Open AccessEfficacy and safety outcomes of one generic nifedipine versus ADALAT long‐acting nifedipine for hypertension management
Author(s) -
Tung YingChang,
Hsu TzyyJer,
Lin ChiaPin,
Hsiao FuChih,
Chu YouChia,
Chen WenJone,
Chu PaoHsien
Publication year - 2020
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/jch.14070
Subject(s) - medicine , nifedipine , myocardial infarction , hazard ratio , heart failure , stroke (engine) , peripheral edema , hyponatremia , confidence interval , anesthesia , adverse effect , mechanical engineering , engineering , calcium
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.