The TECOS, EXAMINE and SAVOR studies – how do they differ and what are their outcomes?
Authors:
Jindřich Špinar 1,3; Lenka Špinarová 2; Jiří Vítovec 2
Authors place of work:
Interní kardiologická klinika LF MU a FN Brno, pracoviště Bohunice, přednosta prof. MUDr. Jindřich Špinar, CSc., FESC
1; I. interní kardio-angiologická klinika LF MU a FN u sv. Anny v Brně, přednostka prof. MUDr. Lenka Špinarová, CSc., FESC
2; Mezinárodní centrum klinického výzkumu – FN u sv. Anny v Brně, ředitel Gorazd B. Stonkin, M. D., MSc., PhD.
3
Published in the journal:
Vnitř Lék 2015; 61(11): 976-983
Category:
Reviews
Summary
The treatment of diabetes mellitus type 2 is effective, but still is not optimal. DPP4 inhibitors (gliptins) are a new group of peroral antidiabetic drugs. The third clinical mortality study with gliptins in patients with diabetes mellitus type 2 was finished in 2015. The studies are known under acronym TECOS, SAVOR and EXAMINE and the tested drugs are sitagliptin, saxagliptin and alogliptin. The studies included about 37 000 patients. The studies confirmed the cardiovascular safety of the DPP4 inhibitors, but the question about increased heart failure remains open. The effectiveness of lowering glycaemia (glycated haemoglobin) was confirmed and also the pancreatic safety is confirmed.
Key word:
effectiveness – gliptins – safety
Zdroje
1. American Diabetes Association. Standards of medical care in diabetes – 2015. Diabetes Care 2015; 38: (Suppl.): S1-S93.
2. Bethel MA, Green JB, Milton J et al. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab 2015; 17: 395–402.
3. Clifton P Do dipeptidyl peptidase IV (DPP-IV) inhibitors cause heart failure? Clin Ther 2014; 36: 2072–2079.
4. Capuano A, Sportiello L, Makotino MI et al. Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy – focus on alogliptin. Drug Des Devel Ther 2013; 7: 989–1001.
5. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: diabetes mellitus evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. December 2008 (http://www .fda .gov/ downloads/ Drugs/ GuidanceCompliance RegulatoryInformation/ Guidances/ucm071627 .pdf).
6. Egan AG, Blind E, Dunder K et al. Pancreatic safety of incretin-based drugs – FDA and EMA assessment. N Engl J Med 2014; 370: 794–797.
7. European Medicine Agency, Committee for Medicinal Products for Human Use. Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus. January 2010 (http://www.ema .europa .eu/ docs/ en_GB/ document_library/ Scientific_guideline/ 2010/ 02/WC500073570 .pdf)
8. Hirshberg B, Katz A Cardiovascular Outcome Studies With Novel Antidiabetes Agents: Scientific and Operational Considerations. Diabetes Care 2013; 36: (Suppl. 2): S253-S258.
9. Holman RR, Paul SK, Bethel MA et al. 10-Year followup of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577–1589.
10. Holman RR, Sourij H, Califf RM Cardiovascular outcome trials of glucoselowering drugs or strategies in type 2 diabetes. Lancet 2014; 383: 2008–2017.
11. Kvapil M Nové léky v terapii diabetes mellitus 2. typu. Vnitř Lék 2013; 59: 713–718.
12. Nissen SE, Wolski K Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457–2471.
13. 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: 1317–1326.
14. Špinar J, Šmahelová A SAVOR-TIMI 53 – Výsledky saxagliptinu a kardiovaskulární výsledky u pacientů s diabetes mellitus 2. typu. Vnitř Lék 2013; 59: 1003–1008.
15. Špinar J Studie SAVOR TIMI a EXAMINE byly prezentována na ESC 2013 – nová data pro DPP-4 inhibitory. Hypertenze a kardiovaskulární prevence 2013; 5: 41–44.
16. Špinar J, Špinarová L, Vítovec J EXAMINE – alogliptin po akutním koronárním syndromu u pacientů s diabetem mellitem 2. typu. Remedia 2014; 24: 301–304.
17. Udell JA, Cavender MA, Bhatt DL 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 2015; 3: 356–366.
18. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose kontrol with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837–853.
19. 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: 1327–1335.
20. Yu O, Filion KB, Ayoulay L et al. Incretin-based drugs and the risk of congestive heart failure. Diabetes Care 2015; 38: 277–284.
21. Zannad F, Cannon CP, Cushman WC et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet 2015; 385: 2067–2076.
Štítky
Diabetology Endocrinology Internal medicineČlánok vyšiel v časopise
Internal Medicine
2015 Číslo 11
Najčítanejšie v tomto čísle
- Clinical importance of basal insulin analogues and insulin Toujeo® 300 units/ml
- Atherosclerosis: from etiology to its possible influencing
- Position of lipoprotein apheresis in present
- Practical approach to statin intolerance