Efficacy and safety of the neuraminidase inhibitor zanamivir in the treatment of influenzavirus infections

New England Journal of Medicine

Volumn 337, Issue 13, 1997, Pages 874-880

  Hayden, Frederick G ^a,i   Osterhaus, Albert D M E ^b   Treanor, John J ^c   Fleming, Douglas M ^d   Aoki, Fred Y ^e   Nicholson, Karl G ^f   Bohnen, Arthur M ^b   Hirst, Hilary M ^g   Keene, Oliver ^h   Wightman, Kevin ^h  

^a UNIVERSITY OF VIRGINIA   (United States)

^b ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

^c UNIVERSITY OF ROCHESTER   (United States)

^d Northfield Health Centre   (United Kingdom)

^e UNIVERSITY OF MANITOBA   (Canada)

^f UNIVERSITY OF LEICESTER   (United Kingdom)

^g GLAXOSMITHKLINE   (United States)

^h GLAXOSMITHKLINE   (United Kingdom)

ⁱ UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SIALIDASE INHIBITOR; ZANAMIVIR;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; EUROPE; FEMALE; HUMAN; INFLUENZA; INFLUENZA VIRUS A; INFLUENZA VIRUS B; INHALATIONAL DRUG ADMINISTRATION; INTRANASAL DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NORTH AMERICA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VIRUS TITRATION;

ADMINISTRATION, INHALATION; ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; ENZYME INHIBITORS; GUANIDINES; HUMANS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; INFLUENZA, HUMAN; NEURAMINIDASE; NOSE; PYRANS; SIALIC ACIDS; TIME FACTORS; TREATMENT OUTCOME; ZANAMIVIR;

EID: 9844220300     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199709253371302     Document Type: Article

References (26)

1. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 1996;45(RR-5):1-24.
2. Hayden FG. Amantadine and rimantadine - clinical aspects. In: Richman DD, ed. Antiviral drug resistance. Chichester, England: John Wiley 1996:59-77.
3. von Itzstein M, Wu WY, Kok GB, et al. Rational design of potent sialidase-based inhibitors of influenza virus replication. Nature 1993;363:418-23.
4. Holzer CT, von Itzstein M, Jin B, Pegg MS, Stewart WP, Wu WY. Inhibition of sialidases from viral, bacterial and mammalian sources by analogues of 2-deoxy-2,3-didehydro-N-acetylneuraminic acid modified at the C-4 position. Glycoconj J 1993;10:40-4.
5. Liu C, Air GM. Selection and characterization of a neuraminidase-minus mutant of influenza virus and its rescue by cloned neuraminidase genes. Virology 1993;194:403-7.
6. Burnet FM. Mucin and mucoids in relation to influenza virus action. IV. Inhibition by purified mucoid of infection and haemagglutination with the virus strain WSE. Aust J Exp Biol Med Sci 1948;26:381-7.
7. Colman PM. Neuraminidase: enzyme and antigen. In: Krug RM, ed. The influenza viruses. New York: Plenum Press, 1989:175-218.
8. Woods JM, Bethell RC, Coates JAV, et al. 4-Guanidino-2,4-dideoxy-2,3-dehydro-N-acetylneuraminic acid is a highly effective inhibitor both of the sialidase (neuraminidase) and of growth of a wide range of influenza A and B viruses in vitro. Antimicrob Agents Chemother 1993;37:1473-9.
9. Hayden FG, Rollins BS, Madren LK. Anti-influenza virus activity of the neuraminidase inhibitor 4-guanidino-Neu5Ac2en in cell culture and in human respiratory epithelium. Antiviral Res 1994;25:123-31. [Erratum, Antiviral Res 1994;25:287.]
10. Ryan DM, Ticehurst J, Dempsey MH, Penn CR. Inhibition of influenza virus replication in mice by GG167 (4-guanidino-2,4-dideoxy-2,3-dehydro-N-acetylneuraminic acid) is consistent with extracellular activity of viral neuraminidase (sialidase). Antimicrob Agents Chemother 1994;38:2270-5.
11. Hayden FG, Treanor JJ, Betts RF, Lobo M, Esinhart JD, Hussey EK. Safety and efficacy of the neuraminidase inhibitor GG167 in experimental human influenza. JAMA 1996;275:295-9.
12. Hayden FG, Gwaltney JM Jr. Viral infections. In: Murray JF, Nadel JA, eds. Textbook of respiratory medicine. 2nd ed. Vol. 1. Philadelphia: W.B. Saunders, 1994:977-1035.
13. Gould AL. A new approach to the analysis of clinical drug trials with withdrawals. Biometrics 1980;36:721-7.
14. Koch GG, Sollecito WA. Statistical considerations in the design, analysis, and interpretation of comparative clinical studies. Drug Inf J 1984;18: 131-51.
15. Koch GG, Edwards S. Clinical efficacy trials with categorical data. In: Peace KE, ed. Biopharmaceutical statistics for drug development. Vol. 86 of Statistics: textbooks and monographs. New York: Marcel Dekker, 1988: 403-57.
16. Fleiss JL. Statistical methods for rates and proportions. 2nd ed. New York: John Wiley, 1981:260-79.
17. Van Voris LP, Betts RF, Hayden FG, Christmas WA, Douglas RG Jr. Successful treatment of naturally occurring influenza A/USSR/77 H1N1. JAMA 1981;245:1128-31.
18. Wingfield WL, Pollack D, Grunert RR. Therapeutic efficacy of amantadine HC1 and rimantadine HC1 in naturally occurring influenza A2 respiratory illness in man. N Engl J Med 1969;281:579-84.
19. Hayden FG, Monto AS. Oral rimantadine hydrochloride therapy of influenza A virus H3N2 subtype infection in adults. Antimicrob Agents Chemother 1986;29:339-41.
20. Douglas RG Jr. Prophylaxis and treatment of influenza. N Engl J Med 1990;322:443-50.
21. Hayden FG, Lobo M, Hussey EK, Eason CU. Efficacy of intranasal GG167 in experimental human influenza A and B virus infection. In: Brown LE, Hampson AW, Webster RG, eds. Options for the control of influenza III. Amsterdam: Elsevier Science B.V., 1996:718-25.
22. Cass LMR, Efthymiopoulos C, Bye A. An overview of the pharmaco-kinetics of the neuraminidase inhibitor GG167. In: Conference program and abstracts of the Third International Conference on Options for Control of Influenza, Cairns, Australia, May 4-9, 1996:37. abstract.
23. 1) influenza in young men. N Engl J Med 1982;307:1042-6.
24. Aoki FY, Crowley JCW. Distribution and removal of human serum albumin-technetium 99m instilled intranasally. Br J Clin Pharmacol 1976;3: 869-78.
25. Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol 1985;37:294-7.
26. Hayden FG, Gwaltney JM Jr. Intranasal interferon-α2 treatment of experimental rhinoviral colds. J Infect Dis 1984;150:174-80.