RLY5016的有效性和安全性的评价聚合物钾活页夹,双盲,安慰剂对照研究在慢性心力衰竭患者(PEARL-HF)试验。
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皮特B,安加SD, Bushinsky哒,Kitzman DW,发病率F,黄工业区
RLY5016的有效性和安全性的评价聚合物钾活页夹,双盲,安慰剂对照研究在慢性心力衰竭患者(PEARL-HF)试验。
心j .欧元2011年4月,32 (7):820 - 8。doi: 10.1093 / eurheartj / ehq502。2011年1月5 Epub。
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21208974 (在PubMed]
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目的:评价疗效和安全性RLY5016 (non-absorbed口头管理,钾(K +)绑定聚合物)在慢性心力衰竭患者血清K +含量(高频)接受标准治疗和螺内酯。方法和结果:一百零五例高频和高钾血症导致停药的历史的肾素血管紧张素醛固酮系统抑制剂/拦截器和/或该项阻滞剂或慢性肾脏疾病(CKD)估计的肾小球滤过率< 60毫升/分钟随机双盲治疗30克/天RLY5016 4周或安慰剂。安体舒通,发起25毫克/天,提高到50毫克/天15天如果K + 5.5毫克当量/ L);和螺内酯的比例滴定50毫克/天。安全评估包括不良事件(AEs)和临床实验室检测。RLY5016 (n = 55)和安慰剂组(n = 49)患者基线特征相似。在治疗结束时,与安慰剂相比,RLY5016水平显著降低血清K +的区别-0.45毫克当量/ L组(P < 0.001);高钾血症的发生率较低(7.3% RLY5016比24.5%安慰剂,P = 0.015);和更高比例的病人安体舒通50毫克/天(91% RLY5016比安慰剂74%,P = 0.019)。CKD患者(n = 66), K +团体之间的差异是-0.52毫克当量/ L (P = 0.031),和高钾血症的发生率是6.7% RLY5016比38.5%安慰剂(P = 0.041)。 Adverse events were mainly gastrointestinal, and mild or moderate in severity. Adverse events resulting in study withdrawal were similar (7% RLY5016, 6% placebo). There were no drug-related serious AEs. Hypokalaemia (K+ <3.5 mEq/L) occurred in 6% of RLY5016 patients vs. 0% of placebo patients (P= 0.094). CONCLUSION: RLY5016 prevented hyperkalaemia and was relatively well tolerated in patients with HF receiving standard therapy and spironolactone (25-50 mg/day).