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Pharmacodynamic, pharmacokinetic and tolerability evaluation of concomitant administration of lesinurad and febuxostat in gout patients with hyperuricaemia.
Fleischmann, Roy; Kerr, Bradley; Yeh, Li-Tain; Suster, Matt; Shen, Zancong; Polvent, Elizabeth; Hingorani, Vijay; Quart, Barry; Manhard, Kimberly; Miner, Jeffrey N; Baumgartner, Scott.
Afiliación
  • Fleischmann R; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA. rfleischmann@mcrcdallas.com.
  • Kerr B; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Yeh LT; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Suster M; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Shen Z; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Polvent E; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Hingorani V; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Quart B; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Manhard K; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
  • Miner JN; Metroplex Clinical Research Center, Dallas, TX, Ardea Biosciences and Translational Sciences Department, Clinical Department, Regulatory Department and Biology Department, Ardea Biosciences, San Diego, CA, USA.
Rheumatology (Oxford) ; 53(12): 2167-74, 2014 Dec.
Article en En | MEDLINE | ID: mdl-24509406
OBJECTIVE: The aim of this study was to evaluate the pharmacodynamics (PDs), pharmacokinetics (PKs) and safety of lesinurad (selective uric acid reabsorption inhibitor) in combination with febuxostat (xanthine oxidase inhibitor) in patients with gout. METHODS: This study was a phase IB, multicentre, open-label, multiple-dose study of gout patients with serum uric acid (sUA) >8 mg/dl following washout of urate-lowering therapy with colchicine flare prophylaxis. Febuxostat 40 or 80 mg/day was administered on days 1-21, lesinurad 400 mg/day was added on days 8-14 and then lesinurad was increased to 600 mg/day on days 15-21. sUA, urine uric acid and PK profiles were evaluated at the end of each week. Safety was assessed by adverse events, laboratory tests and physical examinations. RESULTS: Initial treatment with febuxostat 40 or 80 mg/day monotherapy resulted in 67% and 56% of subjects, respectively, achieving a sUA level <6 mg/dl. Febuxostat 40 or 80 mg/day plus lesinurad 400 or 600 mg/day resulted in 100% of subjects achieving sUA <6 mg/dl and up to 100% achieving sUA <5 mg/dl. No clinically relevant changes in the PKs of either drug were noted. The combination was well tolerated. CONCLUSION: The clinically important targets of sUA <6 mg/dl and <5 mg/dl are achievable in 100% of patients when combining lesinurad and febuxostat.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tiazoles / Tioglicolatos / Triazoles / Supresores de la Gota / Hiperuricemia / Gota Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2014 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tiazoles / Tioglicolatos / Triazoles / Supresores de la Gota / Hiperuricemia / Gota Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2014 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido