SAVOR-TIMI 53

SAVOR-TIMI 53 was a randomized, double-blind, placebo-controlled trial to assess the cardiovascular efficacy and safety of saxagliptin, a DPP-4 inhibitor, when added to standard of care in patients with type 2 diabetes mellitus.

MAIN RESULTS:
Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

N Engl J Med. 2013 Oct 3;369(14):1317-26.

PRESENTATIONS

TIMI 53 Slides
HF Risk Stratification and Efficacy of SGLT2 Inhibitors in Patients with T2DM (Berg, ESC 2019)
SAVOR DM Genetics (Marston, AHA 2019)
A Novel Genetic Risk Score Predicts Ischemic Stroke in Patients with Cardiometabolic Disease (Patel, AHA 2020)
Clinical Applications of a Polygenic Risk Score to Predict Atrial Fibrillation in Patients with Cardiometabolic Disease (Garfinkel, AHA 2021)
A Genetic Risk Score to Predict Peripheral Artery Disease and Acute Limb Ischemia in Patients With Cardiometabolic Disease (Patel, AHA 2021)
Assessment of Atherothrombotic Risk in Patients with Type 2 Diabetes Mellitus (Berg, ACC 2022)

OTHER PUBLICATIONS

The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6.

Baseline characteristics of patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR) – TIMI 53 Trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26.

Incidence of pancreatitis and pancreatic cancer in a randomized controlled multicenter trial (SAVOR-TIMI 53) of the dipeptidyl peptidase-4 inhibitor saxagliptin. Diabetes Care. 2014 Sep;37(9):2435-41.

Heart Failure, Saxagliptin and Diabetes Mellitus: Observations from the SAVOR – TIMI 53 Randomized Trial. Circulation. 2014 Oct 28;130(18):1579-88.

Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Moderate or Severe Renal Impairment: Observations From the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705.

Impact of treatment with saxagliptin on glycaemic stability and beta-cell function in the SAVOR-TIMI 53 study. Diabetes Obes Metab. 2015 May;17(5):487-94.

Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Jun;38(6):1145-53.

Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50.

Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8.

Frequency of Cancer Events with Saxagliptin in the SAVOR-TIMI 53 Trial. Diabetes Obes Metab. 2016 Feb;18(2):186-90.

Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial. Diabetes Care. 2016 Aug;39(8):1329-37.

Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998.

Health-related quality-of-life implications of cardiovascular events in individuals with type 2 diabetes mellitus: A subanalysis from the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-TIMI 53 trial. Diabetes Res Clin Pract. 2017 Aug;130:24-33.

Hypoglycaemia manifestations and recurrent events: Lessons from the SAVOR-TIMI 53 outcome study. Diabetes Obes Metab. 2017 Jul;19(7):1045-1050.

Blood Pressure, Subclinical Myocardial Injury And Cardiovascular Outcomes Among Patients With Diabetes And High Cardiovascular Risk: Observations From The SAVOR-TIMI 53 Trial. Eur Heart J. 2018 Jun 21; 39(24): 2255–2262.

Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163.

Blood pressure and cardiovascular outcomes in patients with diabetes and high cardiovascular risk. Eur Heart J. 2018 Jun 21;39(24):2255-2262.

Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76.

Cardiac and Inflammatory Biomarkers Are Associated with Worsening Renal Outcomes in Patients with Type 2 Diabetes Mellitus: Observations from SAVOR-TIMI 53. Clin Chem. 2019 Jun;65(6):781-790.

Metformin Use and Clinical Outcomes among Patients with Diabetes with or without Heart Failure or Kidney Dysfunction: Observations from the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014.

Clinical Application of a Novel Genetic Risk Score for Ischemic Stroke in Patients with Cardiometabolic Disease. Circulation. 2021;143:470–478.

Genetic Risk Score to Identify Risk of Venous Thromboembolism in Patients with Cardiometabolic Disease. Circ Genom Precis Med. 2021 Feb;14(1):e003006.

Sex, Permanent Drug Discontinuation, and Study Retention in Clinical Trials: Insights From the TIMI trials. Circulation. 2021 Feb 16;143(7):685-695.

Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840.

A Biomarker-Based Score for Risk of Hospitalization for Heart Failure in Patients With Diabetes. Diabetes Care. 2021 Nov;44(11):2573-2581

Assessing reproducibility and utility of clustering of patients with type 2 diabetes and established CV disease (SAVOR -TIMI 53 trial). PLoS One. 2021 Nov 19;16(11):e0259372. doi: 10.1371/journal.pone.0259372. eCollection 2021.