Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: A multicentre, randomised, double-blind trial

The Lancet

Volumn 385, Issue 9982, 2015, Pages 2067-2076

  Zannad, Faiez ^a   Cannon, Christopher P ^b   Cushman, William C ^c   Bakris, George L ^d   Menon, Venu ^e   Perez, Alfonso T ^f   Fleck, Penny R ^f   Mehta, Cyrus R ^g   Kupfer, Stuart ^f   Wilson, Craig ^f   Lam, Hung ^f   White, William B ^h  

^a UNIVERSITÉ DE LORRAINE   (France)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^d UNIVERSITY OF CHICAGO   (United States)

^e LERNER RESEARCH INSTITUTE   (United States)

^f TAKEDA DEVELOPMENT CENTER AMERICAS   (United States)

^g HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^h UNIVERSITY OF CONNECTICUT SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; PLACEBO; ANTIDIABETIC AGENT; BRAIN NATRIURETIC PEPTIDE; PEPTIDE FRAGMENT; PIPERIDINE DERIVATIVE; PRO-BRAIN NATRIURETIC PEPTIDE (1-76); URACIL;

ACUTE CORONARY SYNDROME; ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HEART FAILURE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HOSPITAL ADMISSION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; ANALOGS AND DERIVATIVES; ANGINA, UNSTABLE; CHEMICALLY INDUCED; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DIABETIC CARDIOMYOPATHIES; HOSPITALIZATION; METABOLISM; MIDDLE AGED; RISK FACTOR; STATISTICS AND NUMERICAL DATA;

ACUTE CORONARY SYNDROME; AGED; ANGINA, UNSTABLE; DIABETES MELLITUS, TYPE 2; DIABETIC CARDIOMYOPATHIES; DOUBLE-BLIND METHOD; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; NATRIURETIC PEPTIDE, BRAIN; PEPTIDE FRAGMENTS; PIPERIDINES; RISK FACTORS; STROKE; URACIL;

EID: 84930085787     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)62225-X     Document Type: Article

References (39)

1. J He, LG Ogden, LA Bazzano, S Vupputuri, C Loria, PK Whelton Risk factors for congestive heart failure in US men and women: NHANES I epidemiologic follow-up study Arch Intern Med 161 2001 996 1002
2. WB Kannel, M Hjortland, WP Castelli Role of diabetes in congestive heart failure: the Framingham study Am J Cardiol 34 1974 29 34
3. AA Leung, DT Eurich, DA Lamb et al. Risk of heart failure in patients with recent-onset type 2 diabetes: population-based cohort study J Card Fail 15 2009 152 157
4. HM Krumholz, YT Chen, Y Wang, V Vaccarino, MJ Radford, RI Horwitz Predictors of readmission among elderly survivors of admission with heart failure Am Heart J 139 2000 72 77
5. DM Shindler, JB Kostis, S Yusuf et al. Diabetes mellitus, a predictor of morbidity and mortality in the Studies of Left Ventricular Dysfunction (SOLVD) trials and registry Am J Cardiol 77 1996 1017 1020
6. RM Cubbon, B Adams, A Rajwani et al. Diabetes mellitus is associated with adverse prognosis in chronic heart failure of ischaemic and non-ischaemic aetiology Diab Vasc Dis Res 10 2013 330 336
7. DT Eurich, FA McAlister, DF Blackburn et al. Benefits and harms of antidiabetic agents in patients with diabetes and heart failure: systematic review BMJ 335 2007 497
8. BM Scirica, DL Bhatt, E Braunwald SAVOR-TIMI 53 Steering Committee and Investigators Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus N Engl J Med 369 2013 1317 1323
9. BM Scirica, E Braunwald, I Raz for the SAVOR-TIMI 53 Steering Committee and Investigators Heart failure, saxagliptin and diabetes mellitus: observations from the SAVOR - TIMI 53 randomized trial Circulation 130 2014 1579 1588
10. WB White, CP Cannon, SR Heller for the EXAMINE Investigators Alogliptin after acute coronary syndrome in patients with type 2 diabetes N Engl J Med 369 2013 1327 1335
11. DA Morrow, CP Cannon, RA Jesse et al. National Academy of Clinical Biochemistry Laboratory Medicine practice guidelines: clinical characteristics and utilization of biochemical markers in acute coronary syndromes Clin Chem 53 2007 552 574
12. RL Prentice, BJ Williams, AV Peterson On the regression analysis of multivariate failure time data Biometrika 68 1981 373 379
13. G de Simone, RB Devereux, MJ Roman et al. Does cardiovascular phenotype explain the association between diabetes and incident heart failure? The Strong Heart Study Nutr Metab Cardiovasc Dis 23 2013 285 291
14. S Erqou, CT Lee, M Suffoletto et al. Association between glycated haemoglobin and the risk of congestive heart failure in diabetes mellitus: systematic review and meta-analysis Eur J Heart Fail 15 2013 185 193
15. AK Gitt, M Halle, M Hanefeld et al. Should antidiabetic treatment of type 2 diabetes in patients with heart failure differ from that in patients without? Eur J Heart Fail 14 2012 1389 1400
16. DT Eurich, DL Weir, SR Majumdar et al. Comparative safety and effectiveness of metformin in patients with diabetes mellitus and heart failure: systematic review of observational studies involving 34 000 patients Circ Heart Fail 6 2013 395 402
17. D Aguilar, W Chan, B Bozkurt, K Ramasubbu, A Deswal Metformin use and mortality in ambulatory patients with diabetes and heart failure Circ Heart Fail 4 2011 53 58
18. JJ McMurray, S Adamopoulos, SD Anker for the ESC Committee for Practice Guidelines ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the task force for the diagnosis and treatment of acute and chronic heart failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC Eur Heart J 33 2012 1787 1847
19. CW Yancy, M Jessup, B Bozkurt for the American College of Cardiology Foundation American Heart Association Task Force on Practice Guidelines 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 62 2013 e147 e239
20. AV Hernandez, A Usmani, A Rajamanickam, A Moheet Thiazolidinediones and risk of heart failure in patients with or at high risk of type 2 diabetes mellitus: a meta-analysis and meta-regression analysis of placebo-controlled randomized clinical trials Am J Cardiovasc Drugs 11 2011 115 128
21. RG Bach, MM Brooks, M Lombardero for the BARI 2D Investigators Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial Circulation 128 2013 785 794
22. RM Lago, PP Singh, RW Nesto Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials Lancet 370 2007 1129 1136
23. MA Khan, C Deaton, MK Rutter, L Neyses, MA Mamas Incretins as a novel therapeutic strategy in patients with diabetes and heart failure Heart Fail Rev 18 2013 141 148
24. A Takahashi, M Asakura, S Ito et al. Dipeptidyl-peptidase IV inhibition improves pathophysiology of heart failure and increases survival rate in pressure-overloaded mice Am J Physiol Heart Circ Physiol 304 2013 H1361 H1369
25. T Shigeta, M Aoyama, YK Bando et al. Dipeptidyl peptidase-4 modulates left ventricular dysfunction in chronic heart failure via angiogenesis-dependent and -independent actions Circulation 126 2012 1838 1851
26. L dos Santos, TA Salles, DF Arruda-Junior et al. Circulating dipeptidyl peptidase IV activity correlates with cardiac dysfunction in human and experimental heart failure Circ Heart Fail 6 2013 1029 1038
27. ClinicalTrials.gov. Sitagliptin cardiovascular outcome study (MK-0431-082 AM1) (TECOS). November, 2008. http://www.clinicaltrials.gov/ct2/show/NCT00790205?term=TECOS&rank=1 (accessed April 9, 2014).
28. ClinicalTrials.gov. CAROLINA: cardiovascular outcome study of linagliptin versus glimepiride in patients with type 2 diabetes. Nov 17, 2010. http://www.clinicaltrials.gov/ct2/show/NCT01243424?term=linagliptin+and+cardiovascular+outcomes&rank=1 (accessed April 9, 2014).
29. GG Sokos, LA Nikolaidis, S Mankad, D Elahi, RP Shannon Glucagon-like peptide-1 infusion improves left ventricular ejection fraction and functional status in patients with chronic heart failure J Card Fail 12 2006 694 699
30. M Halbirk, H Norrelund, N Moller et al. Cardiovascular and metabolic effects of 48-h glucagon-like peptide-1 infusion in compensated chronic patients with heart failure Am J Physiol Heart Circ Physiol 298 2010 H1096 H1102
31. JJV McMurray, P Ponikowski, GB Bolli et al. Vildagliptin shows no adverse effect on ejection fraction in diabetic patients with HF http://www.escardio.org/congresses/hf2013/congress-to-you/Pages/vildagliptin-shows-no-adverse-effect-ejection-fraction-diabetic-patients-with-heart-failure.aspx May 27, 2013 (accessed April 9, 2014).
32. G Boerrigter, LC Costello-Boerrigter, GJ Harty, H Lapp, JC Burnett Jr Desserine-proline brain natriuretic peptide 3-32 in cardiorenal regulation Am J Physiol Regul Integr Comp Physiol 292 2007 R897 R901
33. US Department of Health and Human Services Food and Drug Administration and Center for Drug Evaluation and Research (CDER) Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf December, 2008 (accessed April 9, 2014).
34. M Monami, I Dicembrini, E Mannucci Dipeptidyl peptidase-4 inhibitors and heart failure: a meta-analysis of randomized clinical trials Nutr Metab Cardiovasc Dis 24 2014 689 697
35. S Wu, I Hopper, M Skiba, H Krum Dipeptidyl peptidase-4 inhibitors and cardiovascular outcomes: meta-analysis of randomized clinical trials with 55 141 participants Cardiovasc Ther 32 2014 147 158
36. JB Green, MA Bethel, SK Paul et al. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease Am Heart J 166 2013 983 89. e7
37. R Baetta, A Corsini Pharmacology of dipeptidyl peptidase-4 inhibitors: similarities and differences Drugs 71 2011 1441 1467
38. LH Opie Glycaemia and heart failure in diabetes types 1 and 2 Lancet 378 2011 103 104
39. D Aguilar, B Bozkurt, K Ramasubbu et al. Relationship of hemoglobin A1C and mortality in heart failure patients with diabetes J Am Coll Cardiol 54 2009 422 428