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Rokuro Hama, Chairman of Room 502 Osaka 2-3-1, Tennoji-ku Osaka, Japan 543-0062@
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EDITOR- In response to Symmonds et al[1], Panahloo[2] stated that he planned to publish the results from studies WV15759/WV15871. But I still cannot find the published data. I agree Symmonds, because I also confirmed the same data of WV15759/WV15871 in the Japanese new drug approval package (NAP) of oseltmivir dry syrup [3]. According to the figure of Kaplan-Meier curve for proportion of patients without freedom from illness in the Japanese NAP, apparently non- significant earlier time to freedom from illness in children receiving oseltamivir than those receiving placebo is shown until around the median time to freedom from illness. However after about 70 percent of the children receiving placebo became free from illness, children receiving placebo seem becoming free from illness earlier than those receiving oseltamivir. Thus the average duration of illness is 14.7 hours less in placebo group than in oseltamivir group (mean +- standard deviation: 167.9+-11.7 vs 182.6 +- 15.9 hrs respectively; p value is not stated). How could it be explained? Isn't this controversial phenomenon related to the development of resistance? [4] I hope data become published as soon as possible so that we could know the full profile of harm and benefit. HAMA, Rokuro MD Japan Institute of Pharmacovigilance. Tennoji-ku Osaka, Japan
References 1. Symmonds M, Matheson NJ, Harnden A. Guidelines on neuraminidase inhibitors in children are not supported by evidence. BMJ. 2004 Jan 24; 328(7433):227 2. Panahloo Z. Data on neuraminidase inhibitors were made available. BMJ. 2004 Feb 28;328(7438):523. 3. New drug approval package (NAP) of oseltmivir (in Japanese); Tamiflu dry syrup (2002): http://211.132.8.246/shinyaku/g0201/11/5303990_21400AMY00010.html? 4. Kiso M, Mitamura K,Kawaoka Y. et al. Resistant influenza A viruses in children treated with oseltamivir: descriptive study. Lancet. 2004 Aug 28;364(9436):759-65. Competing interests: None declared |
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