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

Bruce Neal, Vlado Perkovic, Kenneth W. Mahaffey, Greg Fulcher, Ngozi Erondu · Diabetes, obesity and metabolism · 2017

Summary

Two large cardiovascular outcome trials of canagliflozin, comprising the CANVAS Program, will complete in early 2017, and accrued data for the sodium glucose co‐transporter 2 (SGLT2) inhibitors has identified questions and opportunities that were not apparent when the trials were designed.

Type: article
Published: 2017-04-03
Cited by: 105
References: 18
Access: Open access
DOI: https://doi.org/10.1111/dom.12924
PubMed: https://pubmed.ncbi.nlm.nih.gov/28244644/
PMC: https://www.ncbi.nlm.nih.gov/pmc/articles/5485085/
OpenAlex: https://openalex.org/W2594590765
Semantic Scholar: https://api.semanticscholar.org/CorpusID:19143364

Keywords

Plan (archaeology), Computer science, Biology

References

Medical Coding in Clinical TrialsDeven Babre — 2010
Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled TrialGreg Fulcher, David R. Matthews, Vlado Perkovic — 2015
Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial.Bruce Neal, Vlado Perkovic, Dick de Zeeuw — 2013
Diabetic Ketoacidosis and Related Events in the Canagliflozin Type 2 Diabetes Clinical ProgramNgozi Erondu, Mehul Desai, Kirk Ways — 2015
Efficacy and Safety of Canagliflozin, an Inhibitor of Sodium–Glucose Cotransporter 2, When Used in Conjunction With Insulin Therapy in Patients With Type 2 DiabetesBruce Neal, Vlado Perkovic, Dick de Zeeuw — 2014
Rosiglitazone: what went wrong?Deborah Cohen — 2010
Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.Pantelis A Sarafidis, Apostolos Tsapas — 2016
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.Jason Wu, Celine Foote, Juuso Blomster — 2016
Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.Christoph Wanner, Silvio E. Inzucchi, John M. Lachin — 2016
Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study–Renal (CANVAS‐R): A randomized, placebo‐controlled trialBruce Neal, Vlado Perkovic, David R. Matthews — 2017

Cited by

Revisiting the Diabetes-Heart Failure ConnectionAlfonso García Santos — 2018
Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled dataMichael J. Davies, Katherine Merton, Ujjwala Vijapurkar — 2017
The use of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes and hypertension: a focus on African-American populationsDavid S. Kountz — 2017
Use of Canagliflozin in Combination With and Compared to Incretin-Based Therapies in Type 2 DiabetesRichard E. Pratley, Eugênio Cersósimo — 2017
Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering DrugsMikhail Kosiborod, Matthew A. Cavender, Alex Z. Fu — 2017
Effects of canagliflozin on cardiovascular risk factors in patients with type 2 diabetes mellitusMatthew J. Budoff, John Wilding — 2017
Pharmacologic Management of Type 2 Diabetes Mellitus: Available Therapies.James Thrasher — 2017
Pharmacologic Management of Type 2 Diabetes Mellitus: Available Therapies.James Thrasher — 2017
Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes.James L. Januzzi, Javed Butler, Petr Jarolı́m — 2017
Canagliflozin and Cardiovascular and Renal Events in Type 2 DiabetesBruce Neal, Vlado Perkovic, Kenneth W. Mahaffey — 2017
HbA1c Outcomes in Patients Treated With Canagliflozin Versus Sitagliptin in US Health Plans.Sarah Thayer, Richard Aguilar, Stephanie Korrer — 2017
Updates on cardiovascular outcome trials in diabeteson behalf of the D&CVD EASD Study Group, Oliver Schnell, Lars Rydén — 2017
Protection cardio-rénale par les inhibiteurs des SGLT2 (gliflozines) : d’EMPA-REG OUTCOME à CANVASAndré Scheen, Philippe Ernest, Bernard Jandrain — 2017
Sodium Glucose Cotransporter-2 Inhibition in Heart Failure: Potential Mechanisms, Clinical Applications and Summary of Clinical TrialsYuliya Lytvyn, Petter Bjornstad, Jacob A. Udell — 2017
SGLT2 Inhibitors Through the Windows of EMPA-REG and CANVAS Trials: A ReviewAshu Rastogi, Anil Bhansali — 2017
The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline CharacteristicsMeg Jardine, Kenneth W. Mahaffey, Bruce Neal — 2017
EMPA-REG OUTCOME trial and Canagliflozin Cardiovascular Assessment Study: Looking beyond the obviousRishad Ahmed, Pallavi Kawatra — 2017
Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors’ Expert ForumWilliam T. Cefalu, Sanjay Kaul, Hertzel C. Gerstein — 2017
The heart failure burden of type 2 diabetes mellitus—a review of pathophysiology and interventionsAnne Pernille Ofstad, Dan Atar, Lars Gullestad — 2018
Long-term use of ipragliflozin improved cardiac sympathetic nerve activity in a patient with heart failure: A case report.Shunsuke Kiuchi, Shinji Hisatake, Takayuki Kabuki — 2018

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

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