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Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease

Yale, J.-F. ; Bakris, G. ; Cariou, B. ; Nieto, J. ; David-Neto, E. ; Yue, D. ; Wajs, E. ; Figueroa, K. ; Jiang, J. ; Law, G. ; Usiskin, K. ; Meininger, G.

Diabetes, obesity & metabolism, 2014-10, Vol.16 (10), p.1016-1027

Oxford, UK: Blackwell Publishing Ltd

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Título:
Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease
Autor: Yale, J.-F. ; Bakris, G. ; Cariou, B. ; Nieto, J. ; David-Neto, E. ; Yue, D. ; Wajs, E. ; Figueroa, K. ; Jiang, J. ; Law, G. ; Usiskin, K. ; Meininger, G.
Assuntos: Aged ; Blood Glucose - drug effects ; Blood Pressure - drug effects ; Body Weight - drug effects ; Canagliflozin ; Confidence intervals ; Diabetes ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - physiopathology ; Diabetic Nephropathies - blood ; Diabetic Nephropathies - drug therapy ; Diabetic Nephropathies - physiopathology ; diabetic nephropathy ; Disease Progression ; Double-Blind Method ; Drug Administration Schedule ; Female ; Glomerular Filtration Rate - drug effects ; Glucosides - therapeutic use ; Humans ; Hypoglycemic Agents - therapeutic use ; Kidney diseases ; Male ; Medical treatment ; randomized trial ; Renal Insufficiency, Chronic - blood ; Renal Insufficiency, Chronic - drug therapy ; Renal Insufficiency, Chronic - physiopathology ; sodium glucose co-transporter 2 (SGLT2) inhibitor ; Sodium-Glucose Transporter 2 - antagonists & inhibitors ; Sodium-Glucose Transporter 2 - drug effects ; Thiophenes - therapeutic use ; Treatment Outcome ; type 2 diabetes mellitus
É parte de: Diabetes, obesity & metabolism, 2014-10, Vol.16 (10), p.1016-1027
Notas: Bristol-Myers Squibb
Eli Lilly
Medtronic
Takeda
Johnson & Johnson
Pfizer
Reata
Appendix S1. DIA3004 Study Group investigators.Table S1. Summary of overall safety and selected AEs during the extension period (weeks 26-52)*.
NovoNordisk
Merck
Novartis
Abbott
ArticleID:DOM12348
Janssen Global Services, LLC
AstraZeneca
istex:48B39286813660A8584C9E66E399192A71DD6CE2
ark:/67375/WNG-4KCXBX6J-K
Sanofi
The DIA3004 Study Group investigators are identified in Appendix S1.
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Descrição: Aim This study evaluated the efficacy and safety of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) and within a subset of Stage 3 chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] ≥30 and <50 ml/min/1.73 m2). Methods In this 52‐week, randomized, double‐blind, placebo‐controlled study, patients (N = 269; mean eGFR, 39.4 ml/min/1.73 m2) received canagliflozin 100 or 300 mg and placebo once daily. Efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and systolic blood pressure (BP); adverse events (AEs) were also recorded. Results At week 52, canagliflozin 100 and 300 mg reduced HbA1c compared with placebo (−0.19, −0.33 and 0.07%, respectively); placebo‐subtracted differences (95% confidence interval) were −0.27% (−0.53, 0.001) and −0.41% (−0.68, −0.14). Canagliflozin also lowered FPG, body weight and BP versus placebo. Overall AE incidence was 85.6, 80.9, and 86.7% with canagliflozin 100 and 300 mg and placebo, respectively. Osmotic diuresis–related AEs were more common with both canagliflozin doses, and incidences of urinary tract infections and volume depletion–related AEs were higher with canagliflozin 300 mg versus placebo. Decreases in eGFR (−2.1, −4.0 and −1.6 ml/min/1.73 m2) were seen with canagliflozin 100 and 300 mg compared with placebo. Canagliflozin 100 and 300 mg provided median percent reductions in urine albumin to creatinine ratio versus placebo (−16.4, −28.0 and 19.7%). Conclusions Canagliflozin improved glycaemic control and was generally well tolerated in patients with T2DM and within a subset of Stage 3 CKD over 52 weeks.
Editor: Oxford, UK: Blackwell Publishing Ltd
Idioma: Inglês

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Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease

Yale, J.-F. ; Bakris, G. ; Cariou, B. ; Nieto, J. ; David-Neto, E. ; Yue, D. ; Wajs, E. ; Figueroa, K. ; Jiang, J. ; Law, G. ; Usiskin, K. ; Meininger, G.

Oxford, UK: Blackwell Publishing Ltd

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