Silver Marcia R, Agarwal Anil, Krause Michelle, Lei Lei, Stehman-Breen Catherine
Division of Nephrology and Hypertension, Case Western Reserve University School of Medicine at Metro Health Medical Center, Cleveland, Ohio 44109-1998, USA.
Am J Geriatr Pharmacother. 2008 Jun;6(2):49-60. doi: 10.1016/j.amjopharm.2008.05.002.
The anemia of chronic kidney disease (CKD) is associated with increased hospitalizations, increased cardiovascular morbidity and mortality, and diminished quality of life in the elderly. Darbepoetin alfa is an erythropoiesis-stimulating agent that has been shown to be effective in treating anemia in patients with CKD (but not on dialysis) when administered using extended-dosing regimens.
The purpose of this post hoc analysis was to examine the efficacy and safety profile of once-monthly (QM) darbepoetin alfa in study patients stratified according to age (ie, <65, 65-74, and > or =75 years).
Patients with CKD but not on dialysis, receiving darbepoetin alfa every other week (Q2W), and with stable hemoglobin (Hb) levels between 11 and 13 g/dL, inclusive, were enrolled in this 33-week, multicenter, open-label, single-arm study. The study was carried out at 36 US centers and consisted of a 24-week QM darbepoetin alfa dose-titration period followed by an 8-week evaluation period. Hb levels were measured Q2W. Study results were stratified according to patient age (<65, 65-74, and > or =75 years).
A total of 152 patients (79 women, 73 men) were enrolled; 55 patients (36%) were <65 years of age, 46 (30%) were 65 to 74 years of age, and 51 (34%) were > or =75 years of age. In patients who received > or =1 dose of darbepoetin alfa, Hb levels > or =11 g/dL were maintained in 76%, 80%, and 71% of patients aged <65, 65 to 74, and > or =75 years, respectively. For patients who completed the study, the proportions who maintained Hb levels > or =11 g/dL were 83%, 88%, and 85%, respectively, for the 3 age groups. The safety profile of QM darbepoetin alfa in this study was consistent with that expected in patients with CKD not receiving dialysis.
Darbepoetin alfa administered QM maintained Hb levels > or =11 g/dL in patients with CKD (not on dialysis) aged <65, 65 to 74, and > or =75 years. This treatment regimen may help optimize anemia management for older community-dwelling and long-term care patients.
慢性肾脏病（CKD）所致贫血与住院率增加、心血管疾病发病率和死亡率升高以及老年人生活质量下降相关。达比加群酯是一种促红细胞生成剂，已证明在使用延长给药方案时，对治疗非透析CKD患者的贫血有效。
本事后分析旨在研究每月一次（QM）达比加群酯在按年龄分层（即<65岁、65 - 74岁和≥75岁）的研究患者中的疗效和安全性。
本33周、多中心、开放标签、单臂研究纳入了非透析的CKD患者，这些患者每两周（Q2W）接受一次达比加群酯治疗，且血红蛋白（Hb）水平稳定在11至13 g/dL（含）之间。该研究在美国36个中心进行，包括一个为期24周的QM达比加群酯剂量滴定期，随后是一个为期8周的评估期。每两周测量一次Hb水平。研究结果根据患者年龄（<65岁、65 - 74岁和≥75岁）进行分层。
共纳入152例患者（79例女性，73例男性）；55例患者（36%）年龄<65岁，46例（30%）年龄在65至74岁之间，51例（34%）年龄≥75岁。在接受≥1剂达比加群酯的患者中，年龄<65岁、65至74岁和≥75岁的患者分别有76%、80%和71%维持Hb水平≥11 g/dL。对于完成研究的患者，三个年龄组中维持Hb水平≥11 g/dL的比例分别为83%、88%和85%。本研究中QM达比加群酯的安全性与未接受透析的CKD患者预期的安全性一致。
每月一次给药的达比加群酯可使年龄<65岁、65至74岁和≥75岁的非透析CKD患者维持Hb水平≥11 g/dL。这种治疗方案可能有助于优化老年社区居住和长期护理患者贫血的管理。
