Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

Edward Roddy; Kris Clarkson; Milisa  Blagojevic-Bucknall; Rajnikant  Mehta; Raymond Oppong; Anthony Avery; Elaine Hay; Carl Heneghan; Liz  Hartshorne; Julie  Hooper; Gemma Hughes; Sue Jowett; Martyn Lewis; Paul Little; Karen  McCartney; Kamal  Mahtani; David Nunan; Miriam  Santer; Sam  Williams; Christian Mallen

doi:10.1136/annrheumdis-2019-216154

Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

Edward Roddy, Kris Clarkson, Milisa Blagojevic-Bucknall, Rajnikant Mehta, Raymond Oppong, Anthony Avery, Elaine Hay, Carl Heneghan, Liz Hartshorne, Julie Hooper, Gemma Hughes, Sue Jowett, Martyn Lewis, Paul Little, Karen McCartney, Kamal Mahtani, David Nunan, Miriam Santer, Sam Williams, Christian Mallen

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Abstract

Objectives: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.

Methods: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: Mean change from baseline was compared between groups over days 1-7 by intention to treat.

Results: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: Mean difference-0.18; 95% CI-0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54).

Conclusion: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications.

Trial registration number: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

Original language	English
Pages (from-to)	276-284
Number of pages	9
Journal	Annals of the Rheumatic Diseases
Volume	79
Issue number	2
Early online date	30 Oct 2019
DOIs	https://doi.org/10.1136/annrheumdis-2019-216154
Publication status	Published - Feb 2020

Keywords

Gout
Primary care
Naproxen
Colchicine
Randomised trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/annrheumdis-2019-216154Licence: Creative Commons: Attribution (CC BY)

Roddy_et_al_Open-label_randomised_pragmatic_trial_(CONTACT)_Annals_of_the_Rheumatic_Diseases_2019
Roddy, E, Clarkson, K, Blagojevic-Bucknall, M, Mehta, R, Oppong, R, Avery, A, Hay, E, Heneghan, C, Hartshorne, L, Hooper, J, Hughes, G, Jowett, S, Lewis, M, Little, P, McCartney, K, Mahtani, K, Nunan, D, Santer, M, Williams, S & Mallen, C (2019), 'An open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care', Annals of the Rheumatic Diseases, pp. 1-9.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. https://doi.org/10.1136/annrheumdis-2019-216154
Final published version, 2.07 MBLicence: Creative Commons: Attribution (CC BY)
Roddy_et_al_Open-label_randomised_pragmatic_trial_(CONTACT)_Annals_of_the_Rheumatic_Diseases_2019_Supplementary_material
Roddy, E, Clarkson, K, Blagojevic-Bucknall, M, Mehta, R, Oppong, R, Avery, A, Hay, E, Heneghan, C, Hartshorne, L, Hooper, J, Hughes, G, Jowett, S, Lewis, M, Little, P, McCartney, K, Mahtani, K, Nunan, D, Santer, M, Williams, S & Mallen, C (2019), 'An open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care', Annals of the Rheumatic Diseases, pp. 1-9.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. https://doi.org/10.1136/annrheumdis-2019-216154
Final published version, 87.4 KBLicence: Creative Commons: Attribution (CC BY)

https://ard.bmj.com/content/early/2019/10/30/annrheumdis-2019-216154Licence: Creative Commons: Attribution (CC BY)

Cite this

Roddy, E., Clarkson, K., Blagojevic-Bucknall, M., Mehta, R., Oppong, R., Avery, A., Hay, E., Heneghan, C., Hartshorne, L., Hooper, J., Hughes, G., Jowett, S., Lewis, M., Little, P., McCartney, K., Mahtani, K., Nunan, D., Santer, M., Williams, S., & Mallen, C. (2020). Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Annals of the Rheumatic Diseases, 79(2), 276-284. https://doi.org/10.1136/annrheumdis-2019-216154

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abstract = "Objectives: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. Methods: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: Mean change from baseline was compared between groups over days 1-7 by intention to treat. Results: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: Mean difference-0.18; 95% CI-0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). Conclusion: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. Trial registration number: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).",

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author = "Edward Roddy and Kris Clarkson and Milisa Blagojevic-Bucknall and Rajnikant Mehta and Raymond Oppong and Anthony Avery and Elaine Hay and Carl Heneghan and Liz Hartshorne and Julie Hooper and Gemma Hughes and Sue Jowett and Martyn Lewis and Paul Little and Karen McCartney and Kamal Mahtani and David Nunan and Miriam Santer and Sam Williams and Christian Mallen",

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Roddy, E, Clarkson, K, Blagojevic-Bucknall, M, Mehta, R, Oppong, R, Avery, A, Hay, E, Heneghan, C, Hartshorne, L, Hooper, J, Hughes, G, Jowett, S, Lewis, M, Little, P, McCartney, K, Mahtani, K, Nunan, D, Santer, M, Williams, S & Mallen, C 2020, 'Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care', Annals of the Rheumatic Diseases, vol. 79, no. 2, pp. 276-284. https://doi.org/10.1136/annrheumdis-2019-216154

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T1 - Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

AU - Roddy, Edward

AU - Clarkson, Kris

AU - Blagojevic-Bucknall, Milisa

AU - Mehta, Rajnikant

AU - Oppong, Raymond

AU - Avery, Anthony

AU - Hay, Elaine

AU - Heneghan, Carl

AU - Hartshorne, Liz

AU - Hooper, Julie

AU - Hughes, Gemma

AU - Jowett, Sue

AU - Lewis, Martyn

AU - Little, Paul

AU - McCartney, Karen

AU - Mahtani, Kamal

AU - Nunan, David

AU - Santer, Miriam

AU - Williams, Sam

AU - Mallen, Christian

PY - 2020/2

Y1 - 2020/2

N2 - Objectives: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. Methods: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: Mean change from baseline was compared between groups over days 1-7 by intention to treat. Results: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: Mean difference-0.18; 95% CI-0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). Conclusion: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. Trial registration number: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

AB - Objectives: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. Methods: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: Mean change from baseline was compared between groups over days 1-7 by intention to treat. Results: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: Mean difference-0.18; 95% CI-0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). Conclusion: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. Trial registration number: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

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KW - Primary care

KW - Naproxen

KW - Colchicine

KW - Randomised trial

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DO - 10.1136/annrheumdis-2019-216154

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JO - Annals of the Rheumatic Diseases

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Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

Abstract

Keywords

UN SDGs

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