Visual Abstract
Introduction: CANA reduced the risk of MACE (cardiovascular [CV] death, nonfatal myocardial infarction, and nonfatal stroke) in the CANVAS Program and CREDENCE trials of patients with type 2 diabetes with high CV risk or nephropathy, respectively, regardless of baseline eGFR. The risk of MACE by renal status had not been examined in Hispanic participants, who have a higher MACE burden.
Methods: This analysis used integrated data from the CANVAS Program (N = 10,142) and CREDENCE (N = 4401). The effects of CANA versus placebo on MACE were assessed in subgroups defined by baseline eGFR (<45, 45-60, and >60 mL/min/1.73 m2) overall and in the Hispanic subgroup.
Results: Of the 14,540 participants with baseline eGFR values, 3028 (21%) self-identified as Hispanic. In the overall population, CANA reduced the risk of MACE (HR, 0.83; 95% CI, 0.75, 0.92), with consistent effects across eGFR subgroups (interaction P value = 0.22; Figure). In the Hispanic subgroup, CANA also reduced the risk of MACE (HR, 0.71; 95% CI, 0.55, 0.92) regardless of eGFR (interaction P value = 0.25). Even the highest risk Hispanic participants with baseline eGFR <45 mL/min/1.73 m2 showed a MACE benefit (HR, 0.51; 95% CI, 0.30, 0.85).
Conclusion: CANA reduced the risk of MACE overall and among Hispanic participants from the CANVAS Program and CREDENCE, regardless of baseline eGFR.
M. R. Weir: Advisory Panel; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Vifor Pharma Management Ltd. J. Gogate: Employee; Self; Janssen Research & Development, LLC. C. Damaraju: Employee; Self; Janssen Research & Development, LLC. R. Correa-rotter: Consultant; Self; GlaxoSmithKline plc., Other Relationship; Self; AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Novo Nordisk Inc., Speaker’s Bureau; Self; AbbVie Inc., Janssen Pharmaceuticals, Inc., Takeda Pharmaceutical Co. K. W. Mahaffey: Consultant; Self; Abbott, Amgen Inc., Anthos, AstraZeneca, Baim Institute for Clinical Research, Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals, Inc., CSL Behring, Elsevier, Inova, Intermountain Health, Johnson & Johnson, Medscape, Mount Sinai, Mundipharma International, MyoKardia, National Institutes of Health, Novartis Pharmaceuticals Corporation, Novo Nordisk, Otsuka America Pharmaceutical, Inc., Portola Pharmaceuticals, Inc., Regeneron Pharmaceuticals Inc., SmartMedics, Theravance Biopharma, Research Support; Self; Afferent, AHA, Amgen Inc., Apple, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Cardiva Medical, Inc, Eidos, Ferring Pharmaceuticals Inc., Gilead Sciences, Inc., Google, Johnson & Johnson, Luitpold Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., National Institutes of Health, Novartis Pharmaceuticals Corporation, Sanifit, Sanofi, St. Jude Medical.
Janssen Scientific Affairs, LLC