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Preventing microalbuminuria in patients with diabetes: rationale and design of the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study

Haller, Hermanna; Viberti, Gian Cb; Mimran, Albertc; Remuzzi, Giusepped; Rabelink, Antonius Je; Ritz, Eberhardf; Rump, Lars Cg; Ruilope, Luis Mh; Katayama, Shigehiroi; Ito, Sadayoshij; Izzo, Joseph L Jrk; Januszewicz, Andrzejl

doi: 10.1097/01.hjh.0000202820.56201.e6
Original papers: Kidney

Diabetic nephropathy has developed into a worldwide epidemic and is responsible for the majority of end-stage renal disease in most countries. Antihypertensive treatment slows the progression of the disease. In addition, blockade of the renin–angiotensin system reduces the degree of albuminuria and angiotensin II receptor blockers (ARBs) have been shown to delay the progression from microalbuminuria to overt proteinuria in patients with diabetes. However, few studies have examined whether the initial stage of diabetic nephropathy (i.e. the development of microalbuminuria) in patients with type 2 diabetes can be slowed or prevented by ARB treatment. The Randomised Olmesartan And Diabetes MicroAlbuminuria Prevention (ROADMAP) study is a placebo-controlled, multicentre, double-blind, parallel group study investigating the effect of the ARB, olmesartan medoxomil, on the incidence of microalbuminuria. A total of 4400 type 2 diabetes patients with normoalbuminuria will be randomized to treatment with 40 mg of olmesartan medoxomil once daily or placebo. Goal blood pressure will be 130/80 mmHg. The primary endpoint of the study is the occurrence of microalbuminuria. In ROADMAP, we will also assess as secondary endpoints the effects of olmesartan on fatal and non-fatal cardiovascular events in patients with diabetes. In addition, within subgroups of the ROADMAP patients, the effects of olmesartan on retinopathy and other microvascular circulations will be analysed. The study is expected to last a median of 5 years. The ROADMAP study will answer the question whether an ARB can prevent or delay the onset of microalbuminuria and whether this translates into protection against cardiovascular events and renal disease.

aNephrology Section, Hanover Medical School, Hanover, Germany

bUnit of Metabolic Medicine, Division of Medicine, KCL Guy's Hospital, London, UK

cHospital Lapeyronie, Montpellier, France

dClinical Research Center for Rare Diseases, Mario Negri Institute of Pharmacological Research, Ospedali Riuniti di Bergamo, Bergamo, Italy

eDepartment of Nephrology, Leiden University Medical Center, Leiden, The Netherlands

fUniversity of Heidelberg, Department of Nephrology, Heidelberg

gMedical Clinic I, Marienhosptial Herne, University Clinic Ruhr-University-Bochum, Herne, Germany

hDivision of Hypertension, Hospital 12 de Octubre, Madrid, Spain

iThe Fourth Department of Medicine, Saitama Medical School, Saitama

jDepartment of Clinical Medicine, Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan

kDepartment of Medicine, State University of New York at Buffalo, Buffalo, New York, USA

lDepartment of Hypertension, Institute for Cardiology, Warsaw, Poland

Received 19 July, 2005

Revised 7 November, 2005

Accepted 8 November, 2005

Correspondence and requests for reprints to Hermann Haller, Professor Medizinische, Hochschule Hannover, Abteilung für Nephrologie, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. Tel: +49 (0)511 532 6319; fax: +49 (0)511 552 366; e-mail: haller.hermann@mh-hannover.de

Conflicts of interest: All steering committee members are consultants for Sankyo for the ROADMAP study. Sponsorship: This study is supported by Sankyo.

Trial registration reference number: NCT00185159, www.clinicaltrials.gov

© 2006 Lippincott Williams & Wilkins, Inc.