Abstract: Objective To evaluate the effects and safety of Tenapanor in hemodialysis patients with hyperphosphatemia by an updated meta-analysis.  Methods  All randomized controlled trials of Tenapanor were systematically searched in the Cochrane Library, PubMed, Embase, Web of Science, CNKI, Wan fang and VIP databases. The primary endpoint was the mean difference (MD) of serum phosphorus changes using Tenapanor versus placebo control, and the secondary endpoint was the rate difference (RD) of the target serum phosphorus level (serum phosphorus level: ≤6 mg/dl). A subgroup analysis was also conducted based on whether phosphate binders were used. Drug-related adverse reactions and diarrhea were collected to determine the safety of Tenapanor.  Results  There were 4 eligible trials that enrolled 677 patients. The studies showed that Tenapanor significantly reduced serum phosphorus level by 2.345mg/dl (95% CI:-2.798～-1.892; P＜0.001) and the achievement of the target serum phosphorus level (RD=0.363; 95% CI:0.147～0.579; P＜0.001) was better than placebo. However, drug-related adverse events (RD=0.461; 95% CI:0.284～0.637; P＜0.001), and diarrhea (RD=0.429; 95% CI:0.354～0.505; P＜0.001) were more serious than placebo. Subgroup analysis found that there were no significant differences in the magnitude of serum phosphorus level with (MD=-2.070; 95% CI:-2.885～-1.255; P＜0.001) or without (MD=-2.468; 95% CI:-3.013～-1.923; P＜0.001) phosphate binders.  Conclusions The randomized placebo-controlled trials showed that Tenapanor significantly reduced serum phosphorus level in hemodialysis patients with hyperphosphatemia with or without use of phosphate binders. Diarrhea was present frequently but no serious drug-related adverse events occurred.

Key words: Tenapanor, Hyperphosphatemia, Hemodialysis, Placebo-controlled trial