Effect of valsartan on the incidence of diabetes and cardiovascular events
Open accessAbstract
BACKGROUND: It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. METHODS: In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of 5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstable angina; and a core composite outcome that excluded unstable angina and revascularization. RESULTS: The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group (hazard ratio in the valsartan group, 0.86; 95% confidence interval [CI], 0.80 to 0.92; P<0.001). Valsartan, as compared with placebo, did not significantly reduce the incidence of either the extended cardiovascular outcome (14.5% vs. 14.8%; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.43) or the core cardiovascular outcome (8.1% vs. 8.1%; hazard ratio, 0.99; 95% CI, 0.86 to 1.14; P=0.85). CONCLUSIONS: Among patients with impaired glucose tolerance and cardiovascular disease or risk factors, the use of valsartan for 5 years, along with lifestyle modification, led to a relative reduction of 14% in the incidence of diabetes but did not reduce the rate of cardiovascular events. (ClinicalTrials.gov number, NCT00097786.)
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Valsartan reduced the risk of incidence of diabetes.
“Normally prescribed for patients with hypertension or heart failure, this angiotensin II receptor antagonist had no overall effect on cardiovascular mortality in spite of its benefits in reducing the risk of the incidence of diabetes [108].”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [108]
For the end points CHD events, there were no improvements compared to placebo.
“So, even though we would expect a medication that corrects hypertension would improve the MetS outcomes, for the end points CHD events, there were no improvements compared to placebo.”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [108]
Valsartan had no overall effect on cardiovascular mortality in patients with impaired glucose tolerance.
“Normally prescribed for patients with hypertension or heart failure, this angiotensin II receptor antagonist had no overall effect on cardiovascular mortality in spite of its benefits in reducing the risk of the incidence of diabetes [108].”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [108]
These findings may be biased because the comparator active treatment groups had different proportions of other antihypertensive treatments known to increase the risk of diabetes, such as β-blockers and thiazide diuretics.
“However, these findings may be biased as the comparator active treatment groups had different proportions of other antihypertensive treatments that are known to increase the risk of diabetes (β-blockers, thiazide diuretics).112,113”
From Prediabetes: a high-risk state for diabetes development (2012) · cites this paper as [112]
In light of current evidence, the effect of ACE inhibitors and ARBs on diabetes is much smaller than that of antidiabetic drugs, and they are not recommended for the treatment of prediabetes.
“In light of current evidence, the effect of these drugs is much smaller than that of the antidiabetic drugs and they are not recommended for the treatment of prediabetes.”
From Prediabetes: a high-risk state for diabetes development (2012) · cites this paper as [112]
In the NAVIGATOR study, valsartan had no effect on cardiovascular mortality.
“In the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) study, treatment with valsartan reduced the risk of incident diabetes compared to placebo (31% versus 33%, p<0.001) in patients with IGT and cardiovascular risk factors, although there was no effect on cardiovascular mortality.228”
From The Vasculature in Prediabetes (2018) · cites this paper as [228]
In the NAVIGATOR study, treatment with valsartan reduced the risk of incident diabetes compared to placebo (31% versus 33%, p<0.001) in patients with IGT and cardiovascular risk factors.
“In the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) study, treatment with valsartan reduced the risk of incident diabetes compared to placebo (31% versus 33%, p<0.001) in patients with IGT and cardiovascular risk factors, although there was no effect on cardiovascular mortality.228”
From The Vasculature in Prediabetes (2018) · cites this paper as [228]
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- Authors
- The NAVIGATOR Study Group
- Affiliations
- University of Glasgow (GB)
- Corresponding author
- The NAVIGATOR Study Group
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-04-22
- Volume
- 362
- Issue
- 16
- Pages
- 1477-1490
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1532542861
- Cited by
- 660
- References
- 38
- Citations by year
- 2026: 9 · 2025: 14 · 2024: 23 · 2023: 23 · 2022: 22 · 2021: 31 · 2020: 22 · 2019: 31 · 2018: 36 · 2017: 39 · 2016: 36 · 2015: 39 · 2014: 58 · 2013: 56 · 2012: 81
- FWCI
- 60.59
- Type
- journal article
- Language
- en
- Open access
- green
- orbi.uliege.be
- Licence
- other-oa
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- ORBi (University of Liège) (submittedVersion, other-oa)
- BORIS (University Library Bern) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Leicester Research Archive (University of Leicester) (submittedVersion)
- UNIFESP Institutional Repository (Universidade Federal de São Paulo) (submittedVersion)
- Funders
- Novartis Pharma
- Duke Clinical Research Institute
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Renin-Angiotensin System Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- valsartan, renin-angiotensin system blockade, impaired glucose tolerance, diabetes incidence, cardiovascular events, nateglinide, lifestyle modification, cardiovascular disease, myocardial infarction, stroke, heart failure hospitalization
- MeSH terms
- Valsartan, Nateglinide, Blood Glucose, Blood Pressure, Body Weight, Cardiovascular Diseases, Cyclohexanes, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Hypoglycemic Agents, Male, Middle Aged, Phenylalanine, Risk Factors, Tetrazoles, Valine, Exercise, Incidence, Proportional Hazards Models, Glucose Intolerance, Angiotensin II Type 1 Receptor Blockers
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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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