From Renal and Urology News, by Jody A. Charnow, Editor
Tolvaptan Lowers ADPKD Albuminuria
Tolvaptan decreases albuminuria over time in patients with autosomal dominant polycystic kidney disease (ADPKD), independent of blood pressure (BP), according to a post-hoc analysis of the TEMPO 3:4 Trial. The finding contrasts with the initial trial report, which concluded that tolvaptan had no effect on albuminuria.
The trial was a 3-year prospective, randomized, placebo-controlled study that included 1,375 ADPKD patients randomized to receive the V2 receptor antagonist tolvaptan or placebo. Researchers measured albuminuria in a spot morning urine sample prior to tolvaptan dosing and expressed as albumin-to-creatinine ratio (ACR). The investigators who conducted the post-hoc analysis noted that the initial TEMPO 3:4 Trial looked at categorical “albuminuria events,” which may have resulted in a loss of sensitivity to detect changes. The post-hoc analysis, led by Ron T. Gansevoort, MD, of University Medical Center Groningen in The Netherlands, examined the effect of tolvaptan on albuminuria as a continuous variable.
At baseline, the patients had a median ACR of 3.2 mg/mmol, and 47.9%, 48.7%, and 3.4% of patients had normal, moderately increased, and severely increased ACR, respectively, Dr. Gansevoort and his colleagues reported online in Nephrology Dialysis Transplantation. Patients with a higher baseline ACR had higher BP and total kidney volume (TKV) and lower estimated glomerular filtration rate (eGFR).
Over 3 years, ACR rose in the placebo arm and decreased in the tolvaptan arm (+23 vs. −0.40 mg/mmol). The difference in ACR increased over time, reaching a maximum of 24% at month 36. At that time, the researchers observed only a minor difference in blood pressure (BP). The decrease in ACR was similar in all subgroups and remained after withdrawal of tolvaptan. During follow-up, higher baseline ACR was associated with more rapid eGFR loss, but not TKV growth rate. Compared with placebo, tolvaptan was associated with a significant beneficial effect on TKV growth in all ACR subgroups, but was stronger in patients with a higher ACR, Dr. Gansevoort's team reported.
“In our opinion, the gradual onset of the ACR lowering response that remains after drug withdrawal indicates that the reduction in albuminuria with V2 receptor antagonists is a reflection of structural benefits that have obtained, such as less growth in TKV during tolvaptan treatment,” the authors wrote.
ADPKD is a relatively low albuminuria disease, so the effect of tolvaptan on albuminuria per se is of limited clinical relevance, the authors pointed out. The new findings are particularly important because they indicate that, in ADPKD patients, tolvaptan induces structural renal benefits and assessing albuminuria status in this disease may help to identify ADPKD patients who may benefit more from tolvaptan treatment, according to the researchers.
From Charity Today, United Kingdom
Tolvaptan now recommended for the treatment of ADPKD
TOLVAPTAN (marketed as Jinarc) has been approved for use in adults with autosomal dominant polycystic kidney disease (ADPKD) by the Scottish Medicines Consortium (SMC). This follows the National Institute for Care and Clinical Excellence’s (NICE) similar decision in October 2015 for patients in England and Wales. Northern Ireland has since adopted NICE’s recommendation, meaning patients across the UK are now eligible to receive the drug if they meet criteria outlined by their associated body. There was previously no licensed drug available to treat ADPKD in the UK.
Tolvaptan slows the progression of cyst development and helps protect renal function. In most cases this is likely to significantly delay the need for dialysis or a kidney transplant for ADPKD patients.
Kidney Research UK participated in the tolvaptan consultation processes with both regulatory bodies and ensured a rounded set of evidence was on offer by sharing the real life experiences of patients affected by ADPKD. [Read more]
PKD Research
From Med Gadget
Polycystic Kidney Disease – Pipeline Review, Market Growth, Segment, Trends and Forecast 2016 – 2020
“Polycystic Kidney Disease Global 2015 Clinical Trials Review, H2” provides an detailed overview of Polycystic Kidney Disease scenario. Report includes top line data relating on Polycystic Kidney Disease Global clinical trials scenario. This report on Polycystic Kidney Disease also includes an review of trial numbers as well as their ( Polycystic Kidney Disease ) average enrollment in uppermost/top countries which are conducted worldwide. Polycystic Kidney Disease report also covers disease clinical trials by country (G7 & E7), sponsor type, region, trial status as well as end points status. Report Polycystic Kidney Disease also includes prominent drugs for in-progress trials (Note: based on number of ongoing trials).
Request for report sample of Polycystic Kidney Disease Market, here: http://www.marketresearchstore.com/report/polycystic-kidney-disease-pipeline-review-h2-2015-46109#RequestSample
Scope of Polycystic Kidney Disease Report:
This report includes a snapshot of worldwide clinical trials landscape on Polycystic Kidney Disease scenario.
Report on Polycystic Kidney Disease also provides top level data related to the Global clinical trials by country (G7 & E7), sponsor type, region, trial status as well as end points status on Polycystic Kidney Disease scenario
Report reviews top companies involved in Polycystic Kidney Disease as well as provides enlists all trials (Trial title, Phase, and Status) pertaining to the company on Polycystic Kidney Disease scenario. [Read more]
Statins Reduce Proteinuria, Mortality in CKD Patients
Statins improve survival and other outcomes in patients with chronic kidney disease (CKD), but they do not appear to slow progression to end-stage renal disease (ESRD), a new meta-analysis finds.
Since previous research yielded inconsistent results, Zhenhong Zhang, MD, Pinsheng Wu, MD, and colleagues at Southern Medical University in China, pooled data from 23 randomized controlled trials (1995–2014) including 39,419 participants for an updated meta-analysis. The causes of CKD included diabetes,hypertension, glomerulonephritis, autosomal dominant polycystic kidney disease, idiopathic membranous nephropathy, and metabolic syndrome. Eight types of statins were examined.
According to results published in Pharmacological Research, statins improved proteinuria, reducing urinary protein excretion to 682.68 mg daily. Statin treatment also reduced all-cause mortality by 22%.
“Statins unquestionably reduce the risk of death in populations with, or at low risk of cardiovascular disease,” the researchers stated. “Our study further indicated that statins had the same effect on non-end stage CKD.” Statins lower lipid levels, protect the vascular endothelium, stabilize plaques, and suppress inflammation.
Tolvaptan slows the progression of cyst development and helps protect renal function. In most cases this is likely to significantly delay the need for dialysis or a kidney transplant for ADPKD patients.
Kidney Research UK participated in the tolvaptan consultation processes with both regulatory bodies and ensured a rounded set of evidence was on offer by sharing the real life experiences of patients affected by ADPKD. [Read more]
PKD Research
From Med Gadget
Polycystic Kidney Disease – Pipeline Review, Market Growth, Segment, Trends and Forecast 2016 – 2020
“Polycystic Kidney Disease Global 2015 Clinical Trials Review, H2” provides an detailed overview of Polycystic Kidney Disease scenario. Report includes top line data relating on Polycystic Kidney Disease Global clinical trials scenario. This report on Polycystic Kidney Disease also includes an review of trial numbers as well as their ( Polycystic Kidney Disease ) average enrollment in uppermost/top countries which are conducted worldwide. Polycystic Kidney Disease report also covers disease clinical trials by country (G7 & E7), sponsor type, region, trial status as well as end points status. Report Polycystic Kidney Disease also includes prominent drugs for in-progress trials (Note: based on number of ongoing trials).
Request for report sample of Polycystic Kidney Disease Market, here: http://www.marketresearchstore.com/report/polycystic-kidney-disease-pipeline-review-h2-2015-46109#RequestSample
Scope of Polycystic Kidney Disease Report:
This report includes a snapshot of worldwide clinical trials landscape on Polycystic Kidney Disease scenario.
Report on Polycystic Kidney Disease also provides top level data related to the Global clinical trials by country (G7 & E7), sponsor type, region, trial status as well as end points status on Polycystic Kidney Disease scenario
Report reviews top companies involved in Polycystic Kidney Disease as well as provides enlists all trials (Trial title, Phase, and Status) pertaining to the company on Polycystic Kidney Disease scenario. [Read more]
From Renal and Urology News
Since previous research yielded inconsistent results, Zhenhong Zhang, MD, Pinsheng Wu, MD, and colleagues at Southern Medical University in China, pooled data from 23 randomized controlled trials (1995–2014) including 39,419 participants for an updated meta-analysis. The causes of CKD included diabetes,hypertension, glomerulonephritis, autosomal dominant polycystic kidney disease, idiopathic membranous nephropathy, and metabolic syndrome. Eight types of statins were examined.
According to results published in Pharmacological Research, statins improved proteinuria, reducing urinary protein excretion to 682.68 mg daily. Statin treatment also reduced all-cause mortality by 22%.
“Statins unquestionably reduce the risk of death in populations with, or at low risk of cardiovascular disease,” the researchers stated. “Our study further indicated that statins had the same effect on non-end stage CKD.” Statins lower lipid levels, protect the vascular endothelium, stabilize plaques, and suppress inflammation.
PKD Fundraising
SickKids' Foundation's holiday campaign featuring Taylum Lamoureux, the local toddler who received a kidney transplant last year after being born with polycystic kidney disease, raised nearly $49 million during November and December.
SickKids – Unpause contributed the best holiday campaign in the foundation's history, the foundation said, with a six per pent increase over the previous year. [Read more]
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