Effects of the sodium-glucose co-transporter 2 inhibitor dapagliflozin in patients with type 2 diabetes and Stages 3b-4 chronic kidney disease
| Autor: | Claire C J Dekkers, David C. Wheeler, C. David Sjöström, Hiddo J.L. Heerspink, Valerie A. Cain, Bergur V. Stefánsson |
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| Přispěvatelé: | Groningen Kidney Center (GKC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Blood Pressure Type 2 diabetes 030204 cardiovascular system & hematology PLACEBO-CONTROLLED TRIAL SGLT2 INHIBITORS chemistry.chemical_compound DOUBLE-BLIND MELLITUS 0302 clinical medicine Glucosides Medicine Dapagliflozin 28-WEEK EXTENSION Randomized Controlled Trials as Topic INADEQUATE GLYCEMIC CONTROL education.field_of_study SGLT2 inhibitor Middle Aged Nephrology CARDIOVASCULAR-DISEASE Creatinine Female type 2 diabetes Erratum Glomerular Filtration Rate Adult medicine.medical_specialty kidney LONG-TERM METFORMIN Population Urology Renal function 030209 endocrinology & metabolism 03 medical and health sciences Clinical Research Diabetes mellitus Albuminuria Humans Hypoglycemic Agents Benzhydryl Compounds Renal Insufficiency Chronic education Sodium-Glucose Transporter 2 Inhibitors 24-WEEK Aged Glycated Hemoglobin Transplantation business.industry diabetic nephropathy Body Weight dapagliflozin medicine.disease Editor's Choice Diabetes Mellitus Type 2 chemistry ORIGINAL ARTICLES business Kidney disease |
| Zdroj: | Nephrology Dialysis Transplantation, 33(11), 2005-2011. Oxford University Press Nephrology Dialysis Transplantation |
| ISSN: | 0931-0509 |
| Popis: | Background. The sodium-glucose co-transporter 2 inhibitor dapagliflozin decreases haemoglobin A1c (HbA1c), body weight, blood pressure (BP) and urinary albumin: creatinine ratio (UACR) in patients with type 2 diabetes. The efficacy and safety of this drug have not been properly defined in patients with type 2 diabetes and Stages 3b-4 chronic kidney disease (CKD).|Methods. In a pooled analysis of 11 phase 3 randomized controlled clinical trials, we determined least square mean changes in HbA1c, body weight, BP, estimated glomerular filtration rate (eGFR) and UACR over 102 weeks in patients with type 2 diabetes and an eGFR between 12 to less than 45mL/min/1.73 m(2) receiving placebo (n = 69) or dapagliflozin 5 or 10mg (n = 151). Effects on UACR were determined in a subgroup of patients with baseline UACR >= 30mg/g (n = 136).Results. Placebo-corrected changes in HbA1c with dapagliflozin 5 and 10mg were 0.03% [95% confidence interval (CI) -0.3-0.3] and 0.03% (95% CI -0.2-0.3) during the overall 102-week period. Dapagliflozin 5 and 10mg compared with placebo reduced UACR by -47.1% (95% CI -64.8 to -20.6) and -38.4% (95% CI -57.6 to -10.3), respectively. Additionally, dapagliflozin 5 and 10mg compared with placebo reduced BP and body weight. eGFR increased with placebo during the first 4weeks but did not change with dapagliflozin. There were no between-group differences in eGFR at the end of follow-up. Adverse events associated with renal function occurred more frequently in the dapagliflozin 10-mg group. These events were mainly asymptomatic increases in serumcreatinine.Conclusions. Dapagliflozin did not decrease HbA1c in patients with type 2 diabetes and Stages 3b-4 CKD, but decreased UACR, BP and body weight to a clinically meaningful extent. These results support a large outcome trial in this population to confirm longterm safety and efficacy in reducing adverse clinical endpoints. |
| Databáze: | OpenAIRE |
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