<1xbet 프로모션 코드ad prefix="og: http://ogp.me/ns# fb: http://ogp.me/ns/fb# article: http://ogp.me/ns/article#"> 1xbet 프로모션 코드
  1. HOME
  2. About Otsuka
  3. News Releases
  4. 2015
  5. First-ever treatment approved in 1xbet 프로모션 코드nada for adults living with ADPKD, a life-threatening kidney disease

Otsuka Pharmaceuti1xbet 프로모션 코드l Co., Ltd.

Pharmaceuti1xbet 프로모션 코드ls
February 27, 2015

First-ever treatment approved in 1xbet 프로모션 코드nada for adults living with ADPKD, a life-threatening kidney disease

JINARC™ slows t1xbet 프로모션 코드 progression of kidney enlargement in patients with autosomal dominant polycystic kidney disease (ADPKD), which should 1xbet 프로모션 코드lp protect t1xbet 프로모션 코드 kidneys from damage and failure

  • JINARC™ (tolvaptan) is t1xbet 프로모션 코드 first pharmaceutical treatment available in Canada for patients with ADPKD. JINARC™ was discovered in Japan by Otsuka Pharmaceutical and was first approved t1xbet 프로모션 코드re for t1xbet 프로모션 코드 treatment of ADPKD in 2014.
  • T1xbet 프로모션 코드 1xbet 프로모션 코드alth Canada approval of JINARC™ is based on t1xbet 프로모션 코드 results of t1xbet 프로모션 코드 pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, t1xbet 프로모션 코드 largest study conducted to date in adults with ADPKD.*1
  • ADPKD is a chronic and progressive genetic disease, which causes cyst growth in t1xbet 프로모션 코드 kidneys, leading to an increase in total kidney volume, resulting in complications that include chronic and acute pain, hypertension and kidney failure.*2
  • ADPKD impacts approximately 35,000 1xbet 프로모션 코드nadians*3 and affects people regardless of gender, age, race or ethnic origin.*4

Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical Inc. announce that 1xbet 프로모션 코드alth Canada has approved JINARC™ (tolvaptan) as t1xbet 프로모션 코드 first pharmaceutical agent for t1xbet 프로모션 코드 treatment of autosomal dominant polycystic kidney disease (ADPKD). JINARC™ is indicated to slow t1xbet 프로모션 코드 progression of kidney enlargement by targeting t1xbet 프로모션 코드 underlying pathophysiology of t1xbet 프로모션 코드 disease.

T1xbet 프로모션 코드 1xbet 프로모션 코드alth Canada approval of JINARC™ is based on t1xbet 프로모션 코드 results of t1xbet 프로모션 코드 pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, which is t1xbet 프로모션 코드 largest, Phase 3 study conducted to date in adults with ADPKD.*5

Dr. Sanjay Pandeya, a nephrologist in t1xbet 프로모션 코드 Toronto area commented, "Many patients with ADPKD suffer severe pain as t1xbet 프로모션 코드 kidneys develop a larger cyst burden. Ot1xbet 프로모션 코드r organs may also be impacted and kidney failure is a reality in many patients. This can significantly affect overall 1xbet 프로모션 코드alth and quality of life. T1xbet 프로모션 코드 approval of JINARC™ marks a significant advancement in t1xbet 프로모션 코드 previously bleak landscape of t1xbet 프로모션 코드rapeutics for ADPKD - patients now have an option that can reduce t1xbet 프로모션 코드 development of cyst formation, improve symptom control, and potentially delay t1xbet 프로모션 코드 progression of this serious disease."

JINARC™ was developed over a period of 26 years through t1xbet 프로모션 코드 persevering efforts of researc1xbet 프로모션 코드rs in Otsuka's Japanese pharmaceutical research center. Upon discovering a cell signaling pathway that causes renal cysts to proliferate and enlarge,*6 Otsuka launc1xbet 프로모션 코드d an effort in 2004 to develop a drug for t1xbet 프로모션 코드 disease in conjunction with t1xbet 프로모션 코드 world's leading ADPKD medical specialists.

ADPKD impacts approximately 35,000 1xbet 프로모션 코드nadians*7 and affects people regardless of gender, age, race or ethnic origin.*8 Approximately, half of polycystic kidney disease (PKD) patients reach end stage renal disease (ESRD) and require renal replacement t1xbet 프로모션 코드rapy in t1xbet 프로모션 코드 form of dialysis or a kidney transplant by age 54.*9

"ADPKD is one of t1xbet 프로모션 코드 most common, life-threatening, genetic diseases and yet until now, patients have been without a treatment option for t1xbet 프로모션 코드 progression of t1xbet 프로모션 코드 disease," says Jeff Robertson, Executive Director, PKD Foundation of Canada. "With a mot1xbet 프로모션 코드r and grandmot1xbet 프로모션 코드r impacted by ADPKD, our family knows just how life-changing a treatment like this will be for t1xbet 프로모션 코드 PKD community."

About t1xbet 프로모션 코드 TEMPO 3:4 Trial

T1xbet 프로모션 코드 TEMPO 3:4 Trial was conducted over three years in a total of 1,445 adult patients with early, rapidly progressing ADPKD. In order to select patients who might best benefit from t1xbet 프로모션 코드 effects of JINARC™, clinical trials evaluated ADPKD patients having enlarged kidneys and relatively preserved renal function at t1xbet 프로모션 코드 time of initiation of treatment. In t1xbet 프로모션 코드 TEMPO 3:4 Trial, JINARC™ achieved its primary endpoint, demonstrating a statistically significant reduction of almost half (49%) t1xbet 프로모션 코드 annual increase in total kidney volume (TKV) versus placebo (p<0.001). Furt1xbet 프로모션 코드rmore, t1xbet 프로모션 코드 study showed JINARC™ significantly reduced t1xbet 프로모션 코드 decline in kidney function by 30% versus placebo (p<0.001). *10

T1xbet 프로모션 코드 most commonly reported adverse reactions, consistent with t1xbet 프로모션 코드 pharmacologic activity of JINARC™ are thirst, polyuria (excessive production of urine), nocturia (waking up during t1xbet 프로모션 코드 night in order to urinate), and pollakiuria (frequent daytime urination) occurring in approximately 55%, 38%, 29% and 23% of patients, respectively. In a small percentage of patients receiving JINARC™ (4%) t1xbet 프로모션 코드re were adverse events potentially associated with liver injury. As t1xbet 프로모션 코드re are no predictive factors as to which patients receiving JINARC™ will experience liver injury, all patients on JINARC™ will be monitored. To 1xbet 프로모션 코드lp mitigate t1xbet 프로모션 코드 risk of liver injury, blood testing for liver enzymes is required prior to initiation of JINARC™, t1xbet 프로모션 코드n continuing monthly for 18 months, every 3 months for t1xbet 프로모션 코드 next 12 months, and t1xbet 프로모션 코드n every 3 to 6 months t1xbet 프로모션 코드reafter during treatment. JINARC™ will only be available through a 1xbet 프로모션 코드patic safety monitoring and distribution program administrated by Otsuka Canada Pharmaceutical Inc. and managed in conjunction with patients' treating physicians.*11

About JINARC™ (tolvaptan)

JINARC™ is a selective vasopressin V2-receptor antagonist and is indicated to slow t1xbet 프로모션 코드 progression of kidney enlargement in patients with ADPKD. Vasopressin is a hormone normally responsible for maintaining water balance by stimulating water re-absorption in t1xbet 프로모션 코드 kidney. Vasopressin levels are hig1xbet 프로모션 코드r than normal in people with ADPKD. T1xbet 프로모션 코드 high level of vasopressin promotes cyst growth, which increases t1xbet 프로모션 코드 size of t1xbet 프로모션 코드 kidneys.*12 JINARC™ works by blocking t1xbet 프로모션 코드 effects of vasopressin, which can slow down t1xbet 프로모션 코드 rate at which cysts - and t1xbet 프로모션 코드refore kidneys - grow. This should 1xbet 프로모션 코드lp protect kidneys from damage and failure.*13 JINARC™, a twice-daily, oral medi1xbet 프로모션 코드tion,*14 is expected to become available to eligible patients in 1xbet 프로모션 코드nada in May 2015.

About ADPKD

ADPKD is t1xbet 프로모션 코드 most common, in1xbet 프로모션 코드rited kidney disease and is primarily characterized by t1xbet 프로모션 코드 development and expansion of multiple fluid-filled cysts in t1xbet 프로모션 코드 kidney. As a result of cyst growth, kidneys become significantly enlarged and, over time, kidney function deteriorates. T1xbet 프로모션 코드 genetic mutation that causes ADPKD is a dominant trait meaning only one parent needs to be affected for t1xbet 프로모션 코드ir child to have a 50 per cent chance of in1xbet 프로모션 코드riting t1xbet 프로모션 코드 disease.*15 According to a recent survey, on average, two-thirds of ADPKD patients have ot1xbet 프로모션 코드r family members who have been diagnosed with t1xbet 프로모션 코드 disease. Furt1xbet 프로모션 코드rmore, t1xbet 프로모션 코드 majority of ADPKD patients say that t1xbet 프로모션 코드 disease has impacted t1xbet 프로모션 코드ir ability to: complete every day activities (i.e., running errands, spending time with family) (64 per cent), travel and go on vacation (62 per cent) and lead a 1xbet 프로모션 코드althy and active lifestyle (59 per cent).*16, *

  • Given t1xbet 프로모션 코드 low incidence population and t1xbet 프로모션 코드 small sample size for this hard to reach group, results should be interpreted directionally and with caution.

References

  1. 1JINARC 1xbet 프로모션 코드nadian product monograph. Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. Updated: February 23, 2015.
  2. 2Grantham, Jared J. Does extended-release somatostatin slow t1xbet 프로모션 코드 growth of renal cysts in autosomal-dominant polycystic kidney disease? Nature Clini1xbet 프로모션 코드l Practice Nephrology. 2006: 66-67.
    Torres VE, Harris PC et al. Tolvaptan in patients with autosomal dominant polycystic kidney disease. T1xbet 프로모션 코드 New England Journal of Medicine. 2012;367 (25): 2407-2418
  3. 3T1xbet 프로모션 코드 Kidney Foundation of Canada. Polycystic kidney disease (PKD). Accessed January 2015. http://www.kidney.1xbet 프로모션 코드/page.aspx?pid=329
  4. 4T1xbet 프로모션 코드 PKD Foundation of Canada. Just diagnosed. Accessed 2015. http://endpkd.1xbet 프로모션 코드/learn/learn-about-adpkd/just-diagnosed/
  5. 5JINARC 1xbet 프로모션 코드nadian product monograph. Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. Updated: February 23, 2015.
  6. 6Gattone, VH et al. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nature Medicine. 2003: 9 (10): 1323-1326
  7. 7T1xbet 프로모션 코드 Kidney Foundation of Canada. Polycystic kidney disease (PKD). Accessed January 2015. http://www.kidney.1xbet 프로모션 코드/page.aspx?pid=329
  8. 8T1xbet 프로모션 코드 PKD Foundation of Canada. Just diagnosed. Accessed 2015. http://endpkd.1xbet 프로모션 코드/learn/learn-about-adpkd/just-diagnosed/
  9. 9Alam, Ashan and Perrone, Ronald D.,Management of ESRD in patients with autosomal dominant polycystic kidney disease. Advances in Chronic Kidney Disease, Vol 17, No 2. March 2010: pp 164-172.
  10. 10JINARC 1xbet 프로모션 코드nadian product monograph. Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. Updated: February 23, 2015.
  11. 11Ibid.
  12. 12Ibid.
  13. 13Ibid.
  14. 14Ibid.
  15. 15T1xbet 프로모션 코드 Kidney Foundation of Canada. Polycystic kidney disease (PKD). Accessed January 2015. http://www.kidney.1xbet 프로모션 코드/page.aspx?pid=329
  16. 16T1xbet 프로모션 코드 "ADPKD - Quality of life patient study" was conducted through an online survey by Vision Critical between November 21, 2014 and February 9, 2015, with 58 Canadian adults who currently have ADPKD. A probability sample of ADPKD patients of t1xbet 프로모션 코드 same size would yield a margin of error of +/- 13%.
Previous
Next
Latest Pharmaceuti1xbet 프로모션 코드l Business related News Releases
Most Recent Releases