Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Mar;68(3):697-707.
doi: 10.1093/jac/dks418. Epub 2012 Nov 9.

Oseltamivir and inhaled zanamivir as influenza prophylaxis in Thai health workers: a randomized, double-blind, placebo-controlled safety trial over 16 weeks

T Anekthananon  1 , S Pukrittayakamee, W Ratanasuwan, P Jittamala, P Werarak, P Charunwatthana, S Suwanagool, S Lawpoolsri, K Stepniewska, P Sapchookul, P Puthavathana, C Fukuda, N Lindegardh, J Tarning, N J White, N Day, W R J Taylor
Affiliations
Randomized Controlled Trial

Oseltamivir and inhaled zanamivir as influenza prophylaxis in Thai health workers: a randomized, double-blind, placebo-controlled safety trial over 16 weeks

T Anekthananon et al. J Antimicrob Chemother. 2013 Mar.

Erratum in

  • J Antimicrob Chemother. 2013 Jul;68(7):1695. Pukritayakamee, S [corrected to Pukrittayakamee, S]

Abstract

Objectives: Long-term chemoprophylaxis using neuraminidase inhibitors may be needed during influenza epidemics but safety data are limited to several weeks. We sought to assess the tolerability of oseltamivir and zanamivir as primary prophylaxis over 16 weeks.

Methods: We conducted a parallel group, double blind, 2 (active drug) :1 (placebo) randomized trial of oral oseltamivir/placebo or inhaled zanamivir/placebo over 16 weeks in healthy, Thai hospital professionals at two Bangkok hospitals. The primary endpoint was study withdrawal due to drug-related (possibly, probably, definitely) serious or adverse events (AEs) graded ≥ 2.

Results: Recruited subjects numbered 129 oseltamivir/65 placebo and 131 zanamivir/65 placebo. A total of 102 grade ≥ 2 AEs were reported or detected in 69 subjects: 23/129 (17.8%) versus 15/65 (23.1%) (P=0.26), and 23/131 (17.6%) versus 8/65 (12.3%) (P=0.28). Intercurrent infections/fevers [26/102 (25.5%)], abnormal biochemistry [25/102 (24.5%)] and gastrointestinal symptoms [18/102 (17.6%)] were the most frequently reported AEs. There were no drug-related study withdrawals. Eight serious AEs were all due to intercurrent illnesses. Laboratory, lung function and ECG parameters were similar between drugs and placebos.

Conclusions: Oseltamivir and zanamivir were well tolerated in healthy hospital professionals. Both drugs can be recommended for primary influenza prophylaxis for up to 16 weeks.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Trial profile.
Figure 2.
Figure 2.
Trends in respiratory symptoms by study week elicited by questionnaire for oseltamivir (OS)/placebo (OSp) and zanamivir (ZAN)/placebo (ZANp), expressed as subject proportions.
Figure 3.
Figure 3.
Trends in gastrointestinal symptoms by study week elicited by questionnaire for oseltamivir (OS)/placebo (OSp) and zanamivir (ZAN)/placebo (ZANp), expressed as subject proportions.
Figure 4.
Figure 4.
Trends in musculoskeletal symptoms by study week elicited by questionnaire for oseltamivir (OS)/placebo (OSp) and zanamivir (ZAN)/placebo (ZANp), expressed as subject proportions.
Figure 5.
Figure 5.
Trends in neurological symptoms by study week elicited by questionnaire for oseltamivir (OS)/placebo (OSp) and zanamivir (ZAN)/placebo (ZANp), expressed as subject proportions.
See this image and copyright information in PMC

References

    1. Taubenberger JK, Morens DM. 1918 Influenza: the mother of all pandemics. Emerg Infect Dis. 2006;12:15–22. - PMC - PubMed
    1. Cauchemez S, Ferguson NM, Wachtel C, et al. Closure of schools during an influenza pandemic. Lancet Infect Dis. 2009;9:473–81. - PMC - PubMed
    1. Barr IG, Hurt AC, Iannello P, et al. Increased adamantane resistance in influenza A(H3) viruses in Australia and neighbouring countries in 2005. Antiviral Res. 2007;73:112–7. - PubMed
    1. Bai GR, Chittaganpitch M, Kanai Y, et al. Amantadine- and oseltamivir-resistant variants of influenza A viruses in Thailand. Biochem Biophys Res Commun. 2009;390:897–901. - PubMed
    1. Hurt AC, Selleck P, Komadina N, et al. Susceptibility of highly pathogenic A(H5N1) avian influenza viruses to the neuraminidase inhibitors and adamantanes. Antiviral Res. 2007;73:228–31. - PubMed

Publication types

MeSH terms