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


METHODS
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).


RESULTS
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.


CONCLUSIONS
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.
Perronne
C
C
Service des maladies infectieuses et tropicales, hôpital Raymond-Poincaré, 104, boulevard Raymond-Poincaré, 92380 Garches, France. c.perronne@rpc.ap-hop-paris.fr
Drugeon
H
H
Zuck
P
P
Filipecki
J
J
Vincent-Lacaze
N
N
Goldfarb
G
G
Léophonte
P
P
D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D048628:Ketolides / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D048628:Ketolides; D017291:Clarithromycin; C106791:telithromycin