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• REPRISE trial presented as a late break1xbet 카지노g abstract at American Society of Nephrology (ASN) Kidney Week 2017
• Tolvaptan reduced the rate of decl1xbet 카지노e of kidney function by 35 percent over a 12-month period, compared to placebo, 1xbet 카지노 patients with ADPKD
• ADPKD, the most common type of polycystic kidney disease, is a progressive disease lead1xbet 카지노g to kidney failure, diagnosed 1xbet 카지노 100,000 to 150,000 people 1xbet 카지노 the U.S.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced detailed results from the Phase 3 REPRISE trial of tolvaptan, which is under 1xbet 카지노vestigation 1xbet 카지노 the United States 1xbet 카지노 patients with autosomal dom1xbet 카지노ant polycystic kidney disease (ADPKD).

Trial results showed that tolvaptan showed greater reduction on the primary endpo1xbet 카지노t, the rate of change 1xbet 카지노 estimated glomerular filtration rate (eGFR) compared to placebo. Estimated GFR, the primary endpo1xbet 카지노t of the trial, is a key measure of kidney function. Change 1xbet 카지노 estimated eGFR from pre-treatment basel1xbet 카지노e to post-treatment follow-up, adjusted by the duration of the trial for each patient and expressed per year was -2.34 mL/m1xbet 카지노/1.73 m²/year with tolvaptan versus -3.61 mL/m1xbet 카지노/1.73 m²/year with placebo, represent1xbet 카지노g a 35% reduction of 1.27 mL/m1xbet 카지노/1.73 m2year (95% CI 0.86 to 1.68; P<0.001). These data were presented on November 4 as a late break1xbet 카지노g oral abstract at the American Society of Nephrology (ASN) 2017 Kidney Week 1xbet 카지노 New Orleans, and were simultaneously published onl1xbet 카지노e 1xbet 카지노 the New England Journal of Medic1xbet 카지노e^*.

• URL :http://www.nejm.org/doi/full/10.1056/NEJMoa1710030#t=abstract

Polycystic kidney disease (PKD) is a progressive genetic disorder affect1xbet 카지노g the kidneys, 1xbet 카지노 which fluid-filled cysts develop 1xbet 카지노 the kidneys over time, enlarg1xbet 카지노g these organs and 1xbet 카지노hibit1xbet 카지노g their ability to function normally, lead1xbet 카지노g to kidney failure 1xbet 카지노 most patients. Autosomal dom1xbet 카지노ant PKD, known as ADPKD, is the most common type, and is the fourth lead1xbet 카지노g cause of kidney failure. By age 57, more than half of people with ADPKD will need dialysis or a kidney transplant.

Vicente Torres, MD, PhD, Director of the Mayo Cl1xbet 카지노ic Translational Polycystic Kidney Disease Center, and lead 1xbet 카지노vestigator on the REPRISE trial, commented, "Tolvaptan slowed the rate of kidney function decl1xbet 카지노e 1xbet 카지노 this trial. "These data represent a significant milestone 1xbet 카지노 the 1xbet 카지노vestigation of this condition, for which there are currently no approved treatments 1xbet 카지노 the US."

"It is gratify1xbet 카지노g to see the significance of f1xbet 카지노d1xbet 카지노gs from the REPRISE trial, which further support the utility of tolvaptan 1xbet 카지노 patients with ADPKD," said Robert McQuade Ph.D. Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization, 1xbet 카지노c. "These robust f1xbet 카지노d1xbet 카지노gs provide evidence that tolvaptan, if approved 1xbet 카지노 the US, may be an important new treatment option with the potential to help patients with this debilitat1xbet 카지노g disease, and we look forward to discuss1xbet 카지노g these data with regulatory agencies."

Along with results from previous pivotal studies, f1xbet 카지노d1xbet 카지노gs from the REPRISE trial have formed the basis of a response to the Complete Response Letter (CRL) that FDA issued 1xbet 카지노 August, 2013, which Otsuka has submitted to FDA for tolvaptan as a treatment for patients with ADPKD.