Reduction in Cardiovascular Events With Atorvastatin in 2,532 Patients With Type 2 Diabetes
Open accessAbstract
OBJECTIVE—This study aims to establish the benefits of lowering cholesterol in diabetic patients with well-controlled hypertension and average/below-average cholesterol concentrations, but without established coronary disease. RESEARCH DESIGN AND METHODS—In the lipid-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA), 10,305 hypertensive patients with no history of coronary heart disease (CHD) but at least three cardiovascular risk factors were randomly assigned to receive 10 mg atorvastatin or placebo. Effects on total cardiovascular outcomes in 2,532 patients who had type 2 diabetes at randomization were compared. RESULTS—During a median follow-up of 3.3 years, concentrations of total and LDL cholesterol among diabetic participants included in ASCOT-LLA were ∼1 mmol/l lower in those allocated atorvastatin compared with placebo. There were 116 (9.2%) major cardiovascular events or procedures in the atorvastatin group and 151 (11.9%) events in the placebo group (hazard ratio 0.77, 95% CI 0.61–0.98; P = 0.036). For the individual components of this composite end point, the number of events occurring in the diabetes subgroup was small. Therefore, although fewer coronary events (0.84, 0.55–1.29; P = 0.14) and strokes (0.67, 0.41–1.09; P = 0.66) were observed among the patients allocated atorvastatin, these reductions were not statistically significant. CONCLUSIONS—Atorvastatin significantly reduced the risk of major cardiovascular events and procedures among diabetic patients with well-controlled hypertension and without a history of CHD or markedly elevated cholesterol concentrations. The proportional reduction in risk was similar to that among participants who did not have diagnosed diabetes. Allocation to atorvastatin prevented ∼9 diabetic participants from suffering a first major cardiovascular event or procedure for every 1,000 treated for 1 year.
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Subgroup analyses of people with diabetes in larger trials and trials in people with diabetes showed significant primary and secondary prevention of ASCVD events and CHD death in people with diabetes.
“Subgroup analyses of people with diabetes in larger trials (101-105) and trials in people with diabetes (106,107) showed significant primary and secondary prevention of ASCVD events and CHD death in people with diabetes.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [105]
The ASCOT-LLA results (Statistical methods; page unavailable) report a significant reduction in total cardiovascular events and procedures among participants with diabetes, including those without preexisting cardiovascular disease. But the reduction in the diabetic subgroup for the endpoint combining fatal CHD and nonfatal myocardial infarction was not statistically significant. The paper reports benefits in an earlier trial among diabetic patients both with and without established cardiovascular disease, but its own results do not establish significant secondary prevention or a reduction in CHD death. (LLM, conf=0.89)
Experimental — accuracy not yet measuredSubgroup analyses of people with diabetes in larger trials and trials in people with diabetes showed significant primary and secondary prevention of ASCVD events and CHD death in people with diabetes.
“Subgroup analyses of people with diabetes in larger trials (94–98) and trials in people with diabetes (99,100) showed significant primary and secondary prevention of ASCVD events and coronary heart disease (CHD) death in people with diabetes.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [98]
In the Results passage labeled “Statistical methods” (page not provided), atorvastatin significantly reduced total cardiovascular events and procedures in the diabetic subgroup, including participants without preexisting cardiovascular disease. But the paper says the reduction in its primary endpoint of fatal CHD and nonfatal myocardial infarction was not statistically significant in that subgroup; Table 4 also shows no significant reduction in CHD death. This source therefore supports the cardiovascular-event portion, not the claim of significant prevention of CHD death. (LLM, conf=0.89)
Experimental — accuracy not yet measuredSubgroup analyses of people with diabetes in larger trials and trials in people with diabetes showed significant primary and secondary prevention of ASCVD events and CHD death.
“Subgroup analyses of people with diabetes in larger trials (92 -96) and trials in people with diabetes (97,98) showed signi fi cant primary and secondary prevention of ASCVD events and CHD death in people with diabetes.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [96]
Subanalyses of diabetic subgroups of larger trials and trials specifically in subjects with diabetes showed significant primary and secondary prevention of CVD events ± CHD deaths in diabetic populations.
“Subanalyses of diabetic subgroups of larger trials (186–190) and trials specifically in subjects with diabetes (191,192) showed significant primary and secondary prevention of CVD events ± CHD deaths in diabetic populations.”
From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [190]
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- Authors
- Sever, P. S., Poulter, N. R., Dahlöf, B., Wedel, H., Collins, R., Beevers, G., Caulfield, M., Kjeldsen, S. E., Kristinsson, A., McInnes, G. T., Mehlsen, J., Nieminen, M., O’Brien, E., Ostergren, J., & for the ASCOT Investigators
- Affiliations
- Imperial College London (GB)
- Sahlgrenska University Hospital/Östra, Gothenburg, Sweden
- Nordic School of Public Health (SE)
- University of Oxford (GB)
- Birmingham City Hospital (GB)
- Queen Mary University of London (GB)
- Oslo University Hospital (NO)
- National University Hospital of Iceland (IS)
- University of Glasgow (GB)
- Frederiksberg Hospital (DK)
- Helsinki University Hospital (FI)
- Beaumont Hospital, Dublin, Ireland
- Karolinska Hospital, Stockholm, Sweden
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2005-05-01
- Volume
- 28
- Issue
- 5
- Pages
- 1151-1157
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2112668155
- Cited by
- 390
- References
- 4
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 9 · 2023: 9 · 2022: 11 · 2021: 9 · 2020: 9 · 2019: 11 · 2018: 13 · 2017: 8 · 2016: 9 · 2015: 21 · 2014: 18 · 2013: 29 · 2012: 19
- FWCI
- 41.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Hirsla (Landspítali University Hospital) (submittedVersion)
- Funders
- Pfizer
- Servier
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- atorvastatin, type 2 diabetes, cardiovascular events, lipid-lowering therapy, hypertension, LDL cholesterol, coronary artery disease, stroke, statins, cardiovascular risk reduction
- MeSH terms
- Atorvastatin, Adult, Aged, Diabetes Mellitus, Type 2, Female, Heptanoic Acids, Humans, Hyperlipidemias, Hypertension, Cholesterol, LDL, Male, Middle Aged, Myocardial Infarction, Pyrroles, Risk Factors, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Stroke
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