Acute exacerbation of chronic bronchitis (AECB) is characterized by increase in cough and worsening of dyspnoea due to, in some cases, bacterial infection. There is always a need to develop first line antimicrobial agents that cover major respiratory pathogens, with low potential to select for resistance, favorable safety and efficacy profiles, and convenient dosing regimen. Objective: To evaluate the outcome of treating AECB patients empirically with Telithromycing 800 mg once daily for 5 days.
Design: Open, prospective. Patients: Male and females aged 18–65 years, identified with AECB, who have not had antibiotics within 14 days before enrollment. Methods: Test of cure (TOC) was defined as disappearance of signs and symptoms of AECB with no requirement for further treatment with antibiotics. Adverse events, including abnormal laboratory values, were monitored, recorded and analyzed.
Two hundred and fifty three patients were enrolled. After 5 days of treatment, the clinical outcome was 85% cure in the per-protocol (PP) patients and 80% in intent-to-treat (ITT) analysis. The cure rates increased after 10 days of treatment to 98% and 90% in the PP and ITT analysis respectively. The main adverse event was gastric upset. Nonetheless, all adverse events were of mild to moderate intensity and were easily alleviated with symptomatic intervention.
The empiric treatment with Telithromycin for AECB patients appears to be safe and efficacious.
The results of this work support those found elsewhere in the literature and the FDA results on Telithromycin in the AECB indication.
A. Abu Hussein, None.