A Randomized , Open Label , Prospective , Comparative Study Evaluating the Efficacy and Safety of Fixed Dose Combination of Cefpodoxime 200 Mg + Clavulanic Acid 125 Mg Vs Cefpodoxime 200 Mg in Acute Bacterial Sinusitis

Background: Fixed dose combination of cefpodoximeclavulanic acid and cefpodoxime both are commonly used in the treatment acute bacterial sinusitis. However, comparative clinical studies between the fixed dose combination of cefpodoxime-clavulanic acid versus cefpodoxime alone are not available. Objective: A postmarketing study was conducted to evaluate the efficacy and safety of fixed dose combination of cefpodoxime proxetil plus potassium clavulonate versus cefpodoxime proxetil in treatment of acute bacterial sinusitis. Material and methods: A total of 202 patients were enrolled in an open label, randomized, parallel group, two arms multicentric study. Patients were treated either with fixed dose combination of cefpodoxime 200 mg plus clavulanic acid 125 mg or cefpodoxime 200 mg; both given as one tablet twice daily for ten days. The efficacy was evaluated at baseline, day three, day five and day ten while the safety was assessed at screening and day 10. Statistical analysis: Intention to treat population was used to analyse the safety results while efficacy was evaluated in per protocol population. Chi square test was used to evaluate the efficacy parameters on six point Likert scale, global evaluation of efficacy and safety by investigators and patients. Results: Cure rate was higher in study group (58.43%) compared to control group (46.81%), however, the difference was not significant. No significant difference was seen in improvement and failure rate in both the groups (p=0.288). On day 3, rhinorrhea was either cured or much improved in significantly higher number of patients receiving study drug compared to control group (p=0.038). Global assessment of efficacy by patients significantly higher number of patients had “excellent” efficacy in the study group compared to control group (p=0.035) while no significant difference was seen in global efficacy assessment done by investigators. No patient reported serious adverse event in either groups. Conclusion: Rhinorrhea in acute bacterial sinusitis is relieved earlier by the combination of cefpodoxime plus potassium clavulonate compared to cefpodoxime alone. Efficacy of the combination is perceived as excellent by significantly more number of patients compared to cefpodoxime alone. Both the study drugs are well tolerated by patients.