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[Cinacalcet in patients on peritoneal dialysis with moderate to severe hyperparathyroidism resistant to conventional
J Portolés1, A Tato, P López-Sánchez
1Servicio de Nefrología, Hospital Universitario Fundación Alcorcón, Madrid, España. jmportoles@fhalcorcon.es
Insights
Cinacalcet effectively manages severe hyperparathyroidism (HPTH) in peritoneal dialysis (PD) patients, improving target achievement safely. This study shows significant reductions in PTH levels and better control of calcium and phosphorus in PD patients resistant to conventional treatments.
Area of Science:
- Nephrology
- Endocrinology
- Pharmacology
Background:
- Cinacalcet is established for hyperparathyroidism (HPTH) in hemodialysis patients.
- Limited research exists on Cinacalcet's efficacy in peritoneal dialysis (PD) patients with HPTH.
- Severe HPTH in PD patients often requires advanced treatment strategies.
Purpose of the Study:
- To assess Cinacalcet's effectiveness in achieving optimal and suboptimal treatment targets for HPTH in PD patients.
- To evaluate the safety profile of Cinacalcet in this patient population.
- To determine the mean time to reach therapeutic targets and analyze economic costs.
Main Methods:
- Prospective, open-label study including 18 PD patients with severe HPTH resistant to conventional therapy.
- Patients received oral Cinacalcet, initiated at 30 mg/day, with monthly titration.
- Kaplan-Meier survival analysis was used to estimate time to reach predefined PTH, calcium, phosphorus, and calcium-phosphorus product targets.
Main Results:
- Significant improvements in PTH levels were observed, with 66.7% achieving PTH < 350 pg/ml by month 3 and 100% by 1 year.
- Achievement of an aggregate of suboptimal targets (PTH, calcium, phosphorus, CaxP) reached 66.7% after 1 year.
- Mean time to reach PTH target was 2.33 months; mean time for all targets was 16.94 months. Cinacalcet was well-tolerated.
Conclusions:
- Adding Cinacalcet to conventional treatment significantly improves target achievement in PD patients with resistant HPTH.
- Cinacalcet demonstrates a favorable safety profile in this cohort.
- The study supports Cinacalcet as a valuable therapeutic option for managing HPTH in PD patients.
Background:
Cinacalcet has improved the management of hyperparathiroidism (HPTH) in hemodialysis. To our knowledge there are no specific studies on peritoneal dialysis (PD).
Aim:
The aim of the present study was to evaluate the efficacy of Cinacalcet on the achievement of optimal and suboptimal targets on treatment of hyperparathiroidism (HPTH) in PD patients. As secondary objectives we have studied the safety of treatment and estimate the mean time to reach these targets, and evaluate economic cost.
Methods:
Eighteen patients undergoing more than 4 months on PD with a severe HPTH (PTH > 500 pg/ml) resistant to conventional treatment with diet, chelants and vitamin D were included in this prospective open-label study. We have used the targets of K/DOQITM-clinical guidelines as optimal target. We have selected as suboptimal targets: PTH < 350 pg/ml, phosphorus < 6 mg/dl and calcium < 10.4 mg/dl (only when simultaneous CaxP was under 55 mg2/dl2). Oral Cinacalcet was given with main meal in a single daily start dose of 30 mg and titrated thereafter monthly. We considered the first value on target as an event and used a Kaplan-Meyer survival analysis to estimate mean time to reach target.
Results:
On inclusion all patients have at least two previous PTH values over 500 pg/ml, PTH mean 695,3 (SD 96) and they were on PD with an appropriate efficacy during a mean of 15.56 months (SD 0.78). Mean follow-up time under Cinacalcet treatment was 12 months. The percentage of patients with a PTH under 350 pg/ml was 66,7% on month 3, 60% on month 6 and 100% after 1 year. The percentage of patients that reach an aggregate of all suboptimal targets (PTH< 350 pg/ml and calcium < 10.4 mg/dl and phosphorus< 6 mg/dl and CaxP < 55 mg2/dl2) was 33.3% on month 6 and 66.7% after 1 year. The mean time to reach PTH target was 2.33 months with a 95% confident interval [1.35-3.32] and to reach the aggregate of all target was 16.94 months [11.38-22.5]. Cinacalcet has been well tolerated, we reduced the dose in a single patient due to secondary effects, but treatment was not discontinued in any case.
Conclusion:
In summary the addition of Cinacalcet to conventional treatment in PD patients with resistant HPTH has improved the achievement of targets, and has been reasonably safe in our patients.
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