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

Peter S. Roland, Francis D. Pien, Craig C. Schultz, Dan C. Henry, Peter J. Conroy, G. Michael Wall, Rekha Garadi, Sheryl J. Dupre, Susan L. Potts, L. Gail Hogg, David W. Stroman

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1175-1183
Number of pages9
JournalCurrent Medical Research and Opinion
Volume20
Issue number8
StatePublished - Aug 2004

Fingerprint

Otitis Externa
Ciprofloxacin
Hydrocortisone
Dexamethasone
Safety
Ear
Suspensions
Otitis
Polymyxin B
Tympanic Membrane
Neomycin
Therapeutics
Multicenter Studies
Signs and Symptoms
dexamethasone, neomycin, polymyxin B drug combination
Edema
Pediatrics
Population

Keywords

  • Fluoroquinolone
  • Otitis externa
  • Ototopical anti-infective
  • Ototoxicity

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Roland, P. S., Pien, F. D., Schultz, C. C., Henry, D. C., Conroy, P. J., Wall, G. M., ... Stroman, D. W. (2004). Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Current Medical Research and Opinion, 20(8), 1175-1183.

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

In: Current Medical Research and Opinion, Vol. 20, No. 8, 08.2004, p. 1175-1183.

Research output: Contribution to journalArticle

Roland, PS, Pien, FD, Schultz, CC, Henry, DC, Conroy, PJ, Wall, GM, Garadi, R, Dupre, SJ, Potts, SL, Hogg, LG & Stroman, DW 2004, 'Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa', Current Medical Research and Opinion, vol. 20, no. 8, pp. 1175-1183.
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. / Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. In: Current Medical Research and Opinion. 2004 ; Vol. 20, No. 8. pp. 1175-1183.
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abstract = "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.",
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AU - Roland, Peter S.

AU - Pien, Francis D.

AU - Schultz, Craig C.

AU - Henry, Dan C.

AU - Conroy, Peter J.

AU - Wall, G. Michael

AU - Garadi, Rekha

AU - Dupre, Sheryl J.

AU - Potts, Susan L.

AU - Hogg, L. Gail

AU - Stroman, David W.

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N2 - 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.

AB - 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.

KW - Fluoroquinolone

KW - Otitis externa

KW - Ototopical anti-infective

KW - Ototoxicity

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