American Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume 31, Issue 1 , Pages 1-8 , January 2010

Azithromycin extended release vs amoxicillin/clavulanate: symptom resolution in acute sinusitis

  • Bradley F. Marple, MD

      Affiliations

    • Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA
    • Corresponding Author InformationCorresponding author. Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390. Tel.: +1 214 648 9588; fax: +1 214 648 8955.
  • ,
  • Craig S. Roberts, PharmD

      Affiliations

    • Global Outcomes Research, Pfizer Inc, New York, NY, USA
  • ,
  • Jennifer R. Frytak, PhD

      Affiliations

    • Health Economics and Outcomes Research, i3 Innovus, Eden Prairie, MN, USA
  • ,
  • Vernon F. Schabert, PhD

      Affiliations

    • Health Economics and Outcomes Research, IMS Health, Santa Barbara, CA, USA
  • ,
  • Jessica C. Wegner

      Affiliations

    • Health Economics and Outcomes Research, i3 Innovus, Eden Prairie, MN, USA
  • ,
  • Helen Bhattacharyya, PhD

      Affiliations

    • Statistics, Pfizer Inc, New York, NY, USA
  • ,
  • Jay F. Piccirillo, MD

      Affiliations

    • Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, MO, USA
  • ,
  • Sonia P. Sanchez, MD

      Affiliations

    • Global Medical, Pfizer Inc, New York, NY, USA

Received 30 June 2008

References 

  1. Sharp HJ, Denman D, Puumala S, et al. Treatment of acute and chronic rhinosinusitis in the United States, 1999–2002. Arch Otolaryngol Head Neck Surg. 2007;133:260–265
  2. Merenstein D, Whittaker C, Chadwell T, et al. Are antibiotics beneficial for patients with sinusitis complaints? A randomized double-blind clinical trial. J Fam Pract. 2005;54:144–151
  3. Williamson IG, Rumsby K, Benge S, et al. Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial. JAMA. 2007;298:2487–2496
  4. Young J, De Sutter A, Merenstein D, et al. Antibiotics for adults with clinically diagnosed acute rhinosinusitis: a meta-analysis of individual patient data. Lancet. 2008;371:908–914
  5. Bucher HC, Tschudi P, Young J, et al. Effect of amoxicillin-clavulanate in clinically diagnosed acute rhinosinusitis: a placebo-controlled, double-blind, randomized trial in general practice. Arch Intern Med. 2003;163:1793–1798
  6. Dolor RJ, Witsell DL, Hellkamp AS, et al. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS Trial: a randomized controlled trial. JAMA. 2001;286:3097–3105
  7. Goetzel RZ, Hawkins K, Ozminkowski RJ, et al. The health and productivity cost burden of the “top 10” physical and mental health conditions affecting six large U.S. employers in 1999. J Occup Environ Med. 2003;45:5–14
  8. Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: developing guidance for clinical trials. Otolaryngol Head Neck Surg. 2006;135(5 suppl):S31–S80
  9. US Food and Drug Administration . Guidance for industry. Acute bacterial sinusitis: developing drugs for treatment. Available at: http://www.fda.gov/CDER/GUIDANCE/3895dft.htm[Accessed December 13, 2007]
  10. Williams JW, Aguilar C, Cornell J, et al. Antibiotics for acute maxillary sinusitis. Cochrane Database Syst Rev. 1999;(3):CD000243;[Updated February 26, 2003]
  11. Marple BF, Roberts CS, de Caprariis PJ, et al. Onset of symptom resolution in adults with acute bacterial rhinosinusitis treated with a single dose of azithromycin extended release compared with 10 days of levofloxacin: a retrospective analysis of a randomized, double-blind, double-dummy trial. Clin Ther. 2007;29:2690–2698
  12. Murray JJ, Emparanza P, Lesinskas E, et al. Efficacy and safety of a novel, single-dose azithromycin microsphere formulation versus 10 days of levofloxacin for the treatment of acute bacterial sinusitis in adults. Otolaryngol Head Neck Surg. 2005;133:194–200
  13. Anderson ER, Murphy MP, Weymuller EA. Clinimetric evaluation of the Sinonasal Outcome Test-16. Student Research Award 1998. Otolaryngol Head Neck Surg. 1999;121:702–707
  14. Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004;2:12
  15. Calhoun KH, Hokanson JA. Multicenter comparison of clarithromycin and amoxicillin in the treatment of acute maxillary sinusitis. Arch Fam Med. 1993;2:837–840
  16. van Buchem FL, Knottnerus JA, Schrijnemaekers VJ, et al. Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis. Lancet. 1997;349:683–687
  17. Lindbaek M, Hjortdahl P, Johnsen UL. Randomised, double blind, placebo controlled trial of penicillin V and amoxicillin in treatment of acute sinusitis infections in adults. BMJ. 1996;313:325–329
  18. Nord CE. Efficacy of penicillin treatment in purulent maxillary sinusitis. A European multicenter trial. Infection. 1988;16:209–214
  19. 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;77:795–800
  20. Casiano RR. Azithromycin and amoxicillin in the treatment of acute maxillary sinusitis. Am J Med. 1991;91(Suppl 3A):27S–30S
  21. Huck W, Reed BD, Nielsen RW, et al. Cefaclor vs amoxicillin in the treatment of acute, recurrent, and chronic sinusitis. Arch Fam Med. 1993;2:497–503
  22. Karma P, Pukander J, Penttilä M, et al. The comparative efficacy and safety of clarithromycin and amoxicillin in the treatment of outpatients with acute maxillary sinusitis. J Antimicrob Chemother. 1991;27(Suppl A):83–90
  23. Mattucci KF, Levin WJ, Habib MA. Acute bacterial sinusitis. Minocycline vs amoxicillin. Arch Otolaryngol Head Neck Surg. 1986;112:73–76
  24. Nicholson KG, Aoki FY, Osterhaus AD, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet. 2000;355:1845–1850

 Parts of this analysis were presented at the 47th Interscience Congress on Antimicrobial Agents and Chemotherapy (ICAAC), Chicago, IL, September 17-20, 2007. Presentation L-483.

PII: S0196-0709(08)00176-2

doi: 10.1016/j.amjoto.2008.08.011

American Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume 31, Issue 1 , Pages 1-8 , January 2010