In response to our comment[
[1]
], Dr Portsmouth and colleagues provide additional information about the results of
the CAPSTONE-1 trial [
[2]
], which we appreciate. In our comment, we underlined that the composition of the study
population should have been taken into account when the study results were analysed,
interpreted and presented.Keywords
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References
de Haas, Esther C. et al. Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults. European Journal of Internal Medicine, Volume 62, e8–e9.
- Baloxavir marboxil for uncomplicated influenza in adults and adolescents.N Engl J Med. 2018; 379: 913-923
- Review Report Xofluza 10 mg and 20 mg.2018 (8 FebruaryAvailable via:)
Genentech USA, Inc. XOFLUZA™ (baloxavir marboxil) [label]. 2018. Available via: www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf.
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Article info
Publication history
Published online: January 02, 2020
Accepted:
December 23,
2019
Received:
December 19,
2019
Identification
Copyright
© 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Baloxavir for influenza: Enrichment obscured lack of effect in North-American adultsEuropean Journal of Internal MedicineVol. 62
- PreviewThe FDA recently approved the use of baloxavir marboxil (baloxavir) in patients aged 12–64 years with uncomplicated influenza [1]. The effectiveness of baloxavir had been tested in one phase III trial named CAPSTONE-1 [2]. It consisted of two subtrials: one subtrial compared baloxavir (40 mg once) with placebo and oseltamivir in adult patients, and the other baloxavir with placebo in adolescent patients (total n = 1436). The trial was performed in Japan, the United States, and Canada. In the reported primary efficacy analysis, baloxavir reduced the time to alleviation of flu symptoms with 26.5 hours compared to placebo.
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