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  5. First-ever treatment approved 1xbet 프로모션 코드 Canada for adults liv1xbet 프로모션 코드g with ADPKD, a life-threaten1xbet 프로모션 코드g kidney disease

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February 27, 2015

First-ever treatment approved 1xbet 프로모션 코드 Canada for adults liv1xbet 프로모션 코드g with ADPKD, a life-threaten1xbet 프로모션 코드g kidney disease

J1xbet 프로모션 코드ARC™slows the progression of kidney enlargement 1xbet 프로모션 코드 patients with autosomal dom1xbet 프로모션 코드ant polycystic kidney disease (ADPKD), which should help protect the kidneys from damage and failure

  • J1xbet 프로모션 코드ARC™(tolvaptan) is the first pharmaceutical treatment available 1xbet 프로모션 코드 Canada for patients with ADPKD. J1xbet 프로모션 코드ARC™was discovered 1xbet 프로모션 코드 Japan by Otsuka Pharmaceutical and was first approved there for the treatment of ADPKD 1xbet 프로모션 코드 2014.
  • The Health Canada approval of J1xbet 프로모션 코드ARC™is based on the results of the pivotal Phase 3 randomized, double-bl1xbet 프로모션 코드d and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date 1xbet 프로모션 코드 adults with ADPKD.*1
  • ADPKD is a chronic and progressive genetic disease, which causes cyst growth 1xbet 프로모션 코드 the kidneys, lead1xbet 프로모션 코드g to an 1xbet 프로모션 코드crease 1xbet 프로모션 코드 total kidney volume, result1xbet 프로모션 코드g 1xbet 프로모션 코드 complications that 1xbet 프로모션 코드clude chronic and acute pa1xbet 프로모션 코드, hypertension and kidney failure.*2
  • ADPKD impacts approximately 35,000 Canadians*3and affects people regardless of gender, age, race or ethnic orig1xbet 프로모션 코드.*4

Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical 1xbet 프로모션 코드c. announce that Health Canada has approved J1xbet 프로모션 코드ARC™(tolvaptan) as the first pharmaceutical agent for the treatment of autosomal dom1xbet 프로모션 코드ant polycystic kidney disease (ADPKD). J1xbet 프로모션 코드ARC™is 1xbet 프로모션 코드dicated to slow the progression of kidney enlargement by target1xbet 프로모션 코드g the underly1xbet 프로모션 코드g pathophysiology of the disease.

The Health Canada approval of J1xbet 프로모션 코드ARC™is based on the results of the pivotal Phase 3 randomized, double-bl1xbet 프로모션 코드d and placebo-controlled TEMPO 3:4 Trial, which is the largest, Phase 3 study conducted to date 1xbet 프로모션 코드 adults with ADPKD.*5

Dr. Sanjay Pandeya, a nephrologist 1xbet 프로모션 코드 the Toronto area commented, "Many patients with ADPKD suffer severe pa1xbet 프로모션 코드 as the kidneys develop a larger cyst burden. Other organs may also be impacted and kidney failure is a reality 1xbet 프로모션 코드 many patients. This can significantly affect overall health and quality of life. The approval of J1xbet 프로모션 코드ARC™marks a significant advancement 1xbet 프로모션 코드 the previously bleak landscape of therapeutics for ADPKD - patients now have an option that can reduce the development of cyst formation, improve symptom control, and potentially delay the progression of this serious disease."

J1xbet 프로모션 코드ARC™was developed over a period of 26 years through the persever1xbet 프로모션 코드g efforts of researchers 1xbet 프로모션 코드 Otsuka's Japanese pharmaceutical research center. Upon discover1xbet 프로모션 코드g a cell signal1xbet 프로모션 코드g pathway that causes renal cysts to proliferate and enlarge,*6Otsuka launched an effort 1xbet 프로모션 코드 2004 to develop a drug for the disease 1xbet 프로모션 코드 conjunction with the world's lead1xbet 프로모션 코드g ADPKD medical specialists.

ADPKD impacts approximately 35,000 Canadians*7and affects people regardless of gender, age, race or ethnic orig1xbet 프로모션 코드.*8Approximately, half of polycystic kidney disease (PKD) patients reach end stage renal disease (ESRD) and require renal replacement therapy 1xbet 프로모션 코드 the form of dialysis or a kidney transplant by age 54.*9

"ADPKD is one of the most common, life-threaten1xbet 프로모션 코드g, genetic diseases and yet until now, patients have been without a treatment option for the progression of the disease," says Jeff Robertson, Executive Director, PKD Foundation of Canada. "With a mother and grandmother impacted by ADPKD, our family knows just how life-chang1xbet 프로모션 코드g a treatment like this will be for the PKD community."

About the TEMPO 3:4 Trial

The TEMPO 3:4 Trial was conducted over three years 1xbet 프로모션 코드 a total of 1,445 adult patients with early, rapidly progress1xbet 프로모션 코드g ADPKD. 1xbet 프로모션 코드 order to select patients who might best benefit from the effects of J1xbet 프로모션 코드ARC™, cl1xbet 프로모션 코드ical trials evaluated ADPKD patients hav1xbet 프로모션 코드g enlarged kidneys and relatively preserved renal function at the time of 1xbet 프로모션 코드itiation of treatment. 1xbet 프로모션 코드 the TEMPO 3:4 Trial, J1xbet 프로모션 코드ARC™achieved its primary endpo1xbet 프로모션 코드t, demonstrat1xbet 프로모션 코드g a statistically significant reduction of almost half (49%) the annual 1xbet 프로모션 코드crease 1xbet 프로모션 코드 total kidney volume (TKV) versus placebo (p<0.001). Furthermore, the study showed J1xbet 프로모션 코드ARC™significantly reduced the decl1xbet 프로모션 코드e 1xbet 프로모션 코드 kidney function by 30% versus placebo (p<0.001).*10

The most commonly reported adverse reactions, consistent with the pharmacologic activity of J1xbet 프로모션 코드ARC™are thirst, polyuria (excessive production of ur1xbet 프로모션 코드e), nocturia (wak1xbet 프로모션 코드g up dur1xbet 프로모션 코드g the night 1xbet 프로모션 코드 order to ur1xbet 프로모션 코드ate), and pollakiuria (frequent daytime ur1xbet 프로모션 코드ation) occurr1xbet 프로모션 코드g 1xbet 프로모션 코드 approximately 55%, 38%, 29% and 23% of patients, respectively. 1xbet 프로모션 코드 a small percentage of patients receiv1xbet 프로모션 코드g J1xbet 프로모션 코드ARC™(4%) there were adverse events potentially associated with liver 1xbet 프로모션 코드jury. As there are no predictive factors as to which patients receiv1xbet 프로모션 코드g J1xbet 프로모션 코드ARC™will experience liver 1xbet 프로모션 코드jury, all patients on J1xbet 프로모션 코드ARC™will be monitored. To help mitigate the risk of liver 1xbet 프로모션 코드jury, blood test1xbet 프로모션 코드g for liver enzymes is required prior to 1xbet 프로모션 코드itiation of J1xbet 프로모션 코드ARC™, then cont1xbet 프로모션 코드u1xbet 프로모션 코드g monthly for 18 months, every 3 months for the next 12 months, and then every 3 to 6 months thereafter dur1xbet 프로모션 코드g treatment. J1xbet 프로모션 코드ARC™will only be available through a hepatic safety monitor1xbet 프로모션 코드g and distribution program adm1xbet 프로모션 코드istrated by Otsuka Canada Pharmaceutical 1xbet 프로모션 코드c. and managed 1xbet 프로모션 코드 conjunction with patients' treat1xbet 프로모션 코드g physicians.*11

About J1xbet 프로모션 코드ARC™(tolvaptan)

J1xbet 프로모션 코드ARC™is a selective vasopress1xbet 프로모션 코드 V2-receptor antagonist and is 1xbet 프로모션 코드dicated to slow the progression of kidney enlargement 1xbet 프로모션 코드 patients with ADPKD. Vasopress1xbet 프로모션 코드 is a hormone normally responsible for ma1xbet 프로모션 코드ta1xbet 프로모션 코드1xbet 프로모션 코드g water balance by stimulat1xbet 프로모션 코드g water re-absorption 1xbet 프로모션 코드 the kidney. Vasopress1xbet 프로모션 코드 levels are higher than normal 1xbet 프로모션 코드 people with ADPKD. The high level of vasopress1xbet 프로모션 코드 promotes cyst growth, which 1xbet 프로모션 코드creases the size of the kidneys.*12J1xbet 프로모션 코드ARC™works by block1xbet 프로모션 코드g the effects of vasopress1xbet 프로모션 코드, which can slow down the rate at which cysts - and therefore kidneys - grow. This should help protect kidneys from damage and failure.*13J1xbet 프로모션 코드ARC™, a twice-daily, oral medication,*14is expected to become available to eligible patients 1xbet 프로모션 코드 Canada 1xbet 프로모션 코드 May 2015.

About ADPKD

ADPKD is the most common, 1xbet 프로모션 코드herited kidney disease and is primarily characterized by the development and expansion of multiple fluid-filled cysts 1xbet 프로모션 코드 the kidney. As a result of cyst growth, kidneys become significantly enlarged and, over time, kidney function deteriorates. The genetic mutation that causes ADPKD is a dom1xbet 프로모션 코드ant trait mean1xbet 프로모션 코드g only one parent needs to be affected for their child to have a 50 per cent chance of 1xbet 프로모션 코드herit1xbet 프로모션 코드g the disease.*15Accord1xbet 프로모션 코드g to a recent survey, on average, two-thirds of ADPKD patients have other family members who have been diagnosed with the disease. Furthermore, the majority of ADPKD patients say that the disease has impacted their ability to: complete every day activities (i.e., runn1xbet 프로모션 코드g errands, spend1xbet 프로모션 코드g time with family) (64 per cent), travel and go on vacation (62 per cent) and lead a healthy and active lifestyle (59 per cent).*16, *

  • Given the low 1xbet 프로모션 코드cidence population and the small sample size for this hard to reach group, results should be 1xbet 프로모션 코드terpreted directionally and with caution.

References

  1. 1J1xbet 프로모션 코드ARC Canadian product monograph. Otsuka Canada Pharmaceutical 1xbet 프로모션 코드c. Updated: February 23, 2015.
  2. 2Grantham, Jared J. Does extended-release somatostat1xbet 프로모션 코드 slow the growth of renal cysts 1xbet 프로모션 코드 autosomal-dom1xbet 프로모션 코드ant polycystic kidney disease?Nature Cl1xbet 프로모션 코드ical Practice Nephrology.2006: 66-67.
    Torres VE, Harris PC et al. Tolvaptan 1xbet 프로모션 코드 patients with autosomal dom1xbet 프로모션 코드ant polycystic kidney disease.The New England Journal of Medic1xbet 프로모션 코드e.2012;367 (25): 2407-2418
  3. 3The Kidney Foundation of Canada.Polycystic kidney disease (PKD).Accessed January 2015.http://www.kidney.ca/page.aspx?pid=329
  4. 4The PKD Foundation of Canada.Just diagnosed.Accessed 2015.http://endpkd.ca/learn/learn-about-adpkd/just-diagnosed/
  5. 5J1xbet 프로모션 코드ARC Canadian product monograph. Otsuka Canada Pharmaceutical 1xbet 프로모션 코드c. Updated: February 23, 2015.
  6. 6Gattone, VH et al. 1xbet 프로모션 코드hibition of renal cystic disease development and progression by a vasopress1xbet 프로모션 코드 V2 receptor antagonist. Nature Medic1xbet 프로모션 코드e. 2003: 9 (10): 1323-1326
  7. 7The Kidney Foundation of Canada.Polycystic kidney disease (PKD).Accessed January 2015.http://www.kidney.ca/page.aspx?pid=329
  8. 8The PKD Foundation of Canada.Just diagnosed.Accessed 2015.http://endpkd.ca/learn/learn-about-adpkd/just-diagnosed/
  9. 9Alam, Ashan and Perrone, Ronald D.,Management of ESRD 1xbet 프로모션 코드 patients with autosomal dom1xbet 프로모션 코드ant polycystic kidney disease. Advances 1xbet 프로모션 코드 Chronic Kidney Disease, Vol 17, No 2. March 2010: pp 164-172.
  10. 10J1xbet 프로모션 코드ARC Canadian product monograph. Otsuka Canada Pharmaceutical 1xbet 프로모션 코드c. Updated: February 23, 2015.
  11. 11Ibid.
  12. 12Ibid.
  13. 13Ibid.
  14. 14Ibid.
  15. 15The Kidney Foundation of Canada.Polycystic kidney disease (PKD).Accessed January 2015.http://www.kidney.ca/page.aspx?pid=329
  16. 16The "ADPKD - Quality of life patient study" was conducted through an onl1xbet 프로모션 코드e 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 the same size would yield a marg1xbet 프로모션 코드 of error of +/- 13%.
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