Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/ hydrocortisone for otitis externa

• Published in: Current medical research and opinion 2004-08, Vol.20 (8), p.1175-1183
• Main Authors: Roland, Peter S., Pien, Francis D., Schultz, Craig C., Henry, Dan C., Conroy, Peter J., Wall, G. Michael, Garadi, Rekha, Dupre, Sheryl J., Potts, Susan L., Hogg, L. Gail, Stroman, David W.
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adolescent; Adult; Aged; Anti-Bacterial Agents - administration & dosage; Anti-Inflammatory Agents - administration & dosage; Child; Child, Preschool; Ciprofloxacin - administration & dosage; Drug Combinations; Female; Fluoroquinolone; Framycetin - administration & dosage; Humans; Infant; Male; Middle Aged; Otitis externa; Otitis Externa - drug therapy; Ototopical anti-infective; Ototoxicity; Pharmaceutical Solutions - administration & dosage; Polymyxin B - administration & dosage; Single-Blind Method; Treatment Outcome
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079902125004312

SUMMARY Objectives: To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10 000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE). Study Design: Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3-4 drops twice daily or N/P/H 3-4 drops three times daily. Population: Patients of either sex and older than 1 year, with a clinical diagnosis of mild, moderate, or severe AOE and intact tympanic membranes were recruited to participate. Outcomes Measured: Signs and symptoms of AOE, including ear inflammation, tenderness, edema and discharge (assessed on Days 3, 8 [End-of-Therapy] and 18 [Test-of-Cure]); microbiologic eradication (presumed or documented); and frequency of adverse events. Results: Patients enrolled numbered 468. In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057). In addition, the clinical response was significantly better with CIP/DEX than with N/P/H at Days 3 and 18 (p = 0. 0279 and p = 0. 0321, respectively), as was the reduction in ear inflammation at Day 18 (p = 0.0268). Both preparations were well tolerated in pediatric and adult patients. Conclusions: 7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated.