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Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study.
Nephrol Dial Transplant. 2012 Aug; 27(8):3270-8.ND

Abstract

BACKGROUND

Optimal treatment for secondary hyperparathyroidism (SHPT) has not been defined. The IMPACT SHPT (ClinicalTrials.gov identifier: NCT00977080) study assessed whether dose-titrated paricalcitol plus supplemental cinacalcet only for hypercalcaemia is superior to cinacalcet plus low-dose vitamin D in controlling intact parathyroid hormone (iPTH) levels in patients with SHPT on haemodialysis.

METHODS

In this 28-week, multicentre, open-label Phase 4 study, participants were randomly selected to receive paricalcitol or cinacalcet plus low-dose vitamin D. Randomization and analyses were stratified by mode of paricalcitol administration [intravenous (IV) or oral]. The primary efficacy end point was the proportion of subjects who achieved a mean iPTH value of 150-300 pg/mL during Weeks 21-28.

RESULTS

Of 272 subjects randomized, 268 received one or more dose of study drug; 101 in the IV and 110 in the oral stratum with two or more values during Weeks 21-28 were included in the primary analysis. In the IV stratum, 57.7% of subjects in the paricalcitol versus 32.7% in the cinacalcet group (P = 0.016) achieved the primary end point. In the oral stratum, the corresponding proportions of subjects were 54.4% for paricalcitol and 43.4% for cinacalcet (P = 0.260). Cochran-Mantel-Haenszel analysis, controlling for stratum, revealed overall superiority of paricalcitol (56.0%) over cinacalcet (38.2%; P = 0.010) in achieving iPTH 150-300 pg/mL during Weeks 21-28. Hypercalcaemia occurred in 4 (7.7%) and 0 (0%) of paricalcitol-treated subjects in the IV and oral strata, respectively. Hypocalcaemia occurred in 46.9% and 54.7% of cinacalcet-treated subjects in the IV and oral strata, respectively.

CONCLUSION

Paricalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia.

Authors+Show Affiliations

Division of Nephrology, Klinikum Coburg, Coburg, Germany. markus.ketteler@klinikum-coburg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22387567

Citation

Ketteler, Markus, et al. "Paricalcitol Versus Cinacalcet Plus Low-dose Vitamin D Therapy for the Treatment of Secondary Hyperparathyroidism in Patients Receiving Haemodialysis: Results of the IMPACT SHPT Study." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 27, no. 8, 2012, pp. 3270-8.
Ketteler M, Martin KJ, Wolf M, et al. Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant. 2012;27(8):3270-8.
Ketteler, M., Martin, K. J., Wolf, M., Amdahl, M., Cozzolino, M., Goldsmith, D., Sharma, A., Marx, S., & Khan, S. (2012). Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 27(8), 3270-8. https://doi.org/10.1093/ndt/gfs018
Ketteler M, et al. Paricalcitol Versus Cinacalcet Plus Low-dose Vitamin D Therapy for the Treatment of Secondary Hyperparathyroidism in Patients Receiving Haemodialysis: Results of the IMPACT SHPT Study. Nephrol Dial Transplant. 2012;27(8):3270-8. PubMed PMID: 22387567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. AU - Ketteler,Markus, AU - Martin,Kevin J, AU - Wolf,Myles, AU - Amdahl,Michael, AU - Cozzolino,Mario, AU - Goldsmith,David, AU - Sharma,Amit, AU - Marx,Steven, AU - Khan,Samina, Y1 - 2012/03/02/ PY - 2012/3/6/entrez PY - 2012/3/6/pubmed PY - 2013/1/12/medline SP - 3270 EP - 8 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 27 IS - 8 N2 - BACKGROUND: Optimal treatment for secondary hyperparathyroidism (SHPT) has not been defined. The IMPACT SHPT (ClinicalTrials.gov identifier: NCT00977080) study assessed whether dose-titrated paricalcitol plus supplemental cinacalcet only for hypercalcaemia is superior to cinacalcet plus low-dose vitamin D in controlling intact parathyroid hormone (iPTH) levels in patients with SHPT on haemodialysis. METHODS: In this 28-week, multicentre, open-label Phase 4 study, participants were randomly selected to receive paricalcitol or cinacalcet plus low-dose vitamin D. Randomization and analyses were stratified by mode of paricalcitol administration [intravenous (IV) or oral]. The primary efficacy end point was the proportion of subjects who achieved a mean iPTH value of 150-300 pg/mL during Weeks 21-28. RESULTS: Of 272 subjects randomized, 268 received one or more dose of study drug; 101 in the IV and 110 in the oral stratum with two or more values during Weeks 21-28 were included in the primary analysis. In the IV stratum, 57.7% of subjects in the paricalcitol versus 32.7% in the cinacalcet group (P = 0.016) achieved the primary end point. In the oral stratum, the corresponding proportions of subjects were 54.4% for paricalcitol and 43.4% for cinacalcet (P = 0.260). Cochran-Mantel-Haenszel analysis, controlling for stratum, revealed overall superiority of paricalcitol (56.0%) over cinacalcet (38.2%; P = 0.010) in achieving iPTH 150-300 pg/mL during Weeks 21-28. Hypercalcaemia occurred in 4 (7.7%) and 0 (0%) of paricalcitol-treated subjects in the IV and oral strata, respectively. Hypocalcaemia occurred in 46.9% and 54.7% of cinacalcet-treated subjects in the IV and oral strata, respectively. CONCLUSION: Paricalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/22387567/Paricalcitol_versus_cinacalcet_plus_low_dose_vitamin_D_therapy_for_the_treatment_of_secondary_hyperparathyroidism_in_patients_receiving_haemodialysis:_results_of_the_IMPACT_SHPT_study_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfs018 DB - PRIME DP - Unbound Medicine ER -