Matthew R Weir1, David A Bushinsky2, Wade W Benton3, Steven D Woods3, Martha R Mayo3, Susan P Arthur3, Bertram Pitt4, George L Bakris5. 1. Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore. Electronic address: mweir@medicine.umaryland.edu. 2. Division of Nephrology, Department of Medicine, University of Rochester School of Medicine, NY. 3. Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, Calif. 4. Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor. 5. Comprehensive Hypertension Center, Department of Medicine, University of Chicago Medicine, Ill.
Abstract
BACKGROUND:Older people are predisposed to hyperkalemia because of impaired renal function, comorbid conditions, and polypharmacy. Renin-angiotensin-aldosterone system inhibitors (RAASi), which are recommended to treat chronic kidney disease and heart failure augment the risk. Patiromer, a nonabsorbed potassium binder, was shown in the phase 3 OPAL-HK study to decrease serum potassium in patients with chronic kidney disease taking RAASi. We studied the efficacy and safety of patiromer in a prespecified subgroup of patients aged ≥65 years from OPAL-HK. METHODS:Chronic kidney disease patients with mild or moderate-to-severe hyperkalemia received patiromer, initially 8.4 g/d or 16.8 g/d, respectively, for 4 weeks (treatment phase, part A). Eligible patients entered an 8-week randomized withdrawal phase (part B) and continued patiromer or switched to placebo. RESULTS:Mean ± standard error change in serum potassium from baseline to week 4 of part A (primary endpoint) in patients aged ≥65 years was -1.01 ± 0.05mEq/L (P < .001); 97% achieved serum potassium 3.8-<5.1mEq/L. The serum potassium increase during the first 4 weeks of part B was greater in patients taking placebo than in those taking patiromer (P < .001). Fewer patients taking patiromer (30%) than placebo (92%) developed recurrent hyperkalemia (serum potassium ≥5.1 mEq/L). Mild-to-moderate constipation occurred in 15% (part A) and 7% (part B) of patients aged ≥65 years. Serum potassium <3.5 mEq/L and serum magnesium <1.4 mg/dL were infrequent (4% each in patients aged ≥65 years in part A). CONCLUSIONS:Patiromer reduced recurrent hyperkalemia and was well tolerated in older chronic kidney disease patients taking RAASi.
RCT Entities:
BACKGROUND: Older people are predisposed to hyperkalemia because of impaired renal function, comorbid conditions, and polypharmacy. Renin-angiotensin-aldosterone system inhibitors (RAASi), which are recommended to treat chronic kidney disease and heart failure augment the risk. Patiromer, a nonabsorbed potassium binder, was shown in the phase 3 OPAL-HK study to decrease serum potassium in patients with chronic kidney disease taking RAASi. We studied the efficacy and safety of patiromer in a prespecified subgroup of patients aged ≥65 years from OPAL-HK. METHODS:Chronic kidney diseasepatients with mild or moderate-to-severe hyperkalemia received patiromer, initially 8.4 g/d or 16.8 g/d, respectively, for 4 weeks (treatment phase, part A). Eligible patients entered an 8-week randomized withdrawal phase (part B) and continued patiromer or switched to placebo. RESULTS: Mean ± standard error change in serum potassium from baseline to week 4 of part A (primary endpoint) in patients aged ≥65 years was -1.01 ± 0.05 mEq/L (P < .001); 97% achieved serum potassium 3.8-<5.1 mEq/L. The serum potassium increase during the first 4 weeks of part B was greater in patients taking placebo than in those taking patiromer (P < .001). Fewer patients taking patiromer (30%) than placebo (92%) developed recurrent hyperkalemia (serum potassium ≥5.1 mEq/L). Mild-to-moderate constipation occurred in 15% (part A) and 7% (part B) of patients aged ≥65 years. Serum potassium <3.5 mEq/L and serum magnesium <1.4 mg/dL were infrequent (4% each in patients aged ≥65 years in part A). CONCLUSIONS: Patiromer reduced recurrent hyperkalemia and was well tolerated in older chronic kidney diseasepatients taking RAASi.
Authors: Essraa Bayoumi; Phillip H Lam; Daniel J Dooley; Steven Singh; Charles Faselis; Charity J Morgan; Samir Patel; Helen M Sheriff; Selma F Mohammed; Carlos E Palant; Bertram Pitt; Gregg C Fonarow; Ali Ahmed Journal: Am J Med Date: 2018-09-19 Impact factor: 4.965
Authors: Meaghan Lunney; Marinella Ruospo; Patrizia Natale; Robert R Quinn; Paul E Ronksley; Ioannis Konstantinidis; Suetonia C Palmer; Marcello Tonelli; Giovanni Fm Strippoli; Pietro Ravani Journal: Cochrane Database Syst Rev Date: 2020-02-27
Authors: Michele Provenzano; Roberto Minutolo; Paolo Chiodini; Vincenzo Bellizzi; Felice Nappi; Domenico Russo; Silvio Borrelli; Carlo Garofalo; Carmela Iodice; Toni De Stefano; Giuseppe Conte; Hiddo J L Heerspink; Luca De Nicola Journal: J Clin Med Date: 2018-12-01 Impact factor: 4.241