Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: Summary of safety analysis from the phase 3 SOLO studies

SOLO I and SOLO II Investigators

    Research output: Contribution to journalArticlepeer-review

    11 Scopus citations

    Abstract

    Oritavancin is a lipoglycopeptide with bactericidal activity against Grampositive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow single-dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating the efficacy and safety of a single 1, 200-mg intravenous (i.v.) dose of oritavancin versus twice-daily i.v. vancomycin for 7 to 10 days in ABSSSI patients. Safety data from both studies were pooled for safety analysis. The database comprised pooled safety data for 976 oritavancin-treated patients and 983 vancomycintreated patients. The incidences of adverse events, serious adverse events, and discontinuations due to adverse events were similar for oritavancin (55.3, 5.8, and 3.7%, respectively) and vancomycin (56.9, 5.9, and 4.2%, respectively). The median time to onset (3.8 days versus 3.1 days, respectively) and the duration (3.0 days for both groups) of adverse events were also similar between the two groups. The most frequently reported events were nausea, headache, and vomiting. Greater than 90% of all events were mild or moderate in severity. There were slightly more infections and infestations, abscesses or cellulitis, and hepatic and cardiac adverse events in the oritavancin group; however, more than 80% of these events were mild or moderate. Subgroup analyses did not identify clinically meaningful differences in the incidence of adverse events attributed to oritavancin. A single 1, 200-mg dose of oritavancin was well tolerated and had a safety profile similar to that of twice-daily vancomycin. The long elimination half-life of oritavancin compared to that of vancomycin did not result in a clinically meaningful delay to the onset or prolongation of adverse events.

    Original languageEnglish
    Article numbere01919-17
    JournalAntimicrobial Agents and Chemotherapy
    Volume62
    Issue number4
    DOIs
    StatePublished - 1 Apr 2018

    Keywords

    • 60-day safety follow-up
    • Clinical safety
    • Elimination half-life
    • Single dose
    • Single-dose treatment

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)
    • Infectious Diseases

    Fingerprint

    Dive into the research topics of 'Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: Summary of safety analysis from the phase 3 SOLO studies'. Together they form a unique fingerprint.

    Cite this