Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy
Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients...
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Dokumentumtípus: | Cikk |
Megjelent: |
2019
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Sorozat: | NEW ENGLAND JOURNAL OF MEDICINE
380 No. 24 |
Tárgyszavak: | |
doi: | 10.1056/NEJMoa1811744 |
mtmt: | 33677430 |
Online Access: | http://publicatio.bibl.u-szeged.hu/26664 |
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490 | 0 | |a NEW ENGLAND JOURNAL OF MEDICINE |v 380 No. 24 | |
520 | 3 | |a Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin-angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically.The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P = 0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P = 0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P = 0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture.In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years. (Funded by Janssen Research and Development; CREDENCE ClinicalTrials.gov number, NCT02065791.). | |
650 | 4 | |a Klinikai orvostan | |
700 | 0 | 1 | |a Jardine Meg J |e aut |
700 | 0 | 1 | |a Neal Bruce |e aut |
700 | 0 | 1 | |a Bompoint Severine |e aut |
700 | 0 | 1 | |a Heerspink Hiddo J L |e aut |
700 | 0 | 1 | |a Charytan David M. |e aut |
700 | 0 | 1 | |a Edwards Robert |e aut |
700 | 0 | 1 | |a Agarwal Rajiv |e aut |
700 | 0 | 1 | |a Bakris George |e aut |
700 | 0 | 1 | |a Bull Scott |e aut |
700 | 0 | 1 | |a Cannon Christopher P. |e aut |
700 | 0 | 1 | |a Capuano George |e aut |
700 | 0 | 2 | |a Kollaborációs szervezet: CREDENCE Trial Investigators |e aut |
700 | 0 | 2 | |a Takács Róbert |e aut |
700 | 0 | 2 | |a et al. |e aut |
856 | 4 | 0 | |u http://publicatio.bibl.u-szeged.hu/26664/1/Petrovic.pdf |z Dokumentum-elérés |