1334. An Analysis of the Safety Profile of Dalbavancin from the Phase 2/3 Clinical Program
Session: Poster Abstract Session: Clinical Trials
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • ISS_Poster_FINAL_IDSA.pdf (77.8 kB)
  • Background:

    Dalbavancin is a lipoglycopeptide antibiotic with activity against Gram-positive pathogens and a long half-life allowing for intermittent weekly dosing.  Over the last ten years, nine phase two or three clinical trials have been performed for treatment of skin or catheter associated infections. 

    Methods:

    We analyzed the safety data obtained from all phase 2 and phase 3 clinical trials of dalbavancin. 

    Results:

    Dalbavancin

    Comparator

    P value

    (N=1778)

    (N=1224)

     

    Number (%) of patients with >1 AE1

    799 (44.9%)

    573 (46.8%)

    0.012

    Number (%) of patients with >1 Tx-related AE1

    328 (18.4%)

    246 (20.1%)

    0.014

    Number (%) with >1 serious AE

    109 (6.1%)

    80 (6.5%)

     

    Number (%) with >1 serious Tx- related AE

    3 (0.2%)

    9 (0.7%)

     

    Total number of AE’s

    2386

    1739

     

    Total number of Tx-related AE’s2

    566 (23.7%)

    459 (26.4%)

    0.0004

    Total number of serious AE’s

    135 (5.7%)

    100 (5.8%)

     

    Total number of serious Tx-related AE’s

    3 (0.1%)

    9 (0.5%)

     

    1Cochran-Mantel-Haenszel analysis p, adjusted for study;

    2 lognormal, Poisson regression model adjusted by study on total number of Tx-related AE’s per patient

    Treatment related adverse events occurring at >1% on either dalbavancin or the comparator included nausea (2.8% vs. 3.3%), diarrhea (2.5% vs. 3.7%), headache (1.5% vs. 1.6%), elevated gamma-glutamyl transferase (1.1% vs. 1.0%), rash (1.0% vs. 1.1%), vomiting (1.0% vs. 0.9%) and pruritus (0.6%vs 1.9%). The median duration of an adverse event on dalbavancin was 3.0 days vs. 4.0 days on the comparator.

    Conclusion:

    Dalbavancin was well tolerated in patients enrolled in the phase 2/3 clinical program with fewer overall treatment related adverse events and a duration of any adverse event, on average, no longer than that of the comparator.

    Michael Dunne, MD, Durata Therapeutics, Inc., Branford, CT, Anita Das, PhD, Inclin, San Francisco, CA and Sailaja Puttagunta, MD, Durata Therapeutics, Branford, CT

    Disclosures:

    M. Dunne, Durata Therapeutics: Employee and Shareholder, Salary

    A. Das, Durata Therapeutics: Consultant, Consulting fee

    S. Puttagunta, Durata Therapeutics: Employee, Salary

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