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

Bramlage P, Fronk EM, Wolf WP, Smolnik R, Sutton G, Schmieder R (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Vascular Health and Risk Management Dove Medical Press

Publisher: Dove Medical Press

Book Volume: 11

Pages Range: 1-8

DOI: 10.2147/VHRM.S75380

Abstract

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.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.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).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.

Authors with CRIS profile

Roland Schmieder Professur für Innere Medizin (Nephrologie)

Involved external institutions

Institut für Pharmakologie und präventive Medizin (IPPMed GmbH) DE Germany (DE) Daiichi Sankyo Europe GmbH DE Germany (DE) Daiichi Sankyo Deutschland GmbH DE Germany (DE)

How to cite

APA:

Bramlage, P., Fronk, E.M., Wolf, W.P., Smolnik, R., Sutton, G., & Schmieder, R. (2015). Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice. Vascular Health and Risk Management, 11, 1-8. https://doi.org/10.2147/VHRM.S75380

MLA:

Bramlage, Peter, et al. "Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice." Vascular Health and Risk Management 11 (2015): 1-8.

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