Optimizing the analysis strategy for the CANVAS Program: A prespecified plan for the integrated analyses of the CANVAS and CANVAS-R trials

Author:

Neal Bruce1234ORCID,Perkovic Vlado15,Mahaffey Kenneth W.6,Fulcher Greg5,Erondu Ngozi7,Desai Mehul7ORCID,Shaw Wayne7,Law Gordon7,Walton Marc K.7,Rosenthal Norm7,de Zeeuw Dick8,Matthews David R.9,

Affiliation:

1. The George Institute for Global Health; Sydney Australia

2. The Charles Perkins Centre; University of Sydney; Sydney Australia

3. Royal Prince Alfred Hospital; Sydney Australia

4. Imperial College London; London UK

5. Royal North Shore Hospital and University of Sydney; Sydney Australia

6. Department of Medicine, Stanford Center for Clinical Research (SCCR); Stanford University; Stanford California

7. Janssen Research & Development, LLC; Raritan New Jersey

8. University Medical Center Groningen; University of Groningen; Groningen The Netherlands

9. University of Oxford; Oxford UK

Funder

Janssen Research & Development, LLC

Janssen Global Services, LLC

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference18 articles.

1. Janssen Research & Development, LLC Canagliflozin as an adjunctive treatment to diet and exercise alone or co-administered with other antihyperglycemic agents to improve glycemic control in adults with type 2 diabetes mellitus 2013 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM334551.pdf

2. Rationale, design, and baseline characteristics of the CANagliflozin cardioVascular Assessment Study (CANVAS)-a randomized placebo-controlled trial;Neal;Am Heart J,2013

3. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): a randomized, placebo-controlled trial;Neal;Diabetes Obes Metab,2017

4. Janssen Research & Development Evaluation of the effects of canagliflozin on renal and cardiovascular outcomes in participants with diabetic nephropathy (CREDENCE) ClinicalTrials.gov 2014 https://clinicaltrials.gov/ct2/show/NCT02065791

5. Effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular events, death, and major safety outcomes in adults with type 2 diabetes: a systematic review and meta-analysis;Wu;Lancet Diabetes Endocrinol,2016

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