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Outcomes of cinacalcet withdrawal in Australian dialysis patients.
Intern Med J. 2019 Jan; 49(1):48-54.IM

Abstract

BACKGROUND

Secondary hyperparathyroidism (SHPT) in chronic kidney disease is associated with cardiovascular and bone pathology. Measures to achieve parathyroid hormone (PTH) target values and control biochemical abnormalities associated with SHPT require complex therapies, and severe SHPT often requires parathyroidectomy or the calcimimetic cinacalcet. In Australia, cinacalcet was publicly funded for dialysis patients from 2009 to 2015 when funding was withdrawn following publication of the EVOLVE study, which resulted in most patients on cinacalcet ceasing therapy. We examined the clinical and biochemical outcomes associated with this change at Australian renal centres.

AIM

To assess changes to biochemical and clinical outcomes in dialysis patients following cessation of cinacalcet.

METHODS

We conducted a retrospective study of dialysis patients who ceased cinacalcet after August 2015 in 11 Australian units. Clinical outcomes and changes in biochemical parameters were assessed over a 24- and 12-month period, respectively, from cessation of cinacalcet.

RESULTS

A total of 228 patients was included (17.7% of all dialysis patients from the units). Patients were aged 63 ± 15 years with 182 patients on haemodialysis and 46 on peritoneal dialysis. Over 24 months following cessation of cinacalcet, we observed 26 parathyroidectomies, 3 episodes of calciphylaxis, 8 fractures and 50 deaths. Eight patients recommenced cinacalcet, meeting criteria under a special access scheme. Biochemical changes from baseline to 12 months after cessation included increased levels of serum PTH from 54 (interquartile range 27-90) pmol/L to 85 (interquartile range 41-139) pmol/L (P < 0.0001), serum calcium from 2.3 ± 0.2 mmol/L to 2.5 ± 0.1 mmol/L (P < 0.0001) and alkaline phosphatase from 123 (92-176) IU/L to 143 (102-197) IU/L (P < 0.0001).

CONCLUSION

Significant increases in serum PTH, calcium and alkaline phosphatase occurred over a 12-month period following withdrawal of cinacalcet. Longer-term follow up will determine if these biochemical and therapeutic changes are associated with altered rates of parathyroidectomies and cardiovascular mortality and morbidity.

Authors+Show Affiliations

Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia. Department of Medicine (RMH), The University of Melbourne, Melbourne, Victoria, Australia.Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia. Department of Medicine (RMH), The University of Melbourne, Melbourne, Victoria, Australia.Department of Nephrology, Royal Hobart Hospital, Hobart, Tasmania, Australia.Department of Nephrology, Royal Hobart Hospital, Hobart, Tasmania, Australia.Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.Department of Nephrology, Sunshine Coast Hospital University Hospital, Sunshine Coast, Queensland, Australia.Department of Nephrology, Sunshine Coast Hospital University Hospital, Sunshine Coast, Queensland, Australia.Department of Nephrology, Canberra Hospital, Canberra, Australian Capital Territory, Australia.Department of Nephrology, Western Health, Melbourne, Victoria, Australia. Department of Medicine, Western Health, Melbourne, Victoria, Australia. Western Health Chronic Disease Alliance, Melbourne, Victoria, Australia.Department of Nephrology, St Vincent's Health, Melbourne, Victoria, Australia.Department of Nephrology, St Vincent's Health, Melbourne, Victoria, Australia.Department of Nephrology, Westmead Hospital, Sydney, New South Wales, Australia.Department of Nephrology, Westmead Hospital, Sydney, New South Wales, Australia. Osteoporosis and Bone Biology Division, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.Department of Nephrology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia. Department of Medicine (RMH), The University of Melbourne, Melbourne, Victoria, Australia.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

29992701

Citation

Ruderman, Irene, et al. "Outcomes of Cinacalcet Withdrawal in Australian Dialysis Patients." Internal Medicine Journal, vol. 49, no. 1, 2019, pp. 48-54.
Ruderman I, Holt SG, Kirkland GS, et al. Outcomes of cinacalcet withdrawal in Australian dialysis patients. Intern Med J. 2019;49(1):48-54.
Ruderman, I., Holt, S. G., Kirkland, G. S., Maslen, S., Hawley, C. M., Oliver, V., Krishnasamy, R., Gray, N. A., Talaulikar, G. S., Nelson, C. L., Rajaram, Y., Gock, H., Au, E., Elder, G. J., Mainra, R., & Toussaint, N. D. (2019). Outcomes of cinacalcet withdrawal in Australian dialysis patients. Internal Medicine Journal, 49(1), 48-54. https://doi.org/10.1111/imj.14036
Ruderman I, et al. Outcomes of Cinacalcet Withdrawal in Australian Dialysis Patients. Intern Med J. 2019;49(1):48-54. PubMed PMID: 29992701.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Outcomes of cinacalcet withdrawal in Australian dialysis patients. AU - Ruderman,Irene, AU - Holt,Stephen G, AU - Kirkland,Geoffrey S, AU - Maslen,Sophie, AU - Hawley,Carmel M, AU - Oliver,Veronica, AU - Krishnasamy,Rathika, AU - Gray,Nicholas A, AU - Talaulikar,Girish S, AU - Nelson,Craig L, AU - Rajaram,Yogeshwar, AU - Gock,Hilton, AU - Au,Eric, AU - Elder,Grahame J, AU - Mainra,Rahul, AU - Toussaint,Nigel D, PY - 2018/04/19/received PY - 2018/06/30/accepted PY - 2018/7/12/pubmed PY - 2019/9/21/medline PY - 2018/7/12/entrez KW - cinacalcet KW - dialysis KW - end-stage kidney disease KW - parathyroid hormone KW - secondary hyperparathyroidism SP - 48 EP - 54 JF - Internal medicine journal JO - Intern Med J VL - 49 IS - 1 N2 - BACKGROUND: Secondary hyperparathyroidism (SHPT) in chronic kidney disease is associated with cardiovascular and bone pathology. Measures to achieve parathyroid hormone (PTH) target values and control biochemical abnormalities associated with SHPT require complex therapies, and severe SHPT often requires parathyroidectomy or the calcimimetic cinacalcet. In Australia, cinacalcet was publicly funded for dialysis patients from 2009 to 2015 when funding was withdrawn following publication of the EVOLVE study, which resulted in most patients on cinacalcet ceasing therapy. We examined the clinical and biochemical outcomes associated with this change at Australian renal centres. AIM: To assess changes to biochemical and clinical outcomes in dialysis patients following cessation of cinacalcet. METHODS: We conducted a retrospective study of dialysis patients who ceased cinacalcet after August 2015 in 11 Australian units. Clinical outcomes and changes in biochemical parameters were assessed over a 24- and 12-month period, respectively, from cessation of cinacalcet. RESULTS: A total of 228 patients was included (17.7% of all dialysis patients from the units). Patients were aged 63 ± 15 years with 182 patients on haemodialysis and 46 on peritoneal dialysis. Over 24 months following cessation of cinacalcet, we observed 26 parathyroidectomies, 3 episodes of calciphylaxis, 8 fractures and 50 deaths. Eight patients recommenced cinacalcet, meeting criteria under a special access scheme. Biochemical changes from baseline to 12 months after cessation included increased levels of serum PTH from 54 (interquartile range 27-90) pmol/L to 85 (interquartile range 41-139) pmol/L (P < 0.0001), serum calcium from 2.3 ± 0.2 mmol/L to 2.5 ± 0.1 mmol/L (P < 0.0001) and alkaline phosphatase from 123 (92-176) IU/L to 143 (102-197) IU/L (P < 0.0001). CONCLUSION: Significant increases in serum PTH, calcium and alkaline phosphatase occurred over a 12-month period following withdrawal of cinacalcet. Longer-term follow up will determine if these biochemical and therapeutic changes are associated with altered rates of parathyroidectomies and cardiovascular mortality and morbidity. SN - 1445-5994 UR - https://wwww.unboundmedicine.com/medline/citation/29992701/Outcomes_of_cinacalcet_withdrawal_in_Australian_dialysis_patients_ DB - PRIME DP - Unbound Medicine ER -