Relevance of positive cardiovascular outcome trial results in clinical practice: Perspectives from the academy for cardiovascular risk, outcomes and safety studies in type 2 diabetes (ACROSST2D)

Therapeutics and Clinical Risk Management

Volumn 13, Issue , 2017, Pages 1569-1576

  Schernthaner, Guntram ^a   Khunti, Kamlesh ^b   Lotan, Chaim ^c   Burnier, Michel ^d   Drexel, Heinz ^e   Prázný, Martin ^f  

^a KRANKENANSTALT RUDOLFSTIFTUNG   (Austria)

^b LEICESTER GENERAL HOSPITAL   (United Kingdom)

^c HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^d LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^e Vorarlberg Institute for Vascular Investigation and Treatment   (Austria)

^f CHARLES UNIVERSITY   (Czech Republic)

Author keywords

Cardiovascular disease; CVOT; DPP 4 inhibitors; GLP 1 agonists; SGLT2 inhibitors; Type 2 diabetes

Indexed keywords

ALBIGLUTIDE; ALOGLIPTIN; CANAGLIFLOZIN; DAPAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DULAGLUTIDE; EMPAGLIFLOZIN; ERTUGLIFLOZIN; EXENDIN 4; GEMIGLIPTIN; GLIMEPIRIDE; INSULIN; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; PLACEBO; SAXAGLIPTIN; SEMAGLUTIDE; SITAGLIPTIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; SULFONYLUREA;

ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL PRACTICE; CONTINUING EDUCATION; DISEASE BURDEN; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; GASTROINTESTINAL SYMPTOM; HEALTH CARE PERSONNEL; HUMAN; LIFE EXPECTANCY; MORTALITY RATE; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT CARE;

EID: 85038831575     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/TCRM.S144362     Document Type: Article

References (46)

1. International Diabetes Federation. IDF Diabetes Atlas, 7th ed. 2015:1–140. Available from: http://www.diabetesatlas.org/. Accessed October 10, 2017.
2. Seshasai SRK, Kaptoge S, Thompson A, et al; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011;364(9):829–841.
3. Schernthaner G, Jarvis S, Lotan C, Prázný M, Wanner C, Wascher TC. Advances in the management of cardiovascular risk for patients with type 2 diabetes: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes. Ther Clin Risk Manag. 2017;13:69–79.
4. Zinman B, Inzucchi SE, Lachin JM, et al. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™). Cardiovasc Diabetol. 2014;13(1):102.
5. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322.
6. Wanner C, Inzucchi SE, Lachin JM, et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016;375(4):323–334.
7. Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–1844.
8. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644–657.
9. Patel A, MacMahon S, Chalmers J, et al; ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560–2572.
10. Bergenstal RM, Bailey CJ, Kendall DM. Type 2 diabetes: assessing the relative risks and benefits of glucose-lowering medications. Am J Med. 2010;123(4):374.
11. UKPDS Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837–853.
12. Hayward RA, Reaven PD, Wiitala WL, et al. Follow-up of glycemic control and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;372(23):2197–2206.
13. Ismail-Beigi F, Genuth S. Clinical implications of the ACCORD trial. J Clin Endocrinol Metab. 2012;97(1):41–48.
14. Ismail-Beigi F, Craven T, Banerji MA, et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet. 2010;376(9739):419–430.
15. Zoungas S, Chalmers J, Neal B, et al. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014;371(15):1392–1406.
16. Dalrymple LS, Katz R, Kestenbaum B, et al. Chronic kidney disease and the risk of end-stage renal disease versus death. J Gen Intern Med. 2011;26(4):379–385.
17. Ronco C, Haapio M, House AA, Anavekar N, Bellomo R. Cardiorenal syndrome. J Am Coll Cardiol. 2008;52(19):1527–1539.
18. Wakisaka M. Letter to the editor on: Wanner C, Inzucchi SE, Zinman B. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016;375(18):1799–1802.
19. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128.
20. 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® trial. Eur Heart J. 2016;37(19):1526–1534.
21. Jardiance 10 mg and 25 mg film-coated tablets [prescribing information]. (eMC) Print friendly, 2017. Germany: Boehringer Ingelheim Limited.
22. Jardiance [prescribing information]. Ingelheim am Rhein, Germany: Boehringer Ingelheim International GmbH; 2016:1–34.
23. Lehmann R, Bianda T, Brändle M, et al. Mesures Visant Contrôle De La Glycémie Chez Les Patients Atteints De Diabète Sucré De Type 2. [Recommendations of SGED/SSED: Measures for blood glucose control in patients with type 2 diabetes mellitus]. 2016:1–17. Baden: Société Suisse d’Endocrinologie et de Diabétologie. French. Available from: http://sgedssed.ch/fr/informations-pour-professionnels/lignes-directrices/. Accessed October 10, 2017.
24. Lehmann R, Bianda T, Brändle M, et al. Empfehlungen der SGED/SSED: Massnahmen zur Blutzuckerkontrolle bei Patienten mit Diabetes mellitus Typ 2. [Recommendations of SGED/SSED: Measures for blood glucose control in patients with type 2 diabetes mellitus]. 2016:1–16. Baden: Schweizerische Gesellschaft für Endokrinologie und Diabetologie. German. Available from: http://sgedssed.ch/informationen-fuer-fachpersonen/richtlinien-guidelines/. Accessed October 10, 2017.
25. Škrha J, Pelikánová T, Kvapil M. Česká diabetologická společnost. [Czech Diabetes Society Recommended treatment for type 2 diabetes mellitus]. Prague: 2016:1–15. Czech.
26. Austrian Diabetes Society (ODG) and the Austrian Lipid Consensus. Co-ordinated by Clodi M. and Toplak H. Diabetes mellitus – Instructions for practice. Revised and extended version 2016. Wiener klinische wochenschrift. [The Central European Journal of Medicine]. 2016;128: S37–S228. German.
27. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Pharmacologic management of type 2 diabetes: 2016 interim update. Can J Diabetes. 2016;40(6):484–486.
28. Dedov II, Shestakova MV, Mayorov AY, et al. Standards of specialized diabetes care. Diabetes Mellitus. 2017;20(1S):1–121.
29. Piepoli MF, Hoes AW, Agewall S, et al. 2016 European guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2016;37(29):2315–2381.
30. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2016;37(27):2129–2200.
31. Roffi M, Patrono C, Collet J-P, et al. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016;37(3):267–315.
32. FDA. FDA drug safety communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density; 2015. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm. Accessed April 27, 2017.
33. PRAC, Committee PRA. PRAC recommendation, EMA/76661/2017. 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/SGLT2_inhibitors_Canagliflozin_20/Recommendation_provided_by_Pharmacovigilance:Risk_Assessment_Committee/WC500221431.pdf. Accessed April 27, 2017.
34. Kohler S, Patel S, DeFronzo RA, et al. Safety and tolerability of combinations of empagliflozin/linagliptin for 52 weeks in subjects with type 2 diabetes, 2015. Available from: http://www.easdvirtualmeeting.org/resources/safety-and-tolerability-of-combinations-of-empagliflozin-linagliptin-for-52-weeks-in-subjects-with-type-2-diabetes--3. Accessed October 10, 2017.
35. Standards of medical care in diabetes-2017: summary of revisions. Diabetes Care. 2017;40(Suppl 1):S4–S5.
36. Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373(3):232–242.
37. Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23):2247–2257.
38. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317–1326.
39. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369(14):1327–1335.
40. Sonesson C, Johansson PA, Johnsson E, Gause-Nilsson I. Cardiovascular effects of dapagliflozin in patients with type 2 diabetes and different risk categories: a meta-analysis. Cardiovasc Diabetol. 2016;15:37.
41. Kosiborod M, Cavender MA, Fu AZ, et al. Lower risk of heart failure and death in patients initiated on SGLT-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study. Circulation. Epub 2017 May 18.
42. Nyström T, Bodegård J, Nathanson D, Thuresson M, Norhammar A, Eriksson JW. Novel oral glucose-lowering drugs are associated with lower risk of all-cause mortality, cardiovascular events and severe hypoglycaemia compared with insulin in patients with type 2 diabetes. Diabetes Obes Metab. 2017;35(6):1364.
43. Toulis KA, Willis BH, Marshall T, et al. All-cause mortality in patients with diabetes under treatment with dapagliflozin: a population-based, open-cohort study in the health improvement network database. J Clin Endocrinol Metab. 2017;102(5):1719–1725.
44. Birkeland KI, Jorgensen ME, Carstensen B, et al. Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic): a multinational observational analysis. Lancet Diabetes Endocrinol. 2017;5(9):709–717.
45. Shah AD, Langenberg C, Rapsomaniki E, et al. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015;3(2):105–113.
46. Scheen AJ. Diabetes: time for reconciliation between cardiologists and diabetologists. Nat Rev Cardiol. 2016;13(9):509–510.