Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan

Abstract The control rate of hypertension remains concerning, indicating the requirement for better management strategies. The calcium channel blockers brand‐name amlodipine and nifedipine with extended‐release formulations demonstrate similar clinical efficacy. However, the efficacy of generic nife...

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Main Authors: Hao‐Wei Lee, Chin‐Chou Huang, Hsin‐Bang Leu, Yenn‐Jiang Lin
Format: Article
Language:English
Published: Wiley 2022-07-01
Series:The Journal of Clinical Hypertension
Subjects:
Online Access:https://doi.org/10.1111/jch.14521
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author Hao‐Wei Lee
Chin‐Chou Huang
Hsin‐Bang Leu
Yenn‐Jiang Lin
author_facet Hao‐Wei Lee
Chin‐Chou Huang
Hsin‐Bang Leu
Yenn‐Jiang Lin
author_sort Hao‐Wei Lee
collection DOAJ
description Abstract The control rate of hypertension remains concerning, indicating the requirement for better management strategies. The calcium channel blockers brand‐name amlodipine and nifedipine with extended‐release formulations demonstrate similar clinical efficacy. However, the efficacy of generic nifedipine remains obscure. We compared the efficacy of generic nifedipine and brand‐name amlodipine in terms of cardiovascular (CV) outcomes. Patients prescribed generic nifedipine (SRFC CYH) or brand‐name amlodipine besylate (Norvasc, Pfizer) between August 1, 2017, and July 31, 2018, were enrolled; patients with CV events within 3 months were excluded. CV outcomes included CV death, nonfatal myocardial infarction (MI), nonfatal ischemic stroke, hospitalization for heart failure, and composite endpoints of 3P‐ and 4P‐major adverse cardiac events (MACE). A total of 1625 patients treated with nifedipine (SRFC CYH) and 16 587 patients treated with Norvasc were included. After propensity score matching, there were 995 and 4975 patients in the nifedipine CYH and Norvasc groups, respectively. At a mean follow‐up period of 30.3 ± 6.4 months, nifedipine CYH was comparable to Norvasc in terms of CV death (P = .107), nonfatal MI (P = .121), nonfatal ischemic stroke (P = .453), hospitalization for heart failure (P = .330), 3P‐MACE (P = .584), and 4P‐MACE (P = .274). Cox regression analysis revealed that nifedipine CYH and Norvasc had similar efficacy in terms of 3P‐MACE (hazard ratio, 0.970; 95% confidence interval, 0.601–1.565, P = .900) and 4P‐MACE (hazard ratio, 0.880; 95% confidence interval, 0.628–1.233, P = .459). In conclusion, Nifedipine SRFC CYH and Norvasc have comparable clinical efficacy for hypertension management.
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spelling doaj.art-6bdcdfa8ac8145129dcc803853826fed2023-10-30T13:26:30ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762022-07-0124787087710.1111/jch.14521Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in TaiwanHao‐Wei Lee0Chin‐Chou Huang1Hsin‐Bang Leu2Yenn‐Jiang Lin3Division of Cardiology Department of Medicine Taipei Veterans General Hospital Taipei TaiwanDivision of Cardiology Department of Medicine Taipei Veterans General Hospital Taipei TaiwanDivision of Cardiology Department of Medicine Taipei Veterans General Hospital Taipei TaiwanDivision of Cardiology Department of Medicine Taipei Veterans General Hospital Taipei TaiwanAbstract The control rate of hypertension remains concerning, indicating the requirement for better management strategies. The calcium channel blockers brand‐name amlodipine and nifedipine with extended‐release formulations demonstrate similar clinical efficacy. However, the efficacy of generic nifedipine remains obscure. We compared the efficacy of generic nifedipine and brand‐name amlodipine in terms of cardiovascular (CV) outcomes. Patients prescribed generic nifedipine (SRFC CYH) or brand‐name amlodipine besylate (Norvasc, Pfizer) between August 1, 2017, and July 31, 2018, were enrolled; patients with CV events within 3 months were excluded. CV outcomes included CV death, nonfatal myocardial infarction (MI), nonfatal ischemic stroke, hospitalization for heart failure, and composite endpoints of 3P‐ and 4P‐major adverse cardiac events (MACE). A total of 1625 patients treated with nifedipine (SRFC CYH) and 16 587 patients treated with Norvasc were included. After propensity score matching, there were 995 and 4975 patients in the nifedipine CYH and Norvasc groups, respectively. At a mean follow‐up period of 30.3 ± 6.4 months, nifedipine CYH was comparable to Norvasc in terms of CV death (P = .107), nonfatal MI (P = .121), nonfatal ischemic stroke (P = .453), hospitalization for heart failure (P = .330), 3P‐MACE (P = .584), and 4P‐MACE (P = .274). Cox regression analysis revealed that nifedipine CYH and Norvasc had similar efficacy in terms of 3P‐MACE (hazard ratio, 0.970; 95% confidence interval, 0.601–1.565, P = .900) and 4P‐MACE (hazard ratio, 0.880; 95% confidence interval, 0.628–1.233, P = .459). In conclusion, Nifedipine SRFC CYH and Norvasc have comparable clinical efficacy for hypertension management.https://doi.org/10.1111/jch.14521amlodipinegenerichypertensionnifedipineoutcome
spellingShingle Hao‐Wei Lee
Chin‐Chou Huang
Hsin‐Bang Leu
Yenn‐Jiang Lin
Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan
The Journal of Clinical Hypertension
amlodipine
generic
hypertension
nifedipine
outcome
title Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan
title_full Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan
title_fullStr Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan
title_full_unstemmed Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan
title_short Comparative efficacy of generic nifedipine versus brand‐name amlodipine for hypertension management in Taiwan
title_sort comparative efficacy of generic nifedipine versus brand name amlodipine for hypertension management in taiwan
topic amlodipine
generic
hypertension
nifedipine
outcome
url https://doi.org/10.1111/jch.14521
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