https://scholars.lib.ntu.edu.tw/handle/123456789/529733
標題: | Efficacy and safety outcomes of one generic nifedipine versus adalat long-acting nifedipine for hypertension management | 作者: | Tung Y.-C. Hsu T.-J. Lin C.-P. Hsiao F.-C. Chu Y.-C. WEN-JONE CHEN Chu P.-H. |
關鍵字: | efficacy; generic drugs; hypertension; nifedipine; safety | 公開日期: | 2020 | 來源出版物: | Journal of Clinical Hypertension | 摘要: | 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. ? 2020 Wiley Periodicals LLC |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/529733 | ISSN: | 1524-6175 | DOI: | 10.1111/jch.14070 | SDG/關鍵字: | nifedipine; generic drug; nifedipine; acute kidney failure; adult; Article; cancer mortality; cause of death; constipation; controlled study; drug efficacy; drug formulation; drug release; drug safety; faintness; female; follow up; hazard ratio; headache; heart failure; heart muscle revascularization; hospitalization; human; hypertension; hypotension; major clinical study; male; malignant neoplasm; peripheral edema; prescription; priority journal; propensity score; risk factor; treatment outcome; hypertension; retrospective study; Taiwan; Drugs, Generic; Humans; Hypertension; Nifedipine; Retrospective Studies; Taiwan |
顯示於: | 醫學院附設醫院 (臺大醫院) |
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