First People's Hospital of Linping District, Hangzhou, Zhejiang, China.
Ren Fail. 2024 Dec;46(2):2410389. doi: 10.1080/0886022X.2024.2410389. Epub 2024 Oct 1.
Hyperphosphatemia occurs universally in end-stage renal disease(ESRD), and the attainment of target serum phosphate levels remains suboptimal with currently available phosphate binders. This meta-analysis aimed to evaluate the efficacy and safety of tenapanor in end-stage renal disease patients with hyperphosphatemia.
Data sources included PubMed, Embase, Web of Science, and Cochrane Library. This meta-analysis included randomized controlled trials evaluating both the efficacy of tenapanor in reducing serum phosphate levels and its safety profile. The risk of bias was assessed using the Cochrane risk of bias tool for RCTs. The GRADE system was used to assess the overall certainty of evidence. A meta-analysis was carried out by using fixed effects ( values < 50%) or random effects ( values ≥ 50%) models to calculate MD with 95% CI for continuous outcome variables and RR with 95% CI for dichotomous variables. Publication bias was evaluated using funnel plots.
A total of seven RCTs involving 877 individuals were included. The pooling analysis demonstrates that the reduction in mean serum phosphorus levels in the tenapanor group was significantly greater than that in the placebo group [MD= -1.06 mg/dl, 95% CI (-1.59, -0.53); = 83%, < 0.0001]. The proportion of patients achieving a serum phosphorus level of < 5.5 mg/dL, along with the incidence of any adverse events (AEs) and gastrointestinal disorders, was higher in the tenapanor group compared to the placebo group.
Tenapanor has the potential to significantly reduce serum phosphorus levels and enhance the rate of achieving target levels compared to placebo, all while maintaining an acceptable safety and tolerability profile.
PROSPERO registration number CRD42024544531.
高磷血症普遍存在于终末期肾病（ESRD）患者中，而目前可用的磷结合剂并不能使血清磷水平达到目标值。本荟萃分析旨在评估特立帕肽在高磷血症的终末期肾病患者中的疗效和安全性。
数据来源包括 PubMed、Embase、Web of Science 和 Cochrane Library。本荟萃分析纳入了评估特立帕肽降低血清磷水平疗效及其安全性的随机对照试验。使用 Cochrane 偏倚风险工具评估随机对照试验的偏倚风险。使用 GRADE 系统评估证据的总体确定性。使用固定效应（ 值＜50%）或随机效应（ 值≥50%）模型对连续变量计算 MD 及其 95%CI，对二分类变量计算 RR 及其 95%CI。采用漏斗图评估发表偏倚。
共纳入 7 项 RCT 涉及 877 名患者。汇总分析表明，特立帕肽组的平均血清磷水平降低显著大于安慰剂组[MD=-1.06mg/dl，95%CI（-1.59，-0.53）； =83%，<0.0001]。特立帕肽组患者达到血清磷水平＜5.5mg/dL的比例以及发生任何不良反应（AE）和胃肠道疾病的比例均高于安慰剂组。
与安慰剂相比，特立帕肽具有显著降低血清磷水平和提高达标率的潜力，同时保持可接受的安全性和耐受性。
PROSPERO 注册号 CRD42024544531。
