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Incidence of hypersensitivity and anaphylaxis with sugammadex.
J Clin Anesth. 2018 Jun; 47:67-73.JC

Abstract

STUDY OBJECTIVE

To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex.

DESIGN

Retrospective analysis.

SETTING

Sugammadex clinical development program and post-marketing experience.

PATIENTS

Surgical patients and healthy volunteers who received sugammadex or placebo/comparator with anesthesia and/or neuromuscular blockade (NMB).

INTERVENTIONS

Sugammadex administered as 2.0 mg/kg at reappearance of the second twitch, 4.0 mg/kg at 1-2 post-tetanic count, or 16.0 mg/kg at 3 min after rocuronium 1.2 mg/kg.

MEASUREMENTS

Three analytical methods were used: 1) automated MedDRA queries; 2) searches of adverse events (AEs) consistent with treatment-related hypersensitivity reactions as diagnosed by the investigator; and 3) a retrospective adjudication of AEs suggestive of hypersensitivity by a blinded, independent adjudication committee (AC). In addition, a search of all post-marketing reports of events of hypersensitivity was performed, and events were retrospectively adjudicated by an independent AC. Anaphylaxis was determined according to Sampson Criterion 1.

MAIN RESULTS

The pooled dataset included 3519 unique subjects who received sugammadex and 544 who received placebo. The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. Similarly, there was a low overall incidence of AEs of treatment-related hypersensitivity (<1%), with no differences between sugammadex and placebo or neostigmine. Finally, the retrospective adjudication of AEs suggestive of hypersensitivity showed a low incidence of hypersensitivity (0.56% and 0.21% for sugammadex 2 mg/kg and 4 mg/kg, respectively), with an incidence similar to subjects who received placebo (0.55%). There were no confirmed cases of anaphylaxis in the pooled studies. During post-marketing use, spontaneous reports of anaphylaxis occurred with approximately 0.01% of sugammadex doses.

CONCLUSIONS

Subjects who received sugammadex with general anesthesia and/or NMB had a low overall incidence of hypersensitivity, with no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine.

Authors+Show Affiliations

Merck & Co, Inc., Kenilworth, NJ, USA. Electronic address: kwan-hong.chris.min@merck.com.Merck & Co, Inc., Kenilworth, NJ, USA.Merck & Co, Inc., Kenilworth, NJ, USA.Merck & Co, Inc., Kenilworth, NJ, USA.Merck & Co, Inc., Kenilworth, NJ, USA.Merck & Co, Inc., Kenilworth, NJ, USA.Johns Hopkins Asthma & Allergy Center, Baltimore, MD, USA.Merck & Co, Inc., Kenilworth, NJ, USA.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

29621739

Citation

Min, K Chris, et al. "Incidence of Hypersensitivity and Anaphylaxis With Sugammadex." Journal of Clinical Anesthesia, vol. 47, 2018, pp. 67-73.
Min KC, Woo T, Assaid C, et al. Incidence of hypersensitivity and anaphylaxis with sugammadex. J Clin Anesth. 2018;47:67-73.
Min, K. C., Woo, T., Assaid, C., McCrea, J., Gurner, D. M., Sisk, C. M., Adkinson, F., & Herring, W. J. (2018). Incidence of hypersensitivity and anaphylaxis with sugammadex. Journal of Clinical Anesthesia, 47, 67-73. https://doi.org/10.1016/j.jclinane.2018.03.018
Min KC, et al. Incidence of Hypersensitivity and Anaphylaxis With Sugammadex. J Clin Anesth. 2018;47:67-73. PubMed PMID: 29621739.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Incidence of hypersensitivity and anaphylaxis with sugammadex. AU - Min,K Chris, AU - Woo,Tiffany, AU - Assaid,Christopher, AU - McCrea,Jacqueline, AU - Gurner,Deborah M, AU - Sisk,Christine McCrary, AU - Adkinson,Franklin, AU - Herring,W Joseph, Y1 - 2018/04/03/ PY - 2018/01/03/received PY - 2018/03/14/revised PY - 2018/03/19/accepted PY - 2018/4/6/pubmed PY - 2019/1/29/medline PY - 2018/4/6/entrez KW - Anaphylaxis KW - Hypersensitivity KW - Sugammadex SP - 67 EP - 73 JF - Journal of clinical anesthesia JO - J Clin Anesth VL - 47 N2 - STUDY OBJECTIVE: To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex. DESIGN: Retrospective analysis. SETTING: Sugammadex clinical development program and post-marketing experience. PATIENTS: Surgical patients and healthy volunteers who received sugammadex or placebo/comparator with anesthesia and/or neuromuscular blockade (NMB). INTERVENTIONS: Sugammadex administered as 2.0 mg/kg at reappearance of the second twitch, 4.0 mg/kg at 1-2 post-tetanic count, or 16.0 mg/kg at 3 min after rocuronium 1.2 mg/kg. MEASUREMENTS: Three analytical methods were used: 1) automated MedDRA queries; 2) searches of adverse events (AEs) consistent with treatment-related hypersensitivity reactions as diagnosed by the investigator; and 3) a retrospective adjudication of AEs suggestive of hypersensitivity by a blinded, independent adjudication committee (AC). In addition, a search of all post-marketing reports of events of hypersensitivity was performed, and events were retrospectively adjudicated by an independent AC. Anaphylaxis was determined according to Sampson Criterion 1. MAIN RESULTS: The pooled dataset included 3519 unique subjects who received sugammadex and 544 who received placebo. The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. Similarly, there was a low overall incidence of AEs of treatment-related hypersensitivity (<1%), with no differences between sugammadex and placebo or neostigmine. Finally, the retrospective adjudication of AEs suggestive of hypersensitivity showed a low incidence of hypersensitivity (0.56% and 0.21% for sugammadex 2 mg/kg and 4 mg/kg, respectively), with an incidence similar to subjects who received placebo (0.55%). There were no confirmed cases of anaphylaxis in the pooled studies. During post-marketing use, spontaneous reports of anaphylaxis occurred with approximately 0.01% of sugammadex doses. CONCLUSIONS: Subjects who received sugammadex with general anesthesia and/or NMB had a low overall incidence of hypersensitivity, with no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. SN - 1873-4529 UR - https://www.unboundmedicine.com/medline/citation/29621739/Incidence_of_hypersensitivity_and_anaphylaxis_with_sugammadex_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0952-8180(17)31371-5 DB - PRIME DP - Unbound Medicine ER -