Data on neuraminidase inhibitors were made available
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《英国医生杂志》
EDITOR—In response to Symmonds et al,1 F Hoffmann-La Roche would like to clarify that data from studies WV15759/WV15871 were made available to the National Institute for Clinical Excellence.
These were double blind, placebo controlled trials, conducted in children aged 6 or older and 12 or younger, to investigate the efficacy and tolerability of oseltamivir in the treatment of influenza among asthmatic children. Of the 355 children randomised to treatment, 170 received oseltamivir 2 mg/kg and 164 received placebo. Of these children, 179 had laboratory confirmed influenza infection, which represented only 70% of the planned recruitment target. This precluded any statistical demonstration of the primary efficacy end point "time to freedom from illness" (incorporating resolution of symptoms and a return to normal activity).
Among the outcomes of this study, a positive effect on forced expiratory volume in one second in the oseltamivir group was seen, an observation that is being further investigated in an ongoing clinical trial in asthmatic children. We would also like to clarify that we plan to publish the results from studies WV15759/WV15871.
Zoya Panahloo, senior medical adviser
United Kingdom F Hoffmann La Roche, Welwyn Garden City, Hertfordshire AL7 3AY zoya.panahloo@roche.com
Competing interests: None declared.
References
Symmonds M, Matheson NJ, Harnden A. Guidelines on neuraminidase inhibitors in children are not supported by evidence. BMJ 2004;328: 227. (24 January.)
These were double blind, placebo controlled trials, conducted in children aged 6 or older and 12 or younger, to investigate the efficacy and tolerability of oseltamivir in the treatment of influenza among asthmatic children. Of the 355 children randomised to treatment, 170 received oseltamivir 2 mg/kg and 164 received placebo. Of these children, 179 had laboratory confirmed influenza infection, which represented only 70% of the planned recruitment target. This precluded any statistical demonstration of the primary efficacy end point "time to freedom from illness" (incorporating resolution of symptoms and a return to normal activity).
Among the outcomes of this study, a positive effect on forced expiratory volume in one second in the oseltamivir group was seen, an observation that is being further investigated in an ongoing clinical trial in asthmatic children. We would also like to clarify that we plan to publish the results from studies WV15759/WV15871.
Zoya Panahloo, senior medical adviser
United Kingdom F Hoffmann La Roche, Welwyn Garden City, Hertfordshire AL7 3AY zoya.panahloo@roche.com
Competing interests: None declared.
References
Symmonds M, Matheson NJ, Harnden A. Guidelines on neuraminidase inhibitors in children are not supported by evidence. BMJ 2004;328: 227. (24 January.)