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Heart Failure, Saxagliptin and Diabetes Mellitus: Observations from the SAVOR - TIMI 53 Randomized Trial.
MedLine Citation:
PMID:  25189213     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: -Diabetes and heart failure frequently coexist. However, few diabetes trials have prospectively evaluated and adjudicated heart failure as an endpoint.
METHODS AND RESULTS: -16,492 patients with type 2 diabetes and a history of, or at risk for, cardiovascular events were randomized to saxagliptin or placebo (mean followup-2.1 years). The primary endpoint was the composite of cardiovascular death, myocardial infarction, or ischemic stroke. Hospitalization for heart failure was a predefined component of the secondary endpoint. Baseline NT-proBNP was measured in 12,301 patients. More patients treated with saxagliptin (289, 3.5%) were hospitalized for heart failure compared to placebo (228, 2.8%) (HR 1.27; 95%CI 1.07-1.51; p=0.007). Corresponding rates at 12-months were 1.9% vs.1.3% (HR 1.46, 95%CI 1.15-1.88, p=0.002, with no significant difference thereafter (time-varying interaction p=0.017). Subjects at greatest risk for hospitalization for heart failure had prior heart failure, eGFR ≤60 ml/min and/or elevated baseline levels of NT-proBNP. There was no evidence of heterogeneity between NT-proBNP and saxagliptin (p for interaction=0.46), though the absolute risk excess for heart failure with saxagliptin was greatest in the highest NT-proBNP quartile (2.1%). Even in patients at high-risk for hospitalization for heart failure, the risk of the primary and secondary endpoints were similar between treatment groups.
CONCLUSIONS: -In the context of balanced primary and secondary endpoints, saxagliptin treatment was associated with an increased risk for hospitalization for heart failure. This increase in risk was highest among patients with elevated levels of natriuretic peptides, prior heart failure, or chronic kidney disease. Clinical Trial Registration Information-ClinicalTrials.gov. Identifier: NCT01107886.
Authors:
Benjamin M Scirica; Eugene Braunwald; Itamar Raz; Matthew A Cavender; David A Morrow; Petr Jarolim; Jacob A Udell; Ofri Mosenzon; KyungAh Im; Amarachi A Umez-Eronini; Pia S Pollack; Boaz Hirshberg; Robert Frederich; Basil S Lewis; Darren K McGuire; Jaime Davidson; Ph Gabriel Steg; Deepak L Bhatt;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-9-4
Journal Detail:
Title:  Circulation     Volume:  -     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2014 Sep 
Date Detail:
Created Date:  2014-9-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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