The following article features coverage from the National Kidney Foundation’s 2019 Spring Clinical Meetings. Click here to read more of Renal & Urology News’ conference coverage.

In a real world study of patients with secondary hyperparathyroidism (SHPT) in 2 hemodialysis (HD) clinics, researchers demonstrated that the calcimimetic etelcalcetide can be used safely and effectively by registered dietitians and nurses following doctors’ orders, Belinda Shanley, MS, RD, from US Renal Care, reported at the National Kidney Foundation’s 2019 Spring Clinical Meetings in Boston.

She described an initial experience lasting 6 months in which 13 HD patients were switched from cinacalcet to etelcalcetide after a washout period. At baseline, all had corrected calcium values exceeding 8.3 mg/dL. Due to concerns about hypocalcemia and adynamic bone disease, patients were started cautiously at a dose of 2.5 mg etelcalcetide 3 times per week. That dose proved ineffective and was raised to 5 mg thrice weekly with incremental increases of 2.5 or 5 mg if PTH remained above 650 pg/mL.

By the end of the initial experience period, 67% of patients had PTH in the target range of 150 to 650 pg/mL and 78% had serum phosphorus between 2.5 and 5.5 mg/dL. Four patients discontinued etelcalcetide, including 2 who had persistently elevated PTH exceeding 1000 pg/mL.

At the start of a 1-year extended observation period, Shanley and colleagues reduced the serum calcium threshold for concern to less than 7.5 mg/dL. They also reinforced physician-recommended interventions, including calcium supplementation, calcium-based phosphate binders, and vitamin D sterols. Of 61 patients receiving etelcalcetide, 63.9% attained PTH targets and 70.5% serum phosphorus targets.

With respect to adverse events, 23 patients experienced episodes of decreased serum calcium, but only 2 patients had symptomatic hypocalcemia (corrected calcium 6.6 mg/dL and 7.5 mg/dL, respectively) that resolved with etelcalcetide discontinuation. Low corrected calcium was also managed by vitamin D sterols, calcium-based phosphate binders, calcium supplementation, and dialysate calcium modifications.

Gastrointestinal side effects were uncommon. Two patients had diarrhea that was managed by adjusting the etelcalcetide dose. Other adverse events reported in previous trials, such as headaches, muscle spasms, hypotension, paresthesia, and congestive heart failure, were not observed in this cohort.

In addition to their real world study, the researchers conducted 2 case studies of etelcalcetide: the first was a cinacalcet-resistant patient and the second a patient with poorly controlled SHPTdue to medication nonadherence. Both achieved in range PTH with the intravenous drug.

“With experience, we became comfortable assessing laboratory parameters to inform on etelcalcetide dosing, improving sHPT control and minimizing dose interruptions,” Shanley and her collaborators stated. “We believe that when used in accordance with the prescribing information, etelcalcetide can be safely utilized by registered dietitians and nurses following physician orders to effectively control sHPT in patients with long-term, poorly controlled sHPT when administered with counseling and guidance.”

Dietitians counseled patients on adjusting their dietary intake of phosphorus and calcium, informed them of the symptoms of hypocalcemia (paresthesia, myalgia, muscle spasms, seizures, and arrhythmias), reinforced the importance of medication adherence, and monitored patients’ laboratory values of PTH, calcium, and phosphorus.

The research was funded by Amgen, the makers of Parsabiv (etelcalcetide).

The following observations and conclusions were obtained through personal experience as a registered dietitian at a dialysis facility. These thoughts and statements are not representative of Belinda Shanley’s employer, US Renal Care.

Read more of Renal & Urology News’ coverage of NKF’s 2019 Spring Clinical Meetings by visiting the conference page.

Reference

Shanley B, Bhatt N, Omlor H. Real-world experience with etelcalcetide in the management of secondary hyperparathyroidism (sHPT) in the hemodialysis (HD) clinic. Poster presented at the National Kidney Foundation’s 2019 Spring Clinical Meetings in Boston, May 8-12, 2019. Poster 221.