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

Autor:	Chin CG; Division of Cardiovascular Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan, ROC.; Division of Cardiovascular Medicine, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, and Taipei Heart Institute, Taipei, Taiwan, ROC., Hsieh YC; Cardiovascular Center, Taichung Veterans General Hospital, and National Chung Hsing University College of Medicine, Taichung, Taiwan, ROC.; Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC., Lin WS; Division of Cardiovascular Medicine, Department of Internal Medicine, Tri-Service General Hospital, and National Defense Medical Center, Taipei, Taiwan, ROC., Lin YJ; Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.; Division of Cardiovascular Medicine, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC., Chiou CW; Division of Cardiovascular Medicine, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC., Lin TH; Division of Cardiovascular Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, ROC., Huang CL; Division of Cardiovascular Medicine, Department of Internal Medicine, Cheng Hsin General Hospital, Taipei, Taiwan, ROC., Hung Y; Division of Cardiovascular Medicine, Department of Internal Medicine, Tri-Service General Hospital, and National Defense Medical Center, Taipei, Taiwan, ROC., Lin YK; Division of Cardiovascular Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan, ROC.; Division of Cardiovascular Medicine, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, and Taipei Heart Institute, Taipei, Taiwan, ROC., Chang SL; Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.; Division of Cardiovascular Medicine, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC., Yeh TC; Division of Cardiovascular Medicine, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC., Lee HC; Division of Cardiovascular Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, ROC., Lai WT; Division of Cardiovascular Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, ROC., Hsieh MH; Division of Cardiovascular Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan, ROC.; Division of Cardiovascular Medicine, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, and Taipei Heart Institute, Taipei, Taiwan, ROC.
Jazyk:	angličtina
Zdroj:	Journal of the Chinese Medical Association : JCMA [J Chin Med Assoc] 2023 May 01; Vol. 86 (5), pp. 472-478. Date of Electronic Publication: 2023 Feb 17.
DOI:	10.1097/JCMA.0000000000000903
Abstrakt:	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 ( ClinicalTrials.gov Identifier: NCT03674658). Competing Interests: Conflicts of interest: The authors declare that they have no conflicts of interest related to the subject matter or materials discussed in this article. (Copyright © 2023, the Chinese Medical Association.)
Databáze:	MEDLINE
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