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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

Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low- dose colchicine for the treatment of gout flares in primary care
Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low- dose colchicine for the treatment of gout flares in primary care
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 (2013001354-95).
0003-4967
Roddy, Edward
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Clarkson, Kris
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Milica, Blagojevic-Bucknall
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Mehta, Rajnikant
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Oppong, Raymond
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Avery, Anthony
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Hay, Elaine M.
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Heneghan, Carl
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Hartshorne, Liz
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Hooper, Julie
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Hughes, Gemma
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Jowett, Sue
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Little, Paul
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Lewis, Martyn
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McCartney, Karen
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Mahtani, Kamal R.
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Nunan, David
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Santer, Miriam
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Williams, Samantha
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Mallen, Christian D.
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Roddy, Edward
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Clarkson, Kris
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Milica, Blagojevic-Bucknall
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Mehta, Rajnikant
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Oppong, Raymond
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Avery, Anthony
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Hay, Elaine M.
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Heneghan, Carl
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Hartshorne, Liz
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Hooper, Julie
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Hughes, Gemma
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Jowett, Sue
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Little, Paul
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Lewis, Martyn
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McCartney, Karen
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Mahtani, Kamal R.
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Nunan, David
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Santer, Miriam
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Williams, Samantha
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Mallen, Christian D.
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Roddy, Edward, Clarkson, Kris, Milica, Blagojevic-Bucknall, Mehta, Rajnikant, Oppong, Raymond, Avery, Anthony, Hay, Elaine M., Heneghan, Carl, Hartshorne, Liz, Hooper, Julie, Hughes, Gemma, Jowett, Sue, Little, Paul, Lewis, Martyn, McCartney, Karen, Mahtani, Kamal R., Nunan, David, Santer, Miriam, Williams, Samantha and Mallen, Christian D. (2019) 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. (doi:10.1136/ annrheumdis-2019-216154).

Record type: Article

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 (2013001354-95).

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Accepted/In Press date: 16 October 2019
e-pub ahead of print date: 30 October 2019

Identifiers

Local EPrints ID: 435478
URI: http://eprints.soton.ac.uk/id/eprint/435478
ISSN: 0003-4967
PURE UUID: c970e6d9-5f15-42fd-934b-80920c9fde38
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260
ORCID for Samantha Williams: ORCID iD orcid.org/0000-0001-9505-6485

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Date deposited: 07 Nov 2019 17:30
Last modified: 23 May 2020 00:31

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Contributors

Author: Edward Roddy
Author: Kris Clarkson
Author: Blagojevic-Bucknall Milica
Author: Rajnikant Mehta
Author: Raymond Oppong
Author: Anthony Avery
Author: Elaine M. Hay
Author: Carl Heneghan
Author: Liz Hartshorne
Author: Julie Hooper
Author: Gemma Hughes
Author: Sue Jowett
Author: Paul Little
Author: Martyn Lewis
Author: Karen McCartney
Author: Kamal R. Mahtani
Author: David Nunan
Author: Miriam Santer ORCID iD
Author: Christian D. Mallen

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