Efficacy and safety of extended-release clarithromycin (5-day short-course) vs telithromycin, in acute bacterial exacerbation of chronic bronchitis

• Published in: Médecine et maladies infectieuses 2005-10, Vol.35 (10), p.507-515
• Main Authors: Perronne, C, Drugeon, H, Zuck, P, Filipecki, J, Vincent-Lacaze, N, Goldfarb, G, Léophonte, P
• Format: Article
• Language: fre
• Subjects: Aged; Anti-Bacterial Agents - therapeutic use; Clarithromycin - administration & dosage; Clarithromycin - therapeutic use; Delayed-Action Preparations; Double-Blind Method; Drug Administration Schedule; Female; Humans; Ketolides - administration & dosage; Ketolides - therapeutic use; Male; Middle Aged; Patient Selection; Treatment Outcome
• ISSN: 0399-077X
• DOI: 10.1016/j.medmal.2005.07.002

The extended-release formulation of clarithromycin (CLA-ER) allows using this macrolide as a single daily dose. The purpose of this study was to evaluate the efficacy and safety of the CLA-ER formulation (500 mgx2) vs telithromycin (TELI) (400 mgx2) as a short course 5-day treatment, once a day, in patients with AECB. This randomized double-blind study was conducted in patients with AECB without severe airflow limitation (FEV1>35%), with sputum purulence (mandatory criterion), and with either increased sputum volume or increased dyspnea, or both (Anthonisen criteria I or II). Three hundred sixty-two patients were assessed (62.6 years of age+/-12.9, men: 58.8%) positive culture on inclusion for 53.8%, with Haemophilus influenzae (N=57), Moraxella catarrhalis (N=42), and Streptococcus pneumoniae (N=41). In the per protocol population, the clinical success rate at day 8 was 97% (161/166) vs 97% (146/151), 97.5% CI=[-4.12 -4.71], the clinical cure rate at day 30 was 78% (129/166) versus 77% (116/151), P=0.85, and mean time without recurrence was 62 days versus 61 days (P=0.51), in CLA-ER and TELI groups, respectively. Fourteen patients in the CLA-ER group (8.2%) and 20 patients in the TELI group (12.4%) experienced at least one treatment-related adverse event (P=0.21), upon which gastrointestinal events were the most commonly reported treatment-related ones. CLA-ER (1000 mg once a day) for 5 days is at least as effective as telithromycin in the treatment of AECB without severe airflow limitation and is well tolerated.