The combined results of three clinical studies presented at the 43rd annual Interscience Conference on Antimicrobial Agents and Chemotherapy demonstrated that Ketek (telithromycin) once a day for five days was active and well-tolerated in patients with acute maxillary sinusitis (AMS) -- including special interest patients (special interest patients are defined as having symptoms for at least seven days, having a causative pathogen at entry, total opacity on sinus X-ray, or severe infection as determined by investigator).

A total of 926 patients with AMS, including those of special interest, participated in the studies. Patients received telithromycin 800 mg once daily for five days (n=608), amoxicillin-clavulanic acid 500/125 mg three times daily for 10 days (n=202) or cefuroxime 250 mg twice daily for 10 days (n=116). Treatment activity was determined during a test-of-cure visit between days 17 and 24 in clinically evaluable patients and in those who had a pathogen identified at the time of entry into the study.

Eighty-one percent of the total population of patients treated with telithromycin demonstrated a response versus 77 percent for the pooled comparators.

Similar results were found for the subsets of patients who had symptoms for at least seven days before starting therapy (81 percent and 78 percent, respectively), for patients with severe symptoms at entry into the study (82 percent and 78 percent, respectively) and particularly among those patients with X-ray evidence of total opacity at entry into the study (86 percent and 77 percent, respectively).

In these studies, the most commonly reported adverse events possibly related to treatment were mild-to-moderate diarrhea (11.6 percent), nausea (7.6 percent) and dizziness (3.3 percent).

Ketek is the first in a new class of antibiotics known as ketolides. Ketek was designed to deliver targeted coverage in community-acquired upper and lower respiratory tract infections. In clinical trials, the most commonly reported side effects (2 percent or more) were diarrhea, nausea and vomiting.

On January 27, 2003, Aventis received an approvable letter from the U.S. Food and Drug Administration (FDA) for Ketek Tablets for the treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis. In the approvable letter, the FDA requested that Aventis provide additional analyses and information prior to marketing approval. The Agency has not required additional clinical studies. Aventis is currently preparing a response to the FDA's approvable letter.