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Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial

The American heart journal, 2013-08, Vol.166 (2), p.217-223.e11 [Peer Reviewed Journal]

Mosby, Inc. ;2013 Mosby, Inc. ;Copyright © 2013 Mosby, Inc. All rights reserved. ;Copyright Elsevier Limited Aug 2013 ;ISSN: 0002-8703 ;EISSN: 1097-6744 ;DOI: 10.1016/j.ahj.2013.05.007 ;PMID: 23895803 ;CODEN: AHJOA2

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Title:
Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial
Author: Neal, Bruce, PhD ; Perkovic, Vlado, PhD ; de Zeeuw, Dick, PhD ; Mahaffey, Kenneth W., MD ; Fulcher, Greg, MD ; Stein, Peter, MD ; Desai, Mehul, MD ; Shaw, Wayne, DSL ; Jiang, Joel, PhD ; Vercruysse, Frank, MD ; Meininger, Gary, MD ; Matthews, David, DPhil
Subjects: Aged ; Biomarkers - blood ; Body mass index ; Canagliflozin ; Cardiovascular ; Cardiovascular disease ; Cardiovascular Diseases - mortality ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Double-Blind Method ; Drug therapy ; Electrocardiography ; Female ; Glucose ; Glucosides - adverse effects ; Glucosides - therapeutic use ; Heart failure ; Humans ; Hypertension ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Male ; Middle Aged ; Plasma ; Regulatory approval ; Research Design ; Sodium-Glucose Transporter 2 - antagonists & inhibitors ; Statins ; Thiophenes - adverse effects ; Thiophenes - therapeutic use ; Triglycerides
Is Part Of: The American heart journal, 2013-08, Vol.166 (2), p.217-223.e11
Description: Sodium glucose co-transporter 2 inhibition is a novel mode of treatment for type 2 diabetes mellitus (T2DM). The sodium glucose co-transporter 2 inhibitor canagliflozin lowered blood glucose, blood pressure, and body weight, with increased risk of urogenital infections in Phase 2 studies. Effects on macrovascular complications of diabetes remain to be determined. CANVAS is a double-blind, placebo-controlled trial designed to evaluate the effects of canagliflozin on the risk of cardiovascular disease and to assess safety and tolerability in patients with inadequately controlled T2DM and increased cardiovascular risk. The first of 2 planned phases randomized 4,330 individuals to placebo, canagliflozin 100 or 300 mg (1:1:1) with planned follow-up of about 2 years to substantiate potential cardiovascular protection by assessing key biomarkers and to achieve initial safety objectives. By the end of mid-September 2012, a total of 7174 patient-years of follow-up were accrued. Mean baseline age was 62 years, duration of diabetes 13 years; hemoglobin A1c 8.2%, fasting plasma glucose 9.3 mmol/L, and body mass index 32 kg/m2 . Of the participants, 34% are female and 57% had a history of atherosclerotic vascular disease. Participants will be followed up to achieve primary safety and tolerability objectives and to investigate secondary outcomes. The planned second phase will not be undertaken. CANVAS will define the effects of canagliflozin on biomarkers and provide data on cardiovascular safety against established regulatory parameters.
Publisher: United States: Mosby, Inc
Language: English
Identifier: ISSN: 0002-8703
EISSN: 1097-6744
DOI: 10.1016/j.ahj.2013.05.007
PMID: 23895803
CODEN: AHJOA2
Source: MEDLINE
ProQuest Central

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Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial

Mosby, Inc. ;2013 Mosby, Inc. ;Copyright © 2013 Mosby, Inc. All rights reserved. ;Copyright Elsevier Limited Aug 2013 ;ISSN: 0002-8703 ;EISSN: 1097-6744 ;DOI: 10.1016/j.ahj.2013.05.007 ;PMID: 23895803 ;CODEN: AHJOA2

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