Abstract: SA-PO669
Etelcalcetide from Controlled Trial to Bedside
Session Information
- Bone and Mineral Metabolism: Clinical - II
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Russo, Domenico, University Federico II, Naples, Naples, Italy
- Di giuseppe, Daniela, VENODIAL, Cava dei tirreni, Italy
- Coppola, Salvatore, P.O. Piedimonte matese, Caserta, Italy
- Di iorio, Biagio, Landolfi Hospital Solofra, Avellino, Italy, Solofra, Italy
- Guastaferro, Pasquale, Sant''Angelo dei lombardi hospital, Avellino, Italy
- Battaglia, Yuri, Hospital-University St. Anna, Ferrara, Italy
- Di Lullo, Luca, U.O.C. Nefrologia e Dialisi, Grottaferrata, Italy
- Scognamiglio, Bernadette, University Federico II, Naples, Naples, Italy
- Panuccio, Vincenzo, UO Nefrologia, Dialisi, Trapianto, Reggio Calabria, Italy
Background
Cinacalcet reduces high PTH levels (SHPT) in dialysis patients.
Relevant complaints associate cinacalcet: nausea, vomiting, hypocalcemia. Therefore, clinicians are forced to reduce dose or discontinue cinacalcet with consequent poor PTH control.
Etelcalcetide in randomized trials resulted non inferior to cinacalcet at lowering PTH. Common adverse events are hypocalcemia and gastrointestinal symptoms.
This pilot observational multicenter study was conducted to evaluate efficacy and occurrence of side effects of etelcalcetide in a “real world” setting that is different from randomized controlled trials.
Methods
Patients on thrice weekly maintenance hemodialysis, stable doses of phosphate binders, calcitriol or active vitamin D were evaluated. Investigator were free in prescriving starting dose and etelcalcetide increments. Biochemistry and side effects were recorded after etelcalcetide . Clinician’s satisfaction was evaluated by questionnaire.
Results
n.73 patients (mean age:61±13 years; males:62 %; diabetics:25 %;dialysis vintage:78±52months ) received etelcalcetide. Many patients (83%) were treated with cinacalcet (median daily dose:30 mg). Cinacalcet-dependent gastrointestinal side effect were 49%; episodes of hypocalcemia were 4. No changes were observed in phosphate binder, vitamin D sterols and ESA doses, and serum hemoglobin concentration.
Further results are reported in table.
Conclusion
The study shows that in high-risk dialysis patients, lower doses of etelcalcetide than that reported before reduce PTH with minimal gastrointestinal discomfort and low occurrence of hypocalcemia requiring drug discontinuation. The effect on PTH seems dose dependent. Almost all participating clinicians regarded etelcalcetide as very handy medication. Larger study and longer follow-up in “real world” setting are mandatory.
| *p<0.01 Vs baseline; ** p<0.02 Vs baseline | BASELINE | 30 DAYS AFTER ETELCALCETIDE | 60 DAYS AFTER ETELCALCETIDE | 90 DAYS AFTER ETELCALCETIDE |
| WEEKLY ETELCALCETIDE DOSE(mg) | 13±4 | 15±5* | 17±9* | 21±17* |
| SERUM PTH (pg/dl) | 630 (443-973) | 518(312-874) | 437(241-1173)* | 459(216-675) * |
| 30% PTH DECREASE (% OF CASES) | 45 | 65 | 71 | |
| MEDIAN SERUM CALCIUM (mg/dl) | 9,1 (8,7-9,6) | 8,7 (8,1-9,2) * | 8,9 (8,0-9,2) | 8,1 (7,2-9,0) * |
| EPISODES OF HYPOCALCEMIA DUE TO ETELCALCETIDE (≤7,5 mg/dl; percentage) | 4,0 (during therapy with cinacalcet) | 6,8** | 8,2** | 5,5** |
| ETELCALCETIDE WITHDRAWAL BY HYPOCALCEMIA (CASES) | 1 | 2 | 0 | |
| SERUM PHOSPHORUS (mg/dl; median) | 5,2 (4,4-6,0) | 5,1 (4,5-5,8) | 5,0 (3,9-6,5) | 4,4 (3,1-6,1) |
| CLINICIAN’S SATISFACTION WITH RESULTS (%) | 56 | 62 | 78 |
*p<0.01 Vs baseline; **p<0.02 Vs baseline