Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial

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Oseltamivir plus usual care versus usual care for influenza-like illness in primary care : an open-label, pragmatic, randomised controlled trial. / Butler, Christopher C; van der Velden, Alike W; Bongard, Emily; Saville, Benjamin R; Holmes, Jane; Coenen, Samuel; Cook, Johanna; Francis, Nick A; Lewis, Roger J; Godycki-Cwirko, Maciek; Llor, Carl; Chlabicz, Sławomir; Lionis, Christos; Seifert, Bohumil; Sundvall, Pär-Daniel; Colliers, Annelies; Aabenhus, Rune; Bjerrum, Lars; Jonassen Harbin, Nicolay; Lindbæk, Morten; Glinz, Dominik; Bucher, Heiner C; Kovács, Bernadett; Radzeviciene Jurgute, Ruta; Touboul Lundgren, Pia; Little, Paul; Murphy, Andrew W; De Sutter, An; Openshaw, Peter; de Jong, Menno D; Connor, Jason T; Matheeussen, Veerle; Ieven, Margareta; Goossens, Herman; Verheij, Theo J.

In: Lancet Oncology, Vol. 395, No. 10217, 2020, p. 42-52.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Butler, CC, van der Velden, AW, Bongard, E, Saville, BR, Holmes, J, Coenen, S, Cook, J, Francis, NA, Lewis, RJ, Godycki-Cwirko, M, Llor, C, Chlabicz, S, Lionis, C, Seifert, B, Sundvall, P-D, Colliers, A, Aabenhus, R, Bjerrum, L, Jonassen Harbin, N, Lindbæk, M, Glinz, D, Bucher, HC, Kovács, B, Radzeviciene Jurgute, R, Touboul Lundgren, P, Little, P, Murphy, AW, De Sutter, A, Openshaw, P, de Jong, MD, Connor, JT, Matheeussen, V, Ieven, M, Goossens, H & Verheij, TJ 2020, 'Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial', Lancet Oncology, vol. 395, no. 10217, pp. 42-52. https://doi.org/10.1016/S0140-6736(19)32982-4

APA

Butler, C. C., van der Velden, A. W., Bongard, E., Saville, B. R., Holmes, J., Coenen, S., ... Verheij, T. J. (2020). Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial. Lancet Oncology, 395(10217), 42-52. https://doi.org/10.1016/S0140-6736(19)32982-4

Vancouver

Butler CC, van der Velden AW, Bongard E, Saville BR, Holmes J, Coenen S et al. Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial. Lancet Oncology. 2020;395(10217):42-52. https://doi.org/10.1016/S0140-6736(19)32982-4

Author

Butler, Christopher C ; van der Velden, Alike W ; Bongard, Emily ; Saville, Benjamin R ; Holmes, Jane ; Coenen, Samuel ; Cook, Johanna ; Francis, Nick A ; Lewis, Roger J ; Godycki-Cwirko, Maciek ; Llor, Carl ; Chlabicz, Sławomir ; Lionis, Christos ; Seifert, Bohumil ; Sundvall, Pär-Daniel ; Colliers, Annelies ; Aabenhus, Rune ; Bjerrum, Lars ; Jonassen Harbin, Nicolay ; Lindbæk, Morten ; Glinz, Dominik ; Bucher, Heiner C ; Kovács, Bernadett ; Radzeviciene Jurgute, Ruta ; Touboul Lundgren, Pia ; Little, Paul ; Murphy, Andrew W ; De Sutter, An ; Openshaw, Peter ; de Jong, Menno D ; Connor, Jason T ; Matheeussen, Veerle ; Ieven, Margareta ; Goossens, Herman ; Verheij, Theo J. / Oseltamivir plus usual care versus usual care for influenza-like illness in primary care : an open-label, pragmatic, randomised controlled trial. In: Lancet Oncology. 2020 ; Vol. 395, No. 10217. pp. 42-52.

Bibtex

@article{aa26dcf0cf3d4d30b46a997ecbeaed8d,
title = "Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial",
abstract = "BACKGROUND: Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.METHODS: We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.FINDINGS: Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94{\%}) and 1526 (93{\%}). 1590 (52{\%}) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95{\%} Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95{\%} [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95{\%} BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95{\%} BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group.INTERPRETATION: Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner.FUNDING: European Commission's Seventh Framework Programme.",
author = "Butler, {Christopher C} and {van der Velden}, {Alike W} and Emily Bongard and Saville, {Benjamin R} and Jane Holmes and Samuel Coenen and Johanna Cook and Francis, {Nick A} and Lewis, {Roger J} and Maciek Godycki-Cwirko and Carl Llor and Sławomir Chlabicz and Christos Lionis and Bohumil Seifert and P{\"a}r-Daniel Sundvall and Annelies Colliers and Rune Aabenhus and Lars Bjerrum and {Jonassen Harbin}, Nicolay and Morten Lindb{\ae}k and Dominik Glinz and Bucher, {Heiner C} and Bernadett Kov{\'a}cs and {Radzeviciene Jurgute}, Ruta and {Touboul Lundgren}, Pia and Paul Little and Murphy, {Andrew W} and {De Sutter}, An and Peter Openshaw and {de Jong}, {Menno D} and Connor, {Jason T} and Veerle Matheeussen and Margareta Ieven and Herman Goossens and Verheij, {Theo J}",
note = "Copyright {\circledC} 2019 Elsevier Ltd. All rights reserved.",
year = "2020",
doi = "10.1016/S0140-6736(19)32982-4",
language = "English",
volume = "395",
pages = "42--52",
journal = "Lancet Oncology",
issn = "1470-2045",
publisher = "TheLancet Publishing Group",
number = "10217",

}

RIS

TY - JOUR

T1 - Oseltamivir plus usual care versus usual care for influenza-like illness in primary care

T2 - an open-label, pragmatic, randomised controlled trial

AU - Butler, Christopher C

AU - van der Velden, Alike W

AU - Bongard, Emily

AU - Saville, Benjamin R

AU - Holmes, Jane

AU - Coenen, Samuel

AU - Cook, Johanna

AU - Francis, Nick A

AU - Lewis, Roger J

AU - Godycki-Cwirko, Maciek

AU - Llor, Carl

AU - Chlabicz, Sławomir

AU - Lionis, Christos

AU - Seifert, Bohumil

AU - Sundvall, Pär-Daniel

AU - Colliers, Annelies

AU - Aabenhus, Rune

AU - Bjerrum, Lars

AU - Jonassen Harbin, Nicolay

AU - Lindbæk, Morten

AU - Glinz, Dominik

AU - Bucher, Heiner C

AU - Kovács, Bernadett

AU - Radzeviciene Jurgute, Ruta

AU - Touboul Lundgren, Pia

AU - Little, Paul

AU - Murphy, Andrew W

AU - De Sutter, An

AU - Openshaw, Peter

AU - de Jong, Menno D

AU - Connor, Jason T

AU - Matheeussen, Veerle

AU - Ieven, Margareta

AU - Goossens, Herman

AU - Verheij, Theo J

N1 - Copyright © 2019 Elsevier Ltd. All rights reserved.

PY - 2020

Y1 - 2020

N2 - BACKGROUND: Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.METHODS: We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.FINDINGS: Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group.INTERPRETATION: Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner.FUNDING: European Commission's Seventh Framework Programme.

AB - BACKGROUND: Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.METHODS: We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.FINDINGS: Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group.INTERPRETATION: Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner.FUNDING: European Commission's Seventh Framework Programme.

U2 - 10.1016/S0140-6736(19)32982-4

DO - 10.1016/S0140-6736(19)32982-4

M3 - Journal article

C2 - 31839279

VL - 395

SP - 42

EP - 52

JO - Lancet Oncology

JF - Lancet Oncology

SN - 1470-2045

IS - 10217

ER -

ID: 232140344