Efficacy and Safety of the Extemporaneous Combination Nebivolol/Amlodipine in Patients with Hypertension Uncontrolled on Monotherapy: The BOTTICELLI Study.

Authors

Massimo Volpe, Giovambattista Desideri, Ralf Dechend, Philippe Van De Borne, Simone Baldini, Suada Meto, Paolo Fabrizzi, Lorenzo Melani, Giorgio Reggiardo, Giuseppe Mancia

Published in

High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension. Jul 31, 2026. Epub Jul 31, 2026.

Abstract

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.
To evaluate efficacy and safety of extemporaneous combination at fixed doses of NEB/AML in adults with hypertension uncontrolled on monotherapy.
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.
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.
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.

PMID:
42538498
Bibliographic data and abstract were imported from PubMed on 01 Aug 2026.

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