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

作者：Corrao Giovanni^*; Soranna Davide; Arfe Andrea; Casula Manuela; Tragni Elena; Merlino Luca; Mancia Giuseppe; Catapano Alberico L

来源：European Journal of Internal Medicine, 2014, 25(8): 745-750.

DOI：10.1016/j.ejim.2014.08.002

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

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. %26lt;br%26gt;Methods: 13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treated with 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. %26lt;br%26gt;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 %26gt;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. %26lt;br%26gt;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.

• 出版日期2014-10