PMID- 27033025
OWN - NLM
STAT- MEDLINE
DCOM- 20170731
LR  - 20221207
IS  - 1590-3729 (Electronic)
IS  - 0939-4753 (Linking)
VI  - 26
IP  - 5
DP  - 2016 May
TI  - A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 
      diabetes stratified by UKPDS 10-year cardiovascular risk score.
PG  - 374-9
LID - S0939-4753(15)00233-1 [pii]
LID - 10.1016/j.numecd.2015.11.004 [doi]
AB  - BACKGROUND AND AIMS: To assess the efficacy and safety of saxagliptin 2.5 and 
      5 mg/d in patients with type 2 diabetes mellitus (T2DM) and high risk of coronary 
      heart disease (CHD) or stroke as estimated by the United Kingdom Prospective 
      Diabetes Study (UKPDS) risk engine. METHODS AND RESULTS: Post hoc analysis of 
      data pooled from 5 previously reported phase 3, randomized, placebo-controlled, 
      24-week studies was conducted. Patients were stratified into subgroups by UKPDS 
      10-year CHD and/or stroke risk >/=20% and CHD and stroke risk <20%. End points were 
      adjusted mean change from baseline in glycated hemoglobin (HbA1c), fasting plasma 
      glucose (FPG), 120-min postprandial glucose (PPG), and body weight and the 
      proportion of patients achieving HbA1c <7% and </=8% at week 24. Pooled safety data 
      were analyzed for adverse events (AEs) and hypoglycemia. Both doses of 
      saxagliptin reduced HbA1c, FPG, and PPG to a greater extent than placebo 
      regardless of UKPDS risk score. The proportions of patients achieving HbA1c <7% 
      and </=8% were greater with saxagliptin than placebo and consistent across risk 
      score groups. AE profile and hypoglycemia incidence were similar for saxagliptin 
      and placebo across UKPDS risk score groups. CONCLUSION: Saxagliptin was well 
      tolerated and improved glycemic control in patients with T2DM regardless of their 
      CHD and stroke UKPDS risk score. Clinical trial registration numbers: 
      Clinicaltrials.gov NCT00121641, NCT00316082, NCT00121667, NCT00313313, and 
      NCT00295633.
CI  - Copyright (c) 2015 The Italian Society of Diabetology, the Italian Society for the 
      Study of Atherosclerosis, the Italian Society of Human Nutrition, and the 
      Department of Clinical Medicine and Surgery, Federico II University. Published by 
      Elsevier B.V. All rights reserved.
FAU - Bonora, E
AU  - Bonora E
AD  - University and University Hospital of Verona, Verona, Italy. Electronic address: 
      enzo.bonora@univr.it.
FAU - Bryzinski, B
AU  - Bryzinski B
AD  - AstraZeneca, Gaithersburg, MD, USA.
FAU - Hirshberg, B
AU  - Hirshberg B
AD  - MedImmune, LLC, Gaithersburg, MD, USA.
FAU - Cook, W
AU  - Cook W
AD  - AstraZeneca, Gaithersburg, MD, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00121641
SI  - ClinicalTrials.gov/NCT00121667
SI  - ClinicalTrials.gov/NCT00295633
SI  - ClinicalTrials.gov/NCT00316082
SI  - ClinicalTrials.gov/NCT00313313
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20151201
PL  - Netherlands
TA  - Nutr Metab Cardiovasc Dis
JT  - Nutrition, metabolism, and cardiovascular diseases : NMCD
JID - 9111474
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptides)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9GB927LAJW (saxagliptin)
RN  - EC 3.4.14.5 (DPP4 protein, human)
RN  - EC 3.4.14.5 (Dipeptidyl Peptidase 4)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/adverse effects/*analogs & derivatives/therapeutic use
MH  - Aged
MH  - Biomarkers/blood
MH  - Blood Glucose/*drug effects/metabolism
MH  - Cardiovascular Diseases/etiology/*prevention & control
MH  - Clinical Trials, Phase III as Topic
MH  - Diabetes Mellitus, Type 2/blood/complications/*drug therapy/enzymology
MH  - Dipeptides/adverse effects/*therapeutic use
MH  - Dipeptidyl Peptidase 4/*metabolism
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/blood/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Coronary heart disease
OT  - Saxagliptin
OT  - Stroke
OT  - Type 2 diabetes
OT  - UKPDS risk score
EDAT- 2016/04/02 06:00
MHDA- 2017/08/02 06:00
CRDT- 2016/04/02 06:00
PHST- 2014/12/10 00:00 [received]
PHST- 2015/11/01 00:00 [revised]
PHST- 2015/11/07 00:00 [accepted]
PHST- 2016/04/02 06:00 [entrez]
PHST- 2016/04/02 06:00 [pubmed]
PHST- 2017/08/02 06:00 [medline]
AID - S0939-4753(15)00233-1 [pii]
AID - 10.1016/j.numecd.2015.11.004 [doi]
PST - ppublish
SO  - Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 
      10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.