Authors: Forget P.; Brankston E.R.¹; Rivard M.²; Conter H.S.³; Boulerice F.⁴; Corriveau R.⁵; Martel J.M.⁶; Laroche C.⁷; Roy R.⁸; Savard C.⁹; Roy D.¹⁰; Kelly R.¹¹

Source: Clinical Drug Investigation, Volume 15, Number 2, 1 February 1998 , pp. 81-90(10)

Publisher: Adis International

Abstract:

The objective of this multicentre, randomised, open-label, general practice (GP) study was to evaluate the efficacy and tolerability of cefprozil (Cefzil, Bristol-Myers Squibb) compared with that of cefuroxime axetil (Ceftin, Glaxo Wellcome) in the treatment of adult subjects with acute sinusitis. Typical of the GP setting, diagnosis was made based solely on clinical signs and symptoms of acute disease. Sinus radiography was performed post-randomisation. A total of 381 adolescent and adult patients were randomly assigned to 10 days' treatment with either cefprozil, 500mg orally twice daily (n = 191), or cefuroxime axetil, 250mg orally twice daily (n = 190). Based on predefined criteria, treatments were found to be equally effective in terms of proportions of patients in the per-protocol population that were cured, improved or failed (p = 0.20). Similar results were observed when the evaluation was performed on the subset of patients with radiographic evidence of sinusitis and when the evaluation was based on the investigator's judgement. Similar rates of adverse events were observed in the two treatment groups.

In summary, cefprozil 500mg twice daily is as well tolerated and as effective as cefuroxime axetil 250mg twice daily for the treatment of adolescent and adult patients with clinical signs and symptoms of acute sinusitis.

Keywords: Cefprozil, therapeutic-use; Cefuroxime-axetil, therapeutic-use; Sinusitis, treatment; Antibacterials, therapeutic-use; Randomised-controlled-trials

Document Type: Original article

Affiliations: 1: Oshawa Clinic, Oshawa, Ontario, Canada 10: Notre-Dame Hospital, Montréal, Québec, Canada 11: Centre Médical Pierrefonds, Pierrefonds, Québec, Canada 2: University of Montréal, Montréal, Québec, Canada 3: Gladstone Professional Centre, Halifax, Nova Scotia, Canada, Canada 4: Bristol-Myers Squibb, Montréal, Québec, Canada 5: Charlesbourg, Québec, Canada 6: Longueuil, Québec, Canada 7: Clinique Médicale Cadillac, Montréal, Québec, Canada 8: Parkdale Clinic, Hamilton, Ontario, Canada 9: CLSC Verdun, Verdun, Québec, Canada

Publication date: 1998-02-01

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