpretation of the data: J.J. Gagne, N.K. Choudhry, J.M. Polinski, D. Hutchins, J. Avorn, W.H. Shrank.
Drafting of the article: J.J. Gagne, D. Hutchins.
Critical revision of the article for important intellectual content: J.J. Gagne, N.K. Choudhry, A.S. Kesselheim, J.M. Polinski, O.S. Matlin, T.A. Brennan, J. Avorn, W.H. Shrank.
Final approval of the article: J.J. Gagne, N.K. Choudhry, A.S. Kesselheim, J.M. Polinski, D. Hutchins, O.S. Matlin, T.A. Brennan, J. Avorn, W.H. Shrank.
Provision of study materials or patients: J.J. Gagne.
Statistical expertise: J.J. Gagne, J.M. Polinski, W.H. Shrank.
Obtaining of funding: J.J. Gagne, W.H. Shrank.
Administrative, technical, or logistic support: J.J. Gagne, D. Hutchins, O.S. Matlin, T.A. Brennan, J. Avorn, W.H. Shrank.
Collection and assembly of data: J.J. Gagne, D. Hutchins.
Gagne JJ, Choudhry NK, Kesselheim AS, Polinski JM, Hutchins D, Matlin OS, et al. Comparative Effectiveness of Generic and Brand-Name Statins on Patient Outcomes: A Cohort Study. Ann Intern Med. 2014;161:400-407. doi: 10.7326/M13-2942
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Published: Ann Intern Med. 2014;161(6):400-407.
Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them.
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.
Observational, propensity score–matched, new-user cohort study.
Linked electronic data from medical and pharmacy claims.
Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008.
Initiation of a generic or brand-name statin.
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.
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).
Results may not be generalizable to other populations with different incomes or drug benefit structures.
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.
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Cardiology, Coronary Risk Factors, Dyslipidemia, Healthcare Delivery and Policy, High Value Care.
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