Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice

Abstract

Background

Clinical trials indicate that the use of fixed-dose combinations (FDCs) is associated with a higher level of treatment adherence and prolonged blood pressure (BP) control. The aim of this study was to document the safety and effectiveness of the FDC olmesartan/amlodipine/hydrochlorothiazide in patients with essential hypertension in clinical practice.

Methods

This multicenter, prospective, 24-week, noninterventional study enrolled 5,831 patients from primary care offices in Germany and Austria. Inclusion criteria were a diagnosis of essential hypertension and newly initiated treatment with the FDC.

Results

The mean age of patients was 63.5 years, almost 50% of patients had a time since diagnosis of essential hypertension of over 5 years, and approximately 70% of patients had at least one cardiovascular risk factor, including 29.4% of patients with diabetes mellitus. Following approximately 24 weeks of treatment, the mean reduction in systolic/diastolic BP was 29.0/14.0 mmHg, a BP response was observed by 94.2% of patients, and a target BP of <140/90 mmHg was attained in 67.5% of patients. At least one adverse drug reaction (ADR) was experienced by 1.2% of patients, with the most common being peripheral edema. Subanalyses demonstrated that the following factors did not have a significant influence on the ADR rate: age (<65 years versus ≥65 years), diabetes mellitus (no/yes), cardiovascular risk (low/high), and concomitant medication (no/yes).

Conclusion

This study demonstrates that in clinical practice, treatment with the three-drug combination as an FDC tablet resulted in a very high proportion of patients with a BP response and control, accompanied by a very low rate of ADRs.

Keywords:

• hypertension
• clinical practice
• fixed-dose combination
• blood pressure
• adverse drug reactions

Author contributions

Peter Bramlage, Eva-Maria Fronk, Wolf-Peter Wolf, Rüdiger Smolnik, and Roland E Schmieder designed the study. Eva-Maria Fronk was responsible for the statistical analyses. Peter Bramlage and Gemma Sutton designed the analyses, interpreted the findings and drafted the first version of the manuscript. All authors revised the article for important intellectual content. All authors approved the final version of the manuscript that was submitted. The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Disclosure

The study was funded and conducted by Daiichi Sankyo Europe GmbH, Munich, Germany. Peter Bramlage and Roland E Schmieder have received research funds and consultancy honoraria from Daiichi Sankyo. Eva-Maria Fronk, Wolf-Peter Wolf, and Rüdiger Smolnik are employees of Daiichi Sankyo. Gemma Sutton has no conflict of interest related to this manuscript. The authors report no other conflicts of interest in this work.