Zanamivir. A review of clinical safety

Drug Safety

Volumn 21, Issue 4, 1999, Pages 267-281

  Freund, Barbara ^a   Gravenstein, Stefan ^a   Elliott, Michael ^b   Miller, Irene ^c  

^a EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^b GLAXOSMITHKLINE   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AMANTADINE; INFLUENZA VACCINE; OSELTAMIVIR; RIMANTADINE; SIALIDASE INHIBITOR; ZANAMIVIR;

ADULT; AGED; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG SAFETY; DRUG TOLERABILITY; HEADACHE; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INFANT; INFLUENZA; INFLUENZA VIRUS A; INFLUENZA VIRUS B; INHALATIONAL DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; JAPAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NORTH AMERICA; PRIORITY JOURNAL; PROPHYLAXIS; REVIEW; TOXICOLOGY; VERTIGO; VIRUS REPLICATION;

ANIMALS; ANTIVIRAL AGENTS; CLINICAL TRIALS; COMORBIDITY; DRUG INTERACTIONS; GUANIDINES; HUMANS; INFLUENZA, HUMAN; PYRANS; SIALIC ACIDS; ZANAMIVIR;

EID: 0032853740     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-199921040-00003     Document Type: Review

References (26)

1. Nicholson KG. Clinical features of influenza. Semin Respir Infect 1992; 7 (1): 26-37
2. Monto AS. Influenza: quantifying morbidity and mortality. Am J Med 1987; 82 Suppl. 6a: 20-5
3. Van Voris LP, Betts RF, Hayden FG, et al. Successful treatment of naturally occurring influenza A/USSR/77/H1N1. JAMA 1981; 245; 1128-31
4. Dolin R, Reichman RC, Madore HP, et al. A controlled trial of amantadine and rimantadine in the prophylaxis of influenza A infection. N Engl J Med 1982; 307: 580-4
5. Woods JM, Bethell RC, Coates JAV, et al. 4-guanidino-2,4-dideoxy-2,3-dehydro-N-acetylneuraminic acid is a highly effective inhibitor of both 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
6. Ryan DM, Ticehurst J, Dempsey MH, et al. Inhibition of influenza virus replication in mice by zanamivir (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
7. Hayden FG, Treanor JJ, Betts RF, et al. Safety and efficacy of the neuraminidase inhibitor GG167 in experimental human influenza. JAMA 1996; 275: 295-9
8. Hayden FG, Lobo M, Hussey EK, et al. Efficacy of intranasal GG167 in experimental human influenza A and B virus infection. In: Brown LE, Hampson AW, Webster RG, editors. Options for the control of influenza III. Amsterdam: Elsevier Science B.V, 1996: 718-25. (Int Cngr Ser; 1123)
9. The MIST Study Group. Randomised trial of efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections. Lancet 1998; 352: 1877-81
10. Fleming D, Makela M, Pauksens K, et al. High-risk and otherwise healthy patients demonstrate alleviation of influenza symptoms 2-5 days curlier following inhaled zanamivir treatment: European study - winter 1997/8 [abstract 789]. 36th Annual Meeting of the Infectious Diseases Society of America: 1998 Nov 12-15: Denver, CO
11. Monto AS, Robinson DP, Herlocher ML, et al. Safety and efficacy of the neuraminidase inhibitor zanamivir in prevention of influenza among healthy adults. JAMA 1999; 282(1): 31-5
12. Matsumoto K, Ogawa N, Nerome K, et al. Safety and efficacy of the neuraminidase inhibitor zanamivir in treating influenza virus infection in adults: results from Japan. Antiviral Ther 1999; 4: 61-8
13. von Itzstein M, Wu W-Y, Kok GB, et al. Rational design of potent sialidase-based inhibitors of influenza virus replication. Nature 1993; 363: 418-23
14. Dines GD, Bethell R, Daniel M. Preclinical development of low toxicity drugs; focus on zanamivir, an anti-influenza drug. Drug Saf 1998; 19 (3): 233-41
15. Cass LMR, Bye A. Repeat inhaled doses of zanamivir dry powder do not affect pulmonary function and bronchial hyper-responsiveness in asthmatic subjects. Respir Med. In press
16. Cass LMR, Efthymiopoulos C, Marsh J, et al. Effect of renal impairment on the pharmacokinetics of zanamivir. Clin Pharmacokinet 1999; 36 Suppl. 1: 1-11
17. Schilling M, Povinelli L, Krause P, et al. Efficacy of zanamivir for chemoprophylaxis of nursing home influenza outbreaks. Vaccine 1998; 16 (18): 1771-4
18. Daniel MJ. Barnett JM, Pearson BA. The low potential for drug interactions with zanamivir: a review. Clin Pharmacokinet 1999; 36 Suppl. 1: 41-50
19. Webster A, Boyce M, Edmundson S, et al. Co-administration of orally inhaled zanamivir with inactivated trivalent influenza vaccine docs not adversely affect the production of anti-haemagglutinin antibodies (HAI) titre in healthy volunteers. Clin Pharmacokinet 1999; 36 Suppl. 1: 51-8
20. Hayden FG. Amantadine and rimantadine resistance in influenza A viruses. Curr Opin Infect Dis 1994; 7: 674-7
21. Treanor JJ, Vrooman PS, Hayden FG, et al. Efficacy of oral GS4104 in treating acute influenza. Final Program, Abstracts and Exhibits Addendum of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1998 Sep 24-28; San Diego (CA), 21
22. Aoki F, Osterhaus A, Rimmelzwana G, et al. Oral GS4104 successfully reduces duration and severity of naturally-acquired influenza. Final Program, Abstracts and Exhibits Addendum of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy: 1998 Sep 24-28; San Diego (CA), 22
23. Hayden FG, Atmar R, Schilling M, et al. Safety and efficacy of oral GS4104 in long-term prophylaxis of natural influenza. Final Program. Abstracts and Exhibits Addendum of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy: 1998 Sep 24-28; San Diego (CA), 22
24. Nicholson KG, Ward P, Kinnersley N. Oseltamivir is an effective treatment for influenza and reduces influenza related complications and need for antibiotics [abstract]. J Antimicrob Chemother 1999; 44 Suppl. A: 41-2
25. Barnett J, Dempsey M, Tisdale M, et al. Susceptibility monitoring of influenza virus clinical isolates to the neuraminidase inhibitor zanamivir (GG 167) during phase II clinical efficacy trials. Abstracts of the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1997 Sep 28-Oct 1; Toronto, Canada, 230
26. Monta AS, Fleming DM, Henry D, et al. Efficacy and safety of the neuraminidase inhibitor zanamivir in the treatment of influenza A and B virus infections. J Infect Dis 1999; 180: 254-61