Azithromycin (3 days) better than amoxicillin-clavulanate (10 days) for sinusitis?

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Q&A

Azithromycin (3 days) better than amoxicillin-clavulanate (10 days) for sinusitis?

J Fam Pract. 2004 February;53(2):93-105

By

Marc R. Via, MD

BACKGROUND: Sinusitis is frequently treated with 7- to 14-day courses of antibiotics in primary care; however, several trials have shown success with shorter reg-imens. This randomized controlled trial compared treatment efficacy using azithromycin for 3 and 6 days with amoxicillin-clavulanate for 10 days.
POPULATION STUDIED: This manufacturer-sponsored, multicenter study, performed in the United States, enrolled 941 adults with acute bacterial sinusitis, defined clinically as presence of either purulent nasal discharge or facial pain, pressure, or tightness for more than 7 but fewer than 28 days, as well as an abnormal plain radiograph. Patients were excluded if they had hypersensitivity to macrolides or penicillins, were receiving systemic antibiotic therapy within 2 weeks prior to enrollment, or had a history of chronic sinusitis.
STUDY DESIGN AND VALIDITY: This was a double-blind randomized controlled study. Allocation concealment is uncertain. Subjects were assigned to receive azithromycin 500 mg/d for 3 days (AZM-3), azithromycin 500 mg/d for 6 days (AZM-6), or amoxicillin-clavulanate 500 mg/125 mg 3 times daily for 10 days (AMC). The subjects were assessed clinically at baseline, by telephone at day 4, and again clinically at days 10 and 28. Analysis of data was done on an intention-to-treat basis.
OUTCOMES MEASURED: The primary outcome was cure at the end of trial (28 days), defined as resolution of signs and symptoms to the level that existed prior to the occurrence of the acute illness. Secondary outcomes were adverse reaction to medication and compliance.
RESULTS: The groups were similar at baseline, and 93.1% followed up at 28 days. In the intention-to-treat population (920 patients), clinical success at 28 days was equivalent among AZM-3 (71.5%), AZM-6 (74.1%), and AMC (71.5%). Subjects treated with AMC reported a higher incidence of treatment-related adverse events than AZM-3 (51.1% vs 31.1%; P=.001; number needed to treat [NNT]=5) or AZM-6 (51.1% vs 37.6%; P=.001; NNT=7). Diarrhea was the most frequently reported adverse event, occurring in 17% to 21% of patients treated with azithromycin and 32% of patients treated with AMC. Compliance was significantly better in the AZM groups compared with the AMC group (AZM-3: 99.2%; AZM-6: 93.9%; and AMC: 82.1%).

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Azithromycin (3 days) better than amoxicillin-clavulanate (10 days) for sinusitis?

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