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Ann Intern Med. 2014 Sep 16;161(6):400-7. doi: 10.7326/M13-2942.

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

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.

PMID:
25222387
DOI:
10.7326/M13-2942
[Indexed for MEDLINE]

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