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| |  DG DISPATCH - ECC: Gatifloxacin Equal to Co-amoxiclav for Acute Sinusitis By Pamela Hunter Special to DG News
MADRID, SPAIN -- May 11, 2000 - The new once-daily fluoroquinolone, gatifloxacin, has been proved to be as effective as a three-times daily course of co-amoxiclav (amoxycillin 500 mg plus clavulanic acid 125 mg) for the treatment of acute sinusitis. Gatifloxacin is licensed in the US by Bristol-Myers Squibb, where it has been recently launched for the treatment of respiratory tract infections. Gatifloxacin is administered at a dose of 400 mg once daily for five to ten days depending upon the severity of the infection. Professor Claude Carbon, from Hopitalier Bichet-Claude Bernard, Paris, France presented the evidence of gatifloxacin's efficacy on Tuesday (May 9) at the European Congress of Chemotherapy, in Madrid, Spain. The researchers compared the efficacy of a five- to ten-day course of once-daily gatifloxacin against that of a five- to ten-day course of co-amoxiclav three times daily in patients with acute sinusitis. The open label, multicenter, multinational, randomised study involved a total of 223 patients. The mean age of the patients was 38.8 years in the gatifloxacin group and 39.9 years in the co-amoxiclav group. Gatifloxacin was given to 109 patients (34.9 percent men), and co-amoxiclav was given to 114 patients (47.4 percent men). All had acute sinusitis confirmed by a sinus X-ray, ultrasound or CT. The causative organisms isolated prior to treatment were Streptococcus pneumoniae (38 percent in the gatifloxacin group and 28 percent in the co-amoxiclav group), Haemophilus influenzae (38.2 percent and 31.3 percent respectively), Moraxella catarrhalis (5.9 percent and 12.5 percent respectively), Staphylococcus aureus (8.8 percent and 18.8 percent respectively) and Streptococcus pyogenes (2.9 percent and 6.3 percent respectively). Clinical and bacteriological assessments were made eight to 14 days after the end of treatment and at a follow-up visit three to four weeks post-treatment. Clinical assessment was made of the resolution of the signs and symptoms of sinusitis using X-ray, ultrasound or CT. Clinical response (cure plus improvement) in the gatifloxacin group was seen in 85.3 percent of patients at the end-of-treatment assessment and in 88.6 percent at the follow-up assessment. The corresponding response rates for the co-amoxiclav group were 82.3 percent and 86 percent, respectively. A bacteriological response was seen in 96.9 percent of gatifloxacin patients at the end of treatment and in 93.5 percent at follow-up. The corresponding bacteriological responses in the co-amoxiclav group were 83.9 percent and 77.4 percent. Of the failures, seven gatifloxacin patients and ten co-amoxiclav patients needed an additional or alternative antibacterial, nine gatifloxacin patients and eight co-amoxiclav patients had less than a 50 percent resolution of signs and symptoms, and one co-amoxiclav patient had no improvements in signs and symptoms. There was no statistical difference in efficacy between the two treatments. There were 40 treatment-associated adverse events reported in the gatifloxacin group and 49 in the co-amoxiclav group. Most of these events were mild to moderate.
Related Link: Bristol-Myers Squibb.
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