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

doi:10.1016/j.ejim.2014.08.002

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 journal › Article › peer-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 language	English
Pages (from-to)	745-750
Number of pages	6
Journal	European Journal of Internal Medicine
Volume	25
Issue number	8
DOIs	https://doi.org/10.1016/j.ejim.2014.08.002
Publication status	Published - Oct 1 2014

Keywords

Brand-name
Cardiovascular events
Databases
Discontinuation
Generic
Statins

ASJC Scopus subject areas

Internal Medicine
Medicine(all)

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Are generic and brand-name statins clinically equivalent? Evidence from a real data-base. / Corrao, Giovanni; Soranna, Davide; Arfè, Andrea; Casula, Manuela; Tragni, Elena; Merlino, Luca; Mancia, Giuseppe; Catapano, Alberico L.

In: European Journal of Internal Medicine, Vol. 25, No. 8, 01.10.2014, p. 745-750.

Research output: Contribution to journal › Article › peer-review

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

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.",

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AU - Corrao, Giovanni

AU - Soranna, Davide

AU - Arfè, Andrea

AU - Casula, Manuela

AU - Tragni, Elena

AU - Merlino, Luca

AU - Mancia, Giuseppe

AU - Catapano, Alberico L.

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N2 - 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.

AB - 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.

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KW - Discontinuation

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