Palliative Care News

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  • Bakitas to present at annual O’Koren Lecture
    Internationally recognized scholar and researcher Marie A. Bakitas will present at UAB on palliative care Feb. 10.

    The UAB School of Nursing will host the annual Dr. Marie L. O’Koren Endowed Chair in Nursing Lecture on Wednesday, Feb. 10, featuring Professor and Marie L. O’Koren Endowed Chair Marie A. Bakitas, CRNP.

    Bakitas, who also is deputy director of the UAB Center for Palliative and Supportive Care, will present “Palliative Care: If it makes a difference ‘Why Wait?’”

    Bakitas is an internationally recognized scholar and researcher whose content expertise focuses on the principles and concepts of hematology and oncology, bone marrow and stem cell transplantation, pain and symptom management, and novel qualitative and mixed methods research, in addition to palliative care.

    If you would like to attend, please RSVP to Lauren Antia, lar@uab.edu or 205-934-2145, by Friday, Feb. 5. The lecture is sponsored by the UAB School of Nursing Office of Research and Scholarship and will take place from 10-11:30 a.m. in the School of Nursing Building, Room 1020.

  • Landmark blood pressure study, published today by NEJM, confirms benefits of lower blood pressure
    Treating patients 50 and older with high blood pressure to a systolic blood pressure of less than 120 mm Hg reduced rates of cardiovascular events, including heart attack, heart failure and stroke, by 25 percent.

    Suzanne Oparil, left, and Cora LewisFinal results from the landmark SPRINT study, published online today in the New England Journal of Medicine, confirm that treating adults 50 years and older with high blood pressure — but without diabetes or prior stroke — to a systolic blood pressure of 120 reduces the risk of cardiovascular disease and can save lives.

    These results from the Systolic Blood Pressure Intervention Trial, or SPRINT, were presented today at the American Heart Association 2015 Scientific Sessions in Orlando. The results are in part products of the work by UAB investigators, including University of Alabama at BirminghamSchool of Medicine professors Suzanne Oparil, M.D., Cora E. Lewis, M.D., David Calhoun, M.D., Stephen Glasser, M.D., and Virginia Wadley Bradley, Ph.D. Their work was highlighted when preliminary findings were announced in September.

    The study demonstrates that treating patients 50 and older with high blood pressure to a systolic blood pressure of less than 120 mm Hg reduced rates of cardiovascular events, including death due to cardiovascular disease, heart failure, stroke and heart attack, by 25 percent. Additionally, reducing systolic blood pressure to this target reduced the risk of death due to all causes by 27 percent compared to a target systolic blood pressure of 140 mm Hg.

    “By design, SPRINT enrolled a diverse population of adults at sufficiently high risk for cardiovascular events and death to ensure adequate statistical power,” said Oparil, principal investigator for the UAB hub of the SPRINT trial, Distinguished Professor of Medicine, and director of the Vascular Biology and Hypertension Program in UAB’s School of Medicine. “Achieving the lower systolic blood pressure goal required use of additional medications — on average, an additional one or more — and extra clinic visits, so the findings represent more work for clinicians and patients. However, we strongly believe that it is worth it in terms of saving lives and reducing cardiovascular death events.”

    “The results of SPRINT are likely to have a major impact on the treatment of hypertension,” added Lewis, co-principal investigator of the UAB hub and professor of preventive medicine. “However, there are many important lessons to be learned from SPRINT to apply the results in a safe and effective manner.”

    In their report, investigators provided detailed data showing that both cardiovascular deaths and overall deaths were lower in the intensive treatment group. Certain types of serious consequences were more common in the intensive group, including low blood pressure, fainting, electrolyte abnormalities and acute kidney damage.

    However, other serious adverse events associated with lower blood pressure, including slow heart rate and falls with injuries, were not increased in the intensive group. In patients with chronic kidney disease, there was no difference in the rate of serious decline in kidney function between the two blood pressure goal groups.

    “The benefits of more intensive blood pressure lowering exceeded the potential for harm, regardless of age, gender, or race or ethnicity,” Oparil said.

    The study continues to examine kidney disease, cognitive function and dementia among SPRINT participants; however, these results are not yet available as additional information will be collected and analyzed over the next year.

    “Although the study provides strong evidence that a lower blood pressure target saves lives, patients and their health care providers may want to wait to see how guideline groups incorporate this study with other scientific reports into any future hypertension guidelines,” said study co-author Lawrence Fine, M.D., chief of the Clinical Applications and Prevention Branch at the National Heart, Lung and Blood Institute. “In the meantime, patients should talk to their health care providers to determine whether this lower goal is best for their individual care.”

    Lewis says it is still important for those with high blood pressure to engage in a healthy diet, be physically active, maintain a healthy weight and learn to check their own blood pressure. All of these, Lewis says, will help to achieve blood pressure control.

    “It’s important to remember that healthy lifestyle changes can make a difference in controlling high blood pressure, no matter the goal,” Lewis said.

    UAB’s School of Medicine played major clinical and leadership roles in the SPRINT study. The study, which began in fall 2009, included more than 9,300 participants age 50 and older, recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. UAB was selected by the NIH as one of five hubs to recruit and direct almost 20 of these clinics from Massachusetts to Puerto Rico; UAB-directed clinics recruited more than 1,950 study participants, surpassing the study’s initial goal for UAB’s network.

    About 36 percent of participants were women, 58 percent were white, 38 percent were African-American, and 11 percent were Hispanic. The SPRINT study did not include patients with diabetes, prior stroke or polycystic kidney disease, as other National Institutes of Health trials were studying those particular populations.

    Approximately 28 percent of SPRINT participants were 75 or older, and 28 percent had chronic kidney disease. The study tested a strategy of using blood pressure medications to achieve the targeted goals of less than 120 mm Hg (intensive treatment group) versus the 140 mm Hg (standard treatment group).

    “Although many classes of medications were available, emphasis was placed on using classes with the best outcomes in large clinical trials, including thiazide-type diuretics, calcium channel blockers, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers,” Oparil said. “Other agents could be added if necessary.”

    The study’s blood pressure intervention, which was to finish in summer 2016, finished earlier after National Heart, Lung and Blood Institute Director Gary H. Gibbons, M.D., took action when the Data and Safety Monitoring Board interpreted the benefits of the lower goal as far outweighing the harms. The findings were announced in September, with the detailed results presented today.

    “SPRINT is part of a proud legacy of NIH-funded clinical trials that will change clinical practice and save lives for decades to come,” Gibbons said. “These results reinforce the compelling public health importance of enhancing the awareness, treatment and control of hypertension in this country and around the world.”

    In addition to primary sponsorship by the NHLBI, SPRINT is co-sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.

    UAB role

    Experts in blood pressure management, primary care physicians, nephrologists or other health care providers have seen SPRINT participants regularly for a period of four to six years. UAB’s Vascular Biology and Hypertension Research Program Clinic, part of the UAB School of MedicineDivision of Cardiovascular Disease and directed by professor of medicine David Calhoun, M.D., was one of several clinics that enrolled patients in Alabama. Athens Internal Medicine had the largest patient population in the study, with the more than 300 enrollees. The UAB Division of Nephrology and Nephrology Associates in Birmingham also participated and enrolled an important subgroup of patients with chronic kidney disease.

    In addition to clinical roles, UAB faculty also have leadership roles in the SPRINT trial. Oparil and Lewis are on the trialwide steering committee and co-lead the morbidity and mortality committee, in which capacity Oparil, Lewis and their committee members review medical records in order to determine whether trial participants have had a heart attack, heart failure, stroke or other cardiovascular event. Lewis also leads the measurement procedures and quality control committee and serves on the executive committee for the study.

    Virginia Wadley Bradley, M.D., professor of medicine in the Division of Gerontology, Geriatrics and Palliative Care, is co-lead of the trial’s MIND committee, which oversees the cognitive and dementia aspects of the trial. Tom Ramsey, a program manager in the Division of Preventive Medicine, is the lead author of the trial’s recruitment paper, which is currently under review. Steve Glasser, M.D., professor of medicine in Preventive Medicine is a cardiologist who also is on the trial’s morbidity and mortality committee.

    “UAB was selected and is able to be a part of this remarkable study because we put together a great team of investigators and staff to run the hub,” said Lewis, the co-principal investigator of the UAB hub. “We recruited a good diversity of clinics that could bring in diverse patients and achieve the study recruitment goals, we wrote an outstanding application, and we have a lot of relevant experience for all aspects of the trial. We are able to provide all of the logistical support, and we have the infrastructure to handle a trial of this scope and magnitude. It was an incredibly competitive selection process.”

  • Landmark study shows intensive blood pressure management may save lives
    Lower blood pressure target of 120 mm Hg greatly reduces cardiovascular complications and deaths in older adults.

    According to initial results of a landmark clinical trial released today at the National Institutes of Health, heart attacks, strokes, acute coronary syndrome, heart failure and death due to cardiovascular causes were reduced by almost one-third and risk of death was lowered by almost one-quarter in participants randomized to a systolic blood pressure goal of 120 mm Hg compared to those randomized to the usual goal of 140 mm Hg.

    The NIH-sponsored the Systolic Blood Pressure Intervention Trial (SPRINT) enrolled more than 9,300 participants age 50 and older with high blood pressure. Participants were assigned at random to a systolic blood pressure target of 120 mm Hg or the usual target of 140 mm Hg, then had the amount and type of blood pressure medication adjusted to achieve the different blood pressure targets.

    The groundbreaking results of this important trial, in which the University of Alabama at Birmingham and the UAB School of Medicine played major clinical and leadership roles, is expected to impact the way physicians across the United States and Puerto Rico treat patients with high blood pressure.

    “SPRINT is a large, well designed and well conducted study, and is certain to influence the way clinicians manage the treatment of patients with high blood pressure and impact the decision making of future national guidelines committees,” said Suzanne Oparil, M.D., principal investigator for the UAB hub of the SPRINT trial, UAB professor of Medicine and director of the Vascular Biology and Hypertension Program in UAB’s School of Medicine. “While these results provide important evidence that treating blood pressure to a lower goal in older or high-risk patients can be beneficial and yield better health results overall, patients should talk to their doctor to determine whether this lower goal is best for their individualized care.”

    The SPRINT study, which began in the fall of 2009, recruited approximately 100 medical centers and clinical practices throughout the United States and Puerto Rico. UAB was selected by the NIH as one of five hubs to recruit and direct almost 20 of these clinics from Massachusetts to Puerto Rico; UAB-directed clinics recruited more than 1,950 study participants, surpassing the study’s initial goal for UAB’s network. The study’s blood pressure intervention, which was to finish in summer 2016, has finished earlier after the National Heart, Lung and Blood Institute Director Gary H. Gibbons, M.D., took action when the Data and Safety Monitoring Board interpreted the benefits of the lower goal as far outweighing the harms.

    “This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50,” Gibbons said. “We are delighted to have achieved this important milestone in the study in advance of the expected closure date for the SPRINT trial and look forward to quickly communicating the results to help inform patient care and the future development of evidence-based clinical guidelines.”

    The SPRINT study is the largest of its kind to examine how maintaining systolic blood pressure at a lower than currently recommended level will impact cardiovascular and kidney diseases. More data in other areas will continue to be collected into 2016.

    “Participants are still continuing in the trial to provide data on more end points and may continue on study drugs,” Oparil said. “SPRINT is a very large and important trial, however, the findings are still preliminary, and we will have to wait for the published paper for details.”

    The NIH funded the SPRINT study in 2009 to answer one question: Will treating high blood pressure to a lower blood pressure goal — 120 mm Hg systolic compared to the traditional goal 140 mm Hg — reduce the risk of heart and kidney diseases, stroke, or age-related declines in memory and thinking?

    High blood pressure is a leading cause of death and disability in the United States and worldwide. More than 60 percent of people over age 65 have high blood pressure, and the number of people with high blood pressure is increasing.

    UAB role

    Experts in blood pressure management, primary care physicians, nephrologists or other health care providers have seen SPRINT participants regularlyfor a period of 4 to 6 years. UAB’s Vascular Biology and Hypertension Research Program Clinic, part of the UAB School of Medicine Division of Cardiovascular Disease and directed by professor of medicine David Calhoun, M.D., was one of several clinics that enrolled patients in Alabama. Athens Internal Medicine had the largest patient population in the study, with the more than 300 enrollees. The UAB Division of Nephrology and Nephrology Associates in Birmingham also participated and enrolled an important subgroup of patients with chronic kidney disease.

    In additional to clinical roles, UAB faculty also have leadership roles in the SPRINT trial. Oparil and Cora E. Lewis, M.D., are on the trial-wide steering committee and co-lead the morbidity and mortality committee, in which capacity Oparil, Lewis and their committee members review medical records in order to determine whether trial participants have had a heart attack, heart failure, stroke or other cardiovascular event. Lewis also leads the measurement procedures and quality control committee and serves on the executive committee for the study.

    Virginia Wadley Bradley, M.D., professor of medicine in the Division of Gerontology, Geriatrics and Palliative Care, is co-lead of the trial’s MIND committee, which oversees the cognitive and dementia aspects of the trial. Tom Ramsey, a program manager in Preventive Medicine, is the lead author of the trial’s recruitment paper, which is currently under review. Steve Glasser, M.D., professor of medicine in Preventive Medicine is a cardiologist who also is on the trial’s morbidity and mortality committee.

    “UAB was selected and is able to be a part of this remarkable study because we put together a great team of investigators and staff to run the hub,” said Lewis, the co-principal investigator of the UAB hub. “We recruited a good diversity of clinics that could bring in diverse patients and achieve the study recruitment goals, we wrote an outstanding application, and we have a lot of relevant experience for all aspects of the trial. We are able to provide all of the logistical support and we have the infrastructure to handle a trial of this scope and magnitude. It was an incredibly competitive selection process.”

    While investigators work to publish their cardiovascular results in the coming weeks, there are additional important questions from the trial that will be answered in 2016 after all of the data are collected, including:

    • How are the 120 and 140 mm Hg benchmarks going to stack up relative to cognitive function and risks of dementia, especially in patients 75 or older?
    • How will the benchmarks affect brain structure in addition to cognitive assessments?
    • What do the two levels of blood pressure mean for hypertension as a cause of kidney disease, especially in African Americans?

    “A lot of studies will exclude people who have chronic kidney disease, but we intentionally included them in the SPRINT trial,” Lewis said. “We want to know what these two levels will mean for kidney disease. It could be that a more aggressive way of treating hypertension would preserve kidney function, or it could be that after a certain age, the kidneys may need a little more blood pressure to adequately perfuse them — that is to get them an adequate blood supply. We really don’t know. It’s going to be incredible to get some answers to these and other questions.”

    Diverse population

    The study population was diverse and included women, racial/ethnic minorities, patients with established chronic kidney disease or cardiovascular disease, and the elderly. The investigators point out that the SPRINT study did not include patients with diabetes, prior stroke, or polycystic kidney disease, as other studies included those populations.

    When SPRINT was designed, the well-established clinical guidelines recommended a systolic blood pressure of less than 140 mm Hg for healthy adults and less than 130 mm Hg for those with kidney disease or diabetes. Investigators designed SPRINT to determine the potential benefits of achieving systolic blood pressure of less than 120 mm Hg for hypertensive adults 50 years and older who are at risk for developing heart disease or kidney disease, or who already had heart or kidney disease and were at risk of disease progression.

    Between 2010 and 2013, the SPRINT investigators randomly divided the study participants into two groups that differed according to targeted levels of blood pressure control. The standard group received blood pressure medications to achieve a target of less than 140 mm Hg. They received an average of two different blood pressure medications. The intensive treatment group received medications to achieve a target of less than 120 mm Hg and received an average of three medications.

    “Our results provide important evidence that treating blood pressure to a lower goal in older or high-risk patients can be beneficial and yield better health results overall,” said Lawrence Fine, M.D., chief, Clinical Applications and Prevention Branch at NHLBI. “But patients should talk to their doctor to determine whether this lower goal is best for their individual care.”

    The study is also examining kidney disease, cognitive function, and dementia among the patients; however, those results are still under analysis and are not yet available, as additional information will be collected over the next year. The primary results of the trial will be published within the next few months.

    In addition to primary sponsorship by the NHLBI, SPRINT is co-sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. 

  • Drug developed from UAB research sharply lowers cholesterol in animal tests
    An Arizona drug company will patent the small peptide drug.

    Crystal structure of the receptor-binding domain of Apolipoprotein E, residues 1-165. Credit: European Bioinformatics Institute.An Arizona drug company will patent a small peptide — developed through research at the University of Alabama at Birmingham — that shows significant ability to lower blood cholesterol in animal models. Capstone Therapeutics Corp. and its joint venture affiliate, LipimetiX Development Inc., recently announced the U.S. Patent application, claiming novel, more potent analogs of its lead peptide, AEM-28.

    LipimetiX, based in Tempe, Arizona, has supported UAB research by G.M. Anantharamaiah, Ph.D., a professor in the UAB School of Medicine’sDivision of Gerontology, Geriatric and Palliative Care, to identify novel analogs of AEM-28 that have greater efficacy than the parent peptide. The new Apo E mimetic peptide, AEM-28-14, showed a 400 percent greater cholesterol-lowering efficacy and a several-fold increase in drug tolerability. Increased efficacy and tolerance have the potential to increase the safe and effective dose range compared with other AEM-28 analogs. Anantharamaiah’s research at UAB focuses on the use of apolipoprotein mimetic peptides to treat atherosclerosis and cardiovascular disease.

    The UAB Institute for Innovation and Entrepreneurship is focused on advancing a strong innovative and entrepreneurial ecosystem at UAB, and has worked to foster the collaboration between Anantharamaiah’s lab and LipimetiX/Capstone to advance treatments developed at UAB to the clinic.

    Capstone and LipimetiX last year announced that the parent drug, AEM-28, showed a generally acceptable safety profile and some significant alterations in blood lipid biomarkers in a human Phase 1a/1b/2a clinical trial.

    “We believe that the profound cholesterol-lowering effect of a single injection of AEM-28-14, accompanied by the enhanced toleration, will allow us to expand upon the statistically significant VLDL cholesterol and triglyceride reductions seen in our recently completed AEM-28 human clinical studies,” said Dennis Goldberg, Ph.D., president of LipimetiX. “Subject to funding, LipimetiX plans to begin development of AEM-28-14 for cholesterol and triglyceride reduction in patients refractory to available therapeutic modalities.”

    AEM stands for chimeric Apolipoprotein E Mimetic peptides. UAB researchers created these small peptides to mimic the function of apolipoprotein E (Apo E), a class of protein essential for metabolism of cholesterol and triglycerides. After a meal, Apo E targets cholesterol- and triglyceride-rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the major cause of cardiovascular, peripheral artery and cerebral artery disease. These diseases can lead to heart attacks, loss of limbs and strokes. Faulty lipid metabolism also contributes to adult onset diabetes, and diabetics are very vulnerable to atherosclerosis and to heart and peripheral artery diseases. 

    UAB scientists patented the first chimeric Apo E mimetic peptide in 1999, reducing the 299-amino acid native Apo E to a 28-amino acid peptide that has two parts. One part of the peptide attaches to the surface of lipoproteins; the other domain binds to Apo E receptors in the liver. 

    In 2010, the founding scientist of LipimetiX obtained worldwide right to patents for Apo E mimetic peptides from the UAB Research Foundation, now a part of the UAB Institute for Innovation and Entrepreneurship. LipimetiX has an exclusive license with the UAB Research Foundation for AEM-28 and its analogs.

    The UAB Institute for Innovation and Entrepreneurship was formed in 2013 to expand the mission and scope of UAB Research Foundation and serve as the nexus for UAB innovation, entrepreneurial educational models, applied research, management of intellectual property and an entry point for industries seeking to partner with UAB investigators. The UAB Institute for Innovation and Entrepreneurship is focused on advancing a strong innovative and entrepreneurial ecosystem at UAB, and has worked to foster the collaboration between Anantharamaiah’s lab and LipimetiX/Capstone to advance treatments developed at UAB to the clinic.

  • Stroke accelerates cognitive decline over time, study finds
    Virginia Wadley, Ph.D., says until this new JAMA study, whether or not stroke survivors are at-risk over the long term was an unknown.

    Stroke has fallen to the fifth-leading cause of death in the United States due to decreases in people dying from it, and this increase in survivors has led to questions about their health in the years following stroke.

    In the United States, about 795,000 residents experience a stroke yearly, according to the American Heart Association. Over the last two decades, while accounting for age, disability rates due to stroke increased by 40 percent, according to the State of U.S. Health report.

    A new Journal of the American Medical Association study looked at 23,572 Reasons for Geographic and Racial Differences in Stroke (REGARDS) study participants age 45 years or older without cognitive impairment, which includes failing memory and processing thoughts more slowly. The research team, which included investigators from the University of Alabama at Birmingham, report those who experienced a stroke had an acute decline in cognitive function and also accelerated and persistent cognitive decline over six years.

    “Many stroke survivors are monitored for physical and cognitive effects only during the acute rehabilitation period during which the bulk of progress is expected to occur,” said senior study author Virginia Wadley, Ph.D., associate professor in the UAB Division of Gerontology, Geriatrics and Palliative Care. “Whether survivors are at risk for greater or more rapid cognitive decline over subsequent years has been difficult to answer, because there seldom have been pre-stroke cognitive data available for comparison.”

    Over the median follow-up of 6.1 years, 515 participants survived incident stroke and 23,057 remained stroke-free.

    “We looked at all REGARDS participants’ rates of cognitive change, including those who have and have not gone on to have a stroke, to detect the impact of stroke on cognition,” Wadley said. “Because we could utilize this data set, we were able to find that stroke survivors are vulnerable to a faster rate of decline in various thinking skills in the years following stroke compared to age/disease-related changes in the years prior to stroke and to changes that occur in peers who have not experienced stroke.”

    Wadley says this finding has important implications for clinical practice, research and potentially health policy.

    “Our findings highlight a need for long-term monitoring and follow-up care for stroke survivors, with a focus on the mounting potential for cognitive impairment in subsequent years. Therapies to support cognitive abilities should be a high priority. And long-term cognitive abilities could be an important domain to evaluate in relation to initial stroke treatments.”

    “Our findings highlight a need for long-term monitoring and follow-up care for stroke survivors, with a focus on the mounting potential for cognitive impairment in subsequent years,” Wadley said. “Therapies to support cognitive abilities should be a high priority. And long-term cognitive abilities could be an important domain to evaluate in relation to initial stroke treatments.”

    This study was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health and REGARDS principal investigators Drs. George and Virginia Howard, both professors in the UAB School of Public Health.

    “The Howards’ generous collaborative spirit and enthusiasm for discovery outside the clinic-based paradigms are the reasons for the scope of knowledge being created in this ongoing research,” Wadley said. “We also are indebted to our gracious study participants who are helping us better understand risks for stroke and cognitive decline; knowledge that ultimately will contribute to reducing these adverse outcomes.”

  • Early palliative care benefits patients, caregivers
    Studies reporting on 207 advanced cancer patients and 122 of their caregivers who participated in a trial called ENABLE III revealed benefits to patients who received care soon after diagnosis versus 12 weeks later.
  • Early palliative care interventions improves advanced cancer survival
    J. Nicholas Dionne-Odom, Ph.D., also from the University of Alabama, and colleagues examined the effect of early versus delayed initiation of a PC intervention for 122 caregivers of 207 patients with advanced cancer.
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