Topical Retapamulin Ointment, 1%, versus Sodium Fusidate Ointment, 2%, for Impetigo: A Randomized, Observer-Blinded, Noninferiority StudyOranje A.P. · Chosidow O. · Sacchidanand S. · Todd G. · Singh K. · Scangarella N. · Shawar R. · Twynholm M.
aDepartment of Dermatology and Venereology (Pediatric Dermatology), Erasmus MC, University Medical Center/Sophia Children’s Hospital, Rotterdam, The Netherlands; bDepartment of Dermatology and Allergy, AP-HP, Université Pierre et Marie Curie, Hôpital Tenon, Paris, France; cDepartment of Dermatology and STD, Victoria Hospital, Bangalore, India; dDivision of Dermatology, University of Cape Town, Cape Town, South Africa; eGlaxoSmithKline, Collegeville, Pa., USA; fGlaxoSmithKline, Greenford, UK
Background: Retapamulin is a novel pleuromutilin antibacterial developed for topical use. Objective: To compare the efficacy and safety of retapamulin ointment, 1% (twice daily for 5 days), with sodium fusidate ointment, 2% (3 times daily for 7 days), in impetigo. Methods: A randomized (2:1 retapamulin to sodium fusidate), observer-blinded, noninferiority, phase III study in 519 adult and pediatric (aged ≧9 months) subjects. Results: Retapamulin and sodium fusidate had comparable clinical efficacies (per-protocol population: 99.1 and 94.0%, respectively; difference: 5.1%, 95% confidence interval: 1.1–9.0%, p = 0.003; intent-to-treat population: 94.8 and 90.1%, respectively; difference: 4.7%, 95% confidence interval: –0.4 to 9.7%, p = 0.062). Bacteriological efficacies were similar. Success rates in the small numbers of sodium-fusidate-, methicillin- and mupirocin-resistant Staphylococcus aureus were good for retapamulin (9/9, 8/8 and 6/6, respectively). Both drugs were well tolerated. Conclusion: Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies.
Prof. Arnold P. Oranje
Department of Dermatology and Venereology (Pediatric Dermatology) Erasmus MC, University Medical Center/Sophia Children’s Hospital
Dr. Molewaterplein 40, NL–3015 CE Rotterdam (The Netherlands)
Tel. +31 6 5331 6268, Fax +31 10 463 6707, E-Mail firstname.lastname@example.org
O.C. is a consultant for GlaxoSmithKline and has received educational and travel grants from Leo Pharmaceuticals. G.T. received departmental funds as a principal investigator of one study center. K.S., N.S., R.S. and M.T. are GlaxoSmithKline Pharmaceutical Company employees. A.P.O. and S.S. declare that they have no conflict of interest.
Received: July 27, 2007
Accepted: August 21, 2007
Number of Print Pages : 10
Number of Figures : 2, Number of Tables : 6, Number of References : 34
Vol. 215, No. 4, Year 2007 (Cover Date: October 2007)
Journal Editor: Saurat, J.-H. (Geneva)
ISSN: 1018–8665 (print), 1421–9832 (Online)
For additional information: http://www.karger.com/DRM