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| |  AAAAI: Moxifloxacin Hastens Symptom Resolution in Acute Sinusitis By Jill Stein Special to DG News NEW YORK, NY -- March 6, 2002 -- Patients with acute bacterial sinusitis who are treated with a ten-day course of moxifloxacin 400 mg po qd appear to feel better faster than patients treated with levofloxacin 500 mg po qd or amoxicillin clavulanate 875 mg/125 mg po bid. Dr. Gavin Corcoran, with the Bayer Corporation, in West Haven, Connecticut, reported these findings here yesterday at the 58th Annual Scientific Meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI). The trial included patients who were 18 years of age or older, with a clinical diagnosis of acute bacterial sinusitis (ABS) and presence of at least one major and two minor symptoms for 7-28 days. Major symptoms included purulent anterior and posterior nasal discharge as well as nasal congestion. Minor symptoms included cough or frequent throat clearing, frontal headache, and facial pain, malar tenderness, or pressure. Ear discomfort, halitosis, and fever were also considered minor symptoms. Symptom improvement was assessed on a daily basis using the Sino-Nasal Outcomes Test-16 (SNOT-16), a symptom survey comprised of 16 common sinusitis symptoms that the patients were asked to rate on a scale of 0 to 3. Daily symptom relief was assessed, via an automated telephone system, from the day of enrollment through the last day of drug therapy. In addition, the rate of callbacks to the physician’s office was measured through 14 days after therapy and the reason for the callback was recorded. All patients who received at least one dose of the study drug comprised the intent-to-treat (ITT) population. Within 746 patients in the ITT population, 715 (96 percent) completed SNOT-16 assessments at pre-treatment and day 3. Of these patients, 715 patients (45 percent (104/233) of patients treated with moxifloxacin, 42 percent (102/242) of the levofloxacin group, and 40 percent (97/240) of amoxicillin clavulanate-treated patients reported symptomatic relief by the third day of therapy. The differences between groups were not statistically significant. For the 746 ITT patients, the callback rates due to lack of symptom relief were 7 percent (18/247) with moxifloxacin, 11 percent (28/248) with levofloxacin, and 13 percent (32/251) with amoxicillin clavulanate. "With clinical equivalence often established between comparator drugs, other outcome measures are becoming increasingly important," Dr. Corcoran said. "The implications of faster symptom relief, decreased callbacks and second antibiotic prescriptions, as provided by moxifloxacin treatment, may positively influence quality of life, well-being, and productivity, as well as reduce overall health care costs." Approximately 18 percent of adults in the United States are diagnosed with ABS each year, accounting for 26.7 million yearly patient visits - leading to an annual cost of $5.78 billion dollars, according to Dr. Corcoran. It is also associated with substantial morbidity, including an estimated 12.5 million lost workdays, 58.7 million days of restricted activity, and 20.3 million bed-days. Accordingly, sinusitis imposes a substantial economic burden on society through direct and indirect health care costs, including facility usage, professional costs, and reduced patient quality of life, he stated.
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