Kidney Week

Abstract: SA-PO143

Effects of Canagliflozin on Serum Potassium in the CANVAS Program

Session Information

• Diabetic Kidney Disease: Clinical - II
  October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

• Weir, Matthew R., University of Maryland School of Medicine, Baltimore, Maryland, United States

Matthew R. Weir,

• Balis, Dainius, Janssen Research & Development, LLC, Raritan, New Jersey, United States

Dainius Balis,

• de Zeeuw, Dick, University of Groningen, University Medical Center Groningen, Groningen, Netherlands

Dick de Zeeuw,

• Perkovic, Vlado, The George Institute for Global Health, Sydney, New South Wales, Australia

Vlado Perkovic,

Background

Canagliflozin (CANA) is a sodium glucose co-transporter 2 (SGLT2) inhibitor used for the treatment of type 2 diabetes mellitus (T2DM). The US label Warnings and Precautions section notes a risk of hyperkalemia with CANA in patients with moderate renal impairment who are taking medications that interfere with potassium excretion. Serum potassium levels were assessed in patients at high cardiovascular (CV) risk in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program, comprised of the CANVAS and CANVAS-R trials.

Methods

The CANVAS Program randomized 10,142 participants with T2DM and high CV risk to CANA or placebo (PBO); 80% were on renin-angiotensin aldosterone system (RAAS) inhibitors at baseline. Serum potassium measurements were performed in a central laboratory; values meeting predefined limit of change criteria (PDLC) were prespecified and assessed using results obtained up to 2 days after the last dose of study drug.

Results

In the CANVAS Program, the risk of decreased serum potassium (PDLC <3.4 mEq/L and >15% decrease from baseline) was similar between the CANA and PBO arms (Table; hazard ratio [HR] 0.96 [95% confidence interval (CI) 0.72, 1.28]). The HR (95% CI) for increased serum potassium (PDLC >5.4 mEq/L and >15% increase from baseline) was 1.03 (0.89, 1.20) and for serum potassium ≥6.5 mEq/L was 0.84 (0.50, 1.41). Generally similar results were seen in subgroups by baseline eGFR (<45, 45-<60, & ≥60 mL/min/1.73 m²; Table).

Conclusion

In the CANVAS Program, no significant differences in the risk of hypo- or hyperkalemia were observed with CANA versus PBO overall or in participants with renal impairment.

Funding

• Commercial Support – Janssen Research & Development, LLC