The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)–TIMI 58 Trial

American Heart Journal

Volumn 200, Issue , 2018, Pages 83-89

  Wiviott, Stephen D ^a   Raz, Itamar ^b   Bonaca, Marc P ^a   Mosenzon, Ofri ^b   Kato, Eri T ^c   Cahn, Avivit ^b   Silverman, Michael G ^d   Bansilal, Sameer ^e   Bhatt, Deepak L ^a   Leiter, Lawrence A ^g   McGuire, Darren K ⁱ   Wilding, John PH ^h   Gause Nilsson, Ingrid AM ^f   Langkilde, Anna Maria ^f   Johansson, Peter A ^f   Sabatine, Marc S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^c KYOTO UNIVERSITY HOSPITAL   (Japan)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^f ASTRAZENECA R AND D   (Sweden)

^g ST MICHAEL'S HOSPITAL   (Canada)

^h UNIVERSITY OF LIVERPOOL   (United Kingdom)

ⁱ UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DAPAGLIFLOZIN; PLACEBO; 2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSIDE;

ADULT; ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DESIGN; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HEART FAILURE; HEART INFARCTION; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; ADMINISTRATION AND DOSAGE; AGED; BRAIN INFARCTION; CLINICAL TRIAL; COMPLICATION; DIURESIS; DRUG EFFECT; DRUG MONITORING; HEART MUSCLE ISCHEMIA; METABOLISM; MORTALITY; PHARMACOKINETICS; PROCEDURES; RISK FACTOR; TREATMENT OUTCOME;

AGED; BENZHYDRYL COMPOUNDS; CEREBRAL INFARCTION; DIABETES MELLITUS, TYPE 2; DIURESIS; DRUG MONITORING; FEMALE; GLUCOSIDES; HEART FAILURE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; MYOCARDIAL ISCHEMIA; RISK FACTORS; SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS; TREATMENT OUTCOME;

EID: 85045458725     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2018.01.012     Document Type: Article

References (30)

1. Roger, V.L., Go, A.S., Lloyd-Jones, D.M., et al. Heart disease and stroke statistics—2011 update: a report from the American Heart Association. Circulation 123 (2011), e18–e209.
2. Handelsman, Y., Bloomgarden, Z.T., Grunberger, G., et al. American Association of Clinical Endocrinologists and American College of Endocrinology—clinical practice guidelines for developing a diabetes mellitus comprehensive care plan—2015. Endocr Pract 21:Suppl. 1 (2015), 1–87.
3. Standards of medical care in diabetes—2016: summary of revisions. Diabetes Care, 39(Suppl. 1), 2016, S4–5.
4. Udell, J.A., Cavender, M.A., Bhatt, D.L., et al. Glucose-lowering drugs or strategies and cardiovascular outcomes in patients with or at risk for type 2 diabetes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol 3 (2015), 356–366.
5. Guidance for industry diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Accessed Januar 12, 2017, at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf, 2008.
6. White, W.B., Cannon, C.P., Heller, S.R., et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 369 (2013), 1327–1335.
7. Green, J.B., Bethel, M.A., Armstrong, P.W., et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med 373 (2015), 232–242.
8. Scirica, B.M., Bhatt, D.L., Braunwald, E., et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 369 (2013), 1317–1326.
9. Scirica, B.M., The safety of dipeptidyl peptidase 4 inhibitors and the risk for heart failure. JAMA Cardiol 1 (2016), 123–125.
10. United Kingdom Prospective Diabetes Study (UKPDS), 13: Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. BMJ 310 (1995), 83–88.
11. Han, S., Hagan, D.L., Taylor, J.R., et al. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes 57 (2008), 1723–1729.
12. Heerspink, H.J., Perkins, B.A., Fitchett, D.H., et al. Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes mellitus: cardiovascular and kidney effects, potential mechanisms, and clinical applications. Circulation 134 (2016), 752–772.
13. Komoroski, B., Vachharajani, N., Feng, Y., et al. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther 85 (2009), 513–519.
14. Sun, Y.N., Zhou, Y., Chen, X., et al. The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus: meta-analysis of randomised controlled trials. BMJ Open, 4, 2014, e004619.
15. Inzucchi, S.E., Zinman, B., Wanner, C., et al. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diab Vasc Dis Res 12 (2015), 90–100.
16. Abdul-Ghani, M., Del Prato, S., Chilton, R., et al. SGLT2 inhibitors and cardiovascular risk: lessons learned from the EMPA-REG OUTCOME study. Diabetes Care 39 (2016), 717–725.
17. Plosker, G.L., Dapagliflozin: a review of its use in patients with type 2 diabetes. Drugs 74 (2014), 2191–2209.
18. Henry, R.R., Rosenstock, J., Edelman, S., et al. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care 38 (2015), 412–419.
19. Sonesson, C., Johansson, P.A., Johnsson, E., et al. Cardiovascular effects of dapagliflozin in patients with type 2 diabetes and different risk categories: a meta-analysis. Cardiovasc Diabetol, 15, 2016, 37.
20. Zinman, B., Wanner, C., Lachin, J.M., et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 373 (2015), 2117–2128.
21. Neal, B., Perkovic, V., Mahaffey, K.W., et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 377 (2017), 644–657.
22. Mahaffey, K.W., Neal, B., Perkovic, V., et al. Canagliflozin for primary and secondary prevention of cardiovascular events: results from the CANVAS program (Canagliflozin Cardiovascular Assessment Study). Circulation 137:4 (2018), 323–334.
23. Hicks, K.A., Tcheng, J.E., Bozkurt, B., et al. 2014 ACC/AHA key data elements and definitions for cardiovascular endpoint events in clinical trials: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). Circulation 132 (2015), 302–361.
24. Burman, C.F., Sonesson, C., Guilbaud, O., A recycling framework for the construction of Bonferroni-based multiple tests. Stat Med 28 (2009), 739–761.
25. Bretz, F., Maurer, W., Brannath, W., et al. A graphical approach to sequentially rejective multiple test procedures. Stat Med 28 (2009), 586–604.
26. Multipe endpoints in clinical trials guidance for industry (draft), US Food and Drug Administration, Center for Drug Evaluation and Research. at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm536750.pdf, 2017.
27. Cavender, M.A., Steg, P.G., Smith, S.C. Jr., et al. Impact of diabetes mellitus on hospitalization for heart failure, cardiovascular events, and death: outcomes at 4 years from the Reduction of Atherothrombosis for Continued Health (REACH) Registry. Circulation 132 (2015), 923–931.
28. Fitchett, D.H., Udell, J.A., Inzucchi, S.E., Heart failure outcomes in clinical trials of glucose-lowering agents in patients with diabetes. Eur J Heart Fail 19 (2017), 43–53.
29. Fitchett, D., Zinman, B., Wanner, C., et al. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME(R) trial. Eur Heart J 37 (2016), 1526–1534.
30. Kaul, S., Is the mortality benefit with empagliflozin in type 2 diabetes mellitus too good to be true?. Circulation 134 (2016), 94–96.