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)
| Autor: | Nihar Bhakta, Robert T. Keenan, Scott Baumgartner, Alexander So, C. Storgard, Thomas Bardin, Puja P. Khanna, Scott Adler, J. Kopicko, Maple Fung |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Gout Placebo-controlled study chemistry.chemical_compound 0302 clinical medicine Clinical endpoint Immunology and Allergy Medicine 030212 general & internal medicine Renal Insufficiency Young adult Aged 80 and over Lesinurad Middle Aged Uricosuric Agents Symptom Flare Up Cardiovascular Diseases Outcomes research Creatinine Thioglycolates Retreatment Drug Therapy Combination Female medicine.drug Adult musculoskeletal diseases medicine.medical_specialty congenital hereditary and neonatal diseases and abnormalities Adolescent Allopurinol Immunology General Biochemistry Genetics and Molecular Biology Gout Suppressants 03 medical and health sciences Young Adult Pharmacotherapy Rheumatology Double-Blind Method Internal medicine Humans Aged 030203 arthritis & rheumatology Inflammation business.industry nutritional and metabolic diseases Triazoles Clinical and Epidemiological Research medicine.disease Surgery Uric Acid chemistry business |
| Zdroj: | Annals of the Rheumatic Diseases Annals of the rheumatic diseases, vol. 76, no. 5, pp. 811-820 |
| ISSN: | 1468-2060 0003-4967 0149-3531 |
| Popis: | ObjectivesDetermine 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.MethodsPatients 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 ResultsPatients (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, pConclusionLesinurad 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.Trial registration numberNCT01493531. |
| Databáze: | OpenAIRE |
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