What Are We Learning from the FDA-Mandated Cardiovascular Outcome Studies for New Pharmacological Antidiabetic Agents?

Publisher: Current Science Country of Publication: United States NLM ID: 101093791 Publication Model: Print Cited Medium: Internet ISSN: 1539-0829 (Electronic) Linking ISSN: 15344827 NLM ISO Abbreviation: Curr Diab Rep Subsets: MEDLINE

Original Publication: Philadelphia, PA : Current Science, c2001-

Cardiovascular Diseases/*prevention & control ; Diabetes Mellitus, Type 2/*drug therapy ; Hypoglycemic Agents/*therapeutic use; Blood Glucose/analysis ; Cardiovascular Diseases/etiology ; Clinical Trials as Topic ; Diabetes Mellitus, Type 2/complications ; Glucagon-Like Peptide-1 Receptor/agonists ; Humans ; Outcome Assessment, Health Care ; Risk Factors ; Sodium-Glucose Transporter 2 Inhibitors ; United States ; United States Food and Drug Administration

Cardiovascular disease (CVD) is common in patients with diabetes. For these patients, clinicians should seek diabetes treatment that is beneficial rather than harmful in relation to CVD. Until recently, there have been many treatments for hyperglycemia, whose impact on CVD has been controversial. The aims of this review are to evaluate the effectiveness of antihyperglycemic medications on risk factors for CVD and to examine the impact of these drugs on CVD in cardiovascular (CV) outcome trials. In this article, we summarize current knowledge about the impacts of these drugs on various risk factors as well as CV outcomes. We identify the recent emergence of trials with antihyperglycemic agents showing newly discovered CV benefits as well as past trials with antihyperglycemic agents not showing much benefit on CV events. Rather than focusing on treatment strategies, we review the effects of individual drug classes on CV outcomes. We also briefly review goal-driven glycemia reduction and its impact on CVD. We conclude that antihyperglycemic agents are associated with improvement in CV risk factors in patients with diabetes and insulin resistance; in fact, a few drugs reduced CV events in randomized CV outcome trials. Therefore, the use of these drugs is appropriate for reducing glucose and decreasing CV event risk in a select subpopulation.

Ann Intern Med. 2013 Aug 20;159(4):262-74. (PMID: 24026259)
Endocr Pract. 2016 Jun;22(6):753-62. (PMID: 27082665)
Diabetes Obes Metab. 2011 Jul;13(7):669-72. (PMID: 21457428)
Clin Pharmacol Ther. 2009 May;85(5):520-6. (PMID: 19129748)
N Engl J Med. 2013 Oct 3;369(14):1317-26. (PMID: 23992601)
J Hypertens. 2006 Oct;24(10):2047-55. (PMID: 16957566)
N Engl J Med. 2010 Apr 29;362(17):1575-85. (PMID: 20228401)
J Clin Endocrinol Metab. 2011 Nov;96(11):3337-53. (PMID: 21900381)
Cardiovasc Diabetol. 2014 Jun 19;13:102. (PMID: 24943000)
Diabetes Care. 2007 Jun;30(6):1487-93. (PMID: 17353504)
Eur J Endocrinol. 2002 May;146(5):717-27. (PMID: 11980629)
N Engl J Med. 2011 Mar 3;364(9):818-28. (PMID: 21366473)
Diabetes Care. 2013 Aug;36(8):2162-8. (PMID: 23412077)
Curr Med Res Opin. 2008 Jan;24(1):275-86. (PMID: 18053320)
J Am Soc Hypertens. 2014 May;8(5):330-9. (PMID: 24631482)
Adv Ther. 2012 Sep;29(9):736-46. (PMID: 22923161)
Diab Vasc Dis Res. 2015 May;12(3):164-74. (PMID: 25780262)
Diabetes Care. 2008 Dec;31(12):2315-7. (PMID: 18809631)
JAMA. 2003 Jul 23;290(4):486-94. (PMID: 12876091)
Diabetes Care. 2013 Aug;36 Suppl 2:S253-8. (PMID: 23882054)
Am J Med. 2007 Sep;120(9 Suppl 2):S18-25. (PMID: 17826042)
Lancet. 1998 Sep 12;352(9131):854-65. (PMID: 9742977)
Lancet. 1998 Sep 12;352(9131):837-53. (PMID: 9742976)
Circulation. 1999 Sep 7;100(10):1134-46. (PMID: 10477542)
Diabetes Care. 2011 May;34 Suppl 2:S258-63. (PMID: 21525465)
N Engl J Med. 2009 Jan 8;360(2):129-39. (PMID: 19092145)
J Am Heart Assoc. 2012 Oct;1(5):e002279. (PMID: 23316290)
Diabetes Care. 2014;37(1):44-9. (PMID: 24356597)
Diabetes Care. 2015 Apr;38(4):696-705. (PMID: 25552421)
Am J Med. 2016 Mar;129(3):340.e1-8. (PMID: 26524706)
N Engl J Med. 2010 Apr 29;362(17):1563-74. (PMID: 20228404)
Am J Cardiovasc Drugs. 2002;2(3):149-56. (PMID: 14727977)
N Engl J Med. 2013 Oct 3;369(14):1327-35. (PMID: 23992602)
Atherosclerosis. 2013 Feb;226(2):305-14. (PMID: 23083681)
Diabetes Obes Metab. 2013 Jul;15(7):593-606. (PMID: 23216746)
Diabetes Care. 2013 Nov;36(11):3460-8. (PMID: 24026560)
Circ J. 2013;77(5):1337-44. (PMID: 23386232)
Diabetes Care. 2013 Aug;36(8):2346-50. (PMID: 23564922)
N Engl J Med. 2015 Jul 16;373(3):232-42. (PMID: 26052984)
Drug Metab Pharmacokinet. 2013;28(3):213-9. (PMID: 23149871)
Cardiovasc Diabetol. 2013 Jan 09;12:8. (PMID: 23298374)
Diabetes Obes Metab. 2014 Jan;16(1):63-74. (PMID: 23859428)
Diabetes Metab Res Rev. 2005 Jan-Feb;21(1):31-8. (PMID: 15624123)
N Engl J Med. 2015 Nov 26;373(22):2117-28. (PMID: 26378978)
N Engl J Med. 2015 Jun 4;372(23):2197-206. (PMID: 26039600)
Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F889-900. (PMID: 26354881)
N Engl J Med. 2008 Oct 9;359(15):1577-89. (PMID: 18784090)
Ther Adv Endocrinol Metab. 2015 Feb;6(1):19-28. (PMID: 25678953)
Diabetes Care. 1998 Oct;21(10):1720-5. (PMID: 9773737)
Lancet. 2015 May 23;385(9982):2067-76. (PMID: 25765696)
Arch Intern Med. 2009 Mar 23;169(6):616-25. (PMID: 19307526)
Am Heart J. 2013 Dec;166(6):983-989.e7. (PMID: 24268212)
J Am Coll Cardiol. 2007 Jan 23;49(3):290-7. (PMID: 17239709)
Diabetes Care. 2010 Nov;33(11):2406-8. (PMID: 20724648)
N Engl J Med. 2007 Jun 14;356(24):2457-71. (PMID: 17517853)
JAMA. 2003 May 21;289(19):2560-72. (PMID: 12748199)
Cardiovasc Diabetol. 2003 Jan 08;2:1. (PMID: 12556246)
Diabetes Care. 2011 May;34 Suppl 2:S101-6. (PMID: 21525438)
Eur J Biochem. 1993 Jun 15;214(3):829-35. (PMID: 8100523)
Ann Intern Med. 2009 Sep 15;151(6):394-403. (PMID: 19620144)
Diabetes Care. 2014 Aug;37(8):2168-76. (PMID: 24842985)
Int J Clin Pract. 2010 Feb;64(3):295-304. (PMID: 20456169)
N Engl J Med. 2015 Dec 3;373(23 ):2247-57. (PMID: 26630143)
Diabetes Metab. 2005 Jun;31(3 Pt 1):233-42. (PMID: 16142014)
Diabetes Care. 2009 Oct;32(10):1880-6. (PMID: 19592625)
J Diabetes Complications. 2014 Jul-Aug;28(4):430-3. (PMID: 24713467)

Keywords: Antihyperglycemic agents; Cardiovascular outcome studies; Cardiovascular risk factors; Diabetes management; Diabetes mellitus; Risk factors for cardiovascular disease

0 (Blood Glucose)
0 (Glucagon-Like Peptide-1 Receptor)
0 (Hypoglycemic Agents)
0 (Sodium-Glucose Transporter 2 Inhibitors)

Date Created: 20160820 Date Completed: 20170804 Latest Revision: 20191210

20240628

10.1007/s11892-016-0788-5

27541296