Extemporaneous combination therapy with nebivolol/amlodipine for the treatment of hypertension: a real-world evidence study in Europe

Abstract

Objective

The investigation of the real-world use of the extemporaneous combination of nebivolol and amlodipine (NA-EXC) in adult patients diagnosed with hypertension in Europe.

Methods

Retrospective analysis of data extracted from seven databases of patient medical records and prescriptions from Italy, Germany, France, Hungary, and Poland, to determine the prevalence and incidence of NA-EXC use and to estimate the number of patients potentially eligible for a single-pill combination of the two antihypertensives. Secondary objectives included: the description of the population of NA-EXC users and the assessment of their adherence to treatment based on the proportion of days covered.

Results

The use of NA-EXC was found to be common in Europe and ranged between 2.9% to 9.9% of all patients identified in the databases with a prescription of nebivolol and/or amlodipine. The estimated numbers of patients potentially eligible in 2019 for a single-pill combination of nebivolol and amlodipine in Italy and Germany were, respectively, 178,133 and 113,240. Users of NA-EXC were mostly aged 70–79 years, had metabolic disorders and other comorbidities; >70% of them had received ≥2 concomitant medications before starting NA-EXC. Adherence to NA-EXC was defined as high only in 15.6% to 35% of patients.

Conclusions

The extemporaneous combination of nebivolol and amlodipine is commonly prescribed in Europe, however adherence to the therapy is poor. The development of a single-pill combination of nebivolol and amlodipine may improve adherence by reducing the number of pills administered to patients and thus simplifying treatment regimens.

Keywords:

• Adherence
• amlodipine
• antihypertensive drugs
• combination therapy
• hypertension
• nebivolol
• real-world evidence

Transparency

Declaration of financial/other relationships

R.C., V.P. have disclosed that they are employees of IQVIA. C.R. worked for IQVIA as an external consultant. G.D. reported personal fees from Menarini Corporate, Bayer, Servier and AlfaSigma. M.M., S.M., M.G. and P.F. has disclosed that he/she is currently an employee of Menarini Group and was employed at the time of study conduct. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors take responsibility for the integrity of the work as a whole and have given final approval for the version to be submitted.

Acknowledgements

Editorial support, funded by Menarini, was provided by Lorenza Lanini on behalf of Health, Publishing and Services s.r.l., according to Good Publication Practice.

Additional information

Funding

This study was funded by Menarini.