Are generic and brand-name statins clinically equivalent? Evidence from a real data-base

Giovanni Corrao, Davide Soranna, Andrea Arfè, Manuela Casula, Elena Tragni, Luca Merlino, Giuseppe Mancia, Alberico L. Catapano

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes. Background: Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes.

Methods: 13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treatedwith generic or brand-name simvastatin during 2008,were followed until 2011 for the occurrence of two outcomes: 1) therapeutic discontinuation and 2) hospitalization for CV events. Hazard ratios (HR) associated with use of generic or brand-name at starting therapy (intention-to-treat analysis) and during follow-up (as-treated analysis) were estimated by fitting proportional hazard Cox models. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders.

Results: Patients who started on generic did not experience a different risk of discontinuation (HR: 0.98; 95% CI 0.94 to 1.02) nor of CV outcomes (HR: 0.98; 95% CI 0.79 to 1.22) from those starting on brand-name. Patients who spent >75% of time of follow-up with statin available on generics did not experience a different risk of discontinuation (HR: 0.94; 95% CI 0.87 to 1.01), nor of CV outcomes (HR: 1.06; 95% CI 0.83 to 1.34), compared with those who mainly or only used brand-name statin.

Conclusions: Our findings do not support the notion that in the real world clinical practice brand-name statins are superior to generics for keeping therapy and preventing CV outcomes.

Original languageEnglish
Pages (from-to)745-750
Number of pages6
JournalEuropean Journal of Internal Medicine
Volume25
Issue number8
DOIs
Publication statusPublished - Oct 1 2014

Keywords

  • Brand-name
  • Cardiovascular events
  • Databases
  • Discontinuation
  • Generic
  • Statins

ASJC Scopus subject areas

  • Internal Medicine
  • Medicine(all)

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