American association of clinical endocrinologists and American college of endocrinology position statement on the association of SGLT-2 inhibitors and diabetic ketoacidosis

Endocrine Practice

Volumn 22, Issue 6, 2016, Pages 753-762

  Handelsman, Yehuda ^a   Henry, Robert R ^b   Bloomgarden, Zachary T ^c   Dagogo Jack, Sam ^d   DeFronzo, Ralph A ^e   Einhorn, Daniel ^f   Ferrannini, Ele ^g   Fonseca, Vivian A ^h   Garber, Alan J ⁱ   Grunberger, George ^j,k,l,m   LeRoith, Derek ^c   Umpierrez, Guillermo E ⁿ   Weir, Matthew R ^o  

^a Metabolic Institute of America American College of Endocrinology   (United States)

^b UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^c MOUNT SINAI SCHOOL OF MEDICINE   (United States)

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

^e UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^f Whittier Institute for Diabetes   (United States)

^g INSTITUTE OF CLINICAL PHYSIOLOGY   (Italy)

^h TULANE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

ⁱ BAYLOR COLLEGE OF MEDICINE   (United States)

^j Grunberger Diabetes Institute   (United States)

^k WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^l OAKLAND UNIVERSITY WILLIAM BEAUMONT SCHOOL OF MEDICINE   (United States)

^m CHARLES UNIVERSITY   (Czech Republic)

ⁿ EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CANAGLIFLOZIN; DAPAGLIFLOZIN; EMPAGLIFLOZIN; GLUCAGON; GLUCOSE; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR;

CLINICAL TRIAL (TOPIC); DIABETIC KETOACIDOSIS; GLUCONEOGENESIS; HUMAN; HYPERGLYCEMIA; HYPOVOLEMIA; INSULIN DEFICIENCY; INSULIN RESISTANCE; LIPOLYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK FACTOR;

EID: 85007514629     PISSN: 1530891X     EISSN: 19342403     Source Type: Journal    
DOI: 10.4158/EP161292.PS     Document Type: Review

References (51)

1. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Bethesda, MD: U.S. Food and Drug Administration; 2015. Available at: http://www.fda.gov/Drugs/DrugSafety/ ucm446845.htm. Accessed April 7, 2016.
2. Centers for Disease Control and Prevention. NCHS National Hospital Discharge Survey. Atlanta, GA: Centers for Disease Control and Prevention; 2010. Available at: http:// www.cdc.gov/nchs/nhds/nhds-tables.htm-first. Accessed April 7, 2016.
3. Erondu N, Desai M, Ways K, Meininger G. Diabetic ketoacidosis and related events in the Canagliflozin Type 2 Diabetes Clinical Program. Diabetes Care. 2015;38:1680-1686.
4. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117-2128.
5. Henry RR, Thakkar P, Tong C, Polidori D, Alba M. Efficacy and safety of canagliflozin, a sodium glucose cotransporter 2 inhibitor, as add-on to insulin in patients with type 1 diabetes. Diabetes Care. 2015;38:2258-2265.
6. Henry RR, 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. 2015;38:412-419.
7. Burge MR, Garcia N, Qualls CR, Schade DS. Differential effects of fasting and dehydration in the pathogenesis of diabetic ketoacidosis. Metabolism. 2001;50:171-177.
8. Kitabchi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglycemic crises in adult patients with diabetes. Diabetes Care. 2009;32:1335-1343.
9. Munro JF, Campbell IW, McCuish AC, Duncan LJ. Euglycaemic diabetic ketoacidosis. Br Med J. 1973;2:578-580.
10. Tahrani AA, Barnett AH, Bailey CJ. SGLT inhibitors in management of diabetes. Lancet Diabetes Endocrinol. 2013;1:140-151.
11. Peters AL, Buschur EO, Buse JB, Cohan P, Diner JC, Hirsch IB. Euglycemic diabetic ketoacidosis: a potential complication of treatment with sodium-glucose cotransporter 2 inhibition. Diabetes Care. 2015;38:1687-1693.
12. Centers for Disease Control and Prevention. Diabetes Public Health Resource: crude and age-adjusted hospital discharge rates for diabetic ketoacidosis (DKA) as first-listed diagnosis per 1,000 diabetic population, United States, 1988-2009. Atlanta, GA: Centers for Disease Control and Prevention; 2016. Available at: http://www.cdc.gov/diabetes/ statistics/dkafirst/fig3.htm. Accessed April 7, 2016.
13. Wang ZH, Kihl-Selstam E, Eriksson JW. Ketoacidosis occurs in both type 1 and type 2 diabetes - a populationbased study from Northern Sweden. Diabet Med. 2008;25: 867-870.
14. Julicher S. Notification to the PRAC/EMA Secretariat of a referral under article 20 of regulation (EC) 726/2004. London, UK: European Medicines Agency; 2015. Available at: http://www.ema.europa.eu/docs/en-GB/document- library/Referrals-document/SGLT2-inhibitors-20/ Procedure-started/WC500187925.pdf. Accessed April 7, 2016.
15. Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015;38:971-978.
16. Karges B, Rosenbauer J, Holterhus PM, et al. Hospital admission for diabetic ketoacidosis or severe hypoglycemia in 31,330 young patients with type 1 diabetes. Eur J Endocrinol. 2015;173:341-350.
17. Hine J, Paterson H, Abrol E, Russell-Jones D, Herring R. SGLT inhibition and euglycaemic diabetic ketoacidosis. Lancet Diabetes Endocrinol. 2015;3:503-504.
18. Storgaard H, Bagger JI, Knop FK, Vilsbøll T, Rungby J. Diabetic ketoacidosis in a patient with type 2 diabetes after initiation of sodium-glucose cotransporter 2 inhibitor treatment. Basic Clin Pharmacol Toxicol. 2016;118:168-170.
19. Hayami T, Kato Y, Kamiya H, et al. Case of ketoacidosis by a sodium-glucose cotransporter 2 inhibitor in a diabetic patient with a low-carbohydrate diet. J Diabetes Investig. 2015;6:587-590.
20. Ogawa W, Sakaguchi K. Euglycemic diabetic ketoacidosis induced by SGLT2 inhibitors: possible mechanism and contributing factors. J Diabetes Invest. 2016;7:135-138.
21. Cartwright MM, Hajja W, Al-Khatib S, et al. Toxigenic and metabolic causes of ketosis and ketoacidotic syndromes. Crit Care Clin. 2012;28:601-631.
22. Rosenstock J, Ferrannini E. Euglycemic diabetic ketoacidosis: a predictable, detectable, and preventable safety concern with SGLT2 inhibitors. Diabetes Care. 2015;38: 1638-1642.
23. Snorgaard O, Eskildsen PC, Vadstrup S, Nerup J. Diabetic ketoacidosis in Denmark: epidemiology, incidence rates, precipitating factors and mortality rates. J Intern Med. 1989;226:223-228.
24. Bravata DM, Sanders L, Huang J, et al. Efficacy and safety of low-carbohydrate diets: a systematic review. JAMA. 2003;289:1837-1850.
25. Shah P, Isley WL. Ketoacidosis during a low-carbohydrate diet. N Engl J Med. 2006;354:97-98.
26. Freeman TF, Willis B, Krywko DM. Acute intractable vomiting and severe ketoacidosis secondary to the Dukan Diet©. J Emerg Med. 2014;47:e109-e112.
27. Keller U, Gerber PP, Stauffacher W. Stimulatory effect of norepinephrine on ketogenesis in normal and insulindeficient humans. Am J Physiol. 1984;247:E732-E739.
28. Weiss M, Keller U, Stauffacher W. Effect of epinephrine and somatostatin-induced insulin deficiency on ketone body kinetics and lipolysis in man. Diabetes. 1984;33:738-744.
29. Cersosimo E, Danou F, Persson M, Miles JM. Effects of pulsatile delivery of basal growth hormone on lipolysis in humans. Am J Physiol. 1996;271:E123-E126.
30. Divertie GD, Jensen MD, Miles JM. Stimulation of lipolysis in humans by physiological hypercortisolemia. Diabetes. 1991;40:1228-1232.
31. Rui L. Energy metabolism in the liver. Compr Physiol. 2014;4:177-197.
32. Cherrington AD. Banting Lecture 1997. Control of glucose uptake and release by the liver in vivo. Diabetes. 1999;48:1198-1214.
33. Wright EM, Hirayama BA, Loo DF. Active sugar transport in health and disease. J Intern Med. 2007;261:32-43.
34. Sapir DG, Owen OE. Renal conservation of ketone bodies during starvation. Metabolism. 1975;24:23-33.
35. Barac-Nieto M. Renal reabsorption and utilization of hydroxybutyrate and acetoacetate in starved rats. Am J Physiol. 1986;251:F257-F265.
36. Kaku K, Watada H, Iwamoto Y, et al. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study. Cardiovasc Diabetol. 2014;13:65.
37. Devenny JJ, Godonis HE, Harvey SJ, Rooney S, Cullen MJ, Pelleymounter MA. Weight loss induced by chronic dapagliflozin treatment is attenuated by compensatory hyperphagia in diet-induced obese (DIO) rats. Obesity (Silver Spring). 2012;20:1645-1652.
38. Yokono M, Takasu T, Hayashizaki Y, et al. SGLT2 selective inhibitor ipragliflozin reduces body fat mass by increasing fatty acid oxidation in high-fat diet-induced obese rats. Eur J Pharmacol. 2014;727:66-74.
39. Cohen JJ, Berglund F, Lotspeich WD. Renal tubular reabsorption of acetoacetate, inorganic sulfate and inorganic phosphate in the dog as affected by glucose and phlorizin. Am J Physiol. 1956;184:91-96.
40. Cahill GF, Jr. Fuel metabolism in starvation. Annu Rev Nutr. 2006;26:1-22.
41. Brandt KR, Miles JM. Relationship between severity of hyperglycemia and metabolic acidosis in diabetic ketoacidosis. Mayo Clin Proc. 1988;63:1071-1074.
42. Sheikh-Ali M, Karon BS, Basu A, et al. Can serum betahydroxybutyrate be used to diagnose diabetic ketoacidosis? Diabetes Care. 2008;31:643-647.
43. Tamez HE, Tamez AL, Garza LA, Hernandez MI, Polanco AC. Dapagliflozin as an adjunct therapy to insulin in the treatment of patients with type 1 diabetes mellitus. J Diabetes Metab Disord. 2015;14:78.
44. Perkins BA, Cherney DZ, Partridge H, et al. Sodiumglucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-ofconcept trial. Diabetes Care. 2014;37:1480-1483.
45. Pieber TR, Famulla S, Eilbracht J, et al. Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes Obes Metab. 2015;17:928-935.
46. Sands AT, Zambrowicz BP, Rosenstock J, et al. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. Diabetes Care. 2015;38:1181-1188.
47. Handelsman Y, Bloomgarden ZT, 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. 2015;21(suppl 1):1-87.
48. Jardiance (empagliflozin) prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc; 2015.
49. Farxiga (dapagliflozin) prescribing information. Princeton, NJ: Bristol-Myers Squibb Company; 2015.
50. Invokana (canagliflozin) prescribing information. Titusville, NJ: Janssen Pharmaceuticals Inc; 2015.
51. Benstetter M. SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis. Healthcare professionals should be aware of possible atypical cases. London, U.K.: European Medicines Agency; 2016. Available at: http://www.ema.europa.eu/ema/ index.jsp?curl=pages/news-and-events/news/2016/02/ news-detail-002470.jsp&mid=WC0b01ac058004d5c1. Accessed April 7, 2016.