Renal safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus

Diabetes, Obesity and Metabolism

Volumn 19, Issue 6, 2017, Pages 897-900

  Desai, Mehul ^a   Yavin, Yshai ^a   Balis, Dainius ^a   Sun, Don ^a   Xie, John ^a   Canovatchel, William ^a   Rosenthal, Norm ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

SGLT2 inhibitor; type 2 diabetes

Indexed keywords

CANAGLIFLOZIN; CREATININE; 2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; EMPAGLIFLOZIN; GLIMEPIRIDE; GLUCOSIDE; SODIUM GLUCOSE COTRANSPORTER 2; SULFONYLUREA DERIVATIVE;

ACUTE KIDNEY FAILURE; ARTICLE; CREATININE BLOOD LEVEL; DRUG SAFETY; ESTIMATED GLOMERULAR FILTRATION RATE; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; POSTMARKETING SURVEILLANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME; ADULT; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; DRUG EFFECTS; EVALUATION STUDY; FEMALE; GLOMERULUS FILTRATION RATE; INCIDENCE; KIDNEY; KIDNEY DISEASE; MALE; TIME FACTOR;

ADULT; BENZHYDRYL COMPOUNDS; CANAGLIFLOZIN; DIABETES MELLITUS, TYPE 2; FEMALE; GLOMERULAR FILTRATION RATE; GLUCOSIDES; HUMANS; HYPOGLYCEMIC AGENTS; INCIDENCE; KIDNEY; KIDNEY DISEASES; MALE; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SODIUM-GLUCOSE TRANSPORTER 2; SULFONYLUREA COMPOUNDS; TIME FACTORS;

EID: 85015266193     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12876     Document Type: Article

References (17)

1. DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012;14(1):5-14.
2. Heerspink HJ, Perkins BA, Fitchett DH, Husain M, Cherney DZ. Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes: cardiovascular and kidney effects, potential mechanisms and clinical applications. Circulation. 2016;134(10):752-772.
3. Remuzzi G, Ruggenenti P, Perico N. Chronic renal diseases: renoprotective benefits of renin–angiotensin system inhibition. Ann Intern Med. 2002;136(8):604-615.
4. US Food and Drug Administration. Canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR): drug safety communication – strengthened kidney warnings. http://www.fda.gov/Safety/Medwatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm. Accessed November 16, 2016.
5. JARDIANCE® (empagliflozin) tablets, for oral use [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2015.
6. JANUVIA™ (sitagliptin) tablets [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2012.
7. BYETTA® (exenatide) injection [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.; 2010.
8. Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017;33(3):553-562.
9. Leiter LA, Yoon KH, Arias P, et al. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015;38(3):355-364.
10. Harpaz R, DuMouchel W, LePendu P, Bauer-Mehren A, Ryan P, Shah N. Performance of pharmacovigilance signal detection algorithms for the FDA adverse event reporting system. Clin Pharmacol Ther. 2013;93(6):539-546.
11. Deshpande G, Gogolak V, Weiss Smith S. Data mining in drug safety. Review of published threshold criteria for defining signals of disproportionate reporting. Pharm Med. 2010;24(1):37-42.
12. Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes: pooled analysis of phase 3 study results. Postgrad Med. 2014;126(3):16-34.
13. US Food and Drug Administration. FDA Briefing Document: Endocrine and Metabolic Drug Advisory Committee Meeting; June 28, 2016; Silver Spring, MD. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM508422.pdf. Accessed November 16, 2016.
14. Perkovic V, Jardine M, Vijapurkar U, Meininger G. Renal effects of canagliflozin in type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(12):2219-2231.
15. Bakris GL, Weir MR. Angiotensin-converting enzyme inhibitor-associated elevations in serum creatinine: is this a cause for concern? Arch Intern Med. 2000;160(5):685-693.
16. 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.
17. Heerspink HJ, Desai M, Jardine M, Balis D, Meininger G, Perkovic V. Canagliflozin slows progression of renal function decline independent of glycemic effects. J Am Soc Nephrol. 2017;28(1):368-375.