An open-label randomized noninferior study of generic name and brand name of propafenone for rhythm control in patients with paroxysmal atrial fibrillation

Chye Gen Chin, Yu Cheng Hsieh, Wei Shiang Lin, Yenn Jiang Lin, Chuen Wang Chiou, Tsung Hsien Lin, Chien Lung Huang, Yuan Hung, Yung Kuo Lin, Shih Lin Chang, Tong Chen Yeh, Hsiang Chun Lee, Wen Ter Lai, Ming Hsiung Hsieh*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Propafenone is a class IC antiarrhythmic agent that is commonly used as the first-line therapy for patients with paroxysmal atrial fibrillation (AF) in Taiwan. This study compared the efficacy and safety of generic (Rhynorm) and brand name (Rytmonorm) propafenone for rhythm control of paroxysmal AF in Taiwan. Methods: This was an open-label randomized multicenter noninferior study conducted in Taiwan. We enrolled 76 patients with AF. To investigate the efficacy of propafenone, we used a wearable electrocardiogram (ECG) event recorder to evaluate the daily burden of AF episodes in patients for 24 weeks. The primary efficacy endpoint was the frequency of AF with clinical significance, which was indicated by AF duration ≥30 seconds. The safety endpoints included proarrhythmic or hemodynamic adverse events. Result: To analyze the efficacy and safety of these agents, 71 patients (five patients with screen failure) were randomized to two groups, specifically a Rhynorm group (n = 37) and a Rytmonorm group (n = 34), for 24 weeks of the treatment period. The baseline patient characteristics were comparable between the groups. However, the Rhynorm group was older (65.4 ± 8.40 vs 59.8 ± 10.8 years; p = 0.02). The primary efficacy endpoint at week 24 decreased by 4.76% ± 18.5% (from 24.3% ± 33.9% to 19.0% ± 28.7%; p = 0.13) in the Rhynorm group and by 3.27% ± 15.2% (from 16.9% ± 26.4% to 13.6% ± 19.2%; p = 0.22) in the Rytmonorm group, with an intergroup difference of 1.5% ± 17.0%; p = 0.71. This finding indicates that Rhynorm is not inferior to Rytmonorm (p = 0.023 for noninferiority). The safety profile of the agents was comparable between the two groups. Conclusion: Our results verified that Rhynorm was noninferior to Rytmonorm in terms of efficacy and safety for treating paroxysmal AF in Taiwan.

Original languageEnglish
Pages (from-to)472-478
Number of pages7
JournalJournal of the Chinese Medical Association
Volume86
Issue number5
DOIs
StatePublished - 1 May 2023

Keywords

  • Atrial fibrillation
  • Propafenone
  • Rhythm control

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