Keitaro Yokoyama1, Masafumi Fukagawa2, Takashi Shigematsu3, Takashi Akiba4, Ken Yoshikawa5, Akira Tsuchiya5, Misato Kuwabara5, Tadao Akizawa6. 1. Harumi Triton Clinic, The Jikei University Hospital, 1-8-8 Harumi, Chuo-ku, Tokyo, 104-0053, Japan. keitaro@jikei.ac.jp. 2. Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan. 3. Department of Nephrology, Wakayama Medical University, Wakayama, Japan. 4. Tokyo Next Nephrology and Dialysis Clinic, Tokyo, Japan. 5. Department of Pharmacovigilance, Drug Reliability Assurance, ONO Pharmaceutical Co., Ltd., Osaka, Japan. 6. Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: Etelcalcetide is a second-generation calcimimetic for the management of secondary hyperparathyroidism (SHPT) in patients on dialysis. We performed a post-marketing surveillance (PMS) to obtain information on the safety and efficacy of etelcalcetide in clinical practice in Japan. METHODS: This PMS enrolled SHPT patients who started initial treatment with etelcalcetide between April 1, 2017 and February 28, 2018 in Japan. Safety [adverse drug reactions (ADRs)] and efficacy [serum intact parathyroid hormone (iPTH), corrected calcium (cCa), phosphorous (P), and alkaline phosphatase (ALP)] were recorded for up to 52 weeks or until treatment discontinuation. Treatment decisions were at the physician's discretion. RESULTS: Of 1226 patients enrolled across 282 centers, safety and efficacy data were available for 1195 and 1192, respectively, while 933 continued treatment to Week 52. The starting dose was 5 mg in 82.0% of patients. There were 218 ADRs in 169 patients (14.1%). Metabolism and nutrition disorders (8.8%), adverse laboratory test results (1.8%), and gastrointestinal disorders (1.6%) were the most frequent classes of ADRs. Hypocalcemia-related ADRs occurred in 104 patients (8.7%). The percentage of patients with iPTH levels within the target range (60-240 pg/mL) steadily increased from 19.5% at Week 0 to 64.1% at Week 52 or last dose. cCa, P, and ALP levels remained well controlled. CONCLUSION: This was the first real-world, large-scale, long-term observational PMS of etelcalcetide in Japan. We did not observe any new safety concerns. Etelcalcetide was associated with clinically relevant improvements in serum iPTH and maintenance of serum cCa, P, and ALP levels.
BACKGROUND:Etelcalcetide is a second-generation calcimimetic for the management of secondary hyperparathyroidism (SHPT) in patients on dialysis. We performed a post-marketing surveillance (PMS) to obtain information on the safety and efficacy of etelcalcetide in clinical practice in Japan. METHODS: This PMS enrolled SHPT patients who started initial treatment with etelcalcetide between April 1, 2017 and February 28, 2018 in Japan. Safety [adverse drug reactions (ADRs)] and efficacy [serum intact parathyroid hormone (iPTH), corrected calcium (cCa), phosphorous (P), and alkaline phosphatase (ALP)] were recorded for up to 52 weeks or until treatment discontinuation. Treatment decisions were at the physician's discretion. RESULTS: Of 1226 patients enrolled across 282 centers, safety and efficacy data were available for 1195 and 1192, respectively, while 933 continued treatment to Week 52. The starting dose was 5 mg in 82.0% of patients. There were 218 ADRs in 169 patients (14.1%). Metabolism and nutrition disorders (8.8%), adverse laboratory test results (1.8%), and gastrointestinal disorders (1.6%) were the most frequent classes of ADRs. Hypocalcemia-related ADRs occurred in 104 patients (8.7%). The percentage of patients with iPTH levels within the target range (60-240 pg/mL) steadily increased from 19.5% at Week 0 to 64.1% at Week 52 or last dose. cCa, P, and ALP levels remained well controlled. CONCLUSION: This was the first real-world, large-scale, long-term observational PMS of etelcalcetide in Japan. We did not observe any new safety concerns. Etelcalcetide was associated with clinically relevant improvements in serum iPTH and maintenance of serum cCa, P, and ALP levels.
Authors: Benjamin Wu; Murad Melhem; Raju Subramanian; Ping Chen; Bethlyn Jaramilla Sloey; Bruno Fouqueray; M Benjamin Hock; Gary L Skiles; Andrew T Chow; Edward Lee Journal: J Clin Pharmacol Date: 2018-03-13 Impact factor: 3.126
Authors: Mark D Jäger; Michaela Serttas; Jan Beneke; Jörg A Müller; Harald Schrem; Alexander Kaltenborn; Wolf Ramackers; Bastian P Ringe; Jill Gwiasda; Wolfgang Tränkenschuh; Jürgen Klempnauer; Georg F W Scheumann Journal: PLoS One Date: 2017-10-17 Impact factor: 3.240