Kidney Week

Abstract: FR-PO301

Efficacy and Safety of Patiromer in Participants with Diabetes: A Pooled Analysis

Session Information

• Fluid and Electrolytes: Clinical
  October 26, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Fluid and Electrolytes

• 902 Fluid and Electrolytes: Clinical

Authors

• Rossignol, Patrick, Clinical Investigation Center-INSERM-CHU of Nancy, VANDOEUVRE LES NANCY, France

Patrick Rossignol,

• Gross, Coleman, Relypsa Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Coleman Gross,

• Mayo, Martha, Relypsa Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Martha Mayo,

• Warren, Suzette, Relypsa Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Suzette Warren,

• Yuan, Jinwei, Relypsa Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Jinwei Yuan,

• Budden, Jeffrey J., Relypsa Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Jeffrey J. Budden,

• Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States

George L. Bakris,

Background

The purpose of this post-hoc pooled analysis was to assess the efficacy and safety of patiromer (PAT) for treatment of hyperkalemia in participants with and without diabetes mellitus (DM⁺ and DM^-).

Methods

We analyzed pooled data through Week 4 (Wk4) from 3 trials of PAT. Study participants who took ≥1 PAT dose and had ≥1 post-baseline (BL) serum potassium (sK) measurement were included. Participants were stratified according to DM⁺ and DM^-, and assessed for: sK change from BL at Wk4, sK over time, and % with any sK measurement in target range (3.8–5.0 mEq/L).

Results

653 participants were included; 82% DM⁺ (mean BL HbA1c and DM duration: 7.4% and 14 years, respectively). Mean BL sK and eGFR were 5.4 mEq/L and 40.3 mL/min/1.73m² in DM⁺, and 5.5 mEq/L and 34.8 mL/min/1.73m² in DM^-. At Wk4, overall mean (SE) sK change from BL was -0.72 (0.02) in DM⁺ and -0.88 (0.06) in DM^- (Figure). In participants with BL sK ≥5.5 mEq/L, mean (SE) sK changes at Wk4 were -1.01 (0.05) in DM⁺ and -1.21 (0.10) in DM^-, and -0.52 (0.03) and -0.51 (0.08), respectively, in DM⁺ and DM^- participants who had BL sK <5.5 mEq/L. Regardless of BL sK status, >95% of all DM⁺ and DM^- participants achieved any sK measurement in the target range through Wk4. The presence or absence of heart failure or eGFR <45 mL/min/1.73m² did not impact these results. At least 1 adverse event (AE) was reported in 31% of DM⁺ and 38% of DM^- participants, most commonly (≥2%) constipation, diarrhea, hypomagnesemia (hypoMg), and nausea. AEs of hypoMg were reported in 2% of both DM⁺ and DM^- participants. Lab values of Mg <1.4 mg/dL occurred in 5% and 1% of DM⁺ and DM^- participants, respectively. Use of proton pump inhibitors and/or loop diuretics was common (43%) in those who experienced low serum Mg.

Conclusion

In this post-hoc analysis of pooled data, PAT was equally effective and well-tolerated in DM⁺ and DM^- participants.

Figure

Funding

• Commercial Support – Relypsa Inc., a Vifor Pharma Group Company