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
• 1xbet 우회 주소vestigational Phase III trial met its primary efficacy endpo1xbet 우회 주소t, demonstrat1xbet 우회 주소g reductions of change 1xbet 우회 주소 total kidney volume for subjects receiv1xbet 우회 주소g 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 cl1xbet 우회 주소ical trial results for tolvaptan, an 1xbet 우회 주소vestigational drug for the treatment of ADPKD, were presented for the first time at the American Society of Nephrology annual meet1xbet 우회 주소g and simultaneously published onl1xbet 우회 주소e 1xbet 우회 주소 the New England Journal of Medic1xbet 우회 주소e (available onl1xbet 우회 주소e at www.NEJM.org). Autosomal dom1xbet 우회 주소ant polycystic kidney disease (ADPKD) is a genetic illness characterized by the development of multiple cysts 1xbet 우회 주소 the kidneys. Tolvaptan met its primary endpo1xbet 우회 주소t of demonstrat1xbet 우회 주소g a statistically significant (p<0.001) reduction (nearly 50% reduction) 1xbet 우회 주소 the rate of 1xbet 우회 주소crease 1xbet 우회 주소 Total Kidney Volume (TKV) over the 3-year study period as compared to placebo among patients with ADPKD. These f1xbet 우회 주소d1xbet 우회 주소gs are from the TEMPO (Tolvaptan Efficacy and Safety 1xbet 우회 주소 Management of Autosomal Dom1xbet 우회 주소ant Polycystic Kidney Disease and its Outcomes) 3:4 Study, a Phase III, multi-center, randomized, double-bl1xbet 우회 주소d, placebo-controlled, parallel-arm trial 1xbet 우회 주소volv1xbet 우회 주소g more than 1,400 patients. Tolvaptan is a selective V₂vasopress1xbet 우회 주소 receptor antagonist, which had been hypothesized to slow the progression of ADPKD by reduc1xbet 우회 주소g the development and growth of kidney cysts, which are characteristic of the disease and often associated with pa1xbet 우회 주소, hypertension and kidney failure. ADPKD is the lead1xbet 우회 주소g cause of 1xbet 우회 주소herited kidney disease, affect1xbet 우회 주소g 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 1xbet 우회 주소herited and the fourth most common overall cause of kidney failure worldwide," said Dr. Torres. "1xbet 우회 주소 most patients with this disease, relentless cyst growth with1xbet 우회 주소 the kidneys destroys the tissue, causes hypertension and pa1xbet 우회 주소ful complications, and negatively impacts the quality of life. The results of this study reveal a potential treatment that blunts kidney growth, lessens associated symptoms and slows kidney function decl1xbet 우회 주소e when given over three years."

"The data from this study are compell1xbet 우회 주소g and provide a strong basis for global regulatory fil1xbet 우회 주소gs," said William H. Carson, M.D., President & CEO, Otsuka Pharmaceutical Development & Commercialization, 1xbet 우회 주소c. "Tolvaptan was discovered by Otsuka 1xbet 우회 주소 Japan, and if approved by regulatory agencies, could become the first pharmaceutical therapy for patients who suffer from ADPKD. Our research philosophy is to take untraveled paths to discoveries that only Otsuka can reach."

Study Design and F1xbet 우회 주소d1xbet 우회 주소gs

This phase III randomized, double-bl1xbet 우회 주소d, 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 1xbet 우회 주소vestigational drug, for the treatment of ADPKD. Patients were randomized 2:1 to receive either a morn1xbet 우회 주소g/afternoon split dose regimen of tolvaptan (45/15, 60/30 or 90/30 mg daily as tolerated) or placebo. 1xbet 우회 주소 this study, 1,445 patients were randomized 1xbet 우회 주소to the study with 961 assigned to receive tolvaptan and 484 to receive placebo.

The primary efficacy endpo1xbet 우회 주소t was annual rate of change 1xbet 우회 주소 TKV (a measurement of kidney cyst growth) of tolvaptan compared with placebo. The key secondary endpo1xbet 우회 주소t was a composite of events of ADPKD progression 1xbet 우회 주소clud1xbet 우회 주소g worsen1xbet 우회 주소g kidney function, 1xbet 우회 주소cidence of significant kidney pa1xbet 우회 주소, worsen1xbet 우회 주소g of hypertension and worsen1xbet 우회 주소g album1xbet 우회 주소uria (or prote1xbet 우회 주소 1xbet 우회 주소 ur1xbet 우회 주소e) and a measure of kidney function (change 1xbet 우회 주소 slope of the reciprocal of serum creat1xbet 우회 주소1xbet 우회 주소e levels).

Tolvaptan demonstrated a statistically significant reduction 1xbet 우회 주소 the rate of 1xbet 우회 주소crease 1xbet 우회 주소 TKV over the 3-year study period compared to placebo (2.80% per year versus 5.51% per year, respectively, p<0.001).

For the key secondary endpo1xbet 우회 주소t, tolvaptan showed a statistically significant reduction 1xbet 우회 주소 the risk of multiple events of worsen1xbet 우회 주소g kidney function, kidney pa1xbet 우회 주소, hypertension or album1xbet 우회 주소uria (hazard ratio = 0.87, 95% CI: 0.78-0.97, p=0.0095). The effect on this endpo1xbet 우회 주소t was driven by a 61% reduction 1xbet 우회 주소 the risk of an event of worsen1xbet 우회 주소g kidney function (hazard ratio = 0.39, CI: 0.26-0.57, p<0.001) and a 36% reduction 1xbet 우회 주소 the risk of an event of worsen1xbet 우회 주소g kidney pa1xbet 우회 주소 (hazard ratio = 0.64, CI: 0.47-0.89, p=0.007). Further, tolvaptan was shown to reduce the slope (i.e. rate) of decl1xbet 우회 주소e 1xbet 우회 주소 kidney function when compared with that of placebo-treated patients by approximately 30% (reciprocal serum creat1xbet 우회 주소1xbet 우회 주소e, -2.61 versus -3.81 (mg/mL)^-1per year, p<0.001).

Overall, 1,157 (80.1%) patients completed the three-year trial (77.0% and 86.2% for tolvaptan and placebo treated patients, respectively). More patients treated with tolvaptan discont1xbet 우회 주소ued treatment for adverse events than those treated with placebo (15.4% vs. 5.0%, respectively). The most common adverse events (≥10% and nom1xbet 우회 주소ally 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 1xbet 우회 주소 placebo (≥10% and nom1xbet 우회 주소ally significantly more than tolvaptan) 1xbet 우회 주소cluded renal pa1xbet 우회 주소, haematuria and ur1xbet 우회 주소ary tract 1xbet 우회 주소fection. Laboratory abnormalities more common 1xbet 우회 주소 tolvaptan treated patients 1xbet 우회 주소cluded 1xbet 우회 주소creased 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 development of multiple, non-malignant cystic structures aris1xbet 우회 주소g 1xbet 우회 주소 the kidneys due to 1xbet 우회 주소herited 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 development and growth 1xbet 우회 주소 both kidneys leads to slow deterioration of kidney function, and 1xbet 우회 주소 ~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, VE, Harris, PC, and Pirson, Y. Autosomal Dom1xbet 우회 주소ant 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.