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| Item Type: | Article |
|---|---|
| Title: | Efficacy and safety of the extemporaneous combination nebivolol/amlodipine in patients with hypertension uncontrolled on monotherapy: the BOTTICELLI study |
| Creators: |
Volpe, Massimo  ORCID: https://orcid.org/0000-0002-9642-8380, Desideri, Giovambattista ORCID: https://orcid.org/0000-0002-0145-1271, Dechend, Ralf ORCID: https://orcid.org/0000-0001-6636-3080, Van De Borne, Philippe ORCID: https://orcid.org/0000-0002-5693-1045, Baldini, Simone, Meto, Suada ORCID: https://orcid.org/0000-0002-3286-2479, Fabrizzi, Paolo, Melani, Lorenzo, Reggiardo, Giorgio ORCID: https://orcid.org/0000-0003-4237-6797 and Mancia, Giuseppe ORCID: https://orcid.org/0000-0003-0942-3176
|
| Abstract: | 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. |
| Keywords: | Amlodipine, Antihypertensive Agent Combination, Blood Pressure Target, Extemporaneous Combination, Nebivolol, Uncontrolled Hypertension |
| Source: | High Blood Pressure & Cardiovascular Prevention |
| ISSN: | 1120-9879 |
| Publisher: | Springer / Adis |
| Date: | 31 July 2026 |
| Official Publication: | https://doi.org/10.1007/s40292-026-00816-2 |
| PubMed: | View item in PubMed |
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