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Clinical Drug Investigation

, Volume 15, Issue 2, pp 81–90 | Cite as

Cefprozil versus Cefuroxime Axetil in the Treatment of Acute Sinusitis

  • Edwin R. Brankston
  • H.S. Conter
  • R. Corriveau
  • J.M. Martel
  • C. Laroche
  • R. Roy
  • C. Savard
  • D. Roy
  • R. Kelly
  • P. Forget
  • M. Rivard
  • F. Boulerice
Clinical Use

Summary

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

Adis International Limited Sinusitis Cefuroxime Drug Invest Acute Sinusitis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Williams Jr JW, Simel DL. Does this patient have sinusitis? Diagnosing acute sinusitis by history and physical examination. JAMA 1993; 270: 1242–6PubMedCrossRefGoogle Scholar
  2. 2.
    Evans Jr FO, Sydnor JB, Moore WEC, et al. Sinusitis of the maxillary antrum. N Engl J Med 1975; 293: 735–9PubMedCrossRefGoogle Scholar
  3. 3.
    Hamory BH, Sande MA, Sydnor Jr A, et al. Etiology and antimicrobial therapy of acute maxillary sinusitis. J Infect Dis 1979; 139: 197–202PubMedCrossRefGoogle Scholar
  4. 4.
    Gwaltney Jr JM, Scheid WM, Sande MA, et al. The microbial etiology and antimicrobial therapy of adults with acute community-acquired sinusitis: a fifteen-year experience at the University of Virginia and review of other selected studies. J Allergy Clin Immunol 1992; 90: 457–62PubMedCrossRefGoogle Scholar
  5. 5.
    Norrby SR. Clinical aspects on upper respiratory tract infections}. Scand J Infect Dis 1983; Suppl. 39: 14-8Google Scholar
  6. 6.
    Mardh PA, Hovelius B, Nordenfeldt E, et al. The incidence of aetiology of respiratory tract infections in general practice — with emphasis on Mycoplasma pneumonia. Infection 1976; 4Suppl. 1: 40PubMedCrossRefGoogle Scholar
  7. 7.
    Royal College of General Practitioners. Office of population consensus. Department of Health and Social Security. Morbidity statistics from general practice 1981–82. HMSO, London 1986Google Scholar
  8. 8.
    van Duijn NP, Brouwer HJ, Lamberts H. Use of symptoms and signs to diagnose maxillary sinusitis in general practice. Comparison with ultrasonography. BMJ 1992; 305: 684PubMedCrossRefGoogle Scholar
  9. 9.
    Gwaltney Jr JM. Acute community-acquired sinusitis. Clin Infect Dis 1996; 23: 1209–25PubMedCrossRefGoogle Scholar
  10. 10.
    Low DE, Desrosiers M, McSherry J, et al. Apractical guide for the diagnosis and treatment of acute sinusitis. Can Med Assoc J 1997; 156(6 Suppl.): S1–S14Google Scholar
  11. 11.
    Reuler JB, Lucas LM, Kumar KL. Sinusitis. A review for generalists. West J Med 1995; 163: 40–8PubMedGoogle Scholar
  12. 12.
    Levine HL. Acute sinusitis: impact and management. Cleve Clin J Med 1991; 58: 296–7Google Scholar
  13. 13.
    Gwaltney Jr JM, Sydnor Jr A, Sande MA. Etiology and antimicrobial treatment of acute sinusitis in adults. Ann Otol Rhinol Laryngol 1981; 90: 68–71Google Scholar
  14. 14.
    Eliasson I, Kamne C, Prellner K. Beta-lactamase production in the upper respiratory tract flora. Eur J Clin Microbiol 1986; 5: 507–12PubMedCrossRefGoogle Scholar
  15. 15.
    Ahmad F, McLeod DT, Croughan MJ, et al. Antimicrobial susceptibility of Branhamella catarrhalis respiratory infections. Antimicrob Agents Chemother 1984; 26: 424–5PubMedCrossRefGoogle Scholar
  16. 16.
    Alverez S, Jones M, Holstsclaw-Berk S, et al. In. vitro susceptibilities and beta-lactamase production of 53 clinical isolates of Branhamella catarrhalis. Antimicrob Agents Chemother 1985; 27: 646–7CrossRefGoogle Scholar
  17. 17.
    Barry AL, Pfaller MA, Fuchs PC, et al. In vitro activities of 12 orally administered antimicrobial agents against four species of bacterial respiratory pathogens from US medical centers in 1992 and 1993. Antimicrob Agents Chemother 1994; 38: 2419–25PubMedCrossRefGoogle Scholar
  18. 18.
    Gwaltney Jr JM. Microbiology of sinusitis. In: Druce HM, editor. Sinusitis: Pathophysiology and treatment. New York: Marcel Dekker, 1994: 41–56Google Scholar
  19. 19.
    Thornsberry C, Brown SD, Yee YC, et al. Increasing penicillin resistance in Streptococcus pneumoniae in the US. Effect on susceptibility to oral cephalosporins. Infect Med 1993; 10Suppl. D: 15–24Google Scholar
  20. 20.
    Simor AE, Rachlis A, Art LL, et al. Emergence of penicillin-resistant Streptococcus pneumoniae in southern Ontario. Can J Infect Dis 1995; 6: 157–60PubMedGoogle Scholar
  21. 21.
    Simor AE, Louie M, The Canadian Bacterial Surveillance Network, et al. Canadian National Survey of Prevalence of antimicrobial resistance among clinical isolates of Streptococcus pneumoniae. Antimicrob Agents Chemother 1996; 40: 2190–3PubMedGoogle Scholar
  22. 22.
    Ramsey PG, Wymuller EA. Complications of bacterial infection of the ears, paranasal sinuses, and oropharynx in adults. Emerg Med Clin North Am 1985; 3: 143–60PubMedGoogle Scholar
  23. 23.
    Yarington CT. Sinusitis as an emergency. Otolaryngol Clin North Am 1979; 12: 447–54PubMedGoogle Scholar
  24. 24.
    Camacho AE, Cobo R, Otte J, et al. Clinical comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of patients with acute bacterial maxillary sinusitis. Am J Med 1992; 93: 271–6PubMedCrossRefGoogle Scholar
  25. 25.
    Brodie DP, Knight S, Cunningham K. Comparative study of cefuroxime axetil and amoxycillin in the treatment of acute sinusitis in general practice. J Int Med Res 1989; 17: 547–51PubMedGoogle Scholar
  26. 26.
    Westphal JF. Cefuroxime axetil, a new cephalosporin for treating infections of the ORL field: clinical synthesis. Rev Laryngol Otol Rhinol (Bord) 1990; 111: 503–5Google Scholar
  27. 27.
    Sydnor A, Gwaltney JM, Cocchetto DM, et al. Comparative evaluation of cefuroxime axetil and cefaclor for treatment of acute bacterial maxillary sinusitis. Arch Otolaryngol Head Neck Surg 1989; 115: 1430–3PubMedCrossRefGoogle Scholar
  28. 28.
    Wiseman LR, Benfield P. Cefprozil. Areview of its antibacterial activity, pharmacokinetic properties and therapeutic potential. Drugs 1993; 45: 295–317PubMedCrossRefGoogle Scholar
  29. 29.
    Barriere SL. Pharmacology and pharmacokinetics of cefprozil. Clin Infect Dis 1992; 14Suppl. 2: S184–8PubMedCrossRefGoogle Scholar
  30. 30.
    Van den Wijngaart W, Verbrugh H, Theopold HM, et al. A noncomparative study of cefprozil at two dose levels in the treatment of acute uncomplicated bacterial sinusitis. Clin Ther 1992; 14: 306–13PubMedGoogle Scholar
  31. 31.
    Russell MD, Nolen T, Allen JM, et al. Cefprozil versus amoxicillin/clavulanate in the treatment of acute, uncomplicated maxillary sinusitis in adults. Infect Med 1997; 14Suppl. A: 43–50Google Scholar
  32. 32.
    Adelgrass J, Bundy JM, The Bacterial Sinusitis Study Group. Comparison of cefprozil and amoxicillin/clavulanate in the treatment of adults with acute bacterial sinusitis [abstract LM37]. Interscience Conference on Antimicrobial Agents and Chemotherapy. American Society of Microbiology, San Francisco: September 1995Google Scholar
  33. 33.
    Wald ER, Chiponis D, Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo-controlled trial. Pediatrics 1986; 77: 795–800PubMedGoogle Scholar
  34. 34.
    Makuch R, Simon RM. Sample size requirements for evaluating a conservative therapy. Cancer Treat Rep 1978; 62: 1037–40PubMedGoogle Scholar
  35. 35.
    Williams Jr JW, Simel DL, Roberts L, et al. Clinical evaluation for sinusitis. Making the diagnosis by history and physical examination. Ann Int Med 1992; 117: 705–10PubMedGoogle Scholar
  36. 36.
    Berg O, Carenfelt C. Analysis of symptoms and clinical signs in the maxillary sinus empyema. Acta Otolaryngol (Stockh) 1988; 105: 343–9CrossRefGoogle Scholar
  37. 37.
    Axelsson A, Chidekel N, Grebelius N, et al. Treatment of acute maxillary sinusitis. A comparison of four different methods. Acta Otolaryngol 1970; 70: 71–6PubMedCrossRefGoogle Scholar
  38. 38.
    Lindbæk M, Hjortdahl P, Johnsen UL-H. Randomised, double-blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults. BMJ 1996; 313: 325–9PubMedCrossRefGoogle Scholar
  39. 39.
    van Buchem FL, Knottnerus JA, Schrijnemaekers VJJ, et al. Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis. Lancet 1997; 349: 683–7PubMedCrossRefGoogle Scholar
  40. 40.
    Willet LR, Carson JL, Williams Jr JW. Current diagnosis and management of sinusitis. J Gen Intern Med 1994; 9: 38–45CrossRefGoogle Scholar
  41. 41.
    Axelsson A, Runze U. Symptoms and signs of acute maxillary sinusitis. ORL J Otorhinolaryngol Relat Spec 1976; 38: 298–308PubMedCrossRefGoogle Scholar
  42. 42.
    Williams JW, Roberts Jr L, Distell B, et al. Diagnosing sinusitis by x-ray: is a single waters view adequate? J Gen Intern Med 1992; 7: 481–5PubMedCrossRefGoogle Scholar
  43. 43.
    Lindbæk M, Johnsen UL-H, Kaastad E, et al. CT findings in general practice patients with suspected sinusitis. Acta Radiol 1996; 37: 708–13PubMedCrossRefGoogle Scholar
  44. 44.
    Kennedy DW. Medical management of sinusitis: educational goals and management guidelines. Ann Otol Rhinol Laryngol 1995; 104Suppl. 167: 22–30Google Scholar
  45. 45.
    Zinreich SJ. Paranasal sinus imaging. Otol Head Neck Surg 1990; 103 Suppl. Part 2: 863–9Google Scholar
  46. 46.
    McAllister WH, Lusk RP, Muntz HR. Comparison of plain radiographs and coronal CT scans in infants and children with recurrent sinusitis. Am J Roentgenol 1989; 153: 1259–64Google Scholar
  47. 47.
    Ceftin (cefuroxime axetil) Product Monograph, Compendium of Pharmaceuticals and Specialties, 32nd edition, 1997, pp. 261-2. Canadian Pharmaceutical Association, Ottawa, Ontario, CanadaGoogle Scholar

Copyright information

© Adis International Limited 1998

Authors and Affiliations

  • Edwin R. Brankston
    • 1
  • H.S. Conter
    • 2
  • R. Corriveau
    • 3
  • J.M. Martel
    • 4
  • C. Laroche
    • 5
  • R. Roy
    • 6
  • C. Savard
    • 7
  • D. Roy
    • 8
  • R. Kelly
    • 9
  • P. Forget
    • 10
  • M. Rivard
    • 11
  • F. Boulerice
    • 12
  1. 1.Oshawa ClinicOshawaCanada L1H 1B9
  2. 2.Gladstone Professional CentreHalifaxCanada
  3. 3.CharlesbourgCanada
  4. 4.LongueuilCanada
  5. 5.Clinique Médicale CadillacMontréalCanada
  6. 6.Parkdale ClinicHamiltonCanada
  7. 7.CLSC VerdunVerdunCanada
  8. 8.Notre-Dame HospitalMontréalCanada
  9. 9.Centre Médical PierrefondsPierrefondsCanada
  10. 10.Clinique Médicale AdoncourLongueuilCanada
  11. 11.University of MontréalMontréalCanada
  12. 12.Bristol-Myers SquibbMontréalCanada

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