Predictors of New-Onset Diabetes in Patients Treated With Atorvastatin
Open accessAbstract
Objectives We sought to examine the incidence and clinical predictors of new-onset type 2 diabetes mellitus (T2DM) within 3 large randomized trials with atorvastatin.Background Statin therapy might modestly increase the risk of new-onset T2DM.Methods We used a standard definition of diabetes and excluded patients with prevalent diabetes at baseline. We identified baseline predictors of new-onset T2DM and compared the event rates in patients with and without new-onset T2DM.Results In the TNT (Treating to New Targets) trial, 351 of 3,798 patients randomized to 80 mg of atorvastatin and 308 of 3,797 randomized to 10 mg developed new-onset T2DM (9.24% vs. 8.11%, adjusted hazard ratio [HR]: 1.10, 95% confidence interval [CI]: 0.94 to 1.29, p = 0.226). In the IDEAL (Incremental Decrease in End Points Through Aggressive Lipid Lowering) trial, 239 of 3,737 patients randomized to atorvastatin 80 mg/day and 208 of 3,724 patients randomized to simvastatin 20 mg/day developed new-onset T2DM (6.40% vs. 5.59%, adjusted HR: 1.19, 95% CI: 0.98 to 1.43, p = 0.072). In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, new-onset T2DM developed in 166 of 1,905 patients randomized to atorvastatin 80 mg/day and in 115 of 1,898 patients in the placebo group (8.71% vs. 6.06%, adjusted HR: 1.37, 95% CI: 1.08 to 1.75, p = 0.011). In each of the 3 trials, baseline fasting blood glucose, body mass index, hypertension, and fasting triglycerides were independent predictors of new-onset T2DM. Across the 3 trials, major cardiovascular events occurred in 11.3% of patients with and 10.8% of patients without new-onset T2DM (adjusted HR: 1.02, 95% CI: 0.77 to 1.35, p = 0.69).Conclusions High-dose atorvastatin treatment compared with placebo in the SPARCL trial is associated with a slightly increased risk of new-onset T2DM. Baseline fasting glucose level and features of the metabolic syndrome are predictive of new-onset T2DM across the 3 trials.
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The benefits of statins far outweigh the risks for the vast majority of patients.
“There are reports indicating increased blood sugar and HbA 1c levels, i.e. increased risk of type 2 diabetes, as a possible adverse effect of long-term statin therapy, but the benefits of statins far outweigh the risks for the vast majority of patients.497,498”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [497]
There are reports indicating increased blood sugar and HbA1c levels, i.e., increased risk of type 2 diabetes, as a possible adverse effect of long-term statin therapy.
“There are reports indicating increased blood sugar and HbA 1c levels, i.e. increased risk of type 2 diabetes, as a possible adverse effect of long-term statin therapy, but the benefits of statins far outweigh the risks for the vast majority of patients.497,498”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [497]
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References 26 · Cited by 333
Research works printed but not linked: 1
- Pedersen TR, Faergeman O, Kastelein JJK, et al., the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simva- statin for secondary prevention after myocardial infarction. JAMA 2005;294:2437-45.
- Authors
- Waters, D. D., Ho, J. E., DeMicco, D. A., Breazna, A., Arsenault, B. J., Wun, C.-C., Kastelein, J. J., Colhoun, H., & Barter, P.
- Affiliations
- San Francisco General Hospital (US)
- Pfizer (United States) (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- University of Dundee (GB)
- The Heart Research Institute (AU)
- Corresponding author
- Waters, David D.
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2011-04
- Volume
- 57
- Issue
- 14
- Pages
- 1535-1545
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W29474508
- Cited by
- 333
- References
- 26
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 10 · 2023: 12 · 2022: 13 · 2021: 11 · 2020: 14 · 2019: 28 · 2018: 12 · 2017: 20 · 2016: 30 · 2015: 36 · 2014: 42 · 2013: 41 · 2012: 38
- FWCI
- 42.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Funders
- Pfizer, Inc
- Biosante
- Merck Schering-Plough
- Pfizer
- Roche
- AstraZeneca
- Merck
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Keywords
- atorvastatin, statin-induced diabetes, diabetes risk factors, fasting blood glucose, body mass index, hypertension, fasting triglycerides, TNT trial, IDEAL trial, SPARCL trial, cardiovascular events, simvastatin, lipid-lowering therapy, hypertriglyceridemia, hyperglycemia, dyslipidemia
- MeSH terms
- Atorvastatin, Adult, Aged, Diabetes Mellitus, Type 2, Female, Forecasting, Heptanoic Acids, Humans, Male, Middle Aged, Pyrroles, Risk Factors, Incidence, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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