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Abstract: PO1733

Patient-Reported Experience with Tenapanor in the OPTIMIZE Trial

Session Information

Category: Health Maintenance, Nutrition, and Metabolism

  • 1300 Health Maintenance, Nutrition, and Metabolism

Authors

  • Edelstein, Susan A., Ardelyx Inc, Fremont, California, United States
  • Yang, Yang, Ardelyx Inc, Fremont, California, United States
  • Stephenson, Brett, Ardelyx Inc, Fremont, California, United States
  • Zhao, Suling, Ardelyx Inc, Fremont, California, United States
  • Pagliaro, Lynae, Ardelyx Inc, Fremont, California, United States
  • Fogli, Jeanene, Ardelyx Inc, Fremont, California, United States
Background

Tenapanor (TEN), a first-in-class phosphate absorption inhibitor (PAI) that works via the paracellular pathway, provides a novel approach for hyperphosphatemia management. The primary goal of this study is to evaluate how to optimize the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis with the use of TEN and its novel mechanism of action.

Methods

Patients with serum phosphorus (sP) >5.5 and ≤10.0 mg/dL during stable phosphate binder (PB) treatment were randomized 1:1 to 2 different treatment cohorts: Cohort 1 (straight switch; n=151) – discontinued current PB and began TEN 30 mg twice daily (BID); or Cohort 2 (50% PB reduction; n=152) – decreased current PB dose by 50% (or more if taking an odd number of PB tablets) and began TEN 30 mg BID. After week 2 investigators could increase PB doses to achieve sP ≤5.5 mg/dL with TEN as the core therapy. Additionally, patients on TEN with sP >5.5 mg/dL could add low dose PB, and patients on TEN and PBs with sP <5.0 mg/dL could reduce PB dose. Participants were monitored for safety and efficacy at weeks 1, 2, 3, 4, 6, 8, and 10. At week 10 or the early termination visit, patients were asked about their experience with their sP management routine during OPTIMIZE compared to before the study. Here we report findings from a selection of questions from the patient experience questionnaires completed by a total of 179 patients (Cohort 1, n=94; Cohort 2, n=85).

Results

When interviewed, 85.1% of patients in Cohort 1 and 83.5% of patients in Cohort 2 reported an improved perception of their sP management routine. Overall, 64.2% of patients (63.8% and 64.8% in Cohort 1 and Cohort 2, respectively) identified an improvement in their sP medication regimen as the top reason for the improved perception, and 30.5% of patients (31.3% and 29.6% in Cohort 1 and Cohort 2, respectively) reported an improved perception of the form or frequency of bowel movements as the top reason for improved perception of their treatment routine.

Conclusion

Patients who were switched to TEN or added TEN to a reduced PB therapy regimen reported improved experience with their sP management. The findings from this analysis show that TEN may improve patient experience with sP management regimens. Further research is needed to elucidate what factors affect a patient’s perspective of sP management.

Funding

  • Commercial Support –