Safety of Dalbavancin in the Treatment of Skin and Skin Structure Infections: A Pooled Analysis of Randomized, Comparative Studies

Michael W. Dunne (), George H. Talbot, Helen W. Boucher, Mark Wilcox and Sailaja Puttagunta
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Michael W. Dunne: Durata Therapeutics, Inc.
George H. Talbot: Talbot Advisors, LLC
Helen W. Boucher: Tufts Medical Center, Tufts University School of Medicine
Mark Wilcox: Leeds Teaching Hospital
Sailaja Puttagunta: Durata Therapeutics, Inc.

Drug Safety, 2016, vol. 39, issue 2, No 5, 147-157

Abstract: Abstract Introduction Dalbavancin is a new lipoglycopeptide that is active against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. It has a half-life of 14.4 days, permitting intravenous treatment of acute bacterial skin and skin structure infections without the need for daily dosing. Objective The objective of these analyses was to compare the adverse event profile of dalbavancin with that of the comparator agents in the treatment of skin and skin structure infections. Methods Data on adverse events and laboratory assessments collected from 3002 patients enrolled in seven late-stage, randomized clinical trials were analyzed for patients receiving dalbavancin or a comparator antibiotic. Results Overall adverse event rates were similar or lower for patients receiving dalbavancin (799/1778; 44.9 %) compared with those receiving comparator agents (573/1224; 46.8 %, p = 0.012). The most common treatment-emergent adverse events were nausea, headache, diarrhea, constipation, vomiting, rash, urinary tract infection, pruritus, and insomnia. The duration and timing of the onset of adverse events were similar for patients receiving dalbavancin relative to the comparators. Conclusion Dalbavancin exhibits a favorable overall safety profile for treatment of acute bacterial skin and skin structure infections due to Gram-positive bacteria.

Date: 2016
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DOI: 10.1007/s40264-015-0374-9

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