(HealthDay)—The U.S. Food and Drug Administration has approved the first device to treat dialysis-related amyloidosis (DRA), a complication of dialysis used to treat kidney failure.

DRA is a rare, yet chronic, condition caused by blood buildup of a protein called beta 2-microglobulin. It occurs most often among people aged 60 or older who have been on dialysis for more than five years, the FDA said in a news release. Symptoms if the protein spreads to the bones may include painful and stiff joints, bone cysts and torn tendons and ligaments.

The newly approved device, the Lixelle Beta 2-microglobulin Apheresis Column, removes the protein from the blood using porous cellulose beads. It was evaluated among 100 clinical trial patients in Japan. The most common side effects noted were temporary low blood pressure and a drop in red blood cell count. The FDA ordered Japanese device maker Kaneka Corp. to conduct a post-approval study of the device's benefits, risks and side effects among users in the United States, the FDA said.
Explore further: Natpara approved for hormone disorder causing low blood calcium More information: The FDA has more about this approval.
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Use of the medication, however, is associated with a 4-fold increased risk of bleeding.

Warfarin does not increase mortality risk among hemodialysis (HD) patients with atrial fibrillation (AF), according to what researchers believe is the first prospective study on the subject.

The oral anticoagulant therapy (OAT) was linked to a 4-fold increased risk of bleeding, and it did not reduce the incidence of ischemic stroke. Results also showed that a history of hemorrhagic events doubled the risk of hemorrhage.

“Our findings confirm that HD patients are at high risk for both thrombosis and bleeding, and that any OAT treatment needs to be performed with great care,” stated Simonetta Genovesi, MD, of the University of Milano-Bicocca in Italy, and colleagues. “In particular, warfarin should not be administered in patients with previous bleeding episodes occurring in the presence or even in the absence of OAT.”

The investigators evaluated the effects of OAT in 134 of 290 HD patients with AF from 10 Italian centers who had paroxysmal, persistent, or permanent AF. During a 2-year period, 115 patients died, only 4 from stroke (3 hemorrhagic, 1 ischemic). Of the 115 patients, 51 received OAT and 64 did not.

Unlike OAT, antiplatelet therapy (e.g., aspirin, ticlopidine, and clopidogrel) was associated with a 71% increased risk of death, the researchers reported in Nephrology Dialysis Transplantation(2015;30:491-498). The investigators suggest the higher prevalence of ischemic heart disease in patients taking antiplatelets could make them more vulnerable.

Continuous warfarin use was associated with better survival compared with discontinuing the medication for reasons such as bleeding (69% vs. 50%). Warfarin might not be the sole factor in better outcomes, however, the researchers suggest.

“These results emphasize the need to identify effective interventions that go beyond anticoagulation to reduce further high mortality in the AF population,” the investigators stated.

Previous retrospective studies on the subject have yielded conflicting results. The researchers urge larger prospective studies and randomized trials to assess the risks and benefits of warfarin and determine best practices for preventing stroke and bleeding in high-risk AF patients on HD.

A strength of the study was the use of computed tomography or magnetic resonance imaging to document whether cerebrovascular events were ischemic or hemorrhagic; a limitation of the study was its non-randomized design.

Source

1. Genovesi, S, et al. Nephrol Dial Transplant (2015) 30:491-498; doi: 10.1093/ndt/gfu334.

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the ONA take:

According to a recent study published in the journal Cancer, researchers have found that a higher intake of lycopene in postmenopausal women may decrease the risk for developing renal cell carcinoma.

Lycopene is a natural oxidant found that in foods such as tomatoes, papaya, pink grapefruit, guava and watermelon. For the study, researchers analyzed data from 96,196 women nationwide who were included in the Women's Health Initiative  from 1993 to 1998 and were followed up with through July 2013 at certain participating sites.

The researchers analyzed the risks for renal cell carcinoma associated with intake of lycopene, vitamin C, and vitamin E.

During the follow-up period, 240 women were diagnosed with kidney cancer. Results showed that participants who consumed more lycopene had a 39% lower risk of renall cell carcinoma compared with those women who reported a lower intake of lycopene.

"Lyopene from food sources has also been associated with decreased risk of breast and prostate cancer, and a diet high in vegetables and fruits are generally well-accepted for promoting good health, said lead researcher Cathryn Bock, Ph.D., M.P.H., associated professors of Oncology at Wayne State University's School of Medicine.

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The U.S. Food and Drug Administration today authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).

Dialysis-related amyloidosis is a chronic, progressive condition caused by the buildup in the body of a protein called beta 2-microglobulin. Dialysis-related amyloidosis is a complication of kidney failure. As beta 2-microglobulin builds up in the blood, deposits of the protein can form in the bones, joints and tendons causing painful and stiff joints, bone cysts that can lead to bone fractures, and torn tendons and ligaments. Beta 2-microglobulin deposits can also affect the digestive tract and organs, such as the heart and lungs.

Dialysis-related amyloidosis most often occurs in patients with kidney failure, especially adults older than 60, who have been on hemodialysis for more than five years.   

The Lixelle Column works by removing beta 2-microglobin from the blood. It contains porous cellulose beads specifically designed to bind to beta 2-microglobulin as the patient’s blood passes over the beads. The device is used in conjunction with hemodialysis, a treatment where blood circulates outside the body through a special filter that removes waste products and extra fluid. The clean blood is returned to the body. When the Lixelle Column is used, the blood passes through the Lixelle Column before it enters the dialysis filter.

The device may help patients who have developed symptoms related to DRA and may be especially useful for those patients who may not have access to extended dialysis therapies or who may not be eligible for a kidney transplant.

“While DRA affects only a small population of patients on dialysis, there are not many treatment options for these patients and some options may not be available to patients in all areas,” said William Maisel, M.D., M.P.H., deputy director for science, chief scientist and acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. “The Lixelle Beta 2-microglobulin Apheresis Column may provide this patient population with an option for relieving some of the debilitating symptoms of DRA.”  

The FDA reviewed the Lixelle Column through the Humanitarian Device Exemption (HDE) pathway after granting it a Humanitarian Use Device (HUD) designation. An HDE is an application that is similar to a premarket approval application (PMA), but it is exempt from the effectiveness requirements that apply to PMAs. Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year. In order to receive HDE approval for a HUD, a company must demonstrate safety and probable benefit of the device (i.e., that the device will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit of the device outweighs the risk of injury or illness from its use), and that there are no legally-marketed comparable devices, other than a device approved under the HDE or investigational device exemption (IDE), available to treat or diagnose the disease or condition.

Data supporting the safety and probable benefit of the Lixelle Column include published clinical studies describing treatment of approximately 100 patients from Japan with DRA, and postmarket safety data from approximately 200 patients in Japan where the device has been approved for use. The studies generally showed improvement in symptoms associated with DRA with use of the device.

The most common adverse events associated with the device’s use are temporary hypotension (low blood pressure) and a decrease in red blood cell count (hematocrit). These are common adverse events for patients undergoing dialysis or any extracorporeal therapy (treatment that takes place outside of the body). As a condition of the HDE approval, the company must conduct a postmarket study to gain more data on the benefits, risks, and adverse events in the U.S. population. 

The Lixelle Column is manufactured by Kaneka Corporation in Osaka, Japan and distributed in the U.S. by its subsidiary, Kaneka Pharma America.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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