Renal and retinal effects of enalapril and losartan in type 1 diabetes
Open accessAbstract
BACKGROUND: Nephropathy and retinopathy remain important complications of type 1 diabetes. It is unclear whether their progression is slowed by early administration of drugs that block the renin-angiotensin system. METHODS: We conducted a multicenter, controlled trial involving 285 normotensive patients with type 1 diabetes and normoalbuminuria and who were randomly assigned to receive losartan (100 mg daily), enalapril (20 mg daily), or placebo and followed for 5 years. The primary end point was a change in the fraction of glomerular volume occupied by mesangium in kidney-biopsy specimens. The retinopathy end point was a progression on a retinopathy severity scale of two steps or more. Intention-to-treat analysis was performed with the use of linear regression and logistic-regression models. RESULTS: A total of 90% and 82% of patients had complete renal-biopsy and retinopathy data, respectively. Change in mesangial fractional volume per glomerulus over the 5-year period did not differ significantly between the placebo group (0.016 units) and the enalapril group (0.005, P=0.38) or the losartan group (0.026, P=0.26), nor were there significant treatment benefits for other biopsy-assessed renal structural variables. The 5-year cumulative incidence of microalbuminuria was 6% in the placebo group; the incidence was higher with losartan (17%, P=0.01 by the log-rank test) but not with enalapril (4%, P=0.96 by the log-rank test). As compared with placebo, the odds of retinopathy progression by two steps or more was reduced by 65% with enalapril (odds ratio, 0.35; 95% confidence interval [CI], 0.14 to 0.85) and by 70% with losartan (odds ratio, 0.30; 95% CI, 0.12 to 0.73), independently of changes in blood pressure. There were three biopsy-related serious adverse events that completely resolved. Chronic cough occurred in 12 patients receiving enalapril, 6 receiving losartan, and 4 receiving placebo. CONCLUSIONS: Early blockade of the renin-angiotensin system in patients with type 1 diabetes did not slow nephropathy progression but slowed the progression of retinopathy. (ClinicalTrials.gov number, NCT00143949.)
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Among people with type 1 or 2 diabetes with established CKD (eGFR <60 mL/min/1.73m2 and UACR >=300 mg/g creatinine), ACE inhibitor or ARB therapy reduces the risk of progression to ESKD.
“Antihypertensive therapy reduces the risk of albuminuria (67)(68)(69)(70), and among people with type 1 or 2 diabetes with established CKD (eGFR <60 mL/min/1.73m 2 and UACR $300 mg/g creatinine), ACE inhibitor or ARB therapy reduces the risk of progression to ESKD (71)(72)(73)(74)(75)(76)(77)(78)(79)(80).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [78]
The Discussion reports that RAS blockade appears to reduce time to creatinine doubling, dialysis, or death in proteinuric patients with type 1 or type 2 diabetes and elevated serum creatinine. It does not specify the claimed eGFR <60 or UACR ≥300 thresholds; this paper’s own trial studied patients without clinically detectable renal disease. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTwo long-term, double-blind studies demonstrated no renoprotective effect of either ACE inhibitors or ARBs among people with type 1 and type 2 diabetes who were normotensive with or without high albuminuria (30-299 mg/g creatinine).
“Moreover, two long-term, double-blind studies demonstrated no renoprotective effect of either ACE inhibitors or ARBs among people with type 1 and type 2 diabetes who were normotensive with or without high albuminuria (formerly microalbuminuria, 30-299 mg/g creatinine) (78,79).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [78]
The Discussion reports that this double-blind trial found no renal structural or functional benefit from an ACE inhibitor or an ARB in normotensive, normoalbuminuric people with type 1 diabetes. This paper does not establish the claim for type 2 diabetes or for participants with high albuminuria; it is one of the two studies cited, not both. (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 [39]
The Discussion reports no nephropathy benefit from ACEi or ARB treatment in normoalbuminuric, normotensive participants with type 1 diabetes. The claim extends that renal finding to patients generally and to treatment benefit overall. The same Discussion reports that both treatments reduced diabetic retinopathy progression. (LLM, conf=0.90)
Experimental — accuracy not yet measuredTwo long-term, double-blind studies demonstrated no kidney-protective effect of either ACE inhibitors or ARBs among people with type 1 and type 2 diabetes who were normotensive with or without high albuminuria.
“Moreover, two long-term, double-blind studies demonstrated no kidney-protective effect of either ACE inhibitors or ARBs among people with type 1 and type 2 diabetes who were normotensive with or without high albuminuria (formerly microalbuminuria, 30-299 mg/g creatinine) (79,80).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [79]
The Methods describe a five-year trial in normotensive, normoalbuminuric people with type 1 diabetes, and the Discussion reports no detected kidney benefit from enalapril or losartan. This paper does not establish that result for type 2 diabetes or for people with elevated albuminuria; those parts of the two-study claim cannot be supported by this source. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn a trial of people with type 1 diabetes exhibiting neither albuminuria nor hypertension, ACE inhibitors or ARBs did not prevent the development of glomerulopathy assessed by kidney biopsy.
“In a trial of people with type 1 diabetes exhibiting neither albuminuria nor hypertension, ACE inhibitors or ARBs did not prevent the development of glomerulopathy assessed by kidney biopsy (78).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [78]
In T1D with neither albuminuria nor elevated blood pressure, neither an ACEi nor an ARB reduced the incidence of albuminuria over 5 years.
“or reduced the incidence of albuminuria over 5 years. 39”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [39]
In T1D with neither albuminuria nor elevated blood pressure, neither an ACEi nor an ARB slowed progression of histologic features of diabetes and CKD over 5 years.
“In T1D with neither albuminuria nor elevated blood pressure, neither an ACEi nor an ARB either slowed the progression of histologic features of diabetes and CKD”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [39]
In a trial of people with type 1 diabetes exhibiting neither albuminuria nor hypertension, ACE inhibitors or ARBs did not prevent the development of glomerulopathy assessed by kidney biopsy.
“In a trial of people with type 1 diabetes exhibiting neither albuminuria nor hypertension, ACE inhibitors or ARBs did not prevent the development of glomerulopathy assessed by kidney biopsy (79).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [79]
Lifestyle intervention or bariatric surgery in T2D, or physical activity in T1D, can stabilize retinopathy.
“Other options that can stabilize retinopathy include lifestyle intervention or bariatric surgery in persons with T2D or physical activity in persons with T1D.524–527”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [525]
The Abstract Methods and Discussion describe a trial of enalapril and losartan in people with type 1 diabetes and report reduced retinopathy progression with those drugs. Searches for physical activity, lifestyle intervention, and bariatric surgery found no passage addressing whether those options stabilize retinopathy; the paper's drug findings neither establish nor contradict the cited claim. No page numbers are available in our copy. (LLM, conf=0.76)
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Diabetic nephropathy: Time to withhold development and progression - A review
Sharaf El Din, U. A. A., Salem, M. M., & Abdulazim, D. O. (2017) · Journal of Advanced Research · doi:10.1016/j.jare.2017.04.004 · Cited by 53 · see citing works
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- Authors
- Mauer, M., Zinman, B., Gardiner, R., Suissa, S., Sinaiko, A., Strand, T., Drummond, K., Donnelly, S., Goodyer, P., Gubler, M. C., & Klein, R.
- Affiliations
- University of Minnesota (US)
- Mount Sinai Hospital (CA)
- McGill University (CA)
- University of Wisconsin–Madison (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-07-02
- Volume
- 361
- Issue
- 1
- Pages
- 40-51
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC2978030
- OpenAlex
- W2108266187
- Semantic Scholar
- 296941038b5b2943e46024dd57c0664eeca76e39
- Cited by
- 791
- References
- 42
- Citations by year
- 2026: 9 · 2025: 23 · 2024: 17 · 2023: 26 · 2022: 34 · 2021: 29 · 2020: 41 · 2019: 32 · 2018: 43 · 2017: 41 · 2016: 43 · 2015: 48 · 2014: 59 · 2013: 72 · 2012: 87
- FWCI
- 62.67
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Deutsches Krebsforschungszentrum
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK051975, DK 51975)
- National Center for Research Resources (M01RR000400, M01-RR00400)
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Nephrology › Renal Diseases and Glomerulopathies
- Keywords
- type 1 diabetes, diabetic nephropathy, diabetic retinopathy, enalapril, losartan, renin-angiotensin system blockade, mesangial expansion, microalbuminuria, retinopathy progression, ACE inhibitors, angiotensin receptor blockers, chronic cough, renal biopsy, blood pressure control, diabetes complications prevention
- MeSH terms
- Adult, Albuminuria, Angiotensin-Converting Enzyme Inhibitors, Diabetes Mellitus, Type 1, Diabetic Nephropathies, Diabetic Retinopathy, Double-Blind Method, Enalapril, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Kidney Glomerulus, Male, Renin-Angiotensin System, Retina, Logistic Models, Disease Progression, Losartan, Angiotensin II Type 1 Receptor Blockers, Mesangial Cells, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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