To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ICAAC: Gatifloxacin Effective In Treatment Of Sinusitis URL: http://www.pslgroup.com/dg/133CA6.htm Doctor's Guide September 29, 1999
SAN FRANCISCO, CA. -- September 29, 1999 -- The results of a multicenter Phase III study comparing the efficacy and safety of gatifloxacin to clarithromycin in the treatment of patients with acute maxillary sinusitis showed gatifloxacin to be equivalent to clarithromycin - even though gatifloxacin was administered less often and for a shorter treatment period. The study findings were presented this week at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
The double-blind multicenter Phase III Study compared 421 randomly selected patients who received 400 mg of gatifloxacin once a day for 10 days or 500 mg of clarithromycin twice a day for 14 days. Clinical success was defined as improvement or resolution of discharge, sinus pain, and sinus tenderness, without the need for additional antibiotic treatment.
Clinical success rates were 90 percent in both test groups. Test of cure rates following seven to 10 days post-treatment was 93 percent for gatifloxacin and 90 percent for clarithromycin. Drug-related adverse reactions were 25 percent more common among clarithromycin patients than among gatifloxacin patients, leading to discontinuation in nine percent of clarithromycin patients, compared with five percent of gatifloxacin patients. Taste perversion-interference with a person's sense of taste-was notably higher in the clarithromycin arm (17 percent for clarithromycin; three percent for gatifloxacin).
Sinusitis is an infection of one or more of the paranasal sinuses (surrounding the nasal passages) that usually complicates a common cold or other viral infection of the upper respiratory tract. Sinusitis is a seasonal problem, and is most likely to occur during the fall, winter and spring months. It is most common in adults ages 20-49, with a higher rate in women (62 percent).
"With antimicrobial resistance to our current supply of antibiotics growing at a rapid rate," remarked Dr. Fogarty, "we're pleased that gatifloxacin has performed so well in our sinusitis trials, and we look forward to its availability."
Gatifloxacin is the first in a new chemical class of antibiotics, an advanced-generation broad-spectrum 8-methoxy fluoroquinolone. Its long half-life allows for once-daily dosing. It is specifically designed to treat respiratory tract and other common infections such as sinusitis, examined in the Phase III study. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.