Effect of canagliflozin on renal and cardiovascular outcomes across different levels of albuminuria: Data from the CANVAS program

Journal of the American Society of Nephrology

Volumn 30, Issue 11, 2019, Pages 2229-2242

  Neuen, Brendon L ^a   Ohkuma, Toshiaki ^a   Neal, Bruce ^a   Matthews, David R ^b   De Zeeuw, Dick ^c   Mahaffey, Kenneth W ^d   Fulcher, Greg ^e   Li, Qiang ^a   Jardine, Meg ^a   Oh, Richard ^f   Heerspink, Hiddo L ^a,c   Perkovic, Vlado ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e ROYAL NORTH SHORE HOSPITAL   (Australia)

^f JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; CANAGLIFLOZIN; CREATININE; PLACEBO;

ACUTE KIDNEY FAILURE; ADULT; ALBUMIN BLOOD LEVEL; ALBUMINURIA; ARTICLE; CARDIOVASCULAR RISK; CONTROLLED STUDY; CREATININE URINE LEVEL; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFECT; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; FRACTURE; HUMAN; HYPERKALEMIA; KIDNEY FUNCTION; LEG AMPUTATION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; AGED; CARDIOVASCULAR SYSTEM; CLINICAL TRIAL; GLOMERULUS FILTRATION RATE;

AGED; ALBUMINURIA; CANAGLIFLOZIN; CARDIOVASCULAR SYSTEM; DIABETES MELLITUS, TYPE 2; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; MALE; MIDDLE AGED; SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS;

EID: 85073746348     PISSN: 10466673     EISSN: 15333450     Source Type: Journal    
DOI: 10.1681/ASN.2019010064     Document Type: Article

References (39)

1. Alicic RZ, Rooney MT, Tuttle KR: Diabetic kidney disease: Challenges, progress, and possibilities. Clin J AmSocNephrol 12: 2032-2045, 2017
2. Afkarian M, SachsMC, Kestenbaum B, Hirsch IB, Tuttle KR, Himmelfarb J, et al.: Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol 24: 302-308, 2013
3. vanderVeldeM, MatsushitaK, Coresh J, AstorBC, WoodwardM, LeveyA, et al.; Chronic Kidney Disease Prognosis Consortium: Lower estimated glomerular filtration rate and higher albuminuria are associated with allcause and cardiovascular mortality. A collaborative meta-analysis of highrisk population cohorts. Kidney Int 79: 1341-1352, 2011
4. Gansevoort RT, Matsushita K, van der VeldeM, Astor BC, WoodwardM, Levey AS, et al.; Chronic Kidney Disease Prognosis Consortium: Lower estimated GFR and higher albuminuria are associated with adverse kidney outcomes. A collaborative meta-analysis of general and highrisk population cohorts. Kidney Int 80: 93-104, 2011
5. Heerspink HJL, Kröpelin TF, Hoekman J, de Zeeuw D; Reducing Albuminuria as Surrogate Endpoint (REASSURE) Consortium: Drug-induced reduction in albuminuria is associated with subsequent renoprotection: A meta-analysis. J Am Soc Nephrol 26: 2055-2064, 2015
6. Heerspink HJL, Greene T, Tighiouart H, Gansevoort RT, Coresh J, Simon AL, et al.; Chronic Kidney Disease Epidemiology Collaboration: Change in albuminuria as a surrogate endpoint for progression of kidney disease: A meta-analysis of treatment effects in randomised clinical trials. Lancet Diabetes Endocrinol 7: 128-139, 2019
7. Heerspink HJ, Perkins BA, Fitchett DH, HusainM, Cherney DZ: Sodium glucose cotransporter 2 inhibitors in the treatment of diabetesmellitus: Cardiovascular and kidney effects, potential mechanisms, and clinical applications. Circulation 134: 752-772, 2016
8. Heerspink HJL, Kosiborod M, Inzucchi SE, Cherney DZI: Renoprotective effects of sodium-glucose cotransporter-2 inhibitors. Kidney Int 94: 26-39, 2018
9. Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, et al.; CANVAS Program Collaborative Group: Canagliflozin and cardiovascular and renal events in type 2 diabetes. NEngl J Med 377: 644-657, 2017
10. Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, et al.: Canagliflozin and renal outcomes in type 2 diabetes: Results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol 6: 691-704, 2018
11. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al.; EMPA-REG OUTCOME Investigators: Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 373: 2117-2128, 2015
12. Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, MattheusM, et al.; EMPA-REGOUTCOME Investigators: Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med 375: 323-334, 2016
13. Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, et al.; DECLARE-TIMI 58 Investigators: Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 380: 347-357, 2019
14. Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, et al.; CREDENCE Trial Investigators: Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 380: 2295-2306, 2019
15. Fine JP, Gray RJ: A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 94: 496-509, 1999
16. Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, et al.; EMPA-REG OUTCOME Investigators: Empagliflozin and clinical outcomes in patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease. Circulation 137: 119-129, 2018
17. Cherney DZI, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, von Eynatten M, et al.: Effects of empagliflozin on the urinary albuminto-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: An exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial. Lancet Diabetes Endocrinol 5: 610-621, 2017
18. Wanner C, Heerspink HJL, Zinman B, Inzucchi SE, Koitka-Weber A, MattheusM, et al.; EMPA-REGOUTCOMEInvestigators: Empagliflozin and kidney function decline in patients with type 2 diabetes: A slope analysis from the EMPA-REG outcome trial. J AmSocNephrol 29: 2755-2769, 2018
19. Muskiet MHA, Wheeler DC, Heerspink HJL: New pharmacological strategies for protecting kidney function in type 2 diabetes. Lancet Diabetes Endocrinol 7: 397-412, 2019
20. Rabelink TJ, de Zeeuw D: The glycocalyx-linking albuminuria with renal and cardiovascular disease. Nat Rev Nephrol 11: 667-676, 2015
21. Cravedi P, Remuzzi G: Pathophysiology of proteinuria and its value as an outcomemeasure in chronic kidney disease. Br J Clin Pharmacol 76: 516-523, 2013
22. Roscioni SS, Lambers Heerspink HJ, de Zeeuw D: Microalbuminuria: Target for renoprotective therapy PRO. Kidney Int 86: 40-49, 2014
23. Thomas MC, Cooper ME, Zimmet P: Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nat Rev Nephrol 12: 73-81, 2016
24. Afkarian M, Zelnick LR, Hall YN, Heagerty PJ, Tuttle K, Weiss NS, et al.: Clinical manifestations of kidney disease among US adults with diabetes, 1988-2014. JAMA 316: 602-610, 2016
25. Retnakaran R, Cull CA, Thorne KI, Adler AI, Holman RR; UKPDS Study Group: Risk factors for renal dysfunction in type 2 diabetes: U.K. Prospective diabetes study 74. Diabetes 55: 1832-1839, 2006
26. Ekinci EI, Jerums G, SkeneA, Crammer P, Power D, Cheong KY, et al.: Renal structure in normoalbuminuric and albuminuricpatientswith type 2diabetes and impaired renal function. Diabetes Care 36: 3620-3626, 2013
27. Chang YK, Choi H, Jeong JY, Na KR, Lee KW, Lim BJ, et al.: Dapagliflozin, SGLT2 inhibitor, attenuates renal ischemia-reperfusion injury [published correction appears in PLoS One 11: E0160478, 2016]. PLoS One 11: E0158810, 2016
28. Terami N, Ogawa D, Tachibana H, Hatanaka T, Wada J, Nakatsuka A, et al.: Long-term treatment with the sodium glucose cotransporter 2 inhibitor, dapagliflozin, ameliorates glucose homeostasis and diabetic nephropathy in db/db mice. PLoS One 9: E100777, 2014
29. Wang XX, Levi J, Luo Y, Myakala K, Herman-Edelstein M, Qiu L, et al.: SGLT2 protein expression is increased in human diabetic nephropathy: SGLT2 protein inhibition decreases renal lipid accumulation, inflammation, and the development of nephropathy in diabetic mice. J Biol Chem 292: 5335-5348, 2017
30. O'Neill J, Fasching A, Pihl L, Patinha D, Franzén S, Palm F: Acute SGLT inhibition normalizes O2 tension in the renal cortex but causes hypoxia in the renal medulla in anaesthetized control and diabetic rats. Am J Physiol Renal Physiol 309: F227-F234, 2015
31. Pugliese G, Solini A, Bonora E, Fondelli C, Orsi E, Nicolucci A, et al.; RIACE Study Group: Chronic kidney disease in type 2 diabetes: Lessons from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian multicentre study. Nutr Metab Cardiovasc Dis 24: 815-822, 2014
32. Yokoyama H, Sone H, Oishi M, Kawai K, Fukumoto Y, Kobayashi M; Japan Diabetes Clinical Data Management Study Group: Prevalence of albuminuria and renal insufficiency and associated clinical factors in type 2 diabetes: The Japan Diabetes Clinical Data Management study (JDDM15). Nephrol Dial Transplant 24: 1212-1219, 2009
33. Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, et al.: Cardiovascular and renal outcomes with canagliflozin according to baseline kidney function. Circulation 138: 1537-1550, 2018
34. Ninomiya T, Perkovic V, de Galan BE, Zoungas S, Pillai A, Jardine M, et al.; ADVANCE CollaborativeGroup: Albuminuria and kidney function independently predict cardiovascular and renal outcomes in diabetes. J Am Soc Nephrol 20: 1813-1821, 2009
35. Matsushita K, Coresh J, Sang Y, Chalmers J, Fox C, Guallar E, et al.; CKD Prognosis Consortium: Estimated glomerular filtration rate and albuminuria for prediction of cardiovascular outcomes: A collaborative meta-analysis of individual participant data. Lancet Diabetes Endocrinol 3: 514-525, 2015
36. Weir MR: Microalbuminuria and cardiovascular disease. Clin J Am Soc Nephrol 2: 581-590, 2007
37. Pecoits-Filho R, Perkovic V: Are SGLT2 inhibitors ready for prime time for CKD? Clin J Am Soc Nephrol 13: 318-320, 2018
38. HerringtonWG, Preiss D, Haynes R, von EynattenM, Staplin N, Hauske SJ, et al.: The potential for improving cardio-renal outcomes by sodiumglucose co-transporter-2 inhibition in people with chronic kidney disease: A rationale for the EMPA-KIDNEY study. Clin Kidney J 11: 749-761, 2018
39. Sanofi. Effect of sotagliflozin on cardiovascular and renal events in patients with type 2 diabetes and moderate renal impairment who are at cardiovascular risk, 2017. Available at: Https://clinicaltrials.gov/ct2/show/NCT03315143. Accessed September 2019