Results of a prospective multicenter non-interventional study in adult outpatients with acute sinusitis treated with Flemoclav Solutab® in routine clinical practice in Russia (FlemENT)

Abstract

Background. According to Russian clinical guidelines, amoxicillin/clavulanic acid is an antibiotic of the 1st choice in treatment of adult outpatients with acute sinusitis with suspected or confirmed bacterial etiology. The growth of bacterial resistance causes reasonable concern of otorhinolaryngologists about the efficacy of commonly used antibiotics in the routine clinical practice. Objective. The objective of this study was to evaluate the clinical success rate and tolerability of acute sinusitis treatment with Flemoclav Solutab® as initial antibiotic treatment in adult outpatients with acute sinusitis in routine clinical practice. Methods. A prospective multi-center study. The study covered adult outpatients with acute sinusitis with suspected or confirmed bacterial etiology treated with Flemoclav Solutab® and included the assessment of effectiveness and tolerability of Flemoclav Solutab® in the patients with acute sinusitis. Besides, the clinical effectiveness of treatment with this antibiotic in the subgroups of patients aged 65 years or older, smokers and non-smokers was assessed. Clinical success was determined as the complete resolution of all the symptoms and clinical signs of acute bacterial sinusitis that did not require supplementary of alternative antimicrobial therapy. In period of October 2015 to February 2016 eighty otorhinolaryngologists from various regions of Russia examined 893 adult outpatients (346 men and 547 women) with acute sinusitis treated with the antibiotic Flemoclav Solutab®. Clinical recovery confirmed by the data of all the examinations was achieved in 97.2% [(868/893), 95% CI 96.1 – 98.3%]. In the subgroup of patients aged 65 years or older the clinical success rate was 98.5% [(128/130), 95% CI 96.3 – 100%], in the subgroup of non-smokers clinical success was 97.3% [(690/709), 95% CI 96.1 – 98.5], in the subgroup of smokers clinical success was 96.7% [(178/186), 95% CI 94.2–99.3%]. Twenty five cases of adverse drug reactions (ADR) were recorded in 20 (2.2%) patients, of them 22 non-serious ADRs were in 17 (1.9%) patients and 3 serious ADRs were in 3 (0.3%) patients. Conclusion. The study proved high clinical success of acute sinusitis treatment with Flemoclav Solutab® in adult outpatients, including the patients aged 65 years or older, smokers and non-smokers. Antimicrobial treatment with Flemoclav Solutab® was well tolerated.