Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial
Abstract
Objective To examine the safety and cardiovascular (CV) effects of saxagliptin in the predefined elderly (≥65 years) and very elderly (≥75 years) subpopulations of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial. Research design and methods Individuals ≥40 years (n = 16,492; elderly, n = 8,561; very elderly, n = 2,330) with HbA1c ≥6.5% (47.5 mmol/mol) and ≤12.0% (107.7 mmol/mol) were randomized (1:1) to saxagliptin (5 or 2.5 mg daily) or placebo in a double-blind trial for a median follow-up of 2.1 years. Results The hazard ratio (HR) for the comparison of saxagliptin versus placebo for the primary end point (composite of CV mortality, myocardial infarction, or ischemic stroke) was 0.92 for elderly patients vs. 1.15 for patients Conclusions The SAVOR-TIMI 53 trial supports the overall CV safety of saxagliptin in a robust number of elderly and very elderly participants, although the risk of heart failure hospitalization was increased irrespective of age category. AEs and serious AEs as well as glycemic efficacy of saxagliptin in elderly patients are similar to those found in younger patients.
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Across trials of DPP-4 inhibitors, there appears to be no interaction by age-group.
“Across the trials of this drug class, there appears to be no interaction by age-group (110-112).”
From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [110]
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Type 2 diabetes mellitus in older adults: clinical considerations and management
Bellary, S., Kyrou, I., Brown, J. E., & Bailey, C. J. (2021) · Nature Reviews Endocrinology · doi:10.1038/s41574-021-00512-2 · Cited by 639 · see citing works
13. Older Adults: <i>Standards of Medical Care in Diabetes—2022</i>
American Diabetes Association Professional Practice Committee (2022) · Diabetes Care · doi:10.2337/dc22-s013 · Cited by 381 · see citing works
13. Older Adults: <i>Standards of Care in Diabetes—2024</i>
American Diabetes Association Professional Practice Committee, ElSayed, N. A., Aleppo, G., Bannuru, R. R., Bruemmer, D., Collins, B. S., Ekhlaspour, L., Hilliard, M. E., Johnson, E. L., Khunti, K., et al. (2024) · Diabetes Care · doi:10.2337/dc24-s013 · Cited by 161 · see citing works
Bilal, A., Yi, F., Gonzalez, G. R., Ali, M., Im, K., Ruff, C. T., Thethi, T. K., & Pratley, R. E. (2024) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2024.108783 · Cited by 14 · see citing works
- Authors
- Leiter, L. A., Teoh, H., Braunwald, E., Mosenzon, O., Cahn, A., Kumar, K. M. P., Smahelova, A., Hirshberg, B., Stahre, C., Frederich, R., Bonnici, F., Scirica, B. M., Bhatt, D. L., Raz, I., & for the SAVOR-TIMI 53 Steering Committee and Investigators
- Affiliations
- St. Michael's Hospital (CA)
- TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA
- Hadassah Medical Center (IL)
- Bangalore Diabetes Centre (IN)
- Department of Internal Gerontometabolic Clinic, Charles University in Prague, Hradec Kralove, Czech Republic
- AstraZeneca (United States) (US)
- AstraZeneca (Sweden) (SE)
- Bristol-Myers Squibb (United States) (US)
- UCT Private Academic Hospital, Cape Town, South Africa
- Brigham and Women's Hospital (US)
- Corresponding author
- Leiter, Lawrence A.
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2015-03-10
- Volume
- 38
- Issue
- 6
- Pages
- 1145-1153
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W1996585036
- Cited by
- 87
- References
- 5
- Citations by year
- 2025: 2 · 2024: 11 · 2023: 7 · 2022: 8 · 2021: 8 · 2020: 7 · 2019: 6 · 2018: 11 · 2017: 10 · 2016: 8 · 2015: 9
- FWCI
- 11.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- Bristol-Myers Squibb
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- saxagliptin, elderly patients, very elderly patients, DPP-4 inhibitors, type 2 diabetes, cardiovascular outcomes, cardiovascular mortality, myocardial infarction, ischemic stroke, heart failure hospitalization, hypoglycemia, glycemic control, HbA1c, drug safety
- MeSH terms
- Adamantane, Adult, Aged, Aged, 80 and over, Blood Glucose, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Dipeptides, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Heart Failure, Glycated Hemoglobin, Hospitalization, Humans, Male, Middle Aged, Myocardial Infarction, Incidence, Treatment Outcome, Stroke, Dipeptidyl-Peptidase IV Inhibitors
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