Vol.53 No.7 July 2005
Postmarketing Surveillance of azithromycin in adult patients
Medical Affairs, Pfizer Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan
Abstract
Azithromycin (AZM: Zithromac®) was approved in March 2000 and launched in June 2000 in Japan. A special investigation of Zithromac® for clinical efficacy evaluation of infectious diseases caused by 6-pathogens was begun to collect and confirm efficacy information on infectious diseases caused by Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma spp., Chlamydia pneumoniae, Moraxella (Branhamella) catarrhalis, and Peptostreptococcus spp. In total, 327 patients were analyzed for safety and 307 for efficacy.
In the 307 in efficacy analysis, efficacy was 85.7% (114/133) for respiratory tract infection, 90.7% (107/118) for sinusitis, and 85.7% (48/56) for dental or oral surgery infection.
Efficacy for the commonest causative organisms was 92.1% (93/101) for H. influenzae, 81.5% (75/92) for S. pneumoniae, 94.1% (32/34) for Mycoplasma spp., 90.9% (10/11) for C. pneumoniae, 94.6% (35/37) for M. catarrhalis, and 84.6% (44/52) for Peptostreptococcus spp.
Of the 327 in safety analysis, 11 cases of adverse drug reactions (ADRs) were reported in 11 patients, with an ADR incidence of 3.36% (11/327). No cases of serious ADR were seen.
Key word
azithromycin, postmarketing surveillance, efficacy, safety
Received
May 2, 2005
Accepted
June 27, 2005
Jpn. J. Chemother. 53 (7): 421-430, 2005
