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Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Moderate or Severe Renal Impairment: Observations From the SAVOR-TIMI 53 Trial
- Source :
- Diabetes Care. 38:696-705
- Publication Year :
- 2014
- Publisher :
- American Diabetes Association, 2014.
-
Abstract
- OBJECTIVE The glycemic management of patients with type 2 diabetes mellitus (T2DM) and renal impairment is challenging, with few treatment options. We investigated the effect of saxagliptin in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-Thrombolysis in Myocardial Infarction (TIMI) 53 trial according to baseline renal function. RESEARCH DESIGN AND METHODS Patients with T2DM at risk for cardiovascular events were stratified as having normal or mildly impaired renal function (estimated glomerular filtration rate [eGFR] >50 mL/min/1.73 m2; n = 13,916), moderate renal impairment (eGFR 30–50 mL/min/1.73 m2; n = 2,240), or severe renal impairment (eGFR RESULTS After a median duration of 2 years, saxagliptin neither increased nor decreased the risk of the primary and secondary composite end points compared with placebo, irrespective of renal function (all P for interactions ≥0.19). Overall, the risk of hospitalization for heart failure among the three eGFR groups of patients was 2.2% (referent), 7.4% (adjusted hazard ratio [HR] 2.38 [95% CI 1.95–2.91], P < 0.001), and 13.0% (adjusted HR 4.59 [95% CI 3.28–6.28], P < 0.001), respectively. The relative risk of hospitalization for heart failure with saxagliptin was similar (P for interaction = 0.43) in patients with eGFR >50 mL/min/1.73 m2 (HR 1.23 [95% CI 0.99–1.55]), eGFR 30–50 mL/min/1.73 m2 (HR 1.46 [95% CI 1.07–2.00]), and in patients with eGFR CONCLUSIONS Saxagliptin did not affect the risk of ischemic cardiovascular events, increased the risk of heart failure hospitalization, and reduced progressive albuminuria, irrespective of baseline renal function.
- Subjects :
- Male
medicine.medical_specialty
Endocrinology, Diabetes and Metabolism
Population
Myocardial Infarction
Renal function
Adamantane
Type 2 diabetes
Saxagliptin
Severity of Illness Index
chemistry.chemical_compound
Internal medicine
Internal Medicine
Humans
Medicine
Diabetic Nephropathies
Renal Insufficiency
Myocardial infarction
education
Aged
Heart Failure
Advanced and Specialized Nursing
education.field_of_study
business.industry
Incidence
Hazard ratio
Dipeptides
Middle Aged
medicine.disease
Surgery
Hospitalization
Stroke
Treatment Outcome
Diabetes Mellitus, Type 2
chemistry
Cardiovascular Diseases
Heart failure
Albuminuria
Cardiology
Female
medicine.symptom
business
Subjects
Details
- ISSN :
- 19355548 and 01495992
- Volume :
- 38
- Database :
- OpenAIRE
- Journal :
- Diabetes Care
- Accession number :
- edsair.doi.dedup.....5f338d24fde15ec4c0f22629b5d3f3df