Efficacy of amlodipine/olmesartan medoxomil ± HCTZ in obese patients uncontrolled on antihypertensive monotherapy

Abstract

Objective:

BP-CRUSH (Blood Pressure Control in All Subgroups With Hypertension) was a phase IV, prospective, open-label, multicenter, single-arm, dose-titration study (N = 999). The present subgroup analysis reports the efficacy/safety of up to 20 weeks of treatment with amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) in obese and non-obese patients with hypertension uncontrolled on antihypertensive monotherapy.

Research design and methods:

Eligible obese (body mass index ≥30 kg/m²; n = 505) and non-obese (<30 kg/m²; n = 494) patients were switched to AML/OM 5/20 mg and uptitrated at 4-week intervals to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 mg + HCTZ 12.5 mg, and AML/OM 10/40 mg + HCTZ 25 mg. Uptitration to higher doses of AML/OM was permitted if mean seated systolic BP (SeSBP) was ≥120 mmHg, or mean seated diastolic BP (SeDBP) was ≥70 mmHg. HCTZ was added if mean SeSBP was ≥125 mmHg, or mean SeDBP was ≥75 mmHg.

Clinical trial registration:

ClinicalTrials.gov identifier: NCT00791258.

Main outcome measures:

The primary efficacy endpoint was the cumulative proportion of patients achieving SeSBP <140 mmHg (<130 mmHg for patients with diabetes mellitus) at 12 weeks. Secondary endpoints included seated cuff BP (SeBP) goal rates, ambulatory BP target rates, and mean change from baseline in SeBP and ambulatory BP at weeks 12 and 20.

Results:

At 12 weeks, 71.6% of obese patients (80.2% non-obese) achieved the primary endpoint of cumulative SeSBP <140 mmHg (<130 mmHg for patients with diabetes). The cumulative SeBP goal of <140/90 mmHg (<130/80 mmHg if diabetes) was achieved by 64.8% and 81.2% of obese patients by weeks 12 and 20, respectively (vs. 77.9% and 88.5% of non-obese patients, respectively). Treatment was well-tolerated, with 26.1% of obese patients (24.9% non-obese) experiencing drug-related treatment-emergent adverse events (TEAEs). There were no serious drug-related TEAEs.

Conclusion:

An AML/OM ± HCTZ treatment regimen provided effective and safe BP control in obese patients with hypertension uncontrolled on monotherapy.

Keywords::

• Amlodipine
• BP control
• Combination therapy
• Hydrochlorothiazide
• Hypertension
• Obesity
• Olmesartan medoxomil

Transparency

Declaration of funding

This study was supported by Daiichi Sankyo, Inc.

Declaration of financial/other relationships

W.H. has received payment for lectures including service on speaker boards from Merck. A.S. and J-F.M. are employees of Daiichi Sankyo, Inc.

J.N. is a member of the speaker’s bureau for Novartis, Boehringer Ingelheim, Daiichi Sankyo, Inc., the Bristol-Myers Squibb/Sanofi Pharmaceutical Partnership, Takeda, and Pfizer Inc. CMRO peer reviewers on this manuscript have no relevant financial relationships to disclose.

Acknowledgments

Medical writing and editorial services were provided by Robert Schupp, PharmD, and Alan J. Klopp, PhD, of inScience Communications, Springer Healthcare.

Part of the work previously presented at: 26th American Society of Hypertension Annual Scientific Meeting and Exposition, May 21–24, 2011. Neutel J, Hsueh WA, Shojaee A, Waverczak WF, Maa J-F. Efficacy of an amlodipine/olmesartan medoxomil algorithm on BP control in obese patients uncontrolled by monotherapy [abstract]. J Clin Hypertens (Greenwich) 2011;13(Suppl 1):A150.