Clin Drug Investig (2017) 37:873–879 DOI 10.1007/s40261-017-0547-7 ORIGINAL RESEARCH ARTICLE Effect of Degarelix, a Gonadotropin-Releasing Hormone Receptor Antagonist for the Treatment of Prostate Cancer, on Cardiac Repolarisation in a Randomised, Placebo and Active Comparator Controlled Thorough QT/QTc Trial in Healthy Men 1 1 1,2 1 ˚ • • • • Hakan Olsson Niclas Petri Lars Erichsen Anders Malmberg Lars Grundemar Published online: 28 June 2017 The Author(s) 2017. This article is an open access publication Abstract Results Time-matched, one-sided 95% upper conﬁdence Background and Objectives Degarelix is a gonadotropin- boundaries for baseline-corrected average changes from releasing hormone antagonist registered for the treatment placebo for the QT interval, corrected using the Fridericia of advanced hormone-dependent prostate cancer. Treat- method (DDQTcF), did not exceed 10 ms at any timepoint, ment causing androgen deprivation is associated with QT with maximum degarelix concentrations reaching approx- prolongation and this study investigated whether degarelix imately threefold the concentrations seen in the treatment at supratherapeutic concentrations has an intrinsic effect of prostate cancer. Furthermore, concentration-exposure per se on cardiac repolarisation and the QT interval. analysis indicated absence of any QT prolongation effects Methods This was a single-centre, randomised, crossover of degarelix. No signiﬁcant effect on any
Clinical Drug Investigation – Springer Journals
Published: Jun 28, 2017
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