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An Olmesartan Medoxomil-Based Treatment Algorithm is Effective in Achieving 24-Hour BP Control in Patients with Type 2 Diabetes Mellitus, Regardless of Age, Race, Sex, or Severity of Hypertension

Subgroup Analysis of the BENIFICIARY Study

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Abstract

Background

Hypertension often occurs concomitantly with diabetes mellitus, such that >50% of adults with type 2 diabetes have hypertension. These individuals are at a greater risk of developing renal and cardiovascular disease. The currently recommended BP goal of <130/80 mmHg for patients with type 2 diabetes is achieved in only 37.5% of treated patients with diabetes and hypertension.

Methods

The antihypertensive efficacy of olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) was investigated in prespecified subgroups (age <65/≥65 years, Blacks/non-Blacks, males/females, or stage 1/ stage 2 hypertension) of patients with hypertension and type 2 diabetes enrolled in an open-label, single-arm study (n= 192). Patients started treatment with OM 20 mg/day and were uptitrated at 3-week intervals to OM 40, OM/HCTZ 40/12.5, and OM/HCTZ 40/25 mg/day if BP was ≥120/70 mmHg. The primary endpoint was the change in mean 24-hour ambulatory SBP from baseline to week 12, assessed by mean 24-hour ambulatory BP monitoring. Secondary endpoints included changes in mean 24-hour ambulatory DBP, mean daytime ambulatory BP, mean nighttime ambulatory BP, and mean office seated BP, and the proportions of patients achieving prespecified ambulatory BP targets.

Setting

This was a multicenter study (24 sites) that took place between November 2006 and November 2007 in the US.

Results

BP reductions were significant (p < 0.0001) and similar among subgroups of patients with type 2 diabetes. Following dose titration to OM/HCTZ 40/25 mg/day, similar proportions of patients in the age, race, and sex subgroups (approximately 60–64% across these subgroups) achieved an ambulatory BP target of <130/80 mmHg. A larger proportion of patients with type 2 diabetes and stage 1 hypertension achieved this same goal compared with patients with stage 2 hypertension (75% vs 46.3%). The combination of OM/HCTZ was well tolerated in all patient subgroups irrespective of age, race, sex, or hypertension severity.

Conclusions

In this open-label study, OM/HCTZ combination therapy was efficacious and well tolerated in subgroups of patients with diabetes and hypertension.

[Clinical Trials Registry Number: NCT00403481]

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Acknowledgments

This study was funded by Daiichi Sankyo, Inc. The authors would like to thank Alan J. Klopp, PhD, and Christopher J. Jones, PhD, of inScience Communications, a Wolters Kluwer business, for providing medical writing support funded by Daiichi Sankyo, Inc.

We thank the following participating investigators: Gregory Collins, MD (Charlotte Clinical Research, Charlotte, NC); Charles H. DeBusk, MD (Heartland Medical, PC, New Tazewell, TN); Andrew Feldman, DO (University Clinical Research Deland, Deland, FL); Robert Frederickson, MD (Brookwood Internists, PC, Birmingham, AL); David Johnson, MD (Searcy Medical Center, Searcy, AR); Dean J. Kereiakes, MD (Lindner Clinical Trial Center, Cincinnati, OH); Marc Kozinn, MD (Cardiology & Internal Medicine, Williamsville, NY); Gregory Lakin, MD (Professional Research Network of Kansas, Wichita, KS); Andrew Lewin, MD (National Research Institute, Los Angeles, CA); Thomas Littlejohn, MD (Piedmont Medical Research Associates, Winston-Salem, NC); Barry Lubin, MD (Hampton Roads Center for Clinical Research Inc., Norfolk, VA); Nicholas Messina, MD (Vista Medical Research, Inc., Mesa, AZ); Bradley Musser, MD (Bexar Clinical Trials, Richardson, TX); Joel Neutel, MD (Orange County Research Center, Tustin, CA); Stephen Ong, MD (MD Medical Research, Oxon Hill, MD); Irwin S. Plisco, MD (Florissant, MO); Jaime Sandoval, MD (Padre Coast Clinical Research, Corpus Christi, TX); Robert Strzinek, MD (Texas FamiliCare Clinical Research, Colleyville, TX); Dan Sugimoto, MD (Cedar-Cross Research Center, Chicago, IL); Jeffrey Wayne, MD (Clinical Trials Research, Lincoln, CA); Robert Weiss, MD (Maine Research Associates, Auburn, ME); Larry I. Gilderman, MD (University Clinical Research, Inc., Pembroke Pines, FL); Daniel Yarrish, MD (Salt Lake Research, LLC, Salt Lake City, UT); Andrea Phillips, MD (Philips Medical Services, Jackson, MS).

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Authors and Affiliations

  1. Orange County Research Center, 14351 Myford Road, Tustin, CA, 92780, USA

    Joel M. Neutel (Medical Director of Clinical Pharmacology)

  2. The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio, USA

    Dean J. Kereiakes

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  1. Joel M. Neutel
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Correspondence to Joel M. Neutel.

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Neutel, J.M., Kereiakes, D.J. & The BENIFICIARY Investigators. An Olmesartan Medoxomil-Based Treatment Algorithm is Effective in Achieving 24-Hour BP Control in Patients with Type 2 Diabetes Mellitus, Regardless of Age, Race, Sex, or Severity of Hypertension. Am J Cardiovasc Drugs 10, 289–303 (2010). https://doi.org/10.2165/11584690-000000000-00000

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