COMPARISON OF TOPICAL CIPROFLOXACIN/DEXAMETHASONE OTIC SUSPENSION VERSUS POLYMYXIN B/NEOMYCIN/HYDROCORTISONE OTIC SUSPENSION FOR THE TREATMENT OF ACUTE OTITIS EXTERNA
Author(s)
Ateequr Rahman, MBA, PhD, Associate Professor1, Shafeequr Rizwan, MD, Physician2, Curtis Waycaster, PhD, Senior Outcomes Researcher3, Michael Wall, PhD, Senior Director of Pharmaceutical Development31Shenandoah University, Winchester, VA, USA; 2 Richardson Medical Center, Rayville, LA, USA; 3 Alcon Laboratories Inc, Fort Worth, TX, USA
OBJECTIVES: The objective of this study was to compare ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension to polymyxin B /neomycin/hydrocortisone (PNH) otic suspension for the treatment of acute otitis externa (AOE). METHODS: Data from two randomized AOE clinical trials were pooled together for this analysis. AOE patients randomly received either CD, 3-4 drops twice a day for seven days, or PNH, 3-4 drops three times a day for seven days. Clinical assessment of ear inflammation, ear tenderness, ear edema and ear discharge were performed on days 3, 8 and 18 of the study. Inflammation and edema were evaluated using the following four point scale: none = 0, mild = 1, moderate = 2, severe = 3. Ear tenderness and otic discharge were rated on a scale where absent =0 and present = 1. A composite clinical score with a range of 0 to 8 was used as the final outcomes measure. Clinical cure was defined as composite clinical score of zero. A Kaplan-Meier survival analysis with a log-rank test was used to compare the cure rates between treatment groups. RESULTS: A total of 1,072 patients (1,242 ears) were included in the analysis (537 CD patients and 535 PNH patients). Both treatment groups were similar with respect to baseline AOE severity and demographic parameters. The log-rank test revealed a significant (p=0.0380) difference in AOE cure rates between the CD and PNH groups. The Kaplan-Meier analysis indicated that CD patients were cured 0.6 days sooner than PNH patients (9.7 versus 10.3 days, respectively) and the time needed to cure 75% of the CD group was 8 days compared to 18 days for the PNH group. CONCLUSION: CD appears to be superior to PNH for the treatment of AOE due to its faster cure rate.
Conference/Value in Health Info
2007-05, ISPOR 2007, Arlington, VA, USA
Value in Health, Vol. 10, No.3 (May/June 2007)
Code
PEY1
Topic
Clinical Outcomes, Medical Technologies
Topic Subcategory
Comparative Effectiveness or Efficacy, Diagnostics & Imaging
Disease
Sensory System Disorders