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Dose determination of cinacalcet hydrochloride in Japanese hemodialysis patients with secondary hyperparathyroidism.
Ther Apher Dial. 2008 Apr; 12(2):117-25.TA

Abstract

Cinacalcet hydrochloride is a calcimimetic agent that activates the calcium-sensing receptor on the surface of parathyroid cells and inhibits parathyroid hormone (PTH) secretion. To manage secondary hyperparathyroidism, cinacalcet, which lowers PTH levels without increasing serum calcium, phosphorus and calcium-phosphorus product (Ca x P) levels, may provide a new potential therapy. To identify the optimal starting dose of cinacalcet for Japanese hemodialysis patients with secondary hyperparathyroidism, this double-blind, placebo-controlled, parallel, dose-finding study was conducted. One hundred and twenty Japanese hemodialysis patients with intact PTH levels greater than or equal to 300 pg/mL were randomized into four groups: placebo, and 12.5, 25 and 50 mg of cinacalcet. The treatment period was three weeks followed by a two-week follow-up observation period. Cinacalcet decreased serum intact PTH levels in a dose-dependent manner, and also decreased serum calcium, phosphorus, Ca x P, tartrate-resistant acid phosphatase and osteocalcin levels. The treatment with cinacalcet was generally well tolerated in this study. However, the incidence of treatment-related adverse events, such as gastrointestinal disorders and hypocalcemia, and the rate of withdrawal from the study due to treatment-related adverse events were higher in the 50 mg dose group than in the other groups. On the basis of both efficacy and safety results, 25 mg has been identified as the optimal starting dose of cinacalcet for Japanese hemodialysis patients with secondary hyperparathyroidism.

Authors+Show Affiliations

Department of Blood Purification and Internal Medicine, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan. takiba@kc.twmu.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18387159

Citation

Akiba, Takashi, et al. "Dose Determination of Cinacalcet Hydrochloride in Japanese Hemodialysis Patients With Secondary Hyperparathyroidism." Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy, vol. 12, no. 2, 2008, pp. 117-25.
Akiba T, Akizawa T, Tsukamoto Y, et al. Dose determination of cinacalcet hydrochloride in Japanese hemodialysis patients with secondary hyperparathyroidism. Ther Apher Dial. 2008;12(2):117-25.
Akiba, T., Akizawa, T., Tsukamoto, Y., Uchida, E., Iwasaki, M., & Koshikawa, S. (2008). Dose determination of cinacalcet hydrochloride in Japanese hemodialysis patients with secondary hyperparathyroidism. Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy, 12(2), 117-25. https://doi.org/10.1111/j.1744-9987.2008.00556.x
Akiba T, et al. Dose Determination of Cinacalcet Hydrochloride in Japanese Hemodialysis Patients With Secondary Hyperparathyroidism. Ther Apher Dial. 2008;12(2):117-25. PubMed PMID: 18387159.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose determination of cinacalcet hydrochloride in Japanese hemodialysis patients with secondary hyperparathyroidism. AU - Akiba,Takashi, AU - Akizawa,Tadao, AU - Tsukamoto,Yusuke, AU - Uchida,Eiji, AU - Iwasaki,Manabu, AU - Koshikawa,Shozo, AU - ,, PY - 2008/4/5/pubmed PY - 2008/5/10/medline PY - 2008/4/5/entrez SP - 117 EP - 25 JF - Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy JO - Ther Apher Dial VL - 12 IS - 2 N2 - Cinacalcet hydrochloride is a calcimimetic agent that activates the calcium-sensing receptor on the surface of parathyroid cells and inhibits parathyroid hormone (PTH) secretion. To manage secondary hyperparathyroidism, cinacalcet, which lowers PTH levels without increasing serum calcium, phosphorus and calcium-phosphorus product (Ca x P) levels, may provide a new potential therapy. To identify the optimal starting dose of cinacalcet for Japanese hemodialysis patients with secondary hyperparathyroidism, this double-blind, placebo-controlled, parallel, dose-finding study was conducted. One hundred and twenty Japanese hemodialysis patients with intact PTH levels greater than or equal to 300 pg/mL were randomized into four groups: placebo, and 12.5, 25 and 50 mg of cinacalcet. The treatment period was three weeks followed by a two-week follow-up observation period. Cinacalcet decreased serum intact PTH levels in a dose-dependent manner, and also decreased serum calcium, phosphorus, Ca x P, tartrate-resistant acid phosphatase and osteocalcin levels. The treatment with cinacalcet was generally well tolerated in this study. However, the incidence of treatment-related adverse events, such as gastrointestinal disorders and hypocalcemia, and the rate of withdrawal from the study due to treatment-related adverse events were higher in the 50 mg dose group than in the other groups. On the basis of both efficacy and safety results, 25 mg has been identified as the optimal starting dose of cinacalcet for Japanese hemodialysis patients with secondary hyperparathyroidism. SN - 1744-9987 UR - https://www.unboundmedicine.com/medline/citation/18387159/Dose_determination_of_cinacalcet_hydrochloride_in_Japanese_hemodialysis_patients_with_secondary_hyperparathyroidism_ L2 - https://doi.org/10.1111/j.1744-9987.2008.00556.x DB - PRIME DP - Unbound Medicine ER -