Cefixime

PURPOSE: A new Extended -Release(ER) formulation of Cefuroxime axetil 500 mg tablets has been recently developed. This pilot study was undertaken to compare the efficacy, safety and tolerability of this new formulation and Cefixime tablets in patients with acute tonsillopharyngitis.

METHODS: Adult patients (n = 100) with a clinical diagnosis of acute pharyngotonsillitis, fulfilling the selection criteria were enrolled in this prospective, multicentric, randomized, assessor-blind, comparative pilot study after obtaining their informed consent. Patients were randomized to receive either 500 mg ER- Cefuroxime axetil tablets once-daily or cefixime 200 mg tablets twice daily for 10 days. Efficacy outcomes included monitoring of clinical and bacteriological response at end of therapy. Safety and tolerability were assessed by monitoring adverse events and laboratory parameters.

RESULTS: A total of 96 patients completed the study with 4 drop-outs (2 from each group) being lost to follow-up. There was a significant decline in mean scores of sore throat, dysphagia, tonsillar erythema, pharyngeal or tonsillar exudate and tender anterior cervical nodes from baseline at end of treatment in both groups. However, difference between groups was not statistically significant. Cure was observed in 91.7% patients in ER-Cefuroxime axetil group and 93.7% patients in cefixime group at end of study (p>0.05). Bacteriological response was observed in similar number of patients in both groups(ER-Cefuroxime axetil (95.8%); Cefixime (97.9%)) at end of therapy. Similar incidences of mild to moderate adverse events mostly gastrointestinal in nature were reported in both groups (ER-Cefuroxime axetil 6% & cefixime--8%). No abnormalities were detected in the laboratory parameters.

CONCLUSION: ER-Cefuroxime axetil tablets once daily were comparable in efficacy, safety and tolerability to Cefixime tablets twice daily in patients with acute tonsillopharyngitis.

CLINICAL IMPLICATIONS: Once-daily ER-Cefuroxime axetil is a better therapeutic option than twice daily cefixime tablets in patients with acute tonsillopharyngitis on account of its dosage convenience.

DISCLOSURE: Anish Desai, None.

Anish A. Desai MD * U Venkatesan MD G S. Kadam MD Ashish S. Gawde MD Vidyagauri P. Baliga PhD Glenmark Pharmaceuticals Ltd, Mumbai, India

COPYRIGHT 2005 American College of Chest Physicians
COPYRIGHT 2005 Gale Group