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Antihypertensive Effect of Irbesartan and Predictors of Response in Obesity- Associated Hypertension

A Prospective Open-Label Study

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Abstract

Background: Obesity-associated hypertension is difficult to treat and puts patients at a substantially increased risk of cardiovascular events. Irbesartan has previously been shown to effectively lower blood pressure (BP) in high-risk groups including patients with type 2 diabetes mellitus or nephropathy, and may therefore also be suitable for the treatment of obesity-associated hypertension. In this study we aimed to: (a) assess the efficacy and tolerability of irbesartan alone and in combination with hydrochlorothiazide in patients with obesity-associated mild-to-moderate hypertension; and (b) investigate patient-associated determinants of poor BP control in this patient group.

Patients and methods: This was a 3-month, prospective, open-label, multicentre, phase IV study in 72 479 hypertensive patients in 6989 general practices across Germany. Main outcome measures were BP reduction (primary parameter of effectiveness) and BP response rates after 3 months, as well as adverse events (AEs). Independent predictors of poor control were identified in a multivariate proportional odds model.

Results: All of the patients were Caucasian, 50.5% were females, mean age was 62.1 ± 11.1 years, mean bodyweight was 88.6 ± 15.4kg, and mean body mass index (BMI) was 30.7 ± 4.8 kg/m2. Almost all the patients were overweight or obese (92.3%). From a baseline value of 162/94mm Hg, systolic and diastolic BP were reduced by a mean of −23/−12mm Hg after 3 months. 66.1% of the patients were responders (reduction of diastolic BP ≥10mm Hg), and 48.0% achieved BP normalisation (i.e. <140/90mm Hg). 79% of patients met their individual treatment goals as defined by the treating physician (mean 135/80mm Hg). AEs were reported in only 322 patients (0.4%). Factors requiring special attention in patients not achieving BP control were age (>55 years), high BMI category (>25 kg/m2), and increased waist circumference.

Conclusion: Treatment with irbesartan (± hydrochlorothiazide) appeared to be effective and well tolerated in the study population of patients with obesity-associated hypertension. Easily recognisable characteristics allow physicians to identify patients whose BP is likely to be difficult to control.

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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The study was planned by the authors in close association with Sanofi-Aventis Group, Berlin, Germany. The conduct and statistical analysis of the study was also sponsored by Sanofi-Aventis Group. The authors received no compensation for this study or its publication. P. Bramlage is also an employee of the Sanofi-Aventis Group, Germany. The other authors have no potential conflicts of interest that are directly relevant to the contents of this article.

The authors wish to acknowledge the statistical work provided by S. Bruns, Winicker Norimed, Nürnberg, Germany, and the input into the manuscript provided by D. Pittrow, MD, PhD, Pöcking, Germany.

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Authors and Affiliations

  1. Department of Medicine, McMaster University, Hamilton General Hospital, Hamilton, Ontario, Canada

    Arya M. Sharma

  2. Institute of Clinical Pharmacology, Technical University, Dresden, Germany

    Peter Bramlage & Wilhelm Kirch

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  1. Arya M. Sharma
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  2. Peter Bramlage
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  3. Wilhelm Kirch
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Correspondence to Arya M. Sharma.

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Sharma, A.M., Bramlage, P. & Kirch, W. Antihypertensive Effect of Irbesartan and Predictors of Response in Obesity- Associated Hypertension . Clin. Drug Investig. 25, 765–776 (2005). https://doi.org/10.2165/00044011-200525120-00003

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