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Editor,—I recently saw the UK guidance for the use of synagis (Palivizumab) brought out by the manufacturer and contributed to (?endorsed) by a number of UK experts. My interpretation of the IMpact-RSV (respiratory syncytial virus) study1appears to be at variance to the conclusions drawn and the recommendations of the “guidance”.
To me, in the above mentioned study,1 compared to placebo, Palivizumab: (a) did not (the trial lacked the power to demonstrate) reduce death or need for mechanical ventilation; (b) reduce RSV related hospitalisation by 55%—the primary outcome of interest.
Based on (b), the “guidance” recommends Palivizumab for premature infants of < 36 weeks' gestation who are < 6 months old at the start of RSV season as well as those with bronchopulmonary dysplasia < 2 years old who have required medical treatment within six months of the RSV season beginning.
Looking at the data in another way, one would need to treat 16 suggested “at risk” babies (20 for babies with bronchopulmonary dysplasia) to prevent one RSV related hospitalisation. Is it worth it in clinical or economic costs?
Clinical—There was no evidence that RSV illness was less severe among hospitalised Palivizumab recipients than among hospitalised placebo recipients. (The paper provides figures for secondary efficacy end points as …
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