Once daily clarithromycin extended-release vs twice-daily amoxicillin/clavulanate in patients with acute bacterial sinusitis: a randomized, investigator-blinded study

• Published in: Current medical research and opinion Vol. 21; no. 1; pp. 61 - 70
• Main Authors: Riffer, Ernie, Spiller, Joy, Palmer, Robert, Shortridge, Virginia, Busman, Todd A., Valdes, Joaquin
• Format: Journal Article
• Language: English
• Published: England Informa UK Ltd 01.01.2005; Taylor & Francis; Informa Healthcare
• Subjects: Acute bacterial sinusitis; Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination - administration & dosage; Amoxicillin-Potassium Clavulanate Combination - therapeutic use; Amoxicillin/clavulanate; Analysis of Variance; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Anti-inflammatory; Clarithromycin; Clarithromycin - administration & dosage; Clarithromycin - therapeutic use; Delayed-Action Preparations; Drug Therapy, Combination - administration & dosage; Drug Therapy, Combination - therapeutic use; Female; Humans; Male; Middle Aged; Single-Blind Method; Sinusitis - drug therapy; Treatment Outcome
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079904X18009

ABSTRACT Objective: To compare the efficacy and tolerability of clarithromycin extended-release (ER) to amoxicillin/clavulanate in patients diagnosed with acute bacterial sinusitis. Research design and methods: In a controlled, multicenter, investigator-blinded study, 437 ambulatory patients at least 12 years old with signs/symptoms and radiographic findings of acute sinusitis were randomized to receive clarithromycin ER 1000 mg once daily or amoxicillin/clavulanate 875 mg/125 mg twice daily for 14 days. Main outcome measures: Clinical and bacteriological response rates were determined at a test-of-cure visit, which was conducted up to 10 days following the completion of treatment. Radiological response was assessed at a follow-up visit. Results: The clinical cure rate in clinically evaluable patients was 98% (184/188) in the clarithromycin ER group and 97% (179/185) in the amoxicillin/clavulanate group (95% CI for the difference in rates [–2.4%, 4.7%]). Clinical cure was sustained at the follow-up visit (96% for each treatment group). The pathogen eradication rates were 94% (61/65) in the clarithromycin ER group and 98% (61/62) in the amoxicillin/clavulanate group (95% CI for difference in rates [–12.0%, 2.9%]). The radiological success rate was 94% (172/183) in both the clarithromycin ER and amoxicillin/clavulanate groups (95% CI for difference in rates [–4.9%, 4.9%]). Symptomatic improvement or relief was observed as early as 2 days–5 days after the initiation of study drug, with a statistically significantly higher resolution rate of sinus pressure ( p = 0.027) and improvement/resolution rate of nasal congestion ( p = 0.035) during treatment with clarithromycin ER. The resolution/improvement rate at the test-of-cure visit for each treatment group was ≥ 94% for the primary acute sinusitis signs/symptoms, with a statistically significantly higher resolution/improvement rate of purulent nasal discharge with clarithromycin ER ( p = 0.010). Both study drugs had a positive and rapid impact on quality of life. Patients reported a high level of satisfaction and probability of using either study antibiotic again, and health care resource use was low, with slightly fewer sinusitis-related physician and outpatient visits required by patients in the clarithromycin ER group ( p = 0.055). The treatment groups were comparable with respect to incidence of drug-related adverse events. Conclusion: In this multinational population of patients with acute bacterial sinusitis, clarithromycin ER was comparable, and for selected measures superior, to amoxicillin/clavulanate based on clinical, bacteriological, and radiological responses as well as quality of life measures, satisfaction with antibiotic therapy, and health care resource utilization.