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Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study).

Publication ,  Journal Article
Bardin, T; Keenan, RT; Khanna, PP; Kopicko, J; Fung, M; Bhakta, N; Adler, S; Storgard, C; Baumgartner, S; So, A
Published in: Annals of the Rheumatic Diseases
May 2017

Determine the efficacy and safety of daily lesinurad (200 or 400 mg orally) added to allopurinol in patients with serum uric acid (sUA) above target in a 12-month, randomised, phase III trial.Patients on allopurinol ≥300 mg (≥200 mg in moderate renal impairment) had sUA level of ≥6.5 mg/dL (≥387 µmol/L) at screening and two or more gout flares in the prior year. Primary end point was the proportion of patients achieving sUA level of <6.0 mg/dL (<357 µmol/L) (month 6). Key secondary end points were mean gout flare rate requiring treatment (months 7 through 12) and proportions of patients with complete resolution of one or more target tophi (month 12). Safety assessments included adverse events and laboratory data.Patients (n=610) were predominantly male, with mean (±SD) age 51.2±10.90 years, gout duration 11.5±9.26 years and baseline sUA of 6.9±1.2 mg/dL (410±71 µmol/L). Lesinurad at 200 and 400 mg doses, added to allopurinol, significantly increased proportions of patients achieving sUA target versus allopurinol-alone therapy by month 6 (55.4%, 66.5% and 23.3%, respectively, p<0.0001 both lesinurad+allopurinol groups). In key secondary end points, there were no statistically significant treatment-group differences favouring lesinurad. Lesinurad was generally well tolerated; the 200 mg dose had a safety profile comparable with allopurinol-alone therapy. Renal-related adverse events occurred in 5.9% of lesinurad 200 mg+allopurinol, 15.0% of lesinurad 400 mg+allopurinol and 4.9% of allopurinol-alone groups, with serum creatinine elevation of ≥1.5× baseline in 5.9%, 15.0% and 3.4%, respectively. Serious treatment-emergent adverse events occurred in 4.4% of lesinurad 200 mg+allopurinol, in 9.5% of lesinurad 400 mg+allopurinol and in 3.9% of allopurinol-alone groups, respectively.Lesinurad added to allopurinol demonstrated superior sUA lowering versus allopurinol-alone therapy and lesinurad 200 mg was generally well tolerated in patients with gout warranting additional therapy.NCT01493531.

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Published In

Annals of the Rheumatic Diseases

DOI

EISSN

1468-2060

ISSN

0003-4967

Publication Date

May 2017

Volume

76

Issue

5

Start / End Page

811 / 820

Related Subject Headings

  • Young Adult
  • Uricosuric Agents
  • Uric Acid
  • Triazoles
  • Thioglycolates
  • Symptom Flare Up
  • Retreatment
  • Renal Insufficiency
  • Middle Aged
  • Male
 

Citation

APA
Chicago
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Bardin, T., Keenan, R. T., Khanna, P. P., Kopicko, J., Fung, M., Bhakta, N., … So, A. (2017). Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study). Annals of the Rheumatic Diseases, 76(5), 811–820. https://doi.org/10.1136/annrheumdis-2016-209213
Bardin, Thomas, Robert T. Keenan, Puja P. Khanna, Jeff Kopicko, Maple Fung, Nihar Bhakta, Scott Adler, Chris Storgard, Scott Baumgartner, and Alexander So. “Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study).Annals of the Rheumatic Diseases 76, no. 5 (May 2017): 811–20. https://doi.org/10.1136/annrheumdis-2016-209213.
Bardin, Thomas, et al. “Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study).Annals of the Rheumatic Diseases, vol. 76, no. 5, May 2017, pp. 811–20. Epmc, doi:10.1136/annrheumdis-2016-209213.
Bardin T, Keenan RT, Khanna PP, Kopicko J, Fung M, Bhakta N, Adler S, Storgard C, Baumgartner S, So A. Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study). Annals of the Rheumatic Diseases. 2017 May;76(5):811–820.

Published In

Annals of the Rheumatic Diseases

DOI

EISSN

1468-2060

ISSN

0003-4967

Publication Date

May 2017

Volume

76

Issue

5

Start / End Page

811 / 820

Related Subject Headings

  • Young Adult
  • Uricosuric Agents
  • Uric Acid
  • Triazoles
  • Thioglycolates
  • Symptom Flare Up
  • Retreatment
  • Renal Insufficiency
  • Middle Aged
  • Male