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

• Published in: The journal of clinical hypertension (Greenwich, Conn.) Vol. 24; no. 7; pp. 870 - 877
• Main Authors: Lee, Hao‐Wei, Huang, Chin‐Chou, Leu, Hsin‐Bang, Lin, Yenn‐Jiang
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01-07-2022; John Wiley and Sons Inc; Wiley
• Subjects: amlodipine; Antihypertensives; Blood pressure; Brand names; Cardiac arrhythmia; Clinical outcomes; Confounding (Statistics); Creatinine; Diabetes; Diuretics; Drugs; generic; Generic drugs; Heart attacks; Heart failure; Heart rate; Hospitals; Hyperlipidemia; Hypertension; Ischemia; Kidney diseases; nifedipine; Original; outcome; Outpatient care facilities; Statins; Stroke; Student's t-test; Survival analysis; United States > US; Taiwan; nifedipine; hypertension; amlodipine; generic; outcome
• ISSN: 1524-6175; 1751-7176
• DOI: 10.1111/jch.14521

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.