Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE)

Abstract

Background: AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength. Methods: Patients with hypertension who received a daily nifedipine GITS dose of 60 mg, either at constant dose (n = 686) or up-titrated from 30 mg (n = 392), were analyzed. Target blood pressure (BP) was <140/90 mmHg (or <130/80 mmHg for those at high/very high cardiovascular risk). Results: Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60 mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30–60 mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were −40.3/−20.7 mmHg and −35.6/−18.5 mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60 mg; 2.0%, 30–60 mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs. Conclusion: Combination therapy with nifedipine GITS 60 mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs.

Trial registration: ClinicalTrials.gov identifier: NCT01118286.

• AdADOSE
• cardiovascular
• hypertension
• nifedipine GITS
• observational study

Acknowledgements

Bayer Pharma provided support in the design and conduct of the study, and in the collection, management, and analysis of the data. The roles of the authors who are employed by Bayer Pharma are itemized in the section above. Caroline Schneider and Klaus Hechenbichler at the Dr. Schauerte Contract Research Organization provided project management and statistical support. Bill Wolvey from PAREXEL provided medical writing support funded by Bayer Pharma.

Declaration of interest

A.K.M., E.U., W.H., and Z.D. have declared that they have no competing interests. T.P. is an employee of Bayer HealthCare, Germany.