Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
J Clin Hypertens (Greenwich). 2022 Jul;24(7):870-877. doi: 10.1111/jch.14521. Epub 2022 Jun 8.
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.
高血压的控制率仍然令人担忧,这表明需要更好的管理策略。钙通道阻滞剂品牌名氨氯地平和硝苯地平的缓释制剂具有相似的临床疗效。然而,硝苯地平的疗效仍然不清楚。我们比较了硝苯地平普通制剂和氨氯地平在心血管(CV)结局方面的疗效。2017 年 8 月 1 日至 2018 年 7 月 31 日期间,患者被开处方硝苯地平普通制剂(SRFC CYH)或氨氯地平贝那普利片(Norvasc,辉瑞),3 个月内有 CV 事件的患者被排除。CV 结局包括 CV 死亡、非致死性心肌梗死(MI)、非致死性缺血性卒中、心力衰竭住院和 3P-和 4P-主要不良心脏事件(MACE)的复合终点。共纳入 1625 例接受硝苯地平(SRFC CYH)治疗的患者和 16587 例接受 Norvasc 治疗的患者。经过倾向评分匹配后,硝苯地平 CYH 组和 Norvasc 组分别有 995 例和 4975 例患者。在平均 30.3±6.4 个月的随访期间,硝苯地平 CYH 与 Norvasc 相比,CV 死亡(P=0.107)、非致死性 MI(P=0.121)、非致死性缺血性卒中(P=0.453)、心力衰竭住院(P=0.330)、3P-MACE(P=0.584)和 4P-MACE(P=0.274)的发生率相似。Cox 回归分析显示,硝苯地平 CYH 和 Norvasc 在 3P-MACE(风险比,0.970;95%置信区间,0.601-1.565,P=0.900)和 4P-MACE(风险比,0.880;95%置信区间,0.628-1.233,P=0.459)方面的疗效相似。总之,硝苯地平 SRFC CYH 和 Norvasc 用于高血压治疗的临床疗效相当。