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Olmesartan for the Delay or Prevention of Microalbuminuria in Type 2 Diabetes
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BACKGROUND: Microalbuminuria is an early predictor of diabetic nephropathy and premature cardiovascular disease. We investigated whether treatment with an angiotensin-receptor blocker (ARB) would delay or prevent the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria. METHODS: In a randomized, double-blind, multicenter, controlled trial, we assigned 4447 patients with type 2 diabetes to receive olmesartan (at a dose of 40 mg once daily) or placebo for a median of 3.2 years. Additional antihypertensive drugs (except angiotensin-converting-enzyme inhibitors or ARBs) were used as needed to lower blood pressure to less than 130/80 mm Hg. The primary outcome was the time to the first onset of microalbuminuria. The times to the onset of renal and cardiovascular events were analyzed as secondary end points. RESULTS: The target blood pressure (<130/80 mm Hg) was achieved in nearly 80% of the patients taking olmesartan and 71% taking placebo; blood pressure measured in the clinic was lower by 3.1/1.9 mm Hg in the olmesartan group than in the placebo group. Microalbuminuria developed in 8.2% of the patients in the olmesartan group (178 of 2160 patients who could be evaluated) and 9.8% in the placebo group (210 of 2139); the time to the onset of microalbuminuria was increased by 23% with olmesartan (hazard ratio for onset of microalbuminuria, 0.77; 95% confidence interval, 0.63 to 0.94; P=0.01). The serum creatinine level doubled in 1% of the patients in each group. Slightly fewer patients in the olmesartan group than in the placebo group had nonfatal cardiovascular events--81 of 2232 patients (3.6%) as compared with 91 of 2215 patients (4.1%) (P=0.37)--but a greater number had fatal cardiovascular events--15 patients (0.7%) as compared with 3 patients (0.1%) (P=0.01), a difference that was attributable in part to a higher rate of death from cardiovascular causes in the olmesartan group than in the placebo group among patients with preexisting coronary heart disease (11 of 564 patients [2.0%] vs. 1 of 540 [0.2%], P=0.02). CONCLUSIONS: Olmesartan was associated with a delayed onset of microalbuminuria, even though blood-pressure control in both groups was excellent according to current standards. The higher rate of fatal cardiovascular events with olmesartan among patients with preexisting coronary heart disease is of concern. (Funded by Daiichi Sankyo; ClinicalTrials.gov number, NCT00185159.).
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“In a trial of people with type 2 diabetes and normal urinary albumin excretion, an ARB reduced or suppressed the development of albuminuria but increased the rate of cardiovascular events (86).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [86]
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“but cardiovascular events were increased. 59”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [59]
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“Available data suggest that ACEi and ARB treatments are not bene fi cial for patients with neither albuminuria nor elevated blood pressure.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [59]
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“In T2D with neither albuminuria nor elevated blood pressure (normal or well-treated), moderately increased albuminuria was observed less frequently with an ARB”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [59]
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“In a trial of people with type 2 diabetes and normal urinary albumin excretion, an ARB reduced or suppressed the development of albuminuria but increased the rate of cardiovascular events (94).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [94]
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Metadata
- Authors
- Haller, H., Ito, S., Izzo, J. L., Januszewicz, A., Katayama, S., Menne, J., Mimran, A., Rabelink, T. J., Ritz, E., Ruilope, L. M., Rump, L. C., & Viberti, G.
- Affiliations
- Medizinische Hochschule Hannover (DE)
- Tohoku University (JP)
- Institute of Cardiology (PL)
- Saitama Medical University (JP)
- Hôpital Lapeyronie (FR)
- Leiden University Medical Center (NL)
- Heidelberg University (DE)
- Hospital Universitario 12 De Octubre (ES)
- Heinrich Heine University Düsseldorf (DE)
- Guy's Hospital (GB)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-03-10
- Volume
- 364
- Issue
- 10
- Pages
- 907-917
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2169506520
- Cited by
- 792
- References
- 30
- Citations by year
- 2026: 15 · 2025: 21 · 2024: 19 · 2023: 26 · 2022: 39 · 2021: 36 · 2020: 39 · 2019: 34 · 2018: 58 · 2017: 51 · 2016: 59 · 2015: 67 · 2014: 66 · 2013: 74 · 2012: 115
- FWCI
- 80.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Leiden Repository (Leiden University) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- CINECA IRIS Institutial Research Information System (University of Genoa) (submittedVersion)
- Research Portal (King's College London) (submittedVersion)
- Open Repository and Bibliography (University of Liège) (submittedVersion, other-oa)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion)
- Funders
- Amgen
- Pfizer
- Sanofi
- Bayer HealthCare
- Dainippon Sumitomo Pharma
- Astellas Pharma
- Shionogi
- Servier
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Keywords
- olmesartan, microalbuminuria, type 2 diabetes, angiotensin receptor blockers, diabetic nephropathy, cardiovascular events, blood pressure control, renal protection, cardiovascular mortality, normoalbuminuria, serum creatinine doubling, antihypertensive therapy, renin-angiotensin system blockade, cardiovascular risk reduction
- MeSH terms
- Adolescent, Adult, Aged, Albuminuria, Blood Pressure, Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Imidazoles, Male, Middle Aged, Tetrazoles, Angiotensin II Type 1 Receptor Blockers, Young Adult
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