Brief observationInitiation of Allopurinol at First Medical Contact for Acute Attacks of Gout: A Randomized Clinical Trial
Section snippets
Materials and Methods
We designed a randomized, double-blind, placebo-controlled, parallel-arm, single-center, noninferiority study of the early initiation of full-dose allopurinol (300 mg) versus placebo in adults with acute gout, both arms receiving indomethacin treatment and a prophylactic dose of colchicine. The Research and Development Committee at the White River Junction Veteran's Affairs Medical Center and the Committee for the Protection of Human Subjects at Dartmouth College approved the original protocol
Results
Of 57 subjects randomized, 31 were allocated to the allopurinol group and 26 were allocated to the placebo group. For the per-protocol analysis, 6 subjects were excluded post-randomization because of failure to adequately comply with the study medication or follow-up visits (Figure 1). The baseline characteristics of the participants were similar between study arms for both the intention-to-treat (Supplemental Table 1) and per-protocol populations (Table 1), neither of whom contained any
Discussion
This first randomized, double-blind, placebo-controlled study of patients started on an adequate dose (300 mg) of allopurinol during the acute gout attack, while simultaneously treated with indomethacin and colchicine, produced surprisingly similar declines in VAS and self-determined gout flares, with narrow CIs. Although an adequate dose of allopurinol is whatever dose is required to achieve a serum urate below the goal of 6.0 mg/dL,24, 25 a starting dose of 300 mg of allopurinol avoids the
Conclusions
In uncomplicated gout, all 3 drugs, nonsteroidal anti-inflammatory drug of choice, a prophylactic dose of colchicine 0.6 mg once daily, and adequately dosed allopurinol 300 mg once daily, may be started during the acute attack. Graded incremental dosing of allopurinol was not used because we wanted to show that the initiation of treatment can be done to advantage with an adequate 300 mg dose, saving unnecessary visits, expense, chronic underdosing, and complexity of therapy.
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Funding: none.
Conflict of Interest: None. The views expressed herein do not necessarily represent the views of the Department of Veterans Affairs or the US Government.
Authorship: All authors had access to the data and played a role in writing this manuscript. Reproducible Research Statement: Research study protocol, STATA statistical code, and data set, without personal identifiers, available from Thomas H. Taylor (e-mail: [email protected]). This study was reviewed by the Veterans Affairs Research and Development Committee and received approval from the Dartmouth Medical School Institutional Review Board.
ClinicalTrials.gov registration number: NCT01310673.