UPMC Physician Resources

Archives for UPMC

Childhood Cancer Focus of St. Baldrick’s Foundation Research Grant to Children’s Hospital of Pittsburgh of UPMC

PITTSBURGH, Nov. 21, 2014 – To improve information flow about childhood cancers, Jean M. Tersak, M.D., an oncologist in the Division of Pediatric Hematology/Oncology at Children’s Hospital of Pittsburgh of UPMC, has been awarded a one-year, $50,000 grant from the St. Baldrick’s Foundation, a volunteer-driven charity dedicated to raising money for childhood cancer research.

Dr. Tersak’s is one of 40 infrastructure grants totaling more than $2.5 million awarded by St. Baldrick’s to support pediatric oncology research. These grants provide resources to institutions to conduct more research and enroll more children in ongoing clinical trials.

The funding will help to support efforts to enhance website communication of research activities to make information more easily accessible to potential patients, families, and referring physicians. Additionally, funding will support the transition to a new database to increase efficiency and refine ability to query the database as a more effective tool to conduct institutional research.

“This generous grant from St. Baldrick’s will help us to be sure that our medical treatments are more widely known and available to anyone who may need them to battle a diagnosis of cancer as a child or young adult,” said Dr. Tersak, who also directs the Survivorship Program at Children’s Hospital. “The grant will increase the efficiency of our program and increase awareness of novel treatments available to patients form our region and beyond.”

“These grants are critically important to saving children’s lives, and would not be possible without our dedicated volunteers and generous donors who believe kids deserve better than medicine is currently able to provide,” said Kathleen Ruddy, chief executive officer for the St. Baldrick’s Foundation.

“Each day in my work, I encounter patients who have been helped along the way through the tremendous efforts of St. Baldrick’s,” added Dr. Tersak, also principal investigator, Children’s Oncology Group.

Dr. Tersak has a special interest in caring for survivors of childhood cancer, including evaluation for medical late effects of treatment and the quality of life in these survivors. She is involved in national research to better understand late effects, ways to prevent them, and early intervention when they do occur.

The Division of Pediatric Hematology/Oncology at Children’s provides diagnosis, treatment and complete follow-up for children, adolescents, and young adults with cancer and blood disorders. The division is the largest, most comprehensive pediatric cancer and blood disease center in western Pennsylvania, eastern Ohio, and northern West Virginia and has been a member of the Children’s Oncology Group, a multi-institutional pediatric cancer research organization sponsored by the National Cancer Institute, since 1961. It’s one of the top-rated pediatric cancer programs in the United States as ranked by U.S. News & World Report.

For more information about Dr. Tersak, please visit www.chp.edu.

Early Diagnosis and Cord Blood Transplantation Prevents Permanent Brain Damage From Rare Inherited Disease, Children’s Hospital of Pittsburgh of UPMC Study Finds

PITTSBURGH, Nov. 19, 2014 – Umbilical cord blood from unrelated donors can halt the progression of the neurodegenerative disease Hurler syndrome if performed before the affected child is less than 9 months old, according to a Children’s Hospital of Pittsburgh of UPMC study that appears online in Annals of Neurology. The findings emphasize the need for early diagnosis of the condition, preferably through newborn screening programs.

Hurler syndrome is the most clinically severe form of an inherited disorder in which the patient lacks a key enzyme needed to break down complex sugars called glycosaminoglycans. The sugar buildup results in progressive organ deterioration and death in childhood. Affected children may not have symptoms until age 3, but the brain undergoes damage before symptoms present.

Umbilical cord blood transplantation from unrelated donors has previously been shown to improve neurological outcomes of children over 2 years of age and prolong life. Hematopoietic stem cells from the cord blood transplants provide a source for the normal enzyme that is donated to the deficient cells decreasing the accumulation of gycosaminoglycans.

Key findings of this study show that treatment of Hurler syndrome with umbilical cord blood transplantation before 9 months of age leads to normal cognitive development. The researchers found children transplanted at 12 and 25 months of age functioned cognitively at a level 2 to 5.3 years below that of those transplanted at 4 months. Early transplantation also predicted better outcomes for language skills and adaptive behaviors.

“The purpose of the study was to determine whether age at transplantation can predict cognitive outcomes,” said Maria Luisa Escolar, MD, MS, director, Program for the Study of Neurodevelopment in Rare Disorders, Children’s Hospital, and associate professor of pediatrics, University of Pittsburgh School of Medicine. “This study highlights the importance of early detection of brain diseases in babies and infants when brain growth is the most accelerated in life, placing them at increased vulnerability for permanent damage.”

Between June 1997 and February 2013, 31 children with Hurler syndrome underwent umbilical cord blood transplantation and were evaluated every six to 12 months thereafter for an average of seven years. Median age at transplantation was 13.8 months. The youngest babies in the study were diagnosed due to family history of the condition.

“Identification of asymptomatic children through statewide newborn screening programs is the only way to diagnose early and prevent brain damage to babies with no family history of Hurler syndrome,” Dr. Escolar said.

“Unfortunately, early diagnosis is often difficult as their initial symptoms may be common in the general population,” added Dr. Escolar. “Therefore, there is a need for newborn screening for Hurler syndrome and similar neurodegenerative diseases that can identify children before symptoms appear, giving the best opportunity for prompt intervention and optimal outcomes.”

Collaborators with Dr. Escolar on the study were Michele Poe, PhD, and Sarah Chagnon, MD, both with Children’s Hospital of Pittsburgh of UPMC.

Financial support for this work was received from the Caterina Marcus Foundation.

For more information on Dr. Escolar and the Program for the Study of Neurodevelopment in Rare Disorders, visit www.chp.edu/ndrd.

Child Abuse, Adversity Associated With Poor Health and Employment Outcomes Later in Life

PITTSBURGH, Nov. 18, 2014 – People who currently fall into low-income and educational brackets are up to five times as likely to have faced abuse and adversity during childhood as people who fall into higher socioeconomic groups, according to a University of Pittsburgh Graduate School of Public Health analysis of Allegheny County residents.

The findings, which will be presented Tuesday at the American Public Health Association’s (APHA) annual meeting in New Orleans, support the merit of “whole family” programs that seek to break the cycle of adversity and negative health, economic and social outcomes that persist over generations.

Eliminating childhood abuse and adversity significantly improves health – reducing heart disease by more than 26 percent and serious mental illness by more than 41 percent, the research team determined in a separate study presented Monday.

“Early childhood is a sensitive period of human development when abuse or parental problems can create lasting negative consequences later in life,” said lead investigator Todd M. Bear, Ph.D., director of the Office of Health Survey Research in Pitt Public Health’s Department of Behavioral and Community Health Sciences. “Our findings provide strong evidence that it is worthwhile for communities to invest in robust intervention programs that provide treatment, educational and employment opportunities, and positive role models to the whole family.”

The analyses used data from the 2009-2010 Allegheny County Health Survey, which interviewed 5,442 randomly selected residents of the county containing Pittsburgh.

Dr. Bear and his colleagues focused on six adverse childhood events reported by adult residents as having happened in their household when they were children: physical, sexual and emotional abuse, parental mental illness, parental substance abuse and domestic violence.

The research team, which included experts in epidemiology and psychiatry, found that:

  • Blacks had 2.5 times higher prevalence of childhood sexual abuse and greater rates of physical abuse when compared with whites.
  • People with a low socioeconomic status had 1.7 to 4.2 times higher prevalence for each of the six adverse childhood events compared with people of higher socioeconomic status.
  • People who reported they were unable to work also reported a prevalence of sexual abuse five times higher than those reporting employment.

The results are consistent with those of similar surveys conducted in other communities nationwide.

“We’ve found nothing to indicate that our findings are unique to Allegheny County,” said Dr. Bear. “These strong links between childhood adversity and poor socioeconomic status later in life, coupled with our findings that eliminating childhood abuse significantly prevents serious health consequences in adulthood, should be useful information for communities nationwide that are determining appropriate interventions to help their most vulnerable populations.”

Additional researchers on both these studies are Patricia I. Documét, M.D., Dr.P.H., Michael Marshal, Ph.D., Ronald Voorhees, M.D., M.P.H., and Edmund Ricci, Ph.D., M.Litt., all of Pitt.

Pitt Epidemiologist Honored for Innovations in Public Health

PITTSBURGH, Nov. 17, 2014 Lewis Kuller, M.D., Dr.P.H., former chair of the University of Pittsburgh Graduate School of Public Health’s Department of Epidemiology, today will receive the prestigious John Snow Award from the American Public Health Association (APHA) and the Royal Society for Public Health in England.

The award, which annually recognizes an outstanding scientist for excellence in epidemiologic practice or research, will be presented to Dr. Kuller in New Orleans at the 2014 APHA annual meeting.

“APHA’s recognition of our work in cardiovascular disease prevention, women’s health and, more recently, aging is a testament to the skill and expertise of our team at Pitt Public Health,” said Dr. Kuller, professor emeritus. “One of my mentors, Dr. Abraham Lilienfeld, was the first recipient of this award, so it is a true honor to follow in his footsteps.”

Awardees are chosen for their contributions to the improvement of human health or substantial reduction in burden of disease through innovations in public health practice based on clear epidemiologic foundations or implementation of epidemiologic approaches to the solution of health problems. Their contributions are practical, explicit and applied, rather than theoretical or implicit.

“Dr. Kuller was selected because of not only his enormous body of work contributing to the field of epidemiology, but also his impact on students and the next generation of epidemiologists,” said E. Oscar Alleyne, Dr.P.H., M.P.H., director of epidemiology at the Rockland County Health Department in New York and chair-elect of the APHA Epidemiology Section.

The Snow Award is one of the oldest in the field of epidemiology. It commemorates John Snow, M.D., a physician who practiced in 19th century Britain and is credited as one of the founding fathers of epidemiology, which is the branch of medicine that deals with the incidence, distribution and possible control of diseases and other factors relating to health.

Dr. Snow used disease incidence data and mapping to determine that a cholera outbreak in the mid-1850s was associated with a public water pump. He convinced authorities to stem the outbreak by disabling the pump, which researchers later discovered had been dug near a cesspit.

Dr. Kuller made significant contributions in the study of cardiovascular disease and the use of noninvasive techniques, such as ultrasound, to detect early heart disease in people without symptoms. He is also recognized for his research on the risks and prevention of cancer, as well as the study of Alzheimer’s disease.

Dr. Kuller received his medical degree from George Washington University in 1959 and completed his residency in medicine at Maimonides Hospital in Brooklyn, N.Y., in 1961. He continued his education at Johns Hopkins University School of Hygiene and Public Health, receiving a doctorate in public health in 1966 and going on to join the faculty.

In 1972, Dr. Kuller came to Pitt Public Health to chair its Department of Epidemiology, which he led for 30 years.

He has published more than 300 scientific articles, mostly in the field of epidemiology, and was recognized in a recent Thomson Reuters list as one of the most highly cited researchers worldwide.

Datasets Used by Policymakers, Scientists for Public Health Analyses Inconsistent

PITTSBURGH, Nov. 17, 2014 – Commercially available datasets containing a wealth of information about food and alcohol establishments differ significantly, raising concerns about their reliability as sources of information that could be used to set public policy or conduct scientific research, according to a University of Pittsburgh Graduate School of Public Health investigation.

The analysis, funded by the Aetna Foundation, will be presented Monday at the American Public Health Association’s (APHA) annual meeting in New Orleans. It examined systematic differences in two commercially available datasets when they were used to determine the relationship between neighborhood socioeconomic characteristics and the density of food and alcohol establishments.

“If we’re making decisions about setting public policy to improve public health – such as incentives for grocery stores that offer fresh produce in economically depressed areas – then we need to be making these decisions based on accurate data to back up the need for such incentives,” said lead investigator Dara Mendez, Ph.D., M.P.H., an epidemiologist at Pitt Public Health. “Our study found that relying on just one of these commercially available datasets likely wouldn’t provide robust information.”

There are numerous datasets available for a fee that give detailed information about food and alcohol establishments across the U.S. Typically, these datasets are purchased by companies that use them for marketing purposes.

Dr. Mendez and her team used two different commercially available datasets containing information about food and alcohol establishments in Allegheny County, which includes Pittsburgh. The information was divided into the 416 distinct census tracts in the county as a means to define neighborhoods. Each census tract consists of an average of 4,000 people.

Both of the datasets showed that the density of alcohol outlets increased as neighborhood poverty increased. However, the datasets differed when it came to grocery stores. One showed that as poverty increased, the number of grocery stores increased. The other showed no association.

“This is a perplexing disagreement that likely comes down to the datasets using different classification systems and also not accurately capturing all the information. For example, because we are familiar with Allegheny County, my team was able to determine that some of the key grocery stores in our area were not included,” said Dr. Mendez. “However, if we were doing a similar analysis for a city we were not familiar with, we likely wouldn’t catch the discrepancy and could come to an inaccurate conclusion.”

The Aetna Foundation funded the study as part of a larger grant to Pitt Public Health to study the potential influence of living in stressful neighborhoods on the health of African-American mothers and their babies.

Additional researchers on this study include Anthony Fabio, Ph.D., M.P.H., and Kevin H. Kim, Ph.D., both of Pitt; and Cecily Hardaway, Ph.D., of Duke University.

APHA Abstract No. 302593, “Examining systematic biases in secondary commercial data sources of food and alcohol environments: Differences across neighborhood racial and socioeconomic characteristics,” will be given as an oral presentation at 12:30 p.m. CST on Monday, Nov. 17, 2014.

Cyber Dating Abuse Common Among Teens, Children’s Hospital of Pittsburgh of UPMC Study Finds

PITTSBURGH, Nov. 17, 2014 – Two in five teens surveyed experienced cyber dating abuse, which involves the use of technology to control, harass, threaten or stalk another person in the context of a dating relationship, in the previous three months, according to a Children’s Hospital of Pittsburgh of UPMC study that appears online today in Pediatrics.

The study is the first about cyber dating abuse among a group of young people who are using school-based health services, said senior investigator Elizabeth Miller, M.D., Ph.D., chief, Division of Adolescent and Young Adult Medicine at Children’s Hospital.

Done in collaboration with the California Adolescent Health Collaborative of the Public Health Institute, California School-Based Health Alliance and Futures Without Violence, the study was conducted at eight school-based health centers in California where students receive confidential clinical health services, including annual check-ups, sports physicals and birth control. The study, conducted during the 2012-2013 school year, assessed teens ages 14 to 19, for exposure to cyber dating abuse, adolescent relationship abuse, sexual behavior, and care-seeking for sexual and reproductive health.

Key findings showed 41 percent of teens reported experiencing this form of abuse within the last three months, with more females than males reporting such victimization. Most commonly, their partners used technology including mobile apps, social networks, texts, or other digital communication to repeatedly contact them to see where they were and who they were with.

“These findings underscore that cyber dating abuse is an emerging concern,” said Dr. Miller, also an associate professor of pediatrics, University of Pittsburgh School of Medicine. “We need to support prevention efforts that increase education about the many different forms of abuse in adolescent relationships, and to encourage parents, teachers, coaches and others to talk to young people about what healthy relationships look like.”

Like previous research examining this form of abuse, the researchers found that teens exposed to cyber dating abuse were more likely to also experience other forms of physical and sexual dating abuse, such as being slapped, choked or made to have sex by a dating partner, and also non-partner sexual assault. Additionally, greater exposure to cyber dating abuse was associated with less contraceptive use among adolescent girls.

“It is concerning to see such a large number of young people reporting these cyber dating abuse experiences, and to learn that experiencing this form of abuse is associated with other unhealthy behaviors such as not using any method of contraception for birth control,” said Rebecca Dick, MS, clinical research coordinator, Division of Adolescent and Young Adult Medicine at Children’s, and the first author of the study.

“Professionals should take cyber dating abuse seriously and actively ask teens if they are being monitored, threatened or sexually coerced by their partner using technology-based communication,” added Dr. Miller. “Given the prevalence of cyber dating abuse in this sample of adolescents, we recommend that relationship abuse prevention education include cyber dating abuse and that such education and counseling be integrated into health assessments in clinical settings.”

Collaborators with Dr. Miller on the study were: Rebecca Dick, MS, Heather L. McCauley, Sc.D., Kelley Jones, MPH, all with Children’s Hospital of Pittsburgh of UPMC; Daniel J. Tancredi, Ph.D., University of California Davis School of Medicine; Sandi Goldstein, MPH, Alison Chopel, DrPH, California Adolescent Health Collaborative, Public Health Institute; Samantha Blackburn, RN, MSN, PNP, California School-Based Health Alliance and California State University Sacramento School of Nursing; Erica Monasterio, RN, MN, FNP-BC, University of California San Francisco School of Nursing; Lisa James, MS, Futures Without Violence; and Jay G. Silverman, Ph.D., University of California, San Diego School of Medicine.

The study was supported by Award No. 2011-MU-MU-0023, awarded by the National Institute of Justice, Office of Justice Programs, U.S. Department of Justice.

For more information on Dr. Miller and the Division of Adolescent and Young Adult Medicine, visit www.chp.edu/CHP/am.

Seven New Solutions: Pitt Innovation Challenge Awards $400,000 to Creative Thinkers

PITTSBURGH, Nov. 13, 2014 — Projects that will help children use devices to treat their asthma, a portable sensor that monitors a condition called ketosis and a Web-based tool to aid recovery from knee injury were each awarded $100,000 prizes last night in the second Pitt Innovation Challenge (PInCh). Also, four other projects received $25,000 awards during last night’s live judging event at the University Club in Oakland.

More than 60 teams participated in the challenge, which was sponsored by the University of Pittsburgh’s Clinical and Translational Science Institute, the Office of the Provost, and the Innovation Institute. During the first phase of the competition, which began in September, each team submitted a video entry to answer the question, “From cell to community:  How can we individualize solutions for better health(care)?” Twenty teams were then asked to provide a written description of their projects, and 10 finalists were chosen to present during the showcase.

“PInCh is a celebration of the pioneering and entrepreneurial spirit of some of the brightest, most enterprising teams of visionary thinkers in and around the Pittsburgh region,” said CTSI director Steven E. Reis, M.D., associate vice chancellor for clinical research, Health Sciences, and professor of medicine, University of Pittsburgh School of Medicine. “This approach is leading to the implementation of some amazing ideas.”

In addition to the cash prize, the winners will also get the assistance of a project manager to begin implementing their ideas.

$100,000 Awards:

  • Nebukin: Game-based software aid to help children properly use nebulizers for inhaled treatment of conditions such as asthma.
  • Nanoketo:  Small portable sensor for monitoring ketosis, a condition common in diabetics in which the body uses fat instead of sugar for energy.
  • ACL Interaction: Web-based tool to individualize rehabilitation of ACL injuries of the knee.

$25,000 Awards:

  • PediaTristan: Educational video series for pediatric patients and families.
  • Psychometabolomics: A screening test for metabolic disorders in hard-to-treat depression.
  • Caring for Cancer Survivors at the Virtual Bedside: Web-based communication for medical teams of childhood cancer survivors.
  • MAGIC (Medication Adherence using Ginger.io in clinic):  App using passive and active data to track mental status of psychiatric patients.

Finalist and semi-finalist videos can be viewed on the PInCH website.

Bacterial or Viral Lung Infection? UPMC Studying Blood Test That Could Reduce Antibiotic Use

PITTSBURGH, Nov. 11 – A new blood biomarker test that indicates whether bacteria is the cause of a patient’s lung infection is now being studied at UPMC Presbyterian, launching a national multicenter trial. The information could help doctors decide when to prescribe antibiotics and possibly reduce overuse of the drugs, which can lead to antibiotic-resistant strains of bacteria.

Patients who go to hospital emergency departments (ED) with coughs and breathing difficulties could have pneumonia, bronchitis, asthma or chronic obstructive pulmonary disease, or even congestive heart failure, explained principal investigator David T. Huang, M.D., M.P.H., associate professor of critical care medicine and emergency medicine, University of Pittsburgh School of Medicine. Aaron Brown, M.D., assistant professor of emergency medicine, and Franziska Jovin, M.D., associate professor of medicine, will lead the study in the ED and hospital.

“Doctors prescribe antibiotics more often than they would like to because it can be really hard to tell if a patient has a lung infection or a non-infectious disease,” he said. “Also, viral infections look very much like bacterial infections, and X-rays typically cannot distinguish between the two. This study will examine whether a novel biomarker can help doctors make more informed decisions about using antibiotics.”

More than 1,500 lung infection patients will be needed to complete the Procalcitonin Antibiotic Consensus Trial (ProACT), which will eventually be expanded to include approximately 10 other sites across the country.

Patients diagnosed in the ED with a lung infection and who are not critically ill will be asked to join ProACT. If they agree, patients will be randomly assigned to either get usual care or to also have a blood test to measure the level of the protein procalcitonin, which previous Swiss studies have shown is high with bacterial infection and low with viral infection. The result and a recommendation about antibiotic use will be available within an hour to the treating ED physician. If the patient is admitted to the hospital, follow-up procalcitonin levels will be checked and made available to the treating hospital physician. The research team will call study patients twice within 30 days of the ED visit to check on their health status and the period of antibiotic use, if any.

“The final decision to use or not use antibiotics is up to the doctor, who also will be taking into account the patient’s medical history and other factors,” Dr. Huang said. “My hope is that we’ll find that patient outcomes are as just as good, while antibiotic use declines.” ProACT is funded by a $5 million, five-year grant, and a one-year trial planning grant, from the National Institute of General Medical Sciences, part of the National Institutes of Health.

FDA Approves Blood Test Developed by UPMC Researchers to Predict Rejection in Organ Transplant Recipients

PITTSBURGH, Nov. 5, 2014 – A first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants has received U.S. Food and Drug Administration (FDA) approval. The test was developed by researchers at Children’s Hospital of Pittsburgh of UPMC to determine a personalized rejection-risk index with cell-based technology.

Cellular rejection affects half of all transplant recipients in their lifetime. If unchecked, rejection can lead to progressive loss of function of the transplanted organ. Therefore, predicting whether rejection will occur is an essential part of the recipient’s care, and has been an unmet need until recently. A biopsy is used to detect ongoing rejection, but this surgical procedure cannot predict rejection.

The research team led by Rakesh Sindhi, M.D., F.A.C.S., co-director, pediatric transplantation, at the Hillman Center for Pediatric Transplantation at Children’s, began work on this test system in late 2006. The technology was licensed by the University of Pittsburgh to Plexision, a Pittsburgh-based biotech company, for development.

Pleximmune, as the test is named, predicts acute cellular rejection with an accuracy approaching or exceeding 80 percent under a variety of conditions. This performance has been established in a study involving more than 200 children who received liver or intestine transplants at Children’s Hospital.

“A common theme in every encounter with our patients is an assessment of whether that child is at risk for rejection and whether this risk will be affected by the planned treatment,” said Dr. Sindhi, who is also director of pediatric transplant research. “It is hoped that the information from such personalized blood tests will improve clinical decision-making and benefit patients in the long run.”

“Our whole philosophy here at Children’s Hospital centers on improving outcomes after transplantation and achieving the goal of a normal life for all the children we transplant,” said George Mazariegos, M.D., F.A.C.S., chief, pediatric transplantation. “This test is a step toward achieving that goal. And it is doubly exciting that the research in Dr. Sindhi’s lab is affecting children at the bedside so directly.”

The Hillman Center for Pediatric Transplantation at Children’s Hospital maintains one of the busiest and most experienced pediatric transplant centers in the United States. The center was established in 1981 under renowned transplant pioneer Thomas E. Starzl, M.D., Ph.D., as the nation’s first pediatric transplant program. Children’s is one of the most active transplant centers for infants, children and adolescents with referrals from all over the world. The team specializes in heart, lung, liver, intestine, multivisceral, kidney, and blood and marrow transplants, and achieves patient outcomes that rank among the world’s best.

Dr. Sindhi is the inventor of technology licensed to Plexision, on which this test system is based. The University of Pittsburgh holds equity in the company; Dr. Sindhi has an unpaid consulting relationship with the company.

For more information on Dr. Sindhi and the Hillman Center for Pediatric Transplantation, visit www.chp.edu/transplant.

Higher Risk of GI, Major Bleeding in Atrial Fibrillation Patients Taking Blood Thinner Dabigatran

PITTSBURGH, Nov. 3, 2014 – Patients with atrial fibrillation who take the blood thinner dabigatran are at greater risk for major bleeding and gastrointestinal bleeding than those who take warfarin, according to a new study by researchers at the University of Pittsburgh Graduate School of Public Health.

The findings, based on Medicare claims data and published today in JAMA Internal Medicine, indicate greater caution is needed when prescribing dabigatran to certain high-risk patients.

Atrial fibrillation, an arrhythmia in which the heart’s upper chambers irregularly contract, can send tiny clots from the heart to the blood vessels in the brain, explained the study’s senior author Yuting Zhang, Ph.D., associate professor and director of the Pharmaceutical Economics Research Group in Pitt Public Health’s Department of Health Policy and Management. For that reason, these patients often are prescribed a blood thinner to limit clot formation with the aim of preventing strokes.

“Dabigatran was introduced in 2010 and, at the time of approval, it was the only available alternative to warfarin,” Dr. Zhang said. “Warfarin dosing can be tricky and regular monitoring with blood tests is required, so doctors and patients were glad to have a drug that was easier to manage. But some recent studies suggest that dabigatran is associated with a higher risk of bleeding.”

To investigate that possibility, the study’s first author, Inmaculada Hernandez, Pharm.D., Pitt Public Health, and the team looked back at pharmacy and medical claims data, which employ a unique identifier code rather than patient names, from 2010 and 2011 of a random national sample of Medicare beneficiaries. They tracked 1,302 dabigatran users and 8,102 warfarin users to see whether they experienced bleeding episodes, classifying the events as major, such as intracranial bleeding or gastrointestinal bleeding requiring a hospital or emergency room stay, or minor, such as gastrointestinal bleeding that was treated on an outpatient basis, or nose bleeds.

They also looked more closely at bleeding episodes in four high-risk subgroups: those who were 75 and older; African-Americans; those with chronic kidney disease; and those with seven or more co-existing medical problems.

Medicare data showed that the incidence of major bleeding was 9 percent and of any bleeding was 32.7 percent in the dabigatran group and 5.9 percent and 26.6 percent, respectively, in the warfarin group. In other words, dabigatran users were 58 percent more likely to have a major bleed and 30 percent more likely to have any kind of bleed than those taking warfarin. African-Americans and patients with chronic kidney disease using dabigatran were about twice as likely to have a major bleed as those taking warfarin. In addition, dabigatran users were more likely than warfarin users to experience gastrointestinal or vaginal bleeding, or blood in the urine, joints or sputum. However, the dabigatran group had a lower risk for bleeding in the brain.

“These findings indicate that physicians should be cautious when prescribing dabigatran, particularly to African-Americans and patients with kidney impairments,” Dr. Hernandez said. “Also, the incidence of gastrointestinal bleeding was high in all the subgroups, so we recommend doctors explain to patients how to detect it so that it can be treated promptly.”

“We plan to examine 2012 data to monitor the risk of stroke for patients on dabigatran, which is the primary indication for taking the blood thinner,” Dr. Zhang said. “It’s possible that for some patients a greater reduction in the risk of stroke will outweigh the higher risk of bleeding with dabigatran compared to warfarin.”

Other co-authors are Seo Hyon Baik, Ph.D., of Pitt Public Health; and Antonio Piñera, M.D., of La Paz University Hospital, Madrid, Spain.

The project was funded by the Commonwealth Foundation for Public Policy Alternatives and the Agency for Healthcare Research and Quality.

Page 1 of 44:1 2 3 4 »Last »