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Exercise During Dialysis Delivers Major Gains - Medscape PDF Print

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Oral anticoagulation linked to renal function decline in elderly - Healio PDF Print

Elderly patients with atrial fibrillation who received treatment with warfarin or dabigatran experienced a decline in renal function, according to results of a post-hoc analysis of the RE-LY study.

At 30-month follow-up, the observed decline in renal function was greater among patients treated with warfarin compared with dabigatran (Pradaxa, Boehringer Ingelheim). Further, the change in renal function was most pronounced among patients previously treated with vitamin K antagonists and in those with diabetes.

Researchers analyzed changes in glomerular filtration rate during long-term anticoagulation treatment among 16,490 patients with AF enrolled in the RE-LY trial. Of those, 5,594 had received treatment with warfarin, 5,424 had received dabigatran 110 mg and 5,472 had received dabigatran 150 mg. Each patient had creatinine measurements collected at baseline and during one or more follow-up visits. Observation periods ranged from 12 to 37 months.

Regardless of treatment, all patients experienced a decline in glomerular filtration rate during oral anticoagulation treatment. The mean decline after an average of 30 months of follow-up was greater among those treated with warfarin (–3.68 mL/min) compared with dabigatran 110 mg (–2.57 mL/min; P = .0009 vs. warfarin) and dabigatran 150 mg (–2.46 mL/min; P = .0002 vs. warfarin).

The treatment groups did not differ significantly with regard to glomerular filtration rate during the first 18 months. Later in the observation period, patients treated with dabigatran 110 mg or 150 mg were significantly less likely than those treated with warfarin to exhibit a decrease in glomerular filtration rate of greater than 25% (HR = 0.81; 95% CI, 0.69-0.96 for 110 mg; HR = 0.79; 95% CI, 0.68-0.93 for 150 mg). The researchers also noted that the glomerular filtration rate was further decreased among patients who spent less than 65% of the time in therapeutic range, both at 24 and 30 months (P <.005 for all).

Patients with diabetes had a lower glomerular filtration rate compared with those without diabetes at baseline and experienced a greater decline during treatment with oral anticoagulation. Among those with diabetes, the decline in glomerular filtration rate was significantly greater during treatment with warfarin compared with dabigatran (P < .005).

The researchers also observed a more pronounced decline in glomerular filtration rate among patients who had previously used vitamin K antagonists compared with those who did use vitamin K antagonists.

“The decline in renal function with both treatments indicates the need for monitoring of renal function at regular intervals … during oral anticoagulation treatment with warfarin as well as with [dabigatran],” the researchers wrote. “The more rapid reduction in renal function during warfarin treatment may be relevant in the selection of anticoagulants for long-term treatment.”

In a related editorial published in the Journal of the American College of Cardiology, Richard W. Asinger, MD,and Gautam R. Shroff, MBBS, from the division of cardiology at Hennepin County Medical Center and the University of Minnesota, Minneapolis, noted that this study “raises provocative questions” about the influence of pharmacotherapy for AF on renal function, but also indicates that the decrease in glomerular filtration rate among patients treated with warfarin does not outweigh the benefits of its use.

“The extraordinarily large number of patients from the RE-LY trial needed to demonstrate these findings highlight the fact that any absolute reduction in [estimated glomerular filtration rate] with warfarin is really quite modest compared with both doses of dabigatran,” Asinger and Shroff wrote. “Thus, even though these observations probably are not a ‘game-changer’ for clinicians, fine-tuning of clinical practice would be appropriate with attention to these findings.” – by Adam Taliercio

Disclosure:The researchers report receiving scientific support from Boehringer Ingelheim. Asinger reports serving as a member of the data and safety monitor board for the Watchman trials, Boston Scientific. Shroff reports no relevant financial disclosures.

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Rockwell Medical, Inc. (NASDAQ:RMTI) Analyst Rating in Focus - Investor Newswire PDF Print

Rockwell Medical, Inc. (NASDAQ:RMTI) shares have been given a 1.8 rating by analysts surveyed by Zacks Investment Research. Sell-side firms often use different terminology for their ratings so this scale provides a simple consensus number. The ratings are calculated on a 1 to 5 scale where 1 represents a Strong Buy and 5 a Strong Sell. When analysts were polled three months ago, the stock had an average rating of 1.8.

Sell-Side brokerage firms have a price target of $16 on shares of Rockwell Medical, Inc. (NASDAQ:RMTI). This is based on analysts one year projections on the stock. The most bearish analyst outlook has a price target of $4, while the most aggressive firm sees the stock reaching $26 within the year.

Earnings Glance Investors will be marking 2015-07-30 on their calendars as this is when Rockwell Medical, Inc. is slated to next issue their quarterly earnings. Analysts surveyed by Zacks are anticipating earnings of $-0.11 per share for the period closing on 2015-06-30. This is the Zacks consensus number based on 5 Wall Street analysts covering the equity. Looking ahead longer term, the Sell-Siders have tagged the stock with expected earnings of $88.7. This is the best estimate for both sales and earnings over the next 3-5 years, as calculated by Zacks. For the most recent quarter, Rockwell Medical, Inc. announced earnings per share of $-0.07 for the fiscal period ending on 2015-03-31. The actual number was $0.03 away from what analysts had expected, or a 30% surprise factor. Rockwell Medical, Inc., formerly Rockwell Medical Technologies, Inc., manufactures hemodialysis concentrate solutions and dialysis kits, and it sells, distributes and delivers these and other ancillary hemodialysis products primarily to hemodialysis providers in the United States, as well as internationally primarily in Asia, Latin America and Europe. Hemodialysis duplicates kidney function in patients with failing kidneys also known as End Stage Renal Disease (ESRD). ESRD is an advanced-stage of chronic kidney disease (CKD) characterized by the irreversible loss of kidney function. Its dialysis solutions (also known as dialysate) are used to maintain life, removing toxins and replacing nutrients in the dialysis patient’s bloodstream. As of December 31, 2011, it was licensed and was developing renal drug therapies. During the year ended December 31, 2011, it acquired an abbreviated new drug application (ANDA) for a generic version of an intravenous Vitamin-D analogue, calcitriol.

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Hemodialysis Industry in China 2014-2018 : Global market size, share, trend ... - Medgadget.com (blog) PDF Print
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This report answers a number of key questions pertaining to the China hemodialysis market. Hemodialysis, also simply referred to as HD, is a therapy that is carried out on patients suffering from chronic or acute renal failure.

To Browse a Full Report with TOC:http://www.researchmoz.us/research-report-on-hemodialysis-industry-in-china–2014-2018-report.html

What makes the China hemodialysis market report important? Globally, there are an estimated 2.2 million people suffering from end stage renal diseases (ESRD) also known as uremia. Of these 2.2 million patients, about 89% are reported to be undergoing hemodialysis. Given the dense population in China, many of these patients are located in the country. Till now, the trend has been that most dialysis patients were either in the United States or Europe as these regions comprise developed countries where patients are able to afford the high cost of hemodialysis.

Similarly, the numbers of patients that constitute the hemodialysis market in developing countries are comparatively low because of the high cost of treatment and a low general level of awareness about the therapy. But things are changing rapidly and it is now being observed that in fast developing countries, such as China, Brazil and India, the growth rate of dialysis patients is well above 15%. The growth rate of the dialysis patient pool in Europe and the US (3% to 5%) pales in comparison.

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The report also observes that of all patients suffering from ESRD, only about 10%-20% receive dialysis in developing countries. In contrast, the proportion is as high as 80% in the United States and Europe.

This report focuses on the China hemodialysis market because the increase in per capita income here has been phenomenal. This has given patients the ability to spend on critical yet expensive procedures such as hemodialysis. With this, the hemodialysis market in China is on an upswing, and is moving ahead at a very rapid speed. The reason for hemodialysis being expensive is the high cost of devices and equipment used for the procedure, the need of skilled medical professionals to carry out the procedure, and the expensive drugs that are used for treating renal failure.

Since all of these components are very critical to the overall hemodialysis market, this report studies them in great detail. The hemodialysis instruments segment is split into dialysis machines, dialysis pipelines, and dialyzer. The latter is a component that faces high technical barriers, but still accounts for a predominant market share. According to the estimates of the report, the hemodialysis market China is valued over CNY 5 billion. The domestic share of this market is pegged at about 30%. Here, the unique trend is that imports are rapidly being substituted by domestically manufactured products. The market for dialysis machines is dominated by multinational brands.

As for the drugs that constitute a vital portion of the hemodialysis market, the leading players are EPO and heparin. Both of these are largely produced within China. Within the hemodialysis market, the cost of services is incurred on healthcare labor as well as beds and ancillary services.

The report projects that by the year 2020, the total number of patients diagnosed with ESRD globally, will be about 4.2 million; of these, over 1 million will be in China alone. This reiterates the importance of the hemodialysis market in China. The CAGR of the hemodialysis market in China will be over 20%, and the market will surpass a value of CNY 70 billion by 2020.

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Fast-tracking precision medicine: Drug re-aimed to target diabetic kidney disease - Medical Xpress PDF Print
Fast-tracking precision medicine: Drug re-aimed to target diabetic kidney disease Study results showed that diabetic kidney disease patients taking any of the three tested doses of baricitinib had lower levels of UACR in their urine than patients taking a placebo -- even after they stopped taking the drug. UACR is an indicator of kidney function. Credit: Bariticitinib trial team

It started out as a treatment for arthritis. But steered by science, it could become a first new approach in two decades for treating the damage that diabetes inflicts on the kidneys of millions of people.

This past weekend, University of Michigan Medical School researchers and their colleagues presented promising results from a clinical trial of the experimental drug baricitinib in people with . In a randomized, controlled Phase II study, it reduced a key sign of kidney damage, with higher doses producing the largest effect, few side effects, and signs of sustained impact even after patients stopped taking it.

U-M researchers not only helped conduct the clinical study - their scientific discoveries set the trial in motion. It's a fast-track example of the new treatment-development approach known as precision medicine.

The trial results presented this week at the American Diabetes Association Scientific Sessions come just three and a half years after the U-M research team linked up with the company that makes the drug, Eli Lilly & Co.

That connection resulted from the work of a team led by Matthias Kretzler, M.D. and Frank Brosius, M.D., which had worked for years to pinpoint the importance of a cell-signaling system called JAK-STAT in diabetic .

By plowing through massive amounts of data on abnormal genetic activity in diseased human kidney tissue, and studying specially bred mice, the team showed JAK-STAT was over-active in multiple kidney cells damaged by diabetes.

But JAK-STAT also plays a key role in diseases where immune-system cells attack normal tissues - such as rheumatoid arthritis. Lilly scientists had developed baricitinib to calm the painful, inflamed joints of RA patients, and had received FDA permission to do trials that showed the drug's safety and impact.

These tiny structures inside the kidney, called glomerular filters, suffer damage from diabetes and grow less effective at filtering the blood. The basic research that led to the clinical trial found that a cell-signaling pathway inside these structures could be a drug target -- and an existing drug being developed for arthritis already targeted that pathway. Credit: University of Michigan

When they learned that Kretzler was scheduled to speak about his research to another group at Lilly, they went to his talk and raised the possibility of using baricitinib against diabetic kidney disease. The international clinical trial, which enrolled 129 adult patients, began quickly—just 14 months after that meeting.

"This is the first example of implementing precision medicine in diabetic kidney disease, which affects 8 million Americans and will surely affect more as the growing diabetes epidemic continues," says Kretzler. "It shows that the full translational research pipeline is in place, where we can study disease mechanisms, test our findings in model systems, identify drug candidates, find the right partners to take it to a clinical trial, and complete the trial - in 42 months."

The trial showed baricitinib reduced a measure of kidney dysfunction called urinary albumin/ creatinine ratio or UACR, substantially compared with placebo after six months. It also showed that patients had lower levels of two compounds in urine or blood that indicate inflammation in the kidneys, called IP-10 and sTNFR2. The only significant side effect was mild anemia in the group that received the highest dose, which was expected based on previous research. Brosius directed the animal research studies and co-led the multi-institutional clinical trial. He notes that treatment of diabetic kidney disease costs the U.S. billions of dollars yearly. Currently, the standard approach to treating in people with diabetes is to control blood pressure using decades-old drugs called ACE inhibitors and ARBs. "The long-term effects of America's obesity and diabetes epidemics means that millions more kidneys are at risk. So America urgently needs new approaches to stem the damage that diabetes inflicts on kidney cells," says Brosius, who heads U-M's Division of Nephrology and the Michigan Kidney Translational Core Center that helped support this work. "So does the world, as nations like China feel the effects of obesity and diabetes epidemics." Promise of university-industry cooperation The new trial results are the first step in determining if baricitinib or other drugs that act on the JAK-STAT system could fight these effects. But they also show promise of combining basic university research, which can uncover specific targets for precise-acting drugs, with drug compounds developed by pharmaceutical companies. Even drugs left on the shelf years ago, or already in use for other diseases, could be tested for new uses based on research findings from teams like the U-M group. The U-M Medical School's Business Development team helped make the linkage between U-M and Lilly possible, and has brokered other agreements under which companies sponsor research by U-M teams to find specific targets for drugs. The basic research was funded by the National Institutes of Health, the European Union and the Juvenile Diabetes Research Foundation International. This includes the development of a bank of diseased tissue taken during patient biopsies, the creation of a "humanized" mouse model, and high-level computing resources. Other faculty members at U-M are looking for pathways involved in other ways that diabetes damages organs and tissues - from nerves to eyes. The approach, called systems biology, combines detailed studies of biological processes with advanced computing to create a computer model of a disease. "Not only does system biology works for finding new drug targets and repurposing drug compounds that already have been tested safely in humans. It can work quickly," says Kretzler.
Explore further: Two drugs are no more effective than one to treat common kidney disease More information: Read the abstract of results presented at the ADA meeting: www.abstractsonline.com/pp8/#!… 9/presentation/12757
Provided by University of Michigan Health System 51 shares

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