Renal Dialysis Unit, Manchester Royal Infirmary and Manchester Academic Health Science Centre, Manchester, United
School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Nephron. 2018;140(4):265-274. doi: 10.1159/000492603. Epub 2018 Oct 23.
BACKGROUND/AIMS: This post-marketing observational study assessed the long-term safety of lanthanum carbonate (LaC) in US patients with end-stage renal disease (NCT00567723).
Patients (≥18 years old) undergoing dialysis, who had Medicare as their primary healthcare payer, and records in the United States Renal Data System were followed-up for 5 years. Patients who had received LaC for at least 12 consecutive weeks formed the exposed cohort. During the same time period, patients who had undergone dialysis for at least 12 consecutive weeks and had been treated with any other phosphate binder formed the primary comparator cohort. A historical cohort was also evaluated. Primary outcomes were all-cause mortality, and time to and incidence of first bone-fracture event requiring hospitalization. Secondary outcomes were time to first occurrence of and incidence of specific gastrointestinal (GI) disease, liver disease, malignancy, and major infectious episode requiring hospitalization. -Results: 2,026 and 8,094 patients were included in the exposed and primary comparator cohorts, respectively. A Cox proportional hazards model showed that patients receiving LaC were not at increased risk of all-cause mortality (adjusted hazard ratio 0.94; 95% CI 0.88-1.01; p = 0.078), bone fractures (0.86; 0.71-1.05; p = 0.130), specific GI disease (0.86; 0.76-0.97; p = 0.015), liver disease (0.88; 0.70-1.09; p = 0.236), malignancy (0.85; 0.54-1.34; p = 0.496), or major infectious episodes (0.87; 0.80-0.94; p < 0.001) requiring hospitalization compared with primary comparator patients.
LaC was not associated with increased risk of mortality, bone fractures, or any secondary outcome.
背景/目的：本上市后观察性研究评估了碳酸镧（LaC）在接受透析治疗、医疗保险为主要医疗支付方且有美国肾脏数据系统记录的美国终末期肾病（ESRD）患者中的长期安全性（NCT00567723）。
患者（≥18 岁）接受透析治疗，医疗保险为主要医疗支付方，且有美国肾脏数据系统记录，随访 5 年。至少接受 12 周连续 LaC 治疗的患者形成暴露队列。在此期间，至少接受 12 周透析治疗且接受任何其他磷酸盐结合剂治疗的患者形成主要比较队列。还评估了历史队列。主要结局是全因死亡率以及首次发生需要住院的骨折事件的时间和发生率。次要结局是首次发生和发生率特定胃肠道（GI）疾病、肝脏疾病、恶性肿瘤和需要住院的重大感染事件的时间。
暴露队列和主要比较队列分别纳入 2026 例和 8094 例患者。Cox 比例风险模型显示，接受 LaC 治疗的患者全因死亡率（校正风险比 0.94；95%置信区间 0.88-1.01；p = 0.078）、骨折（0.86；0.71-1.05；p = 0.130）、特定 GI 疾病（0.86；0.76-0.97；p = 0.015）、肝脏疾病（0.88；0.70-1.09；p = 0.236）、恶性肿瘤（0.85；0.54-1.34；p = 0.496）或需要住院的重大感染事件（0.87；0.80-0.94；p < 0.001）的风险与主要比较队列患者相比无显著增加。
与主要比较队列患者相比，LaC 治疗不增加死亡率、骨折或任何次要结局的风险。
