Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes
Open accessAbstract
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.
“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]
The Background describes a trial in people with type 2 diabetes and normoalbuminuria, and the Discussion reports that ARB therapy delayed the onset of microalbuminuria by 23%. The Cardiovascular End Points section reports more cardiovascular deaths with olmesartan (15 vs. 3), but the overall cardiovascular composite was similar between groups (4.3% vs. 4.2%). The claim therefore overstates the finding by saying cardiovascular events increased generally. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn T2D with neither albuminuria nor elevated blood pressure, cardiovascular events were increased with an ARB.
“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]
The Cardiovascular End Points section reports more cardiovascular deaths with olmesartan than placebo (15 vs. 3), but the overall cardiovascular composite was similar (4.3% vs. 4.2%). The Discussion reports a mean baseline blood pressure of 136/81 mm Hg, so the study does not establish an increase in cardiovascular events specifically among patients without elevated blood pressure. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAvailable data suggest that ACEi and ARB treatments are not beneficial for patients with neither albuminuria nor elevated blood pressure.
“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]
The Discussion (page not available in our copy) reports that trials with relatively low baseline blood pressure found no protective effect of ACE inhibitors or ARBs against developing microalbuminuria. That supports the claim for this specific outcome, but not the broader assertion that the treatments offer no benefit to all patients without albuminuria or elevated blood pressure; the paper also reports a benefit from olmesartan in its normoalbuminuric study population. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn T2D with neither albuminuria nor elevated blood pressure, moderately increased albuminuria was observed less frequently with an ARB.
“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]
The Results report less new microalbuminuria with olmesartan than placebo in patients with type 2 diabetes and normoalbuminuria. But the claim’s blood-pressure qualification is too broad: the Discussion reports a mean baseline pressure of 136/81 mm Hg, and the Primary End Point section identifies higher baseline systolic pressure as associated with a more favorable response. Blood pressure was controlled in most, not all, patients during follow-up (Blood-Pressure Control). Our copy provides no page numbers for these passages. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn 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.
“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]
The Background identifies the trial population as patients with type 2 diabetes and normoalbuminuria, and the Discussion reports that ARB therapy delayed the onset of microalbuminuria by 23%. The Cardiovascular End Points section reports more cardiovascular deaths with olmesartan (15 vs. 3), but the overall cardiovascular composite was similar between groups (4.3% vs. 4.2%). Thus, the claim overstates the finding as an increase in cardiovascular events generally. (LLM, conf=0.90)
Experimental — accuracy not yet measured
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- 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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