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Efficacy and safety...
Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A) : The DERIVE Study
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- Fioretto, Paola (författare)
- Department of Medicine, University of Padova, Padova, Italy
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- Del Prato, Stefano (författare)
- Department of Clinical & Experimental Medicine, University of Pisa, Pisa, Italy
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- Buse, John B. (författare)
- Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
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- Goldenberg, Ronald (författare)
- LMC Diabetes & Endocrinology, Thornhill, Canada
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- Giorgino, Francesco (författare)
- Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy
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- Reyner, Daniel (författare)
- AstraZeneca, Gaithersburg, Maryland, USA
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- Langkilde, Anna Maria (författare)
- AstraZeneca, Gothenburg, Sweden
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- Sjöstrom, C. David (författare)
- AstraZeneca, Gothenburg, Sweden
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- Sartipy, Peter (författare)
- Högskolan i Skövde,Institutionen för biovetenskap,Forskningscentrum för Systembiologi,AstraZeneca, Gothenburg, Sweden,Bioinformatik, Bioinformatics
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(creator_code:org_t)
- 2018-07-10
- 2018
- Engelska.
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Ingår i: Diabetes, obesity and metabolism. - : Wiley-Blackwell Publishing Inc.. - 1462-8902 .- 1463-1326. ; 20:11, s. 2532-2540
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Abstract
Ämnesord
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- Aims: Dapagliflozin is a selective inhibitor of sodium glucose co-transporter 2 (SGLT2). This study assessed the efficacy and safety of dapagliflozin 10 mg vs placebo in patients with type 2 diabetes (T2D) and moderate renal impairment (estimated glomerular filtration rate [eGFR], 45-59 mL/min/1.73 m(2); chronic kidney disease [CKD] stage 3A). Materials and methods: In this double-blind, parallel group, Phase 3 study (NCT02413398, ) patients with inadequately controlled T2D (HbA1c 7.0%-11.0%) were randomized (1:1) to dapagliflozin 10 mg once daily (N = 160) or matching placebo (N = 161) for 24 weeks. Randomization was stratified by pre-enrolment glucose-lowering therapy. The primary endpoint was change from baseline in HbA1c at Week 24. Results: At Week 24, compared with placebo, dapagliflozin significantly decreased HbA1c (difference [95% CI], -0.34% [-0.53, -0.15]; P < 0.001), body weight (difference [95% CI], -1.25 kg [-1.90, -0.59]; P < 0.001), fasting plasma glucose (difference [95% CI], -0.9 mmol/L [-1.5, -0.4]; P = 0.001) and systolic blood pressure (difference [95% CI], -3.1 mmHg [-6.3, 0.0]; P < 0.05). Decreases from baseline in eGFR were greater with dapagliflozin than placebo at Week 24 (-2.49 mL/min/1.73 m(2) [-4.96, -0.02]), however, eGFR returned to baseline levels at Week 27 (3 weeks post-treatment) (0.61 mL/min/1.73 m(2) [-1.59, 2.81]). No increase in adverse events (AEs; 41.9% vs 47.8%) or serious AEs (5.6% vs 8.7%) were reported with dapagliflozin versus placebo. No AEs of bone fractures, amputations or DKA were reported. Conclusions: The findings of this study (NCT02413398, ) support the positive benefit/risk profile of dapagliflozin for the treatment of patients with T2D and CKD 3A.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Bioinformatik
- Bioinformatics
- INF502 Biomarkers
- INF502 Biomarkörer
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Fioretto, Paola
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Del Prato, Stefa ...
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Buse, John B.
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Goldenberg, Rona ...
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Giorgino, France ...
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Reyner, Daniel
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Langkilde, Anna ...
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Sjöstrom, C. Dav ...
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Sartipy, Peter
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