Journal
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Volume 52, Issue 8, Pages 631-641Publisher
DUSTRI-VERLAG DR KARL FEISTLE
DOI: 10.5414/CP202091
Keywords
gamma-cyclodextrin; neuromuscular blockade; rocuronium; vecuronium; surgical thromboprophylaxis
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Funding
- Merck Sharp Dohme Corp.
- Merck Co., Inc.
- Whitehouse Station, NJ, USA
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Objective: To investigate the potential effect of sugammadex on anti-Xa anticoagulant activity of enoxaparin and the activated partial thromboplastin time (APTT) of unfractionated heparin (UFH). Methods: This two-part, randomized, double-blind, placebocontrolled, four-period cross-over study was performed in healthy males (18 45 years). In each period, subjects received 40 mg enoxaparin (in part 1), 5,000 units UFH (in part 2), or placebo followed by 4 or 16 mg/kg sugammadex, or placebo. Treatments were separated by >= 4 days. Primary endpoints were anti-Xa activity and APTT both time-averaged from 3 to 30 minutes post-dose. Geometric mean ratios (GMRs) and their two-sided 90% confidence limits were calculated for anticoagulant plus sugammadex (4 or 16 mg/kg) vs. anticoagulant plus placebo. The pre-specified threshold for a potential effect of clinical relevance was a 90% upper confidence limit (UCL) > 1.50. Results: In part 1 (n = 13), the 90% UCLs were 1.07 and 1.08 for GMRs of anti-Xa activity after dosing with 4 and 16 mg/kg sugammadex, respectively. In part 2 (n = 43), the 90% UCLs for GMRs of APTT were 1.06 and 1.15. Neither sugammadex dose produced a treatment effect that met the pre-specified criterion for potential clinical relevance. Treatments were generally well tolerated. Conclusions: In healthy subjects, treatment with 4 mg/kg and 16 mg/kg sugammadex did not change either anti-Xa activity or APTT to a clinically meaningful extent following pretreatments with enoxaparin or UFH.
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