Topical retapamulin ointment (1%, wt/wt) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: Results of a randomized controlled trial - 09/08/11
on Behalf of the SB275833/032 Study Team
Reprint requests: Scott Matthew White, MD, Medicine Development Center, GlaxoSmithKline, 1250 S Collegeville Rd, Mailcode UP42316, Collegeville, PA 19426.Philadelphia and Collegeville, Pennsylvania; and Winston-Salem, North Carolina
Abstract |
Background |
New antibacterial agents with activity against pathogenic strains resistant to established antibiotics are needed to treat patients with secondarily infected dermatitis (SID).
Objective |
We sought to determine the clinical safety and efficacy of topical retapamulin ointment 1% versus oral cephalexin for the treatment of SID.
Methods |
Patients with SID were randomly assigned to retapamulin ointment 1% (twice daily [bid]) for 5 days, or oral cephalexin (500 mg bid) for 10 days. The primary efficacy end point was clinical response at follow-up. Secondary outcomes included microbiologic response at follow-up, safety, and compliance.
Results |
Retapamulin was as effective as cephalexin (clinical success rates at follow-up: 85.9% and 89.7%, respectively). Microbiologic success rates at follow-up were 87.2% for retapamulin and 91.8% for cephalexin. Retapamulin was well tolerated and the topical formulation was preferred over the oral drug.
Limitations |
An imbalance existed in the number of patients with the clinical outcome “unable to determine” (15 retapamulin, 2 cephalexin), mainly because of their failure to attend the study visit. If those who failed to attend visits (who did not withdraw as a result of drug-related events) are removed from the analysis, the clinical success rates are 89.9% for retapamulin and 89.7% for cephalexin.
Conclusions |
Retapamulin ointment 1% (bid) for 5 days was as effective as oral cephalexin (bid) for 10 days in treatment of patients with SID, and was well tolerated.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AE, bid, CI, ITT, ITTB, ITTC, MIC, MRSA, PPC, SAE, SID
Plan
| Supported by GlaxoSmithKline Pharmaceutical Company. Disclosure: Mr Breton, Dr Hirman, Ms Scangarella, Dr Shawar, and Dr White are employees of GlaxoSmithKline Pharmaceutical Company. |
Vol 55 - N° 6
P. 1003-1013 - décembre 2006 Retour au numéro
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