Tenapanor, phosphate binder dual treatment improves hyperphosphatemia
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Patients with chronic kidney disease on maintenance dialysis experienced improved control of hyperphosphatemia with a dual treatment of tenapanor and phosphate binders compared with the latter alone, according to a study.
“The use of a dual mechanism treatment with tenapanor and phosphate binders may result in enhanced control of serum phosphorus concentration compared with monotherapy with either agent, which may be particularly relevant for the management of patients with persistent hyperphosphatemia,” Pablo E. Pergola, MD, PhD, of Renal Associates PA in San Antonia, Texas, and colleagues wrote. “The use of tenapanor may also allow for a reduction in phosphate binder dose and pill burden, increasing the overall tolerability of hyperphosphatemia treatment and thereby, improving patient adherence.”
To better manage hyperphosphatemia, researchers investigated the efficacy of a dual treatment approach. In this multicenter double-blind randomized phase 3 trial, 235 patients receiving maintenance dialysis with hyperphosphatemia who had prior treatment with phosphate binders enrolled in the study. Researchers randomly assigned patients to either placebo or dual treatment groups for 4 weeks. Mean age was 54.5 years. Researchers evaluated efficacy by comparing the difference in mean change from baseline on day 1 in serum phosphorus concentration. Secondary efficacy involved the proportion of patients recording serum phosphorus below 5.5 mg/dL at the end of the 4 weeks.
During the study period, patients receiving the dual treatment experienced a larger mean change in serum phosphorus concentration from baseline to week 4 compared to the placebo group (0.84 mg/dL vs. 0.19 mg/dL. A significantly larger proportion of patients receiving tenapanor and binder achieved a serum phosphorus concentration below 5.5 mg/dL at week 1 (49.1% vs. 21%), week 2 (41.4% vs. 23.5%), week 3 (47.4% vs. 17.6%) and week 4 (37.1% vs. 21.8%) compared with the placebo and binder, according to the researchers. Four of the 119 patients receiving the dual treatment and two of the 116 receiving the placebo and binder could not complete the study due to diarrhea as an adverse event caused by the treatment.
“In our trial, a significantly larger proportion of patients receiving tenapanor and binder achieved a serum phosphorus concentration below 5.5 mg/dL (37.1%–49.1%) compared with placebo and binder (17.6%–23.5%) across the 4 weeks of treatment,” Pergola and colleagues wrote. “Additionally, treatment with tenapanor and binder resulted in significantly more pronounced relative reductions in iFGF23 and cFGF23 concentrations at week 4 compared with placebo and binder, consistent with previous studies of tenapanor.”
“These findings indicate that evaluation of long-term safety and efficacy of this dual-mechanism treatment of hyperphosphatemia is merited,” they concluded.
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