Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Summary

The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Timeline

Start

2014-08

Primary completion

2016-08

Completion

2016-08

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Comparison between Teuto generic warfarin and Marevan was inconclusive (ΔINR +0.29 [95% CI -0.09 to +0.68], n = 84). PMID 33793580 ↗

Publications

• Gomes Freitas C, Walsh M, Coutinho EL, Vincenzo de Paola AA, Atallah AN. Examining therapeutic equivalence between branded and generic warfarin in Brazil: The WARFA crossover randomized controlled trial. PLoS One. 2021 Apr 1;16(4):e0248567. doi: 10.1371/journal.pone.0248567. eCollection 2021.
• Freitas CG, Walsh M, Atallah AN. Design and rationale for the WARFA trial: a randomized controlled cross-over trial testing the therapeutic equivalence of branded and generic warfarin in atrial fibrillation patients in Brazil. BMC Cardiovasc Disord. 2017 Jun 7;17(1):148. doi: 10.1186/s12872-017-0584-4.

Drugs

Indications