To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: DG DISPATCH - ICAAC: Spectracef (Cefditoren Pivoxil) Effective For Sinusitis, Pharyngitis, Bronchitis Exacerbations URL: http://www.pslgroup.com/dg/1E1EBA.htm Doctor's Guide September 20, 2000
By Cameron Johnston Special to DG News
TORONTO, ONTARIO -- September 20, 2000 -- A new broad spectrum antibiotic, Sprectracef (cefditoren pivoxil), is effective in treating maxillary sinusitis, streptococcal pharyngitis and exacerbations from acute chronic bronchitis, according to three separate studies.
These findings were presented yesterday (Sept. 19) during three separate presentations at the Interscience Congress on Antimicrobial Agents and Chemotherapy (ICAAC) annual meeting, being held in Toronto, Canada.
In one poster presentation, Sprectracef (Tap Pharmaceuticals Inc) was compared with clavulinic acid and Augmentin (amoxicillin) and was found to be equivalent on most scores for treating patients with acute maxillary sinusitis.
The cure rates for either of the two drugs ranged from 82 to 84 percent. The percentages of people who reported the same level of pre-treatment signs were more or less than also similar for the two drugs, whether taken 48 hours or seven to 14 days post-therapy.
The 775 patients in the study were randomized to receive either Spectracef 200 mg BID for a period of 10 days, or Augmentin (875 mg BID for up to 10 days.
In a much larger, phase III trial, involving more than a thousand people with streptococcal pharyngitis, patients were randomized to receive either Sprectracef 200 mg BID for 10 days or penicillin 250 mg four times daily, each for 10 days.
Clinical cure rates in the study were similar. At 48-hours post-treatment, the cure rate or eradication rates were 94 percent and 90 percent for cefditoren and penicillin, respectively. At a follow-up visit 19 to 25 days post-treatment, the eradication rates were still 89 and 86 percent, respectively.
In a third trial, Sprectracef was found to be equivalent to clarithromycin for eradicating pathogens associated with exacerbations of acute chronic bronchitis. This study involved 903 patients who were randomized to receive either 200 or 400 mg BID of Sprectracef or clarithromycin at 500 mg/day, dosed twice daily for 10 days.
Patients were evaluated within 48 hours and seven to 14 days after the last dose. At seven to 14 day follow-up the clinical cure rates for evaluable patients were 81 percent, 78 percent and 83 percent for Spectracef 200 mg, 400 mg and clarithromycin, respectively.
Among patients taking the 400-mg BID dose of Spectracef, the eradication rate was 78 percent at 48 hours post-treatment and remained high, at 73 percent, one month post-treatment. The drug is also pathogens-specific, maintaining its toxic effect on H. influenza in 80 percent of evaluable patients at the higher dose, and in 94 percent at the lower dose, as compared to 78 percent for clarithromycin-treated patients.
The average adult experiences these respiratory infections two or three times annually, said John Seely, PhD, vice president of research and development at TAP Pharmaceuticals Inc., the drug's manufacturer.
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