Literature DB >> 25222387

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, William H Shrank.   

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.

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Year:  2014        PMID: 25222387     DOI: 10.7326/M13-2942

Source DB:  PubMed          Journal:  Ann Intern Med        ISSN: 0003-4819            Impact factor:   25.391


  48 in total

1.  Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

Authors:  Aaron S Kesselheim; Joshua J Gagne
Journal:  Drug Saf       Date:  2015-10       Impact factor: 5.606

2.  Active Surveillance of Follow-on Biologics: A Prescription for Uptake.

Authors:  Ameet Sarpatwari; Joshua J Gagne; Nicole L Levidow; Aaron S Kesselheim
Journal:  Drug Saf       Date:  2017-02       Impact factor: 5.606

3.  Real World Evidence: Time for a Switch?

Authors:  Rachel E Sobel; Andrew Bate; Robert F Reynolds
Journal:  Drug Saf       Date:  2018-12       Impact factor: 5.606

4.  Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017.

Authors:  Makoto Kinoshita; Koutaro Yokote; Hidenori Arai; Mami Iida; Yasushi Ishigaki; Shun Ishibashi; Seiji Umemoto; Genshi Egusa; Hirotoshi Ohmura; Tomonori Okamura; Shinji Kihara; Shinji Koba; Isao Saito; Tetsuo Shoji; Hiroyuki Daida; Kazuhisa Tsukamoto; Juno Deguchi; Seitaro Dohi; Kazushige Dobashi; Hirotoshi Hamaguchi; Masumi Hara; Takafumi Hiro; Sadatoshi Biro; Yoshio Fujioka; Chizuko Maruyama; Yoshihiro Miyamoto; Yoshitaka Murakami; Masayuki Yokode; Hiroshi Yoshida; Hiromi Rakugi; Akihiko Wakatsuki; Shizuya Yamashita
Journal:  J Atheroscler Thromb       Date:  2018-08-22       Impact factor: 4.928

5.  Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.

Authors:  Joshua J Gagne; Jennifer M Polinski; Wenlei Jiang; Sarah K Dutcher; Jing Xie; Joyce Lii; Lisa A Fulchino; Aaron S Kesselheim
Journal:  Drugs       Date:  2017-03       Impact factor: 9.546

6.  Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

Authors:  R A Hansen; J Qian; R L Berg; J G Linneman; E Seoane-Vazquez; S Dutcher; S Raofi; C D Page; P L Peissig
Journal:  Clin Pharmacol Ther       Date:  2017-10-10       Impact factor: 6.875

Review 7.  FDA Policy and Cardiovascular Medicine.

Authors:  Joseph S Ross; Aaron S Kesselheim
Journal:  Circulation       Date:  2015-09-22       Impact factor: 29.690

Review 8.  Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products.

Authors:  Bryan Newman; Kimberly Witzmann
Journal:  Pharmaceut Med       Date:  2020-04

9.  Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record.

Authors:  Mitesh S Patel; Susan C Day; Scott D Halpern; C William Hanson; Joseph R Martinez; Steven Honeywell; Kevin G Volpp
Journal:  JAMA Intern Med       Date:  2016-06-01       Impact factor: 21.873

10.  Comparative impact of implementing the 2013 or 2014 cholesterol guideline on vascular events in a quality improvement network.

Authors:  Brent M Egan; Susan E Sutherland; William F Childers; Ruthanne M Dahlheimer; George A Helmrich; Daryl A Lapeyrolerie; Nancy Markle; Dennis W Murphy; Locke Simmons; Robert A Davis; Peter Tilkemeier; Angelo Sinopoli
Journal:  Ther Adv Cardiovasc Dis       Date:  2016-01-04
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