作者
George L Bakris, Bertram Pitt, Matthew R Weir, Mason W Freeman, Martha R Mayo, Dahlia Garza, Yuri Stasiv, Rezi Zawadzki, Lance Berman, David A Bushinsky, AMETHYST-DN Investigators
发表日期
2015/7/14
期刊
Jama
卷号
314
期号
2
页码范围
151-161
出版商
American Medical Association
简介
Importance
Hyperkalemia is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system (RAAS) inhibitors with stage 3 or greater chronic kidney disease (CKD) who may also have diabetes, heart failure, or both.
Objectives
To select starting doses for a phase 3 study and to evaluate the long-term safety and efficacy of a potassium-binding polymer, patiromer, in outpatients with hyperkalemia.
Design, Setting, and Participants
Phase 2, multicenter, open-label, dose-ranging, randomized clinical trial (AMETHYST-DN), conducted at 48 sites in Europe from June 2011 to June 2013 evaluating patiromer in 306 outpatients with type 2 diabetes (estimated glomerular filtration rate, 15 to <60 mL/min/1.73 m2and serum potassium level >5.0 mEq/L). All patients received RAAS inhibitors prior to and during study treatment.
Interventions
Patients were stratified by baseline …
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