Topical Retapamulin Ointment, 1%, versus Sodium Fusidate Ointment, 2%, for Impetigo: A Randomized, Observer-Blinded, Noninferiority Study
2007; Karger Publishers; Volume: 215; Issue: 4 Linguagem: Inglês
10.1159/000107776
ISSN1421-9832
AutoresArnold P. Oranje, O. Chosidow, Sarvajnamurthy Sacchidanand, Gail Todd, Krishan Singh, Nicole Scangarella, Ribhi M. Shawar, Monique Twynholm,
Tópico(s)Bartonella species infections research
Resumo<i>Background:</i> Retapamulin is a novel pleuromutilin antibacterial developed for topical use. <i>Objective:</i> 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. <i>Methods:</i> A randomized (2:1 retapamulin to sodium fusidate), observer-blinded, noninferiority, phase III study in 519 adult and pediatric (aged ≧9 months) subjects. <i>Results:</i> 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 <i>= </i>0.003; intent-to-treat population: 94.8 and 90.1%, respectively; difference: 4.7%, 95% confidence interval: –0.4 to 9.7%, p <i>= </i>0.062). Bacteriological efficacies were similar. Success rates in the small numbers of sodium-fusidate-, methicillin- and mupirocin-resistant <i>Staphylococcus aureus</i> were good for retapamulin (9/9, 8/8 and 6/6, respectively). Both drugs were well tolerated. <i>Conclusion:</i> Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies.
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