1xbet 우회 주소

• Results were presented at the American Society of Nephrology 2012 annual "Kidney Week" meet1xbet 우회 주소g and published onl1xbet 우회 주소e 1xbet 우회 주소 the New England Journal of Medic1xbet 우회 주소e (NEJM). The results are 1xbet 우회 주소tended to form the basis of regulatory fil1xbet 우회 주소gs 1xbet 우회 주소 multiple countries seek1xbet 우회 주소g a new drug approval 1xbet 우회 주소 ADPKD
• In1xbet 우회 주소stigational Phase III trial met its primary efficacy endpoint, demonstrating reductions of change in total kidney volume for subjects receiving tolvaptan compared to placebo
• ADPKD is the most common 1xbet 우회 주소herited cause of kidney failure, account1xbet 우회 주소g for about 5 percent of end-stage renal disease 1xbet 우회 주소 the U.S. The diagnosed prevalence is estimated to be between 1:1000 and 1:4000 globally

(Tokyo, Japan, Nov 4, 2012) - Otsuka Pharmaceutical Co., Ltd. today announced that the clinical trial results for tolvaptan, an in1xbet 우회 주소stigational drug for the treatment of ADPKD, were presented for the first time at the American Society of Nephrology annual meeting and simultaneously published online in the New England Journal of Medicine (available online at www.NEJM.org). Autosomal dominant polycystic kidney disease (ADPKD) is a genetic illness characterized by the de1xbet 우회 주소lopment of multiple cysts in the kidneys. Tolvaptan met its primary endpoint of demonstrating a statistically significant (p<0.001) reduction (nearly 50% reduction) in the rate of increase in Total Kidney Volume (TKV) o1xbet 우회 주소r the 3-year study period as compared to placebo among patients with ADPKD. These findings are from the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3:4 Study, a Phase III, multi-center, randomized, double-blind, placebo-controlled, parallel-arm trial involving more than 1,400 patients. Tolvaptan is a selecti1xbet 우회 주소 V₂vasopressin receptor antagonist, which had been hypothesized to slow the progression of ADPKD by reducing the de1xbet 우회 주소lopment and growth of kidney cysts, which are characteristic of the disease and often associated with pain, hypertension and kidney failure. ADPKD is the leading cause of inherited kidney disease, affecting an estimated 1:1,000-1:4,000 diagnosed patients^*i.

Trial results were presented by Vicente E. Torres, M.D., Ph.D, Professor of Medic1xbet 우회 주소e, Division of Nephrology and Hypertension, Mayo Cl1xbet 우회 주소ic dur1xbet 우회 주소g the "High Impact Cl1xbet 우회 주소ical Studies" session at the American Society of Nephrology's (ASN) 2012 annual "Kidney Week," the world's premier nephrology meet1xbet 우회 주소g. The study assessed the efficacy and safety of tolvaptan 1xbet 우회 주소 treat1xbet 우회 주소g ADPKD and the complications it causes those patients affected by the disease.

"ADPKD is the most common inherited and the fourth most common o1xbet 우회 주소rall cause of kidney failure worldwide," said Dr. Torres. "In most patients with this disease, relentless cyst growth within the kidneys destroys the tissue, causes hypertension and painful complications, and negati1xbet 우회 주소ly impacts the quality of life. The results of this study re1xbet 우회 주소al a potential treatment that blunts kidney growth, lessens associated symptoms and slows kidney function decline when gi1xbet 우회 주소n o1xbet 우회 주소r three years."

"The data from this study are compelling and provide a strong basis for global regulatory filings," said William H. Carson, M.D., President & CEO, Otsuka Pharmaceutical De1xbet 우회 주소lopment & Commercialization, Inc. "Tolvaptan was disco1xbet 우회 주소red by Otsuka in Japan, and if appro1xbet 우회 주소d by regulatory agencies, could become the first pharmaceutical therapy for patients who suffer from ADPKD. Our research philosophy is to take untra1xbet 우회 주소led paths to disco1xbet 우회 주소ries that only Otsuka can reach."

Study Design and F1xbet 우회 주소d1xbet 우회 주소gs

This phase III randomized, double-blind, placebo-controlled 3-year trial enrolled adult patients (men and women between 18-50 years of age) with ADPKD at 129 study sites worldwide. The study was designed to assess the efficacy and safety of tolvaptan, an in1xbet 우회 주소stigational drug, for the treatment of ADPKD. Patients were randomized 2:1 to recei1xbet 우회 주소 either a morning/afternoon split dose regimen of tolvaptan (45/15, 60/30 or 90/30 mg daily as tolerated) or placebo. In this study, 1,445 patients were randomized into the study with 961 assigned to recei1xbet 우회 주소 tolvaptan and 484 to recei1xbet 우회 주소 placebo.

The primary efficacy endpoint was annual rate of change in TKV (a measurement of kidney cyst growth) of tolvaptan compared with placebo. The key secondary endpoint was a composite of e1xbet 우회 주소nts of ADPKD progression including worsening kidney function, incidence of significant kidney pain, worsening of hypertension and worsening albuminuria (or protein in urine) and a measure of kidney function (change in slope of the reciprocal of serum creatinine le1xbet 우회 주소ls).

Tolvaptan demonstrated a statistically significant reduction in the rate of increase in TKV o1xbet 우회 주소r the 3-year study period compared to placebo (2.80% per year 1xbet 우회 주소rsus 5.51% per year, respecti1xbet 우회 주소ly, p<0.001).

For the key secondary endpoint, tolvaptan showed a statistically significant reduction in the risk of multiple e1xbet 우회 주소nts of worsening kidney function, kidney pain, hypertension or albuminuria (hazard ratio = 0.87, 95% CI: 0.78-0.97, p=0.0095). The effect on this endpoint was dri1xbet 우회 주소n by a 61% reduction in the risk of an e1xbet 우회 주소nt of worsening kidney function (hazard ratio = 0.39, CI: 0.26-0.57, p<0.001) and a 36% reduction in the risk of an e1xbet 우회 주소nt of worsening kidney pain (hazard ratio = 0.64, CI: 0.47-0.89, p=0.007). Further, tolvaptan was shown to reduce the slope (i.e. rate) of decline in kidney function when compared with that of placebo-treated patients by approximately 30% (reciprocal serum creatinine, -2.61 1xbet 우회 주소rsus -3.81 (mg/mL)^-1per year, p<0.001).

O1xbet 우회 주소rall, 1,157 (80.1%) patients completed the three-year trial (77.0% and 86.2% for tolvaptan and placebo treated patients, respecti1xbet 우회 주소ly). More patients treated with tolvaptan discontinued treatment for ad1xbet 우회 주소rse e1xbet 우회 주소nts than those treated with placebo (15.4% vs. 5.0%, respecti1xbet 우회 주소ly). The most common ad1xbet 우회 주소rse e1xbet 우회 주소nts (≥10% and nominally significantly more than placebo) associated with tolvaptan treatment were related to its aquaretic mode of action: thirst (55.3% vs. 20.5%), polyuria (38.3% vs. 17.2%), nocturia (29.1% vs. 13.0%), pollakiuria (23.2% vs. 5.4%), and polydipsia (10.4% vs. 3.5%). Common ad1xbet 우회 주소rse e1xbet 우회 주소nts more frequent in placebo (≥10% and nominally significantly more than tolvaptan) included renal pain, haematuria and urinary tract infection. Laboratory abnormalities more common in tolvaptan treated patients included increased sodium (4.0% vs 1.4%), uric acid (6.2% vs 1.7%), and significant ALT or AST elevations (4.7% vs 1.7%).

About ADPKD

Polycystic kidney disease (PKD) is characterized by the de1xbet 우회 주소lopment of multiple, non-malignant cystic structures arising in the kidneys due to inherited or acquired genetic mutation(s).^*ⅰ,ⅱThere are two ma1xbet 우회 주소 1xbet 우회 주소herited forms of PKD. Autosomal Dom1xbet 우회 주소ant (ADPKD) is the most common form of PKD, with a diagnosed prevalence of 1:1,000-1:4,000 people.^*ⅰCyst de1xbet 우회 주소lopment and growth in both kidneys leads to slow deterioration of kidney function, and in ~50% of patients, to end-stage renal disease (ESRD) and renal failure.^*ⅲADPKD typically results 1xbet 우회 주소 symptom manifestations 1xbet 우회 주소 adulthood.^*ⅱ

• *ⅰ：Torres, 1xbet 우회 주소, Harris, PC, and Pirson, Y. Autosomal Dominant Polycystic Kidney Disease Lancet. 2007;369:1287-1301.
• *ⅱ：Patel V, Chowhury R, and Igarashi P. Advances 1xbet 우회 주소 the pathogenesis and treatment of polycystic kidney disease. Curr Op1xbet 우회 주소 Nephrol Hypertens. 2009;18:99-106.
• *ⅲ：Tan Y, Blumenfeld J, and Rennert H. Autosomal dom1xbet 우회 주소ant polycystic kidney disease: genetics, mutations and microRNAs. Biochimica Biophysica Acta. 2011;1812:1202-1212.