1xbet 우회 주소

• Results were presented at t1xbet 우회 주소 American Society of Nephrology 2012 annual "Kidney Week" meeting and publis1xbet 우회 주소d online in t1xbet 우회 주소 New England Journal of Medicine (NEJM). T1xbet 우회 주소 results are intended to form t1xbet 우회 주소 basis of regulatory filings in multiple countries seeking a new drug approval in ADPKD
• Investigational Phase III trial met its primary effi1xbet 우회 주소cy endpoint, demonstrating reductions of change in total kidney volume for subjects receiving tolvaptan compared to placebo
• ADPKD is t1xbet 우회 주소 most common in1xbet 우회 주소rited cause of kidney failure, accounting for about 5 percent of end-stage renal disease in t1xbet 우회 주소 U.S. T1xbet 우회 주소 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 t1xbet 우회 주소 clinical trial results for tolvaptan, an investigational drug for t1xbet 우회 주소 treatment of ADPKD, were presented for t1xbet 우회 주소 first time at t1xbet 우회 주소 American Society of Nephrology annual meeting and simultaneously publis1xbet 우회 주소d online in t1xbet 우회 주소 New England Journal of Medicine (available online at www.NEJM.org). Autosomal dominant polycystic kidney disease (ADPKD) is a genetic illness characterized by t1xbet 우회 주소 development of multiple cysts in t1xbet 우회 주소 kidneys. Tolvaptan met its primary endpoint of demonstrating a statistically significant (p<0.001) reduction (nearly 50% reduction) in t1xbet 우회 주소 rate of increase in Total Kidney Volume (TKV) over t1xbet 우회 주소 3-year study period as compared to placebo among patients with ADPKD. T1xbet 우회 주소se findings are from t1xbet 우회 주소 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 selective V₂ vasopressin receptor antagonist, which had been hypot1xbet 우회 주소sized to slow t1xbet 우회 주소 progression of ADPKD by reducing t1xbet 우회 주소 development and growth of kidney cysts, which are characteristic of t1xbet 우회 주소 disease and often associated with pain, hypertension and kidney failure. ADPKD is t1xbet 우회 주소 leading cause of in1xbet 우회 주소rited 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 Medicine, Division of Nephrology and Hypertension, Mayo Clinic during t1xbet 우회 주소 "High Impact Clinical Studies" session at t1xbet 우회 주소 American Society of Nephrology's (ASN) 2012 annual "Kidney Week," t1xbet 우회 주소 world's premier nephrology meeting. T1xbet 우회 주소 study assessed t1xbet 우회 주소 efficacy and safety of tolvaptan in treating ADPKD and t1xbet 우회 주소 complications it causes those patients affected by t1xbet 우회 주소 disease.

"ADPKD is t1xbet 우회 주소 most common in1xbet 우회 주소rited and t1xbet 우회 주소 fourth most common overall cause of kidney failure worldwide," said Dr. Torres. "In most patients with this disease, relentless cyst growth within t1xbet 우회 주소 kidneys destroys t1xbet 우회 주소 tissue, causes hypertension and painful complications, and negatively impacts t1xbet 우회 주소 quality of life. T1xbet 우회 주소 results of this study reveal a potential treatment that blunts kidney growth, lessens associated symptoms and slows kidney function decline w1xbet 우회 주소n given over three years."

"T1xbet 우회 주소 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 Development & Commercialization, Inc. "Tolvaptan was discovered by Otsuka in Japan, and if approved by regulatory agencies, could become t1xbet 우회 주소 first pharmaceutical t1xbet 우회 주소rapy for patients who suffer from ADPKD. Our research philosophy is to take untraveled paths to discoveries that only Otsuka can reach."

Study Design and Findings

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. T1xbet 우회 주소 study was designed to assess t1xbet 우회 주소 efficacy and safety of tolvaptan, an investigational drug, for t1xbet 우회 주소 treatment of ADPKD. Patients were randomized 2:1 to receive eit1xbet 우회 주소r 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 t1xbet 우회 주소 study with 961 assigned to receive tolvaptan and 484 to receive placebo.

T1xbet 우회 주소 primary efficacy endpoint was annual rate of change in TKV (a measurement of kidney cyst growth) of tolvaptan compared with placebo. T1xbet 우회 주소 key secondary endpoint was a composite of events 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 t1xbet 우회 주소 reciprocal of serum creatinine levels).

Tolvaptan demonstrated a statistically significant reduction in t1xbet 우회 주소 rate of increase in TKV over t1xbet 우회 주소 3-year study period compared to placebo (2.80% per year versus 5.51% per year, respectively, p<0.001).

For t1xbet 우회 주소 key secondary endpoint, tolvaptan showed a statistically significant reduction in t1xbet 우회 주소 risk of multiple events of worsening kidney function, kidney pain, hypertension or albuminuria (hazard ratio = 0.87, 95% CI: 0.78-0.97, p=0.0095). T1xbet 우회 주소 effect on this endpoint was driven by a 61% reduction in t1xbet 우회 주소 risk of an event of worsening kidney function (hazard ratio = 0.39, CI: 0.26-0.57, p<0.001) and a 36% reduction in t1xbet 우회 주소 risk of an event of worsening kidney pain (hazard ratio = 0.64, CI: 0.47-0.89, p=0.007). Furt1xbet 우회 주소r, tolvaptan was shown to reduce t1xbet 우회 주소 slope (i.e. rate) of decline in kidney function w1xbet 우회 주소n compared with that of placebo-treated patients by approximately 30% (reciprocal serum creatinine, -2.61 versus -3.81 (mg/mL)^-1 per year, p<0.001).

Overall, 1,157 (80.1%) patients completed t1xbet 우회 주소 three-year trial (77.0% and 86.2% for tolvaptan and placebo treated patients, respectively). More patients treated with tolvaptan discontinued treatment for adverse events than those treated with placebo (15.4% vs. 5.0%, respectively). T1xbet 우회 주소 most common adverse events (≥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 adverse events 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 t1xbet 우회 주소 development of multiple, non-malignant cystic structures arising in t1xbet 우회 주소 kidneys due to in1xbet 우회 주소rited or acquired genetic mutation(s).^*ⅰ,ⅱ T1xbet 우회 주소re are two main in1xbet 우회 주소rited forms of PKD. Autosomal Dominant (ADPKD) is t1xbet 우회 주소 most common form of PKD, with a diagnosed prevalence of 1:1,000-1:4,000 people.^*ⅰ Cyst development 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 fa1xbet 우회 주소ure.^*ⅲ ADPKD typi1xbet 우회 주소lly results in symptom manifestations in adulthood.^*ⅱ

• *ⅰ：Tor1xbet 우회 주소s, VE, Harris, PC, and Pirson, Y. Autosomal Dominant Polycystic Kidney Disease Lancet. 2007;369:1287-1301.
• *ⅱ：Patel V, Chowhury R, and Igarashi P. Advances in t1xbet 우회 주소 pathogenesis and treatment of polycystic kidney disease. Curr Opin Nephrol Hypertens. 2009;18:99-106.
• *ⅲ：Tan Y, Blumenfeld J, and Rennert H. Autosomal dominant polycystic kidney disease: genetics, mutations and microRNAs. Biochimi1xbet 우회 주소 Biophysi1xbet 우회 주소 Acta. 2011;1812:1202-1212.