Emma England, Maneka Sheffield, Penelope Poyah, David Clark, Jo-Anne Wilson
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Protocols are commonly used with other IV irons, but there are limited Canadian data for FDI, and no protocol exists.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of FDI for patients with CKD and to ascertain information related to its use in Canadian provinces.</p><p><strong>Methods: </strong>This retrospective cohort study involved patients with non-dialysis-dependent CKD (NDD-CKD) and patients undergoing peritoneal dialysis (PD) who received FDI in a tertiary hospital in Nova Scotia between June 2020 and May 2021. Each patient was followed for a minimum of 6 months. The efficacy outcomes were the changes from baseline in hemoglobin, transferrin saturation (TSAT), and ferritin after the first dose of FDI and at 3 and 6 months. The safety outcomes were the frequency and types of adverse reactions to FDI. Electronic surveys were sent to 33 Canadian renal pharmacists to gather information about FDI use, dosing, administration, monitoring, funding, and safety in their respective organizations.</p><p><strong>Results: </strong>A total of 52 infusions were administered to 35 patients during the study period. The median times between doses 1 and 2 and between doses 2 and 3 were 19.1 and 6.6 weeks, respectively. The median change from baseline to first post-FDI follow-up blood work was significant for hemoglobin (9.0 g/L, <i>p</i> = 0.023), TSAT (11 percentage points, <i>p</i> < 0.001), and ferritin (271.4 μg/L, <i>p</i> < 0.001). Median darbepoetin doses decreased from baseline to 6 months (<i>p</i> < 0.001). Three adverse reactions occurred. At least 15 (65%) of the 23 survey respondents reported that FDI was funded by their province or was listed on their hospital drug formulary.</p><p><strong>Conclusion: </strong>This study provides evidence that FDI is an effective and safe treatment for anemia in NDD-CKD and PD patients.</p>","PeriodicalId":51646,"journal":{"name":"CANADIAN JOURNAL OF HOSPITAL PHARMACY","volume":"76 2","pages":"94-101"},"PeriodicalIF":0.6000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10049766/pdf/cjhp-76-94.pdf","citationCount":"0","resultStr":"{\"title\":\"Ferric Derisomaltose Evaluation in Patients with Non-Dialysis-Dependent Chronic Kidney Disease or Peritoneal Dialysis.\",\"authors\":\"Emma England, Maneka Sheffield, Penelope Poyah, David Clark, Jo-Anne Wilson\",\"doi\":\"10.4212/cjhp.3310\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Iron deficiency anemia is common in patients with advanced chronic kidney disease (CKD). Ferric derisomaltose (FDI) enables iron repletion in a single dose, unlike other forms of iron for IV administration, which require multiple doses. Protocols are commonly used with other IV irons, but there are limited Canadian data for FDI, and no protocol exists.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of FDI for patients with CKD and to ascertain information related to its use in Canadian provinces.</p><p><strong>Methods: </strong>This retrospective cohort study involved patients with non-dialysis-dependent CKD (NDD-CKD) and patients undergoing peritoneal dialysis (PD) who received FDI in a tertiary hospital in Nova Scotia between June 2020 and May 2021. Each patient was followed for a minimum of 6 months. The efficacy outcomes were the changes from baseline in hemoglobin, transferrin saturation (TSAT), and ferritin after the first dose of FDI and at 3 and 6 months. The safety outcomes were the frequency and types of adverse reactions to FDI. Electronic surveys were sent to 33 Canadian renal pharmacists to gather information about FDI use, dosing, administration, monitoring, funding, and safety in their respective organizations.</p><p><strong>Results: </strong>A total of 52 infusions were administered to 35 patients during the study period. The median times between doses 1 and 2 and between doses 2 and 3 were 19.1 and 6.6 weeks, respectively. The median change from baseline to first post-FDI follow-up blood work was significant for hemoglobin (9.0 g/L, <i>p</i> = 0.023), TSAT (11 percentage points, <i>p</i> < 0.001), and ferritin (271.4 μg/L, <i>p</i> < 0.001). Median darbepoetin doses decreased from baseline to 6 months (<i>p</i> < 0.001). Three adverse reactions occurred. 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引用次数: 0
摘要
背景:缺铁性贫血在晚期慢性肾脏疾病(CKD)患者中很常见。异麦芽糖铁(FDI)可以单剂量补充铁,不像其他形式的静脉注射铁,需要多次剂量。协议通常与其他IV铁一起使用,但加拿大FDI数据有限,没有协议存在。目的:评价FDI对CKD患者的疗效和安全性,并确定其在加拿大各省使用的相关信息。方法:这项回顾性队列研究纳入了2020年6月至2021年5月在新斯科舍省一家三级医院接受FDI的非透析依赖型CKD (NDD-CKD)患者和腹膜透析(PD)患者。每位患者至少随访6个月。疗效结果是在第一剂FDI后、3个月和6个月时血红蛋白、转铁蛋白饱和度(TSAT)和铁蛋白较基线的变化。安全性指标为FDI不良反应的频率和类型。电子调查发送给33名加拿大肾脏药剂师,以收集有关各自组织中FDI使用、剂量、管理、监测、资金和安全性的信息。结果:35例患者在研究期间共接受52次输注。剂量1和剂量2以及剂量2和剂量3之间的中位时间分别为19.1周和6.6周。从基线到首次fdi后随访血液检查的中位数变化在血红蛋白(9.0 g/L, p = 0.023)、TSAT(11个百分点,p < 0.001)和铁蛋白(271.4 μg/L, p < 0.001)方面具有显著性意义。达贝泊汀的中位剂量从基线到6个月下降(p < 0.001)。发生了三个不良反应。在23个调查对象中,至少有15个(65%)报告说,外国直接投资是由其所在省资助的,或者列在其医院药物处方中。结论:本研究证明FDI是治疗NDD-CKD和PD患者贫血的有效、安全的方法。
Ferric Derisomaltose Evaluation in Patients with Non-Dialysis-Dependent Chronic Kidney Disease or Peritoneal Dialysis.
Background: Iron deficiency anemia is common in patients with advanced chronic kidney disease (CKD). Ferric derisomaltose (FDI) enables iron repletion in a single dose, unlike other forms of iron for IV administration, which require multiple doses. Protocols are commonly used with other IV irons, but there are limited Canadian data for FDI, and no protocol exists.
Objectives: To evaluate the efficacy and safety of FDI for patients with CKD and to ascertain information related to its use in Canadian provinces.
Methods: This retrospective cohort study involved patients with non-dialysis-dependent CKD (NDD-CKD) and patients undergoing peritoneal dialysis (PD) who received FDI in a tertiary hospital in Nova Scotia between June 2020 and May 2021. Each patient was followed for a minimum of 6 months. The efficacy outcomes were the changes from baseline in hemoglobin, transferrin saturation (TSAT), and ferritin after the first dose of FDI and at 3 and 6 months. The safety outcomes were the frequency and types of adverse reactions to FDI. Electronic surveys were sent to 33 Canadian renal pharmacists to gather information about FDI use, dosing, administration, monitoring, funding, and safety in their respective organizations.
Results: A total of 52 infusions were administered to 35 patients during the study period. The median times between doses 1 and 2 and between doses 2 and 3 were 19.1 and 6.6 weeks, respectively. The median change from baseline to first post-FDI follow-up blood work was significant for hemoglobin (9.0 g/L, p = 0.023), TSAT (11 percentage points, p < 0.001), and ferritin (271.4 μg/L, p < 0.001). Median darbepoetin doses decreased from baseline to 6 months (p < 0.001). Three adverse reactions occurred. At least 15 (65%) of the 23 survey respondents reported that FDI was funded by their province or was listed on their hospital drug formulary.
Conclusion: This study provides evidence that FDI is an effective and safe treatment for anemia in NDD-CKD and PD patients.
期刊介绍:
The CJHP is an academic journal that focuses on how pharmacists in hospitals and other collaborative health care settings optimize safe and effective drug use for patients in Canada and throughout the world. The aim of the CJHP is to be a respected international publication serving as a major venue for dissemination of information related to patient-centred pharmacy practice in hospitals and other collaborative health care settings in Canada and throughout the world.