Comparative effectiveness of generic nifedipine versus Adalat long-acting nifedipine for hypertension treatment: A multi-institutional cohort study.

This retrospective multi-institutional database analysis aimed to evaluate the blood-pressure-lowering efficacy and clinical outcomes of a generic versus brand-name nifedipine for hypertension management. A total of 12 693 patients who were prescribed a generic or brand-name nifedipine between January 1, 2011, and December 31, 2018, were identified from the Chang Gung Research Database of Chang Gung Memorial Hospitals, Taiwan. Among them, 2112 (21.4%) were prescribed generic nifedipine. After propensity score matching, both the generic and brand-name groups consisted of 2102 patients. At a mean follow-up of 3 years, the changes in office systolic (p for interaction = .791) and diastolic blood pressure (p for interaction = .689) did not differ significantly between the patients who received the generic and the brand-name nifedipine. There was no significant difference between the two study groups regarding the composite of all-cause mortality, acute myocardial infarction, stroke, coronary revascularization, or hospitalization for heart failure (hazard ratio 0.98, 95% confidence interval 0.85-1.13; p = .774). In conclusion, the generic nifedipine was comparable to its brand-name counterpart regarding office blood pressure reduction and the composite cardiovascular outcome for the treatment of patients with hypertension.

Efficacy and safety outcomes of one generic nifedipine versus ADALAT long-acting nifedipine for hypertension management.

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.

Fixed-dose combination of amlodipine and atorvastatin improves clinical outcomes in patients with concomitant hypertension and dyslipidemia.

Hypertension and dyslipidemia are important risk factors for cardiovascular disease. However, the clinical outcomes of fixed-dose combination (FDC) versus free-equivalent combination (FEC) of amlodipine and atorvastatin in the treatment of concurrent hypertension and dyslipidemia remain unknown. In this study, we included patients with newly diagnosed hypertension and dyslipidemia, without previously established cardiovascular disease, and treated with either FDC or FEC of amlodipine and atorvastatin were identified from the National Health Insurance Research Database of Taiwan and follow-up for 5 years. By using 1:1 propensity score matching, a total of 1756 patients were enrolled in this study. The composite of major adverse cardiovascular events, including all-cause mortality, myocardial infarction (MI), stroke, and coronary revascularization, occurred more frequently in the FEC group than in the FDC group (hazard ratio, 1.88; 95% confidence interval [CI], 1.42 to 2.5). Although the all-cause mortality did not differ (hazard ratio, 0.46; 95% CI, 0.36 to 1.59), the FEC group developed increased MI, stroke, and coronary revascularization (hazard ratio, 2.87; 95% CI, 1.07 to 7.68; hazard ratio, 1.97; 95% CI, 1.41 to 2.74; and hazard ratio, 2.44; 95% CI, 1.26 to 4.69, respectively). Furthermore, as an unexpected result, a higher risk to develop new-onset diabetes mellitus was observed with FEC regimens (hazard ratio, 2.19; 95% CI, 1.6 to 3.0). In conclusion, although the all-cause mortality did not differ between the two groups, the FDC regimen of amlodipine and atorvastatin improved clinical outcomes when compared to FEC in patients with newly diagnosed hypertension and dyslipidemia.