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Rationale and design of a study comparing two fixed-dose combination regimens to reduce albuminuria in patients with type II diabetes and hypertension

Journal of Human Hypertension volume 19, pages 139–144 (2005)Cite this article

Abstract

Diabetic nephropathy is the leading cause of end-stage renal disease (ESRD). The early stage of nephropathy is manifested by the presence of low levels of urinary albumin (microalbuminuria or urinary albumin excretion ⩾30 and <299 mg/day). Albuminuria is a marker for development of nephropathy in type II diabetes and for increased cardiovascular morbidity and mortality. Recent studies have demonstrated the importance of antihypertensive agents that inhibit the renin–angiotensin–aldosterone (RAA) system to reduce the risk and slow down the progression of renal disease. A new clinical trial, GUARD (Gauging Albuminuria Reduction With Lotrel in Diabetic Patients With Hypertension), is designed to compare the change in urinary albumin to creatinine ratio after 1 year of initial treatment with either amlodipine besylate/benazepril HCl or benazepril HCl/hydrochlorothiazide. Other objectives include a comparison of the proportion of patients who progress to overt diabetic nephropathy and the safety of these two combination therapies in these high-risk patients.

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Acknowledgements

This study is sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ.

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Authors and Affiliations

  1. Department of Preventive and Internal Medicine, Rush University Medical Center, Chicago, IL, USA

    G L Bakris

  2. Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, USA

    R D Toto

  3. Division of Nutrition and Preventive Medicine, Department of Medicine, William Beaumont Hospital, Royal Oak, MI, USA

    P A McCullough

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  1. G L Bakris
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  2. R D Toto
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on behalf of the GUARD (Gauging Albuminuria Reduction With Lotrel in Diabetic Patients With Hypertension) Study Investigators

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Correspondence to G L Bakris.

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Bakris, G., Toto, R., McCullough, P. et al. Rationale and design of a study comparing two fixed-dose combination regimens to reduce albuminuria in patients with type II diabetes and hypertension. J Hum Hypertens 19, 139–144 (2005). https://doi.org/10.1038/sj.jhh.1001789

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