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Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): a randomized, placebo-controlled trial

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Title: Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): a randomized, placebo-controlled trial
Authors: Neal, B
Perkovic, V
Matthews, DR
Mahaffey, KW
Fulcher, G
Meininger, G
Erondu, N
Desai, M
Shaw, W
Vercruysse, F
Yee, J
Deng, H
De Zeeuw, D
CANVAS-R Trial Collaborative Group
Item Type: Journal Article
Abstract: AIMS: The primary aim of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) is to determine whether the favourable effects of inhibition of the sodium glucose co-transporter 2 (SGLT2) on blood glucose, blood pressure and body weight are accompanied by protection against adverse renal outcomes. MATERIALS AND METHODS: CANVAS-R is a prospective, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes with a history or high risk of cardiovascular events. Patients were randomly assigned to once-daily placebo or canagliflozin 100 mg (with optional uptitration to 300 mg) for a planned average of 2.5 years of follow-up. The primary outcome is kidney disease progression, defined by class change in albuminuria. The two secondary outcomes are the composite of hospitalized heart failure or cardiovascular death, and cardiovascular death alone. Effects on end-stage renal disease and a range of other outcomes will also be explored. RESULTS: A total of 5812 participants were recruited at 422 sites in 24 countries between January 2014 and May 2015. The mean baseline age was 64 years, mean duration of diabetes was 14 years, mean glycated haemoglobin level was 8.3% and mean body mass index was 32 kg/m(2) . Of these participants, 37% were women, 71% had a history of cardiovascular disease, 22.3% had microalbuminuria and 8.7% had macroalbuminuria. The mean baseline estimated glomerular filtration rate was 76 mL/min/1.73 m(2) . The study will have at least 90% power ( P = .05) to detect a 22% or greater reduction in the risk of progression of albuminuria. CONCLUSIONS: The trial should define the potential renoprotective effect of canagliflozin and will provide additional important new data about its effects on vascular outcomes, death and kidney failure.
Issue Date: 25-Jan-2017
Date of Acceptance: 15-Nov-2016
URI: http://hdl.handle.net/10044/1/44987
DOI: https://dx.doi.org/10.1111/dom.12829
ISSN: 1463-1326
Publisher: Wiley
Start Page: 387
End Page: 393
Journal / Book Title: Diabetes Obesity & Metabolism
Volume: 19
Issue: 3
Copyright Statement: © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Keywords: Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
cardiovascular disease
SGLT2 inhibitor
type 2 diabetes
DIABETIC-NEPHROPATHY
KIDNEY-DISEASE
TYPE-2
OUTCOMES
MICROALBUMINURIA
METAANALYSIS
PROGRESSION
PREVENTION
IRBESARTAN
INHIBITORS
1103 Clinical Sciences
Publication Status: Published
Conference Place: England
Appears in Collections:Faculty of Medicine
Epidemiology, Public Health and Primary Care



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