A Randomized, Double-Blind, Placebo-Controlled Trial of a Highly Purified Equine F(ab)2 Antibody Black Widow Spider Antivenom - 21/03/13
, Gregory Bogdan, PhD a, Kennon Heard, MD a, b, Becki Bucher Bartelson, PhD a, Walter Garcia-Ubbelohde, MD c, Sean Bush, MD d, Tom Arnold, MD e, Richard C. Clark, MD f, Gregory W. Hendey, MD g, Christopher Holstege, MD h, Elizabeth A. Spradley, MNM a
Address for correspondence: Richard C. Dart, MD, PhDRésumé |
Study objective |
Black widow spider antivenom has never been tested in a randomized clinical trial, to our knowledge. We explore various efficacy measures for a novel F(ab)2 antivenom in patients with moderate to severe pain caused by black widow spider envenomation.
Methods |
A randomized, placebo-controlled, double-blind, clinical trial was conducted in 12 academic emergency departments. We included patients at least 10 years old with moderate to severe latrodectism. Subjects received either a single intravenous infusion of antivenom or placebo. Pain was assessed with the visual analog scale. The primary efficacy outcome was the difference in pre- and posttreatment visual analog scale score. Prospectively defined secondary outcomes included treatment failures and time to clinically important decrease in pain.
Results |
Twenty-four subjects were enrolled between October 2005 and October 2006; 13 were randomized to antivenom and 11 to placebo. The median change in visual analog scale at 150 minutes posttreatment was −50.0 mm (Interquartile Range [IQR] −67, −41 mm) in the antivenom treatment group and −46.0 mm (IQR −51, 0 mm) in the placebo treatment group (P=.14). There were 7 treatment failures (64%; 95% confidence interval 35% to 92%) in the placebo group and 3 (23%; 95% confidence interval 0.2% to 46%) in the antivenom group (P=.06). The median time to a clinically important decrease in pain after treatment was shorter in the antivenom group compared with the placebo group (30 minutes [IQR 30, 60 minutes] versus 90 minutes [IQR 30, 90 minutes]; P=.03). No serious adverse events or deaths were reported.
Conclusion |
Although the overall reduction in pain was similar for antivenom- and placebo-treated subjects, antivenom reduced pain more rapidly than placebo. No significant adverse events occurred in either group.
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| Supervising editors: Lewis S. Nelson, MD; Michael L. Callaham, MD |
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| Dr. Nelson and Dr. Callaham were the supervising editors on this article. Dr. Dart did not participate in the editorial review or decision to publish this article. |
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| Author contributions: RCD and GB conceived of the study, designed the trial, obtained research funding, and supervised the conduct of the trial and data collection. BBB provided statistical analysis. RCD, KH, and BBB drafted the article, and all authors contributed to its revision. RCD takes responsibility for the paper as a whole. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). Financial support for conduct of the trial was provided to the coordinating clinical site (Rocky Mountain Poison & Drug Center [RMPDC]) by Rare Disease Therapeutics, Nashville, TN; and Instituto Bioclon S.A. de C.V., Talapalan, Mexico. Drs. Dart, Bogdan, Heard, and Bucher Bartelson, and Ms. Spradley are employed by RMPDC and received standard salary throughout the duration of the conduct of the trial. Dr. Garcia-Ubbelohde is employed by Instituto Bioclon S.A. de C.V. and received standard salary throughout the duration of the conduct of the trial. Drs. Bush, Arnold, Clark, Hendey, and Holstege received funds from RMPDC to cover administration and procedural costs associated with the conduct of the trial at their respective investigative sites. Dr. Heard was also supported by award K08DA020573 from the National Institute on Drug Abuse. No RMPDC employee received direct compensation for their role in this trial. No funding was influenced or modified by data outcomes. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Drug Abuse or the National Institutes of Health. |
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| Publication date: Available online February 4, 2013. |
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| Please see page 459 for the Editor's Capsule Summary of this article. |
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Vol 61 - N° 4
P. 458-467 - avril 2013 Retour au numéro
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