The sodium-free potassium binder patiromer may enable patients with advanced chronic kidney disease (CKD) and resistant hypertension (RHTN) to remain on spironolactone treatment, according to study findings presented at the National Kidney Foundation’s 2019 Spring Clinical Meetings in Boston.
In phase 2 AMBER (A randoMized, double-blind, placebo-controlled, parallel group study of patiromer for the enablement of spironolactone use for Blood PrEssure control in patients with Resistant hypertension and chronic kidney disease; NCT03071263), Rajiv Agarwal, MBBS, MD, of Indiana University School of Medicine in Indianapolis, and colleagues compared the efficacy of patiromer vs placebo in 295 patients concomitantly taking spironolactone, an aldosterone antagonist. Patients had an estimated glomerular filtration rate (eGFR) of 25 to 45 mL/min/1.73 m2 and screening serum potassium levels of 4.3 to 5.1 mEq/L.
Dr Agarwal reported that a significantly higher proportion of patiromer than placebo recipients remained on spironolactone therapy at 12 weeks: 86% vs 66%.
Investigators observed no new safety signals with patiromer. The most common adverse reactions include constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence. Approximately 9% of patients in clinical trials experienced serum magnesium values less than 1.4 mg/dL.
“The AMBER data suggest that patients treated with patiromer may be more likely to stay on spironolactone therapy, a life-saving medicine for those with RHTN,” Dr Agarwal said in a news release from Relypsa, the makers of patiromer (Veltassa) and the study’s sponsor.
Agarwal R , Rossignol P, Garza D, et al. Patiromer to enable spironolactone in patients with resistant hypertension and CKD: Primary results of AMBER. Late-breaking abstract presented at the National Kidney Foundation’s 2019 Spring Clinical Meetings in Boston, May 8-12, 2019. Abstract 442.
Vifor Pharma’s Phase-II AMBER study meets primary endpoint (news release). Relypsa; May 10, 2019. Zurich, Switzerland.