PMID- 22093196
OWN - NLM
STAT- MEDLINE
DCOM- 20120109
LR  - 20131121
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 162
IP  - 5
DP  - 2011 Nov
TI  - 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.
PG  - 818-825.e6
LID - 10.1016/j.ahj.2011.08.006 [doi]
AB  - OBJECTIVES: Saxagliptin, a dipeptidyl peptidase 4 inhibitor, improves glycemic 
      control in patients with type 2 diabetes mellitus (T2DM) by increasing endogenous 
      active, intact glucagon-like peptide 1 and glucose-dependent insulinotropic 
      polypeptide in response to food, which augments insulin secretion and decreases 
      glucagon release. RESEARCH DESIGN AND METHODS: SAVOR-TIMI 53 is a phase 4, 
      randomized, double-blind, placebo-controlled trial conducted in 25 countries that 
      is designed to evaluate the safety and efficacy of saxagliptin during long-term 
      treatment of approximately 16,500 patients with T2DM. Eligible patients who are 
      either treatment naive or on any background antidiabetic treatment (except 
      incretin therapy) with history of established cardiovascular (CV) disease or 
      multiple risk factors are randomized 1:1 to saxagliptin 5 mg QD (2.5 mg in 
      subjects with moderate/severe renal impairment) or matching placebo, stratified 
      by qualifying disease state. The primary end point is the composite of CV death, 
      nonfatal myocardial infarction, or nonfatal ischemic stroke. The trial will 
      continue until approximately 1,040 primary end points accrue, providing 85% power 
      to identify a 17% relative reduction of the primary end point with saxagliptin 
      versus placebo and 98% power to test for noninferiority of saxagliptin versus 
      placebo (reject the upper limit of 95% CI for a hazard ratio <1.3 at a 1-sided alpha 
      of .025). CONCLUSION: SAVOR-TIMI 53 is testing the hypothesis that treatment with 
      saxagliptin is safe and reduces CV events in high-risk patients with T2DM.
CI  - Copyright (c) 2011 Mosby, Inc. All rights reserved.
FAU - Scirica, Benjamin M
AU  - Scirica BM
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, Boston, MA, USA. bscirica@partners.org
FAU - Bhatt, Deepak L
AU  - Bhatt DL
FAU - Braunwald, Eugene
AU  - Braunwald E
FAU - Steg, Ph Gabriel
AU  - Steg PG
FAU - Davidson, Jaime
AU  - Davidson J
FAU - Hirshberg, Boaz
AU  - Hirshberg B
FAU - Ohman, Peter
AU  - Ohman P
FAU - Price, Deborah L
AU  - Price DL
FAU - Chen, Roland
AU  - Chen R
FAU - Udell, Jacob
AU  - Udell J
FAU - Raz, Itamar
AU  - Raz I
LA  - eng
SI  - ClinicalTrials.gov/NCT01107886
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Dipeptides)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 9GB927LAJW (saxagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy
MH  - Dipeptides/administration & dosage/*therapeutic use
MH  - Dipeptidyl-Peptidase IV Inhibitors/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - France
MH  - Humans
MH  - Israel
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/*complications/mortality
MH  - Research Design
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - United States
EDAT- 2011/11/19 06:00
MHDA- 2012/01/10 06:00
CRDT- 2011/11/19 06:00
PHST- 2011/05/02 00:00 [received]
PHST- 2011/08/05 00:00 [accepted]
PHST- 2011/11/19 06:00 [entrez]
PHST- 2011/11/19 06:00 [pubmed]
PHST- 2012/01/10 06:00 [medline]
AID - S0002-8703(11)00622-3 [pii]
AID - 10.1016/j.ahj.2011.08.006 [doi]
PST - ppublish
SO  - Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.