Working in conjunction with researchers at the Harvard Medical School Partners Center for Genetics and Genomics in Boston, MA, the Zucker Hillside team utilized a cutting-edge technology called whole genome association (WGA) to search the entire human genome in 178 patients with schizophrenia and 144 healthy individuals. WGA technology was used to examine over 500,000 genetic markers in each individual, the largest number of such markers examined to date, and the first published study to utilize WGA technology in a psychiatric illness. Previous studies have been much more limited in scope, often incorporating less than 10 markers.

The study results are scheduled to be published online in Molecular Psychiatry.

Of the 500,000 genetic markers, the researchers found that the most significant link with schizophrenia came from a marker located in a chromosomal region called the pseudoautosomal region 1 (PAR1), which is on both the X and Y chromosomes. The marker was located adjacent to two genes, CSF2RA and IL3RA, which previously were thought to play a role in inflammation and autoimmune disorders. Those two genes produce receptors for two cytokines, GM-CSF and interleukin-3. Cytokines are involved in the body’s response to infection, and may play a role in the brain’s response to injury.

By then examining the DNA sequence of those genes in a separate group of patients with schizophrenia and healthy individuals, the research team – working in conjunction with PGx Health in New Haven, CT — observed multiple gene abnormalities in patients with schizophrenia that were not found, or were found much less commonly, in healthy individuals.

“WGA technology allowed us to shine a light across virtually the entire genome, rather than looking at just one gene at a time,” said Todd Lencz, PhD, the first author of the study, and an investigator at Zucker Hillside and The Feinstein Institute. “Using WGA, we found genes that had not been previously considered in studies of schizophrenia.” Dr. Lencz added that “the critical next step is confirming these results in independent datasets.”

Anil Malhotra, MD, also of Zucker Hillside and The Feinstein, and senior investigator of the study, noted: “If these results are confirmed, they could open up new avenues for research in schizophrenia and severe mental illness. A role for cytokines could help explain why prenatal exposure to viruses is a risk factor for schizophrenia, thus providing a bridge between genetic risk and environmental exposures.”

###

The study was funded by a private donation from the Donald and Barbara Zucker Foundation, an award from the KeySpan Energy, and grants from the National Institute of Mental Health; NARSAD, the Mental Health Research Association (formerly known as National Alliance for Research on Schizophrenia and Depression); and the Stanley Medical Research Institute.

About The Feinstein Institute for Medical Research

Headquartered in Manhasset, NY, and part of the North Shore-LIJ Health System, The Feinstein Institute for Medical Research is among the top six percent of all institutions that receive funding from the National Institutes of Health. Building on its strengths in neurodegenerative and psychiatric disorders, genomics and human genetics, immunology and inflammation, and oncology and cell biology, its goal is to understand the biological processes that underlie various diseases and translate this knowledge into new tools for diagnosis and treatment. For more information, please visit feinsteininstitute/.

Contact: Terry Lynam

North Shore-Long Island Jewish (LIJ) Health System

Unlike primary level stroke care, currently certified by The Joint Commission, comprehensive center recommendations do not have national certification, largely due to the challenges of establishing uniform quality measures.

“Patients rightfully expect that wherever the ambulance takes them for a stroke, there should be a basic level of quality care,” said Dr. David Chiu, medical director of Methodist’s Eddy Scurlock Stroke Center and article co-author. “They should also be aware that some hospitals have comprehensive stroke center capabilities to treat even the sickest stroke patient, other hospitals are primary stroke centers able to provide good quality care for the average stroke patient, and still others are not equipped to give emergency stroke treatment at all.”

Under Chiu’s leadership, Methodist’s stroke center implemented 13 measures to demonstrate the feasibility of the BAC’s recommendations. Measures include timeliness of brain imaging interpretation, timeliness and consideration of antiplatelet treatment regimens for carotid stent patients and documentation of National Institutes of Health Stroke Score. Outcomes measures included morbidity and mortality rates for stroke, cerebral aneurysm, diagnostic/therapeutic imaging, carotid endarterectomy and stent patients.

“We see too many differences in stroke care across this country. Patients and families deserve to know an institution’s qualifications when their loved one is suffering a stroke and needs proper medical attention,” said Joan Censullo, M.S., R.N., FAHA, project specialist with the Methodist Neurological Institute and lead author. “We’ve shown at Methodist that if properly implemented, national certification for the comprehensive (highest) level of stroke care can be a reality.”

The BAC’s guidelines for the first level of stroke care became the foundation for The Joint Commission’s Primary Stroke Center certification, which The Methodist Hospital received in 2006. The BAC proposed comprehensive stroke center guidelines in 2005.

Approximately 780,000 people suffer a new or recurring stroke every year. In Harris County, where The Methodist Hospital is located, stroke mortality is twice the national average.

For more information on stroke care at Methodist, go to methodistneuroinstitute.

About The Methodist Hospital

With 18 beds, the Eddy Scurlock Stroke Center at The Methodist Hospital in Houston is the largest dedicated stroke unit in Texas and designated a certified primary stroke center by The Joint Commission. The Center is a leader in all areas of stroke research, including diagnosis, innovative treatment, prevention, rehabilitation and recovery.

The Methodist Neurological Institute houses the practice and research activities of the departments of neurology, neurosurgery, neuroradiology, neurophysiology and physical medicine & rehabilitation at The Methodist Hospital. The mission of the NI is to advance the discovery of the origins, mechanisms and treatment of neurological disease and to provide comprehensive care for patients with disorders and injuries of the brain and spinal cord.

Methodist is primarily affiliated with Weill Cornell Medical College and New York Presbyterian Hospital. Methodist is also affiliated with the University of Houston. Ranked among the country’s top centers in 14 specialties in U.S News & World Report’s 2007 America’s Best Hospitals issue, Methodist is ranked in more specialties than any other hospital in Texas, and is 9th in the nation for neurology and neurosurgery.

Methodist Hospital Houston
6565 Fannin St.
Houston, TX 77030
United States
methodisthealth

The results of the survey are reported by researchers at Dana-Farber Cancer Institute and their colleagues in the March issue of the journal Pediatrics. Their findings are in general accord with the recommendations of medical organizations that have previously weighed in on the issue.

“Physicians who perform hematopoietic cell transplants in children are well positioned to judge the advisability of private cord blood banking, but their views had never been systematically sought and collected,” says the study’s senior author, Steven Joffe, MD, MPH, of Dana-Farber. “We found that these physicians have performed relatively few transplants involving privately banked cord blood, and that their position on such banking is generally in line with that of larger medical organizations.”

Cord blood is a source of “hematopoietic” (blood forming) cells that can be used in stem cell transplants to treat a range of diseases and disorders. Expanding the collection of cord blood for use in public cord blood banks increases the chance that more people are eligible for transplant, because stem cells culled from cord blood do not have to match a patient’s tissue type as closely as donated bone marrow does. Cord blood stored in public banks is made available to unrelated children and adults in need of a stem cell transplant.

Private cord blood banks are for-profit companies that, unlike public banks, store umbilical cord blood for personal or family use. Private cord blood banks typically charge a $1,500 – $2,000 collection fee and an annual $100 – $200 storage fee. Families may decide to store cord blood privately if a relative has, or is at risk for, a disease such as leukemia or aplastic anemia that can be treated by a stem cell transplant. Families without such at-risk members may choose to have the blood stored as a form of “biological insurance,” in case the child or another family member unexpectedly develops a disease that can be treated by stem cell transplant.

For the current study, surveys were sent to 152 pediatric hematopoietic cell transplant physicians in the United States and Canada, 93 of whom responded. Questions addressed the number of transplants physicians had performed using privately banked cord blood, their willingness to use such blood in specific situations, and their recommendations to parents regarding private cord blood banking.

The respondents reported that of the thousands of stem cell transplants they had performed, only 50 involved privately banked cord blood. Forty one of those cases were “allogeneic” transplants, in which blood from one individual was used to treat another member of the family. And in 36 of those cases, families already knew of a member who was a candidate for a transplant prior to banking the cord blood. The researchers identified only four or five cases in which cord blood that had been privately banked “just in case” it would someday be needed was actually used to treat a sibling of the donor. They also identified only nine cases in which children whose cord blood had been banked subsequently underwent transplants using their own stem cells (known as autologous transplantation), despite the fact that this is the primary use for which private cord blood banks market their services.

Few of the respondents said they would choose a patient’s own cord blood over other alternatives as a source of stem cells for treatment of acute lymphoblastic leukemia. By contrast, more than half said they would use an individual’s own cord blood to treat high-risk neuroblastoma, or to treat severe aplastic anemia in the absence of an available sibling donor.

In addition, few would recommend banking of cord blood in families without a member known to have, or be at risk for, a disease that can be treated by transplantation.

“In the absence of a family member known to be a candidate for stem cell transplantation, the chances that privately banked cord blood will be used are quite small,” Joffe says. “Families need to balance the high cost of banking such blood against the remote odds of its ever being needed. Pediatricians, family physicians, obstetricians, nurse midwives, and other professionals who work with families should educate parents about the medical community’s consensus view on this issue.”

The lead author of the study is Ian Thornley, MD, of North Shore Medical Center in Salem, Mass. Co-authors are Mary Eapen, MD, of the Medical College of Wisconsin, Milwaukee; Lillian Sung, MD, PhD, of the Hospital for Sick Children in Toronto; Stephanie Lee, MD, MPH, of the Fred Hutchinson Cancer Research Center, Seattle; and Stella Davies, MD, PhD of Cincinnati Children’s Hospital Medical Center.

Dana-Farber Cancer Institute (dana-farber) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.

Dana-Farber Cancer Institute
44 Binney St., OS 382 A
Boston
MA 02215
United States
dana-farber

Dr Ian Walker, a traffic psychologist from the University of Bath in the UK, used a bicycle fitted with a computer and an ultrasonic distance sensor to record data from over 2,500 overtaking motorists in Salisbury and Bristol.

Dr Walker, who was struck by a bus and a truck in the course of the experiment, spent half the time wearing a cycle helmet and half the time bare-headed. He was wearing the helmet both times he was struck.

He found that drivers were as much as twice as likely to get particularly close to the bicycle when he was wearing the helmet.

Across the board, drivers passed an average of 8.5 cm (3 1/3 inches) closer with the helmet than without

The research has been accepted for publication in the journal Accident Analysis & Prevention.

“This study shows that when drivers overtake a cyclist, the margin for error they leave is affected by the cyclist’s appearance,” said Dr Walker, from the University’s Department of Psychology.

“By leaving the cyclist less room, drivers reduce the safety margin that cyclists need to deal with obstacles in the road, such as drain covers and potholes, as well as the margin for error in their own judgements.

“We know helmets are useful in low-speed falls, and so definitely good for children, but whether they offer any real protection to somebody struck by a car is very controversial.

“Either way, this study suggests wearing a helmet might make a collision more likely in the first place.”

Dr Walker suggests the reason drivers give less room to cyclists wearing helmets is down to how cyclists are perceived as a group.

“We know from research that many drivers see cyclists as a separate subculture, to which they don’t belong,” said Dr Walker.

“As a result they hold stereotyped ideas about cyclists, often judging all riders by the yardstick of the lycra-clad street-warrior.

“This may lead drivers to believe cyclists with helmets are more serious, experienced and predictable than those without.

“The idea that helmeted cyclists are more experienced and less likely to do something unexpected would explain why drivers leave less space when passing.

“In reality, there is no real reason to believe someone with a helmet is any more experienced than someone without.

“The best answer is for different types of road user to understand each other better.

“Most adult cyclists know what it is like to drive a car, but relatively few motorists ride bicycles in traffic, and so don’t know the issues cyclists face.

“There should definitely be more information on the needs of other road users when people learn to drive, and practical experience would be even better.

“When people try cycling, they nearly always say it changes the way they treat other road users when they get back in their cars.”

The study also found that large vehicles, such as buses and trucks, passed considerably closer when overtaking cyclists than cars.

The average car passed 1.33 metres (4.4 feet) away from the bicycle, whereas the average truck got 19 centimetres (7.5 inches) closer and the average bus 23 centimetres (9 inches) closer.

However, there was no evidence of 4x4s (SUVs) getting any closer than ordinary cars.

Previously reported research from the project showed that drivers of white vans overtake cyclists an average 10 centimetres (4 inches) closer than car drivers.

To test another theory, Dr Walker donned a long wig to see whether there was any difference in passing distance when drivers thought they were overtaking what appeared to be a female cyclist.

Whilst wearing the wig, drivers gave him an average of 14 centimetres (5.5 inches) more space when passing.

In future research, Dr Walker hopes to discover whether this was because female riders are seen as less predictable than male riders, or because women are not seen riding bicycles as often as men on the UK’s roads.

###

11,257 adult cyclists were injured and 109 killed on the UK’s roads in 2004, the latest year for which figures are available. However, for each bicycle accident officially recorded there are as many as 14 more which do not go on police records, and so the number injured is certainly an under-estimate. Being struck by an overtaking car is arguably the most dangerous form of collision for a cyclist, with a particularly high mortality rate.

This work was funded by the Engineering and Physical Sciences Research Council. A bicycle was modified for the project by Jeff Brewster from the University of Bath’s Department of Mechanical Engineering. It carried an ultrasonic distance sensor which could measure how close vehicles passed to within a millimetre and a video system so that vehicle type could be classified.

This research has been accepted for publication in Accident Analysis & Prevention, the world’s top-rated peer-reviewed ergonomics journal.

The University of Bath is one of the UK’s leading universities, with an international reputation for quality research and teaching. In 19 subject areas the University of Bath is rated in the top ten in the country.

Useful links:

The University of Bath

Department of Psychology

Dr Walker’s ‘overtaking’ webpage

Contact: Andrew McLaughlin

University of Bath

Pulmonary embolism is caused when a blood clot travels to a person’s lungs from another location in the body, usually the legs. Symptoms may include shortness of breath, chest pain and coughing up blood. Anyone, including people who are otherwise healthy, can develop a blood clot and subsequent pulmonary embolism. Additionally, some patients show no symptoms, making pulmonary embolism particularly difficult to diagnosis. If left untreated, the mortality rate for patients with pulmonary embolism is approximately 30%. The risk of death can be reduced, however, with anti-clotting medications.

“Pulmonary embolism is very difficult to diagnose clinically,” said J. Anthony Parker, M.D., Ph.D., a Beth Israel Deaconess Medical Center researcher who authored an invited perspective on the study in JNM. “Untreated, it has a high mortality rate. However, the treatment for pulmonary embolism also has serious side effects. As such, it is important not to over-treat pulmonary embolism. More accurate diagnosis, including both improved sensitivity and specificity, should result in better patient outcomes.”

In the JNM study, titled “Detection of Pulmonary Embolism with Combined Ventilation – Perfusion SPECT and Low-Dose CT: Head-to-Head Comparison with Multidetector CT Angiography,” researchers in Denmark tested the diagnostic accuracy of SPECT/CT imaging for pulmonary embolism against that of multidetector CT angiography (MDCT) alone, which is the current first-line imaging technique for diagnosing pulmonary embolism. Their study found that SPECT plus low-dose CT had a sensitivity of 97% and a specificity of 100%, whereas MDCT alone had a sensitivity of 68% and a specificity of 100%. Having an effective technique for diagnosing pulmonary embolism leads to more rapid and successful diagnosis.

In a related article also published in this month’s JNM, researchers discuss the role of SPECT in imaging pulmonary embolism and how the technology has advanced. The authors of “SPECT in Acute Pulmonary Embolism” write that there is renewed interest in this modality as the initial imaging test for pulmonary embolism as a result of improved instrumentation and improved interpretation of lung scans, as well as concerns about high radiation exposure from CT angiography, particularly to the female breast. The article supports the conclusions found by the researchers in Denmark – SPECT/CT imaging may considerably improve the diagnosis of pulmonary embolism. The article also suggests that SPECT might be useful for follow-up examinations for determining therapy’s response.

Co-authors of “Detection of Pulmonary Embolism with Combined Ventilation-Perfusion SPECT and Low-Dose CT: Head-to-Head Comparison with Multidetector CT Angiography” include: Henrik Gutte, Jann Mortensen, Camilla Bardram Johnbeck, Peter von der Reck, Ulrik Sloth Kristoffersen, and Andreas KjГ¦r, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Henrik Gutte, Camilla Bardram Johnbeck, Ulrik Sloth Kristoffersen, Andreas KjГ¦r, Cluster for Molecular Imaging, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark; Claus Verner Jensen, Peter von der Recke, Department of Radiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Claus Leth Petersen, Department of Clinical Physiology and Nuclear Medicine, Frederiksberg Hospital, Frederiksberg, Denmark; and Jesper KjГ¦rgaard, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Co-authors of “SPECT in Acute Pulmonary Embolism” include: Paul D. Stein, Fadi Matta, Departments of Internal Medicine and Research and Advanced Studies Program, College of Osteopathic Medicine, Michigan State University, East Lansing, Michigan; Leonard M. Freeman, Departments of Nuclear Medicine and Diagnostic Radiology, Montefiore Medical Center, New York, New York; H. Dirk Sostman, Office of the Dean, Weill Cornell Medical College and Methodist Hospital, Houston, Texas; Lawrence R. Goodman, Department of Radiology, Medical College of Wisconsin, Milwaukee, Wisconsin; Pamela K. Woodard, Department of Radiology, Washington University, St. Louis, Missouri; David P. Naidich, Department of Radiology, New York University, New York, New York; Alexander Gottschalk, Department of Radiology, Michigan State University, East Lansing, Michigan; Dale L. Bailey, Department of Nuclear Medicine, University of Sydney, Sydney, Australia; Abdo Y. Yaekoub, Department of Internal Medicine, St. Joseph Mercy Oakland, Pontiac, Michigan; Charles A. Hales, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; Russell D. Hull, Department of Medicine, University of Calgary, Calgary, Alberta, Canada; Kenneth V. Leeper, Jr., Department of Medicine, Emory University, Atlanta, Georgia; Victor F. Tapson, Department of Medicine, Duke University, Durham, North Carolina; and John G. Weg, Department of Medicine, University of Michigan, Ann Arbor, Michigan.

Source:
Amy Shaw
Society of Nuclear Medicine

Dr. Rodriguez and colleagues studied 45 patients with locally advanced breast cancer in which the gene HER-2 was over-expressed. The patients received lapatinib for six weeks, followed by a combination of weekly trastuzumab and three-weekly docetaxel, given over 12 weeks, before primary surgery. Biopsies were performed at the time of diagnosis and also after six weeks of lapatinib and cells from the tumours were obtained and analyzed.

“We saw significant tumour regression after six weeks of single agent lapatinib,” said Dr. Rodriguez. “Bi-dimensional tumour measurements showed a median decrease of minus 60.8%. We had previously showed that tumour-causing breast cancer stem cells were resistant to conventional preoperative chemotherapy; indeed, residual cancers that were exposed to such chemotherapy showed an increase in tumour-causing cells and enhanced tumour initiation by the formation of mammospheres, small tumours that form when tumour-causing cells are cultured in a test tube, which reflect the capacity of the cells to self-renew. So we were excited to see that the results with lapatinib were different.”

Dr. Rodriguez’s results suggest that specific signalling inhibitors of the pathways responsible for stem cell self-renewal could provide a possible therapy for eliminating tumour-causing cells in order to achieve the long-term eradication of cancer.

Cancer stem cells help maintain the malignant tissue in the tumour by regenerating the tumour after attack from chemotherapy drugs. “This indicates that the stem cells themselves should be the specific target of chemotherapy drugs,” said Dr: Rodriguez. “Rather than the broad brush approach, in which cells are killed indiscriminately, targeting the stem cells may be more effective and also prevent some of the unpleasant side effects associated with conventional chemotherapy treatment.”

Scientists believe that cancer stem cells come into being through damage to their own DNA, which affects the regulation of their self-renewal. Other cells divide into two ‘daughter’ cells, but a stem cell can divide into a new stem cell and a ‘progenitor’ cell. The progenitor cell loses the power of self-renewal, but can still change into the cell type of the tissue served by the stem cell. The stem cell population then continues to renew itself as it generates new cells for the tissue. “This means that, unlike other cells, the stem cell has lost control over its own population size,” said Dr. Rodriguez.

Lapatinib has few side effects, and those that exist are minimal, including diarrhoea and acne. But it is expensive. “In the US it costs between $2000 and $3000 a month,” he said.

“This is an exciting finding, and we will be starting further studies on stem cells in order to confirm it. We will also look into its applicability in testing novel agents targeting tumour-initiating cells. This finding should also apply to other types of cancers and research of tumour-initiating stem cells in other cancers is ongoing,” said Dr. Rodriguez.

“International studies are currently underway looking at the effect of lapatinib in lung, colon, head and neck, gastric, oesophageal, and bladder cancer and lymphoma, among others,” he said.

###

Lapatinib has not yet been licensed for use in the EU, although it has been approved in Switzerland and received a positive opinion regarding a conditional marketing authorisation from the European Medicines Agency in December. This conditional authorisation refers to its use in patients with advanced or metastatic breast cancer with HER-2 over-expression in the tumours.

Catalogue no: 204

Source: Mary Rice

ECCO-the European CanCer Organisation

Adenotonsillectomy is a common surgical procedure in the United States. Most of the time, it is performed to treat recurring bouts of tonsillitis.

During the past decade, however, doctors have also used the surgery to treat obstructive sleep apnea (OSA), a condition in which people periodically stop breathing during sleep due to an obstruction in the upper airway. OSA is usually seen in older, heavier adults, but it can strike children, as well.

Researchers enrolled 60 children diagnosed with OSA who were scheduled for surgery to remove their tonsils and adenoids.

Each child’s caregiver filled out a standard survey on sleep-related quality of life before the testing and then again about 120 days after the operation.

Results showed significant improvements in quality of life for the children after the surgery. The greatest change was seen in the score for sleep disturbance, which dropped by about 11 points from pre-surgery levels.

Researchers say, that from the study there was found to be a definite improvement in sleep disturbance, physical suffering, emotional distress, and daytime problems in their children after adenotonsillectomy for OSA.

Leeds Met’s Faculty of Health will be providing a drop in Men’s Health Clinic at the stadium as part of an innovative drive to promote men’s health through Leeds Met’s pioneering partnership with Leeds Rugby.

A clinic, staffed by professional nurses, will be available at half time and after the game, offering free confidential advice to men and boys. Leeds Met are working in partnership with the Leeds Men’s Health Network and local Primary Care Trusts to provide men with Health MOTs, information and services, in line with government guidance. Professor Alan White, the world’s first professor of Men’s Health, who leads the Leeds Met Centre for Men’s Health, will also be on hand.

Professor White said: “The presence of a regular captive audience at the sporting matches presents a unique opportunity to target a significant number of men on a range of topical men’s health issues and get them involved in taking appropriate action where necessary.

“The message that is emerging is that men are interested in their health however they may not find it so easy to access health care services but that when the opportunity was presented for health checks they were more than willing to participate.”

Professor White has worked with the Bradford Health of Men team over the past five years developing outreach services men in an attempt to get them engaged in the health service and to see changes in their health status. In Leeds, his work with the Leeds Men’s Health Network saw the establishment of the Men’s Health Week as part of the National programme of activities coordinated by the Men’s Health Forum, of which he is chair of the board.

Further similar events are also planned at sporting events at Headingley Carnegie Stadium in the future.

Kick off for the Leeds Carnegie match is at 2.45pm and the match will be televised on Sky Sports.

Leeds Cricket Football & Athletic Co Ltd

The results showed that in 63 patients with chronic kidney disease (with a mean estimated glomerular filtration rate of 46 mL/min/1.73m2) and heart failure on standard renin-angiotensin-aldosterone-system (RAAS) blocker therapy, RLY5016 dose titration successfully allowed treatment with the maximum labeled dose of the aldosterone antagonist spironolactone while maintaining normal serum potassium levels. After eight weeks of treatment, 57 patients (90%) had serum potassium levels in the normal range, and in over half of the patients, no more than one dose titration was required to achieve and maintain a normal serum potassium level. Among patients with diabetes and albuminuria, both blood pressure and albumin:creatinine ratio were significantly reduced, suggesting that RLY5016 may enable beneficial treatment with RAAS inhibitors in these high risk patients. RLY5016 was well tolerated in the study with mild to moderate gastrointestinal side effects noted in only 10 patients (16%).

“After clearly demonstrating the potassium-lowering effects of RLY5016 versus placebo in earlier studies, we were very pleased to see that patients with moderate to severe kidney disease could be effectively kept in a safe serum potassium range through few dose titrations, most of which occurred early in the study,” said I-Zu Huang, M.D., Vice President of Clinical Development. Relypsa’s President, Gerrit Klaerner, Ph.D., noted, “The opportunity to present our latest trial results at such an important meeting, underscores the medical community’s continued interest in RLY5016. I am proud of our clinical team executing another study in record time and delivering more compelling evidence that many patients with chronic kidney disease, who are facing high mortality risk and progression to dialysis, do not receive appropriate RAAS inhibitor treatment due to hyperkalemia.”

About RLY5016 and Hyperkalemia

Hyperkalemia is a condition frequently prevalent in patients that suffer from renal impairment, hypertension, diabetes and heart failure. It is characterized by elevated serum potassium levels, which can lead to cardiac arrhythmia and sudden death. Patients with chronic kidney disease are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors. Although RAAS inhibition in such patients has been shown to prolong kidney function, many are untreated or undertreated due to the undesirable side effect of increasing serum potassium.

RLY5016 is a high capacity non-absorbed oral potassium binder being developed for the management of elevated serum potassium levels. Relypsa has completed several clinical trials of RLY5016 that have demonstrated the preliminary efficacy, safety and tolerability of RLY5016 for the prevention of hyperkalemia.

Source:

Relypsa, Inc.