Palliative Care News
Palliative care helps patients get the most out of life, whether they’re newly diagnosed, a survivor, or nearing the end of their journey. UAB’s palliative care pioneers provide a fresh look at the fast-growing specialty and its emphasis on listening, choices, patient goals, and quality of life.
What do you want out of life?
For someone facing a serious, chronic illness, the answers to that question take on a sharp focus. A patient with heart disease might want enough energy to walk around the neighborhood. A cancer survivor may want to feel like herself again after rounds of chemotherapy. Others might have a goal of seeing their children get married—or perhaps to get married themselves.
Helping patients get the most out of life is the aim of palliative care—which could surprise some people who associate the specialty with hospice, or care delivered in the final days and hours. Palliative care services do indeed benefit people nearing the end of their journey, but the field has become much broader over time. Many patients with a life-threatening disease now start receiving palliative care early—sometimes soon after diagnosis—to support them throughout their fight. In fact, palliative care now ranks among the fastest growing medical specialties—67 percent of U.S. hospitals with 50 or more beds offer it, according to a 2015 report from the Center to Advance Palliative Care (CAPC)—in part because patients, families, and physicians like its emphasis on personalized treatment goals and quality of life.
Care + comfort
Perhaps the best way to understand the value of palliative care is to recall a time—not long ago—when such care was scarce. Marie Bakitas, D.N.Sc., remembers it well. Earlier in her career, before becoming the Marie L. O’Koren Endowed Chair and professor in the UAB School of Nursing and associate director of the UAB Center for Palliative and Supportive Care (CPSC), Bakitas wondered about the “invisible” patients—the ones who weren’t responding to pioneering cancer treatments. They didn’t have a lot of resources or support, she noted.
Likewise, J. Nicholas Dionne-Odom, Ph.D., a School of Nursing postdoctoral fellow who worked as an intensive-care unit nurse for 10 years, saw patients and families navigating a traumatic “alien environment” of life-sustaining machines and uncomfortable procedures. “They often were dumbstruck,” he explains. “It was not how they imagined the end of their lives.”
The “extra layer of support” that palliative care provides can make all the difference, both physically and emotionally, Bakitas says. Teams of specialists focus on the patient’s comfort, managing symptoms such as pain, breathing issues, nausea, vomiting, and sleeping problems, to name a few examples, along with depression, anxiety, and spiritual issues. They also help patients and families make health-care decisions and plan for the future.
What these teams don’t do is replace a patient’s primary- or specialty-care physicians. Many patients concurrently receive treatments geared toward cure or remission, and the palliative care team works in tandem with their doctors. That’s the case with many cancer patients, says Rodney Tucker, M.D., director of the UAB CPSC. The same goes for “a heart-failure patient struggling earlier in the disease process, or a patient and family early in the diagnosis of Alzheimer’s disease who need a discussion about advance care planning and what to anticipate,” he adds. “Any patient with an illness that is life-threatening or life-limiting — one that causes severe decreases in quality of life — could benefit from palliative care.” Age, disease, and stage of disease progression do not matter.
“We’ve shown that people who engage in palliative care early and concurrently have improved survival rates,” Tucker says. “That’s the opposite of what many people think — that if I’m acknowledging my serious illness, then I’m giving up hope. When people are aware of all their choices, then they often select options that improve the quality of their lives when the quantity of their lives is limited.”
Symptoms, choices and goals
Here’s an example of one of those choices: Let’s say you’re a cancer patient with a normal life expectancy, but you’re dealing with the side effects from treatment. Is the best solution a medication with its own powerful side effects such as confusion or drowsiness? Or do you pursue other forms of symptom management with less impact on your day-to-day life?
Elizabeth Kvale, M.D., might advise you to choose the latter. She directs the UAB Supportive Care and Survivorship Clinic, located at The Kirklin Clinic of UAB Hospital. UAB was among the first palliative care programs to establish an outpatient clinic, around 2000, and it’s where Kvale and her team help patients who are living with cancer, advanced heart disease, lung disease, or other serious conditions. Some of those patients still receive medical treatment for their chronic diseases, while others have completed it. Kvale and her colleagues help all of them manage symptoms. She compares the clinic to “a good corner man in a boxing match, who can keep patients patched up enough to stay in the fight if they want to do that.”
A few blocks away, another team, led by Ashley Nichols, M.D., staffs UAB Hospital’s 12-bed Palliative and Comfort Care Unit. Each room resembles a hotel suite, with comfortable leather couches, warm lighting, and wood accents—and the comparison is appropriate, Nichols says, because it is a “transitional unit.” Here, critically ill patients and their families have an option beyond the ICU while they are in the hospital, and for many of them, the next stop is their own home. “That’s where so many patients want to be,” says Nichols, a School of Medicine assistant professor. “So we work to control their symptoms, and we work with families and community hospice partners to develop a care plan to get them back home.”
Beyond the unit, Nichols and her group visit patients with every kind of disease throughout UAB Hospital, provide care at the Veterans Affairs Medical Center and Children’s of Alabama, and coordinate continued care with community hospice partners; they even do a few home visits. Typically, the team works with physicians on late-stage care, “but we’re also consulted more upstream—earlier in the disease process—when teams recognize an uncontrolled symptom burden, such as shortness of breath from chronic obstructive pulmonary disease, pain from a newly diagnosed cancer, or depression and anxiety associated with any chronic illness,” Nichols says. “If a symptom bothers patients, then it bothers us. We can partner with them and their physicians early and help manage symptoms throughout the course of the disease, as well as talk about goals for the patient’s care.”
Those goals are the key to quality palliative care, no matter the setting. What do patients want to accomplish—today, tomorrow, and in the rest of their lives? What kind of care will help them achieve their aims? Helping patients weigh the benefits of medical interventions against the potential costs to their quality of life, not to mention their pocketbook, is “the crux of what we do,” says Kvale, an associate professor in the School of Medicine. “Our objective is to align our care plan with patient and family goals. We also want to provide a space where it is OK for them to begin exploring other options, such as not seeking further invasive treatments.”
Strength in numbers
A hospital is not the easiest place to perform a full-immersion baptism, but UAB Pastoral Care chaplains have made it happen, thanks to an arrangement with UAB’s therapy pool. They also have officiated marriages for patients, complete with music and wedding cake; nurses helped one bride with a dress and makeup.
Mostly, though, they simply talk with patients about their sources of strength and the big questions that arise in tough times, sometimes without bringing up religion at all.
The chaplains are part of the interdisciplinary teams that staff the Palliative and Comfort Care Unit and the Supportive Care and Survivorship Clinic. Both groups bring together a variety of specialists who can help patients relax physically and cope mentally: physicians, nurses, psychologists, social workers, dieticians, physical therapists, music therapists, and even massage and pet therapists, in addition to spiritual care. In meetings, each professional provides a different perspective on what each patient needs; the result is a comprehensive, holistic, seamless care plan, Nichols says.
Teams also support families and caregivers. “Most of our patients live in the community and try to manage their illnesses with the help of a caregiver, so if we aren’t helping them engage with what’s going on with the patient, then the system is likely to fail,” Kvale says. “It’s a place where palliative care can have a big impact.”
A way forward
Listening may be the teams’ most powerful tool. When patients and families share their stories, they reveal much about their symptoms and quality of life—but also their joys, fears, loves, regrets, relationships, and unfinished business.
“We listen with no agenda; we’re not trying to diagnose anything or resolve relationship issues,” says counselor Kay Knowlton, Ph.D. The overriding emotion is grief, she adds—grief over the end of life, or grief over life changes caused by illness. For example, a patient in the Supportive Care and Survivorship Clinic whose cancer is in remission might not look sick, but chemotherapy and radiation may have affected her sight, hearing, cognitive function, and ability to return to work.
“She’s coping with losses as well,” says Diane Tucker, Ph.D., a UAB psychology professor who also counsels palliative care patients. “She can’t go back to where she was before treatment.”
Diane Tucker and Knowlton help patients and families adjust to their new normal by talking with them about the future—how to move forward and accomplish what they consider important—without discounting the sadness, worry, or anger they might be experiencing. Tucker notes that suffering and pain are partly psychological. Helping patients handle their tension and fear can bring some relief.
Often, the psychologists help patients leave a legacy for their loved ones. Patients might write letters to their children or grandchildren, to be read when they are graduating from high school, getting married, or marking other milestones. Patients and families also can use the hospital unit’s art station to create a treasured memento.
Knowlton recalls helping one nine-year-old girl make handprints with her ill grandmother. The big and small handprints touched at the thumbs. “It didn’t mean that the girl wasn’t going to cry anymore, but it was a connection she needed because her grandma was leaving,” Knowlton says.
Likewise, the marriage ceremonies that the chaplains have performed create legacies for family members. Sometimes it means that the survivors can receive benefits. But these special moments also become pieces of family history that they can cherish for the rest of their lives.
Although palliative care has made great strides in recent years, millions more patients stand to benefit from it—if they can access it. The specialty is scarce or nonexistent in smaller hospitals, rural areas, and minority and underserved communities, says Bakitas. Alabama traditionally has ranked among the states with the lowest access, with less than one third of hospitals offering palliative care, according to the 2015 CAPC report. And there are a host of reasons why: lack of palliative care knowledge among health providers, socioeconomic factors, geographic distance, and transportation issues, among others.
Bakitas, along with Dionne-Odom, is bridging those gaps via telehealth—teaching palliative care principles to patients over the phone. Health coaches “show patients how to build upon the strengths of their personal, family, and community resources,” Bakitas says. They also talk about problem-solving and decision-making, self-care, early symptom management, communicating health concerns to clinicians, and emotional and spiritual topics. “We help people think about their illness in context,” she explains. “The illness is not who they are; it’s only a piece of their lives.”
Dionne-Odom develops telehealth programs for family caregivers as well as patients newly diagnosed with advanced illness. Caregivers often experience levels of stress and anxiety equal to—and sometimes greater than—those of patients, he notes. Talking with a health coach offers an outlet to express what they’re experiencing and to learn skills and coping abilities.
In fact, a recent study led by Dionne-Odom was the first to show that early palliative care benefits caregivers as well as patients. For caregivers of patients with advanced cancer living in rural areas, depression scores improved when those caregivers received palliative care via telehealth within a month after diagnosis, as opposed to those whose patients received care four months later. For patients in the study, one-year survival improved by 15 percent.
Now, with support from the National Palliative Care Research Center, Dionne-Odom is laying the groundwork for a new intervention to coach family caregivers at diagnosis, through the course of disease, and into bereavement. He hopes to implement the initiative in rural areas of Alabama and the Deep South.
Bakitas also is expanding her investigations with a $3.5-million National Institute of Nursing Research grant to study whether early palliative care, delivered by phone, can improve quality of life, mood, and symptom burden for advanced heart-failure patients and their caregivers. The American Cancer Society also awarded her a grant to study the impact of a phone-based intervention for veterans, minorities, and rural patients with advanced cancer.
What patients want
UAB researchers also are expanding palliative care’s boundaries by adapting it for other serious diseases. Few specialists had studied the intricacies of chronic pain in patients with HIV before Jessica Merlin, M.D., M.B.A., began her work. “It’s not clear why there’s a lot of chronic pain with HIV,” says Merlin, assistant professor and director of the HIV Pain/Palliative Care Clinic at UAB’s 1917 Clinic. “Does something with HIV predispose patients to pain?” To complicate matters, some patients might experience chronic pain not caused by HIV, such as migraines or arthritis, and current medications aren’t entirely effective and may carry risks, she adds.
Now Merlin is developing an intervention—supported by a National Institutes of Health grant—that relies on behavioral therapy instead. “It’s unlikely that a pill can take away chronic pain, so we need to help patients put their pain in the background and themselves in the foreground,” Merlin explains. She envisions a program in which patients learn pain self-management skills from a trained provider.
“This is practical,” Merlin says. Medical research suggests that “when patients come to physicians and other providers, their highest priorities are treating pain and other symptoms.”
Lessons at the bedside
To ensure that health professionals understand quality-of-life issues, the UAB CPSC has a robust educational program. UAB students and residents in medicine, nursing, clinical psychology, and social work rotate through or intern in the clinic and hospital unit. For many, “this may be the first encounter with a patient who’s dying,” Nichols says. And that leads to important early lessons about discussing difficult end-of-life decisions with patients, handling anger and sadness from families, and responding personally to the loss of a patient. It also influences how future professionals look at life and death, Nichols adds. “Death is not a failure, but an opportunity to support patients and families.”
Physicians, nurses, and others seeking advanced training can join UAB’s specialized fellowship program or its clinical training academy, which has attracted professionals from as far away as Australia to observe UAB palliative experts at work. In addition, “we have trained 85 health-care institutions across the country and one in Korea about building business plans around palliative care,” Rodney Tucker says.
"We've shown that people who engage in palliative care early and concurrently have improved survival rates"
Palliative care will continue to grow and become more common throughout health care, say UAB’s experts. The field’s focus on patients and their goals offers a template for personalized medicine. And demand for it will rise as health care shifts toward “managing disease crises at home quickly and efficiently so that patients don’t need to come to the hospital,” Nichols says.
“We must learn better ways to partner with care organizations closer to the patient—including those that may not be considered palliative care, such as home-care organizations and skilled nursing facilities,” Rodney Tucker says. This year, the CPSC will establish the Southeast Institute for Innovation in Palliative and Supportive Care, which will educate health workers in communities throughout the region and conduct research to better understand the needs of seriously ill patients and families. Some of those initiatives may build on UAB’s pioneering work in telehealth and the training of lay navigators—people in community settings who can help patients make sense of the health-care system and their options.
While the new institute will give UAB a greater voice in the national conversation about palliative care, the specialists on UAB’s care teams feel privileged to help Alabama’s mothers and fathers, sons and daughters, and their families and friends maximize their lives when facing tough situations and choices.
“The truth is that none of us know how much time we have left,” Knowlton notes. “So what is today about? How can we live today in the best way possible?”
Pioneering a new kind of care
Some of the seeds for palliative care’s rapid growth were planted in the 1990s by a team led by UAB psychiatrist John Shuster, nurse scientist Pam Fordham, and medical oncologist Amos Bailey. Their partnership brought together the UAB schools of Medicine and Nursing and Cooper Green Hospital to promote clinical care, education, and research in the emerging field. The group soon established some of the nation’s earliest fellowship programs for physicians and training tracks for nurse practitioners.
Ten years ago, the UAB Center for Palliative and Supportive Care opened two clinical units, at UAB Hospital and the Birmingham Veterans Affairs Medical Center, within six months. At that time, when many major cities across the country barely had one inpatient palliative care facility, Birmingham had three, counting Cooper Green’s unit.
Nationally, UAB is one of only 11 Palliative Care Leadership Centers, which train and mentor other institutions launching their own clinical programs, and was among the first nursing education programs in palliative care. UAB also is a founding member of the national Palliative Care Research Cooperative Group.
UAB professor awarded $15,000 for work in palliative care.
Keith M. Swetz, M.D., is nationally known for his clinical skill, especially in caring for patients with advanced heart failure. The University of Alabama at Birmingham School of Medicine Division of Gerontology, Geriatrics and Palliative Care associate professor has been awarded one of the 2016 Hastings Center Cunniff-Dixon Physician Awards in the early-career category.
“Now in the seventh year of our collaboration with the Cunniff-Dixon Foundation, The Hastings Center is prouder than ever to be working together to honor these physicians,” said Mildred Z. Solomon, Ed.D., president of The Hastings Center. “They possess an uncommon combination of bedside and organizational skills that is transforming the experience of dying in America.”
Swetz, section chief in Palliative Care at the Birmingham VA Medical Center, earned a reputation locally as the “go-to guy” for hospice and palliative care, according to Marie Bakitas, DNSc, NP-C, FAAN, professor in the UAB School of Nursing and associate director of the UAB Center for Palliative and Supportive Care. He is one of five physicians being honored by The Hastings Center Cunniff-Dixon Physician Awards, including Marian Hodges, M.D., from Providence Health & Services in Portland, Ore.; Paul Tatum III, M.D., from University of Missouri-Columbia; Ross Alber, M.D., Ph.D., from Hartford HealthCare in Hartford, Conn.; and Rashmi Sharma, M.D., from University of Washington in Seattle.
The awards were made in three categories: a senior award and a mid-career award of $25,000 each and three early-career awards of $15,000 apiece. Each recipient has been exemplary in one or more of four areas: medical practice, teaching, research and community.
The Cunniff-Dixon Foundation, whose mission is to enrich the doctor-patient relationship near the end of life, funds the awards. The Hastings Center, a bioethics research institute that has done groundbreaking work on end-of-life decision-making, co-sponsors the awards. Duke University Divinity School’s Program in Medicine, Theology and Culture oversees the selection process.
UAB assistant professor leads the way in providing therapy for HIV patients with chronic pain.
Recent studies suggest many individuals with HIV have chronic pain. Estimates range from 39 percent all the way to 85 percent. Chronic pain is an important comorbid condition in individuals with HIV, as it is common and causes substantial disability.
In the current HIV treatment era, HIV is a chronic disease with a near-normal life expectancy. However, individuals with HIV can have higher rates of other health problems than the general population.
A new reference guide for HIV care providers, “Chronic Pain and HIV: a practical approach,” offers insight into the assessment, diagnosis, testing and management of various chronic pain problems in patients with HIV.
Lead editor Jessica Merlin, M.D., an assistant professor in the University of Alabama at BirminghamSchool of Medicine Division of Infectious Diseases and Division of Geriatrics, Gerontology and Palliative Care, says the guide addresses issues that HIV care providers have when trying to provide relief to HIV patients with chronic pain, including pharmacological and non-pharmacological therapies.
“Chronic pain is increasingly recognized as an important comorbidity in HIV-infected patients, and may influence adherence to antivirals and retention in care,” Merlin said. “Individuals with HIV also have higher rates of mental illness and addiction than the general population. HIV, mental illness and addiction are all highly stigmatized health problems, further compounding patients’ suffering.”
HIV and the medications once used to treat the disease can lead to nerve pain in the hands and feet in as many as 40 percent of patients. Also, for reasons that are not well-understood, patients with HIV may have a high burden of musculoskeletal pain, like joint pain, back pain and more widespread pain.
Non-pharmacologic treatments are an important mainstay of therapy, including graded exercise, complementary and alternative therapies, and behavioral therapies. Importantly, behavioral therapies are among the safest and most effective treatments for chronic pain. In 2014, Merlin was awarded a K23 Career Development Award from the National Institute of Mental Health. She is working on developing and pilot-testing a behavioral intervention that is specifically tailored to improving chronic pain in individuals with HIV.
Ideally, when medications are used, they should be prescribed alongside non-pharmacologic therapies.
“A multimodal approach is the most effective approach,” Merlin said. “Our book helps front-line HIV primary care providers use this approach with their patients.”
“Managing chronic pain is rewarding; but it can be challenging, and is often not taught in HIV providers’ medical training. This book is the first practical guide on the topic for HIV care providers, and fills an important need.”
Medications such as opioids may not be as effective, and carry significant risks.
“Chronic pain can be challenging to manage to begin with, and even more challenging to manage in the setting of mental health and addiction problems found in individuals with HIV,” Merlin said. “Long-term treatment with opioids, such as morphine, oxycodone and others, has been commonly used to treat chronic pain in general and in individuals with HIV. Opioid therapy carries risks such as worsening of mood, development of addiction and overdose, and these risks can be heightened in the presence of pre-existing mental illness and addiction.”
Studies suggest that HIV care providers may feel unprepared to treat chronic pain.
“Managing chronic pain is rewarding; but it can be challenging, and is often not taught in HIV providers’ medical training,” Merlin said. “This book is the first practical guide on the topic for HIV care providers, and fills an important need.”
“Chronic Pain and HIV: a practical approach,” published by John Wiley & Sons, Inc., is available for purchase online on Amazon.com. The Kindle version is available now, and the hardback version will be available in April for $120.
The incontinence risk is heightened particularly among men who have sex with men, according to lead author Alayne Markland, D.O., associate professor in the Division of Gerontology, Geriatrics and Palliative Care in UAB's School of Medicine.
Study published in the American Journal of Gastroenterology shows fecal incontinence risk from anal intercourse is heightened for both women and men, with men almost three times as likely to experience incontinence.
Engaging in the practice of anal intercourse may increase risks for bowel problems, including fecal incontinence and bowel leakage, according to a University of Alabama at Birmingham Department of Medicine study published in the American Journal of Gastroenterology.
The incontinence risk is heightened particularly among men who have intercourse with men, according to lead author Alayne Markland, D.O., associate professor in the Division of Gerontology, Geriatrics and Palliative Care in UAB’s School of Medicine. The researchers analyzed data from the 2009-2010 National Health and Nutrition Examination Surveys from 6,150 adults. They found 37 percent of women and almost 5 percent of men reported trying anal intercourse at least once. Women engaging in anal intercourse were 50 percent more likely than their peers to report having fecal incontinence at least once a month. The men’s odds of incontinence were almost tripled.
“The study did not provide data on the frequency of the practice of anal intercourse and the impact of incontinence, but it did show a relationship between the practice of anal intercourse and fecal incontinence — more so among men than women,” Markland said. “What we don’t know is whether someone who has anal intercourse one or two times is at the same increased risk for fecal incontinence as someone who has anal intercourse regularly.”
Overall, 4,170 adults ages 20-69 (2,070 women and 2,100 men) completed sexual behavior questionnaires and responded to fecal incontinence questions as part of the NHANES surveys. Overall, 8.3 percent of women and 5.6 percent of men in the study had fecal incontinence. Fecal incontinence rates were higher among women (9.9 percent) and men (11.6 percent) reporting anal intercourse than among women (7.4 percent) and men (5.3 percent) not reporting anal intercourse.
Fecal incontinence was determined to have occurred by researchers who reviewed responses to survey questions about leakage of mucus, liquid or stool and occurred at least monthly. The study showed that most adults who experience fecal incontinence have only occasional bouts of diarrhea. However, fecal incontinence can be chronic; it is often caused by muscle and nerve damage around the rectum, constipation, certain diseases, surgical procedures, and childbirth.
Markland says previous clinical trials have shown that pelvic floor muscle or anal exercises can be an effective treatment for fecal incontinence, and she recommends those engaging in anal intercourse consider these exercises to help guard against decreased anal sphincter tone.
Markland says little is known about how anal intercourse might affect bowel function, even though the survey showed the practice is common among both heterosexual and homosexual couples.
“We really know very little about the connection between anal intercourse and fecal incontinence, especially among women,” Markland said. “Older studies among predominately HIV-positive males showed that men who have intercourse with men may have impaired rectal muscle strength. But one thing I think this study does show is that it is important that both the patient and clinical provider need to be aware of the potential risks associated with anal incontinence and be willing to discuss what those risks may be.”
Markland says previous clinical trials have shown that pelvic floor muscle or anal exercises can be an effective treatment for fecal incontinence, and she recommends those engaging in anal intercourse consider these exercises to help guard against decreased anal sphincter tone.
“These are also known as Kegel exercises,” Markland said. “But, doing these exercises has not been studied as a preventive measure for lowering the odds of having fecal incontinence in a general population. All we can do is speculate.”
Markland maintains an NHANES data set, and her primary research interest is in incontinence, specifically bowel leakage. She completed the study using indirect funding from several grants.
“I am always looking for potentially modifiable factors that may be related to bowel leakage,” Markland said. “Anal intercourse has been understudied in our population in general, and anal incontinence and bowel incontinence were evaluated only in men who have intercourse with men in older studies. I thought we really needed to look at both men and women and assess the prevalence and associations between anal intercourse and fecal incontinence in both genders.”
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, firstname.lastname@example.org 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.
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.
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.Final results from the landmark SPRINT study, published online today in the
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.
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.”