Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Department of Computer Science, National Chiao-Tung University, Hsien-Chu, Taiwan.
J Clin Hypertens (Greenwich). 2020 Dec;22(12):2296-2305. doi: 10.1111/jch.14070. Epub 2020 Oct 9.
Data regarding the long-term outcomes of generic antihypertensive drugs are limited. This nationwide retrospective database analysis aimed to evaluate the efficacy and safety of a generic versus brand-name nifedipine for hypertension treatment. Patients who were prescribed generic or brand-name nifedipine between January 1, 2008, and December 31, 2013, were identified from the National Health Insurance Research Database of Taiwan. The efficacy outcomes included all-cause mortality and the composite cardiovascular (CV) outcome, including CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for heart failure. Safety outcomes included headache, peripheral edema, constipation, acute kidney injury, hypotension, syncope, new diagnosis of cancer, and cancer death. Among the 98 335 patients who were eligible for analysis, 21 087 (21.4%) were prescribed generic nifedipine. Both the generic and the brand-name groups included 21 087 patients after propensity score matching. At a mean follow-up of 4.1 years, the generic nifedipine was comparable to the brand-name drug with regard to all-cause mortality (7.2% vs. 7.1%; hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.95-1.09) and the composite CV outcomes (11.6% vs. 11.9%; HR 0.97; 95% CI 0.92-1.03). The generic nifedipine was associated with higher rates of headache, peripheral edema, and constipation but a modest reduction in the risk of newly diagnosed cancer (7.1% vs. 7.8%; subdistribution HR 0.90, 95% CI 0.84-0.97). The risks of acute kidney injury, hypotension, syncope, and cancer death were not significantly different between the two groups. In conclusion, the generic nifedipine was comparable to the brand-name drug with regard to the risks of all-cause mortality and the composite CV outcome. The finding of cancer risk could be chance and should be interpreted with caution.
关于普通降压药物长期疗效的数据有限。本项全国范围的回顾性数据库分析旨在评估普通硝苯地平与品牌硝苯地平治疗高血压的疗效和安全性。从台湾全民健康保险研究数据库中确定了 2008 年 1 月 1 日至 2013 年 12 月 31 日期间开处普通或品牌硝苯地平的患者。疗效结果包括全因死亡率和复合心血管（CV）结局，包括 CV 死亡、非致死性心肌梗死、非致死性卒中、冠状动脉血运重建和心力衰竭住院。安全性结局包括头痛、外周水肿、便秘、急性肾损伤、低血压、晕厥、新发癌症诊断和癌症死亡。在符合分析条件的 98335 例患者中，21087 例（21.4%）开处普通硝苯地平。在倾向评分匹配后，普通和品牌组各包括 21087 例患者。在平均 4.1 年的随访中，普通硝苯地平与品牌药物在全因死亡率（7.2% vs. 7.1%；风险比 [HR] 1.02，95%置信区间 [CI] 0.95-1.09）和复合 CV 结局（11.6% vs. 11.9%；HR 0.97；95% CI 0.92-1.03）方面相当。普通硝苯地平与更高的头痛、外周水肿和便秘发生率相关，但新发癌症风险适度降低（7.1% vs. 7.8%；亚分布 HR 0.90，95% CI 0.84-0.97）。两组之间急性肾损伤、低血压、晕厥和癌症死亡的风险无显著差异。总之，普通硝苯地平与品牌药物在全因死亡率和复合 CV 结局方面风险相当。癌症风险的发现可能是偶然的，应谨慎解释。
