Key result
Nebivolol plus amlodipine lowers diastolic blood pressure by ~15 mmHg in uncontrolled hypertension.
Why the study?
Combination antihypertensive therapy achieves sustained blood pressure reductions, but the efficacy and safety of extemporaneous nebivolol/amlodipine needed evaluation in patients uncontrolled on monotherapy.
Does the extemporaneous combination of nebivolol and amlodipine reduce blood pressure in adults with hypertension uncontrolled on monotherapy?
Does the extemporaneous combination of nebivolol and amlodipine reduce blood pressure in adults with hypertension uncontrolled on monotherapy?
Mean Difference: -15.2
p-value: p=<0.001
The extemporaneous combination of nebivolol and amlodipine significantly reduced both systolic and diastolic blood pressure in patients with hypertension uncontrolled on monotherapy.
May support nebivolol-amlodipine use in uncontrolled hypertension; leaves open need for randomized trials on fixed-dose outcomes.
Introduction Hypertension is the leading cause of cardiovascular disease, and its complications are preventable with blood pressure (BP)-lowering treatment. Combination treatment with 2 or more antihypertensive agents achieves sustained BP reductions. Nebivolol (NEB), a highly β1-selective beta-blocker with vasodilating properties, and amlodipine (AML), a dihydropyridine calcium channel blocker, are widely prescribed as monotherapies or in combination. Aim To evaluate efficacy and safety of extemporaneous combination at fixed doses of NEB/AML in adults with hypertension uncontrolled on monotherapy. Methods This phase 4, open-label, multicentre study enrolled adults with hypertension uncontrolled on monotherapy. After 4-week run-in on NEB 5 mg or AML 5 mg, patients with uncontrolled BP initiated NEB/AML 5/5 mg. Those still uncontrolled after 4 weeks were up-titrated to NEB/AML 5/10 mg, while controlled patients continued NEB/AML 5/5 mg for the full 8-week period. The primary endpoint was the change from baseline in mean sitting DBP after 8 weeks of treatment. Secondary endpoints included the change from baseline in mean sitting SBP, the proportion of patients achieving guideline-recommended BP targets, and safety. Results A total of 301 patients, mean age 52.1 (± 8.5) years, entered the run-in period; of these, 276 completed the study, with 182 achieving goal BP on NEB/AML 5/5 mg and 94 up-titrated to NEB/AML 5/10 mg. Overall, mean sitting DBP decreased by −15.2 (± 8.3) mmHg and SBP by −24.2 (± 11.8) mmHg (both p<0.001) over the treatment period. At study end, 63.0% of patients achieved BP <130/80 mmHg. NEB/AML dose regimens were well tolerated, and no serious treatment-emergent adverse events were reported. Conclusion This study adds to the existing evidence supporting the efficacy and safety of the NEB/AML combination at two dose levels in managing hypertension and bringing patients at target goal.
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Volpe et al. (2026) studied Hypertension uncontrolled on monotherapy (n=301). Nebivolol/Amlodipine was evaluated on Change from baseline in mean sitting DBP after 8 weeks of treatment (MD -15.2, p=<0.001). The extemporaneous combination of nebivolol and amlodipine significantly reduced mean sitting diastolic blood pressure by 15.2 mmHg after 8 weeks in patients with uncontrolled hypertension.
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