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Law enforcement, gun retailers resources for safe, temporary storage

Carol Runyan
Carol Runyan

Law enforcement agencies and gun retailers can be resources to concerned families for storing guns to prevent suicide, according to a new study from the University of Colorado Anschutz Medical Campus. It is the first to examine the extent to which these organizations are willing to offer voluntary, temporary storage – especially when a household member is in crisis – according to surveys conducted in eight mountain west states.

“Most people, including health providers, may not know what safe outside-the-home storage is available and what their options are,” said Carol Runyan, lead investigator and professor of epidemiology at the Colorado School of Public Health at CU Anschutz. “A suicide attempt by a gun is almost always fatal, and often the time between contemplating suicide by gun and acting is short. If medical advice to an at-risk patient is to remove guns from the household, where exactly should they be stored and where are those resources available?”

Researchers from the Colorado School of Public Health and the CU School of Medicine sought to understand how, and under what circumstances, law enforcement agencies (LEAs) and retailers could be partners to gun-owning families and health care providers, particularly when concerned about the mental health of a household member, by safely and temporarily providing gun storage. They surveyed law enforcement agencies and gun retailers in Colorado, Arizona, Idaho, Montana, Nevada, New Mexico, Utah, and Wyoming to gauge their willingness to provide storage under various conditions to both gun owners and non-owners.

“Friends don’t let friends drive drunk,” Runyan said. “When a friend who has guns is going through a tough time, we should ask them about safe storage. It’s not about taking away guns or their gun rights, it’s about trying to be safe and looking out for each other.”

According to the Centers for Disease Control, gun ownership and gun-related suicides are more prevalent in these states than in the US overall, and that of 44,193 US suicides in 2015, half involved guns.

“It’s not about taking guns away from people, it’s about safe storage, especially in a home with a person in crisis,” Runyan said. “A gun that is easily accessible to a person in crisis increases the chance that a person is going to die.”

Law enforcement agencies already store guns under circumstances such as domestic abuse or confiscations, she said, but other resources might not be well known to the public.

Study authors received responses from 448 LEAs and 95 retailers to questioners sent beginning in April 2016. Three-fourths of LEAs indicated they would provide temporary storage compared to half of retail respondents. LEAs were most willing to provide storage when a gun owner was concerned about the mental health of a family member, as were about two thirds of retailers. Retailers were also willing to consider storage requests from a gun owner during a time of travel or when hosting family visitors.

Most, (97.3%) of LEAs were very or somewhat likely to recommend not having guns in the home when someone is in crisis – something Runyan said people working to prevent suicide agree with. Researchers excluded prisons, jails, airport police, conservation law enforcement, campus police, state police/highway patrols and tribal police from their sample.

Retailers, excluding pawn shops and large chain stores, recommended storage with a LEA (54.6%), in the gun store (61.4%) or with family and friends (67%).  Of all surveyed, about two-thirds of LEAs and half the retailers reported having received requests for storage services in the previous year.

Runyan said storing guns in another’s household presented the risk that the gun might not be stored properly or might still be available to the individual experiencing a health crisis, indicating this option should be used cautiously.

Runyan said, “We have crime shows on TV that focus on homicide all the time, but not suicide. The general public may not be aware what a problem suicide is, and in this region suicide by gun is a higher problem than the country overall.”

Runyan and her colleagues at CU Anschutz in Aurora, Colo., are working to produce more studies regarding lethal means counseling by health care providers and the connection to community resources for suicide prevention. According to their report, options for temporary, voluntary storage of guns away from the home are an important piece to inform future public health initiatives for suicide prevention.

The study, “Law enforcement and gun retailers as partners for safely storing guns to prevent suicide – a study in eight mountain west states,” was published last week in the September issue of the American Journal of Public Health.

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Four sisters with cancer get care

Roberta Aberle and her three sisters share an unfortunate bond: cancer.

Her two oldest sisters passed away from the disease. She and one sister are still fighting the disease. All four sisters were diagnosed in their 40s or 50s, and all have received treatment through UCHealth – Aberle at the University of Colorado Cancer Center on the CU Anschutz Medical Campus and her sisters at Poudre Valley Hospital in Fort Collins.

“Our family is definitely satisfied in the care we’ve received,” said Aberle, 53, who lives in Aurora, where she can easily access treatment at CU Anschutz, “and I’m 100 percent confident in the care I’m getting right in my backyard.”

A former quality and process improvement professional for UCHealth, she now applies her skills as an advocate and resource for people with cancer. She’s spreading the word about the treatment she received from CU physicians, and her own story of cancer, far and wide.

Years of diagnoses

“Sadness took root in our family in 2005,” Aberle said. That was the year the first of her sisters, Brenda, received her cancer diagnosis.

Roberta Alberle
Roberta Alberle, CU Cancer Center patient

Brenda passed away in 2008, and a year later, sister Carol was diagnosed. Both Aberle and her oldest sister Debby got cancer diagnoses in 2012. Debby passed away six months after her diagnosis, but Aberle has survived, outliving her original prognosis by half a decade.

Aberle remembers Leap Day 2012 vividly. That was the day she went in for a quick assessment of a minor pain in her side. Despite her significant risk factors of having multiple first-degree relatives diagnosed with cancer before age 50, she never imagined a life-altering diagnosis.

“I was feeling healthy and energetic and working my dream job,” she said. “Nothing could have been going better at that time.”

She came out with a diagnosis of inoperable primary peritoneal cancer, one of the most rare and lethal forms of cancer, and recommendations to begin arranging for palliative and end-of-life care.

“I was in utter disbelief,” she said. “I had just been thinking how ill everyone in my family is and that I’m not prepared to be the person who outlives my entire family, and now I had cancer, too.”

While the disease has devastated the family, it has also mystified them. All four sisters have had reproductive cancers, but none the exact same type, and each has had a different outcome. Aberle shares the same genetic marker for cancer susceptibility with one of her sisters, but the other two sisters did not have the marker. And on top of everything, in 2015 their father was diagnosed with melanoma and lymphoma.

“Cancer has blown our family to bits,” Aberle said, “but a bit falls to the floor and we pick it up and glue it back on. It’s created a bond that can’t be broken.

A powerful treatment

Despite her family’s devastation and her own grim prognosis, Aberle was determined to fight her cancer. For the next year and a half, she underwent chemotherapy and entered clinical drug trials. Then, she received hyperthermic intraperitoneal chemotherapy (HIPEC), a rare cancer treatment that combines chemotherapy and surgery in a single procedure. The CU School of Medicine Department of Surgery is one of very few care providers in the United States that offer HIPEC.

During Aberle’s HIPEC treatment in 2013, CU surgeons opened her abdomen, removed the visible cancer cells and then doused the remaining cells with heated chemotherapy drugs. This procedure is followed by standard intraperitoneal (IP) chemotherapy. Because both HIPEC and IP techniques deliver chemotherapy directly to cancer cells in the abdomen (unlike systemic chemotherapy delivery, which circulates throughout the body), they can destroy microscopic cancer cells and has helped some patients live decades longer.

But it’s not an easy procedure for patients.

“It’s an invasive procedure, and it was a very difficult and painful recovery,” Aberle said. “I had a port inserted into my abdomen and staples up the length of my belly. Now, I have adhesions and scar tissue that still cause pain sometimes.”

Since HIPEC, Aberle’s cancer has returned, but she still believes it was the right treatment for her.

“It bought me additional time and got me farther down the path to the next available treatment,” she said. “I have no doubt in my mind that, if I had not had access to CU surgeons, I would not have survived this long.”

Survival on her own terms

Now five years into her battle with cancer, Aberle is still determined to fight the disease, and she’s grateful that the care providers at CU Anschutz continue to empower her to do that.

“My survival is 95 percent connected to the care I’m getting from the University of Colorado,” she said. “No one has ever relinquished their hope in me or objected when I say I want to keep going. It is phenomenal to be working with these doctors.”

Two years ago, Aberle took disability leave in order to devote more time and energy to conquering her cancer and to doing the things that are most important to her: spending time with loved ones and sharing her experience to help others.

“I’m not fooling myself that I’m going to live to 103,” she said. “There’s going to be a point when I want to go to palliative care and hospice, but I want to make my sure that we’ve done everything possible first. I know I’m with the right team at the CU Cancer Center, because they share in that philosophy right along with me.”

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Despite efforts, barriers to emergency contraceptives remain

Efforts to win greater access to emergency contraceptives (EC) saw some success in 2013 after the U.S. Food and Drug Administration removed age restrictions on over-the-counter sales of the levonogestrel drug Plan B.

But a new study shows those needing EC can still encounter cost and availability barriers.

Laura Borgelt, PharmD, professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences
Laura Borgelt, PharmD, professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences

Researchers at the University of Colorado School of Medicine discovered this when they asked 633 Colorado pharmacies in 2014 about EC access. They found EC completely accessible to just 23 percent of those who use them.

They report their findings in the latest issue of the journal Women’s Health Issues, “Barriers to Single-Dose Levonorgestrel-Only Emergency Contraception Access in Retail Pharmacies.” The study was selected by the editor of Women’s Health Issues as an Editor’s Choice article for the September/October 2017 edition.

Women’s Health Issues is the official journal of the Jacobs Institute of Women’s Health, which is based in the Department of Health Policy and Management at Milken Institute School of Public Health (Milken Institute SPH) at the George Washington University.

Study author Van (Mimi) Chau, a student at CU School of Medicine, under the mentorship of Carol Stamm, MD, along with colleagues that included Laura Borgelt, PharmD,  a professor at the  University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences  used the Little Blue Book 2014, which physicians use for referrals, to identify Colorado pharmacies, and then had three researchers call the pharmacies posing as women seeking levonogestrel-only emergency contraception (LNG-EC). Chau was part of the University’s Leadership, Education, Advocacy and Development (LEADS) track while she worked on the project.

Study says barriers to emergency contraceptives remain
Study says barriers to emergency contraceptives remain

They asked each pharmacy whether they had LNG-EC in stock, whether it was located on the shelf or had to be requested from the pharmacy, whether a generic version was available, how much the product cost, and whether any additional documentation — such as proof of age or a prescription — was required to purchase the drug. The authors defined EC as being “completely accessible” at a pharmacy if the responding employee reported having it available on store shelves that day for purchase without presenting an ID or prescription. Accessibility is important because EC must be taken within 120 hours of intercourse, and research suggests it is most effective within the first 24 hours.

Chau and her colleagues found that 87 percent of pharmacies reported having LNG-EC in stock, but it was only completely accessible at 23 percent of the stores surveyed. Of the stores with the drug in stock, 42 percent reported it was behind the counter — i.e., had to be requested from a pharmacy employee — and 56 percent told callers an ID or prescription was required for purchase. Independent pharmacies were significantly less likely to have EC in stock (58 percent of independent stores vs. 90 percent of chain stores and 100 percent of 24-hour stores) or demonstrate complete access (10 percent vs. 25 percent and 15 percent), the authors report.

Requiring EC purchasers to request the drug from a pharmacy employee and present additional documentation are potentially substantial barriers, the authors note, because people may find it embarrassing to interact with an employee about reproductive healthcare and may lack the requested documents. Adolescents may not have identification or may not meet the age limit pharmacy employees believe to be in place.

When considering why pharmacy employees report outdated policies for documentation and behind-the-counter access, the authors point out that the age cutoff for LNG-EC products changed four times before being lifted completely, and suggest “delays in updating store policies or lag in information dissemination may explain the variability in knowledge among pharmacy staff about FDA regulations and requirements.”

“Although federal policy restrictions on LNG-EC have been removed, this study demonstrates that retail pharmacy-level policies can still create tangible hindrances in obtaining appropriate health care,” Chau and her co-authors write.

The study, “Barriers to Single-Dose Levonorgestrel-Only Emergency Contraception Access in Retail Pharmacies,” has been published in the September/October issue of Women’s Health Issues.

Guest contributor: Contact for this story is Jackie Brinkman.

 

 

 

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Dental students treat underserved in ACTS Program

When Matthew Iritani enters a dental office, it feels like home.

As a boy, Iritani spent hours watching his father, Mark Iritani, DDS, an orthodontist, work with patients. His mother, Patra Watana, DMD, a pediatric dentist, would come to his elementary school to teach the children about oral health.

“I always knew I wanted to grow up to be like mom and dad and go into the profession,” says Iritani, 25, a fourth-year student at the CU School of Dental Medicine.

Today, Iritani is closer to his dream. Through the CU School of Dental Medicine’s Advanced Clinical Training & Services (ACTS) program, he is able to have hands-on experience at the Salud Family Health Centers Sterling clinic.

Service to Colorado communities

Initiated in 1986, the ACTS program was one of the first programs of its kind and has become a national model for service learning programs designed to integrate students into underserved communities. ACTS provides hands-on experiences for fourth-year dental students as they practice in clinics around the state of Colorado. The number of days spent in the community are among the highest in the nation, giving our students the expertise, confidence and skills to immediately improve lives once they graduate.

CU dental student Matthew Iritani and preceptor Dr. Petros Yoon
Fourth-year dental student Matthew Iritani is pictured with his ACTS preceptor Petros Yoon, DDS, outside the Salud Family Health Centers Sterling clinic.

This year, each of the 76 fourth-year dental students will rotate through four to five of the 35 ACTS partner sites, a mixture of urban and rural statewide. More than 70 community dentists, many (46 percent) of whom are CU alumni and also participated in the ACTS program, have faculty appointments as preceptors and oversee the students during their ACTS rotation.

“All of the patients the students see are underserved in some way and have barriers accessing dental care,” says Tamara Tobey, DDS, Director of the ACTS program and an Associate Professor/Clinical Track.

Students appreciate the challenge, she says.

“Our students say it’s one of the best experiences during dental school, it’s valuable for their training and treating these patients is very worthwhile,” says Tobey, adding that prospective dental students often talk about ACTS as a reason they are interested in attending the CU School of Dental Medicine.

Tobey, a 1992 CU School of Dental Medicine graduate, was a student in the program and also a preceptor for more than 20 years.

“It’s always been our goal to expose students to community health centers and diverse populations,” she says. “Our students realize they really are making a difference in those patients’ lives and they might be drawn to working in community health practice as a career. We want to make sure they’re exposed to all options so they can make choices that are meaningful for them.”

From student to teacher

Petros Yoon, DDS, Dental Director at the Salud Family Health Centers Sterling clinic, graduated from the CU School of Dental Medicine in 2015. He now shares his knowledge and experience as a preceptor.

“As an ACTS preceptor, I want to guide the students and help advance their clinical skills and give them practical, real-world experience,” Yoon says. Each student assigned to the Salud Sterling clinic works with Yoon for four weeks, with a two-week break in between so they can go back to the dental school to care for their patients there and meet other school requirements.

Sterling is a small town in comparison to Denver; it has a population of about 14,000 people. It’s a hub for area residents to come for medical and dental services. Some patients drive 60 miles for their appointments.

“We have large families who come to our clinic and we make every effort to see the whole family if we can,” he says. “Sterling is a very tight-knit community and we are proud to serve and be a part of their families.”

Empathic skills are also important for students, who need to learn how to communicate with diverse patient populations, from children to seniors. Time management while providing quality of care is also a critical skill for students to learn. In the dental school setting, because of other variables such as classes, a student may only see two patients a day, one in the morning and one in the afternoon.

In the Sterling clinic, students may see four to five patients a day. Yoon oversees the students’ work, but gives them the opportunity to practice general dentistry, including exams, fillings, oral surgery and more.

“Here, we help them learn how to think critically on the spot, supported by evidence-based research and their clinical training,” Yoon says. “These are skills you really can’t practice unless you’re in a real-life situation.”

For Yoon, providing support to students comes naturally. As a CU dental student, he rotated through the Salud Fort Lupton clinic and understands the importance of the ACTS program. Even if dental students want to take another path – orthodontics, for example – the experience they get in a community health center will be rewarding.

Many opportunities to practice in community

“Petros is the best – he was a fourth year when I was a first year and would help me even then,” Iritani says. “One of the big reasons I wanted to go to Sterling as a rotation was because of him.”

Iritani also has worked in the dental clinic at Denver Health’s Westside Family Health Center and will be assigned to the Worthmore Dental Clinic in Aurora, caring for refugees. He’ll have two more affiliations in the spring.

Iritani is applying for CU’s Graduate Orthodontics Program and hopes to join his dad’s practice. His dad, Mark Iritani, is a 1985 graduate of the CU School of Dental Medicine and also practiced in an underserved part of Colorado as a young dentist.

“ACTS is valuable because it exposes you to what it would be like to work in both public health and private practice,” Matthew Iritani says. “I think the opportunity to see patients in different situations has been beneficial – especially since I went into dentistry because I want to help people.”

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Hard Call podcast explores tough ethical decisions in health care

Some of the toughest ethical challenges in life play out in health care. The Hard Call podcast series, launched over the summer by the CU Center for Bioethics and Humanities, explores heart-wrenching choices confronting real patients, families and care teams. And in a novel, creative twist for a podcast, it also asks listeners to vote on what they would do if they were facing the same decisions.

Hard Call: Derailed” was the first story launched. It tracks a patient with emerging bipolar disorder through five episodes. The story was funded by the Colorado Health Foundation and the Community First Foundation, and it has been championed by mental health organizations such as the National Behavioral Health Innovation Center. Derailed quickly garnered listeners from across the US and in Australia, Canada, England and Ireland.

Wynia Matthew, MD
Matthew Wynia, MD, MPH, director of the CU Center for Bioethics and Humanities, collaborates with Elaine Appleton Grant, a journalist and radio producer, on the new podcast series, “Hard Call.”

The second story is “Hard Call: The Electronic Heart.” This four-part podcast series follows a patient, nicknamed “Max” to protect his privacy, through a set of critical decisions about a very risky and expensive treatment toward the end of life.

Hard Call collaborators Matthew Wynia, MD, MPH, director of the CU Center for Bioethics and Humanities at the Anschutz Medical Campus, and Elaine Appleton Grant, an experienced journalist and public radio producer, say the two storylines have brought different listeners to the program. “The first Hard Call story, about a patient with bipolar disorder, has drawn a large number of listeners particularly interested in mental wellness and the care of patients with mental illness,” Grant said. “The second patient’s story is of interest to anyone who’s lived through difficult decisions around end of life care, or people interested in heart disease and how it’s being treated these days.”

Listen to a Colorado Public Radio interview with Wynia about the ‘Hard Call’ series and the story about a Denver man suffering from bipolar disorder here.

Each Hard Call episode ends with a difficult choice facing one person in the story and the provocative question, “What would you do?” Listeners are asked to vote on the Hard Call website. They can also see how others voted and join the discussion online.

Hard Call is a collaboration between creative minds in health care, radio and theater. Episodes are available in iTunes, Google Play, other podcast platforms and on the web.  It is made possible by the CU Center for Bioethics and Humanities, with support from the Colorado Health Foundation and the Community First Foundation.

The CU Center for Bioethics and Humanities, located on the University of Colorado Anschutz Medical Campus, engages today’s and tomorrow’s health professionals and the community in substantive, interdisciplinary dialogue about ethical issues confronting patients, professionals and society.

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Physical Therapy Program Celebrates 70 Years

On September 7, the CU Physical Therapy Program celebrated its 70th anniversary. More than 400 people gathered at the Denver Art Museum for an evening dedicated to the hard work of faculty, students, staff, alumni and community supporters. Among the crowd, three honorees were celebrated for their outstanding contributions to the Physical Therapy (PT) Program.

Patrick Grant, JD, MBA, chairman of the National Western Stock Show was recognized for his long-time support of the program. He received care from faculty in the Physical Therapy Program, allowing him to continue enjoying the activities he loved. Out of his appreciation for the care he received, he initiated the first PT scholarship fund, which provides annual support for several students pursuing their education in physical therapy. Mr. Grant also became the founding chairman of the Scholarship and Endowment Advisory Board, charged with facilitating community support.

In recognition of his support during his tenure as dean of the CU School of Medicine, Richard Krugman, MD, was honored. He assisted the PT Program leadership throughout his 20+ years in the School of Medicine. Dr. Krugman was instrumental in transitioning the master’s program to a doctorate in physical therapy degree, expanding research efforts, and creating the Scholarship and Endowment Advisory Board. He also established the Krugman Award, which is given to a physical therapy student annually in recognition of leadership and service to the community.

Joanne Posner-Mayer, PT (’73), was also recognized for her tremendous support of the students and faculty in the PT Program. She has been active with the program since her time at CU as a student. Since its inception, Ms. Posner-Mayer has been a member of the Scholarship and Endowment Advisory Board and personally provides an annual scholarship to a student committed to dance. She also created the program’s first major endowment to enhance diversity among the PT student body.

Showcasing the importance of scholarships, student Kevin Morris, said, “Scholarship support represents opportunity. Your generosity has helped my dream of becoming a doctor of physical therapy a reality.”

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CU Anschutz Block Party, 2017

Under clear blue skies Wednesday, the CU Anschutz Medical Campus enjoyed its most-successful CU Anschutz Block Party yet, with more than 3,500 faculty, staff, students and community members attending the fifth annual event.

A record 130 booths (40 more than last year) representing CU Anschutz organizations, departments and programs as well as the Aurora community filled the Bonfils Circle in front of Building 500. The fun and food trucks brought out folks from all walks – including health care professionals in scrubs and researchers in lab coats – to enjoy a midday break with colleagues from across CU Anschutz and the wider community.

Games included pingpong, lawn bowling and a first-ever zipline. Music on the main stage was performed by Denver-area rock bands Wildermiss and iZCALLi.

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New oral diabetes drug shows promise

A University of Colorado Anschutz Medical Campus study finds sotagliflozin helps control glucose and reduces the need for insulin in patients with type 1 diabetes.

Principal results were published today in the New England Journal of Medicine of a global Phase 3 clinical trial in patients with type 1 diabetes treated with sotagliflozin. Sotagliflozin is an investigational new oral drug for patients with type 1 diabetes that has shown promise in improving glucose control without any increase in severe hypoglycemia or diabetic ketoacidosis compared to insulin alone.

Garg
Dr. Satish Garg

Among 1,402 trial participants given the drug, sotagliflozin showed clinically meaningful and statistically significant effects on glucose control. Concentrations of hemoglobin A1C, a measure of plasma glucose, were improved. Patients experienced a lower rate of confirmed severe hypoglycemia than observed in patients on placebo and also had weight loss.

According to lead investigator Satish Garg, MD, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, no oral medication has ever been approved for the treatment of type 1 diabetes and sotagliflozin has the potential to become the first new treatment innovation in nearly a century since insulin.

Most patients do not achieve optimal glycemic control with insulin alone. A1C concentrations, hypertension and reduction in body weight are critical issues which significantly impact people living with type 1 diabetes.

“If approved by the FDA, sotagliflozin may be the first oral drug that helps patients with type 1 diabetes in improving their glucose control without any weight gain or increase and severe hypoglycemia,” Garg said. “If long-term use continues to show similar metabolic improvements in patients with type 1 diabetes, it is likely that the long-term complications of diabetes would be significantly reduced.”

Sotagliflozin would be used in conjunction with insulin. Trial participants taking the drug as an oral pill alongside traditional insulin treatments experienced significant improvements in glucose control, a drop in systolic and diastolic blood pressure and weight loss.

Sotagliflozin is a unique dual inhibitor that works by inhibiting two sodium-glucose transporters: SGLT1 and SGLT2. Each modulates glucose levels. SGLT1 regulates the uptake of glucose in the gut while SGLT2 regulates the re-uptake of glucose in the kidney, according to the authors.

“Sotagliflozin added to insulin therapy can potentially help patients with type 1 diabetes improve their glucose control and hopefully manage the disease with fewer complications,” Garg said. “This would not be a replacement for insulin; it is an adjunctive therapy. However, because it works in the gut and the kidneys, it doesn’t require insulin to have an effect.”

The inTandem3 study was a double-blind, placebo controlled and randomized Phase 3 trial including adults with type 1 diabetes at 133 sites worldwide. In conjunction with this publication, the data were announced today at the 53rd Annual Meeting of the European Association Study for Diabetes in Lisbon, Portugal.

The 24-week trial evaluated the safety and efficacy of sotagliflozin at 400mg per day in randomized patients treated with any insulin regimen – pumps or injections. Eligible patients included men and nonpregnant women aged 18 and older, and they were required to self-monitor blood glucose.

The study met its primary endpoint with statistical significance, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C less than seven percent at week 24, no episode of severe hypoglycemia and no episode of diabetic ketoacidosis after randomization.

The outcome on every secondary endpoint favored sotagliflozin over placebo, achieving statistical significance for all four secondary endpoints, including change from baseline in A1C, body weight, systolic blood pressure in patients with baseline SBP less than or equal to 130 mm Hg and bolus insulin dose. Sotagliflozin significantly reduced A1C compared to placebo after 24 weeks of treatment.

“As is known with sodium glucose cotransporter 2 (SGLT2) inhibitors, patients experienced more episodes of diabetic ketoacidosis in the trial,” Garg said.

Diarrhea and genital mycotic infection also affected participants more than placebo, but less than one percent discontinued the study due to these effects.

“Sotagliflozin may reduce the bad effects of insulin and the dose patients need,” Garg said. “Patients in our study had lower weights, no severe hypoglycemia and better blood pressure.”

Garg is a faculty member at the University of Colorado School of Medicine at the Anschutz Medical Campus and is editor in-chief of Diabetes Technology and Therapeutics Journal.

Garg and his colleagues are working to publish more results on other inTendem1 and 2 phase 3 clinical trials in type 1 diabetes, including data on continuous glucose monitoring in future publications.

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New arrival bolsters Cardiothoracic Surgery team

The recent addition of Jay Pal, MD, PhD, to the Division of Cardiothoracic Surgery at the University of Colorado School of Medicine both maintains and deepens its expertise in treating heart failure and other serious cardiac problems. It’s also gained a guy who would rather focus on teamwork than individual achievement.

Pal joined the team June 19 after nearly four years with the University of Washington in Seattle, where he honed his skills in heart transplant surgery and implantation of left ventricular assist devices (LVADs) and other mechanical tools that support circulation in heart failure patients. He’s successfully retrieved and transplanted donor organs from remote areas in Alaska, pushing the boundaries of time for safe transplant. He’s developed expertise in less invasive techniques for LVAD surgery. For patients with acute cardiac problems, Pal has worked extensively with methods of short-term circulatory support, such as extracorporeal membrane oxygenation (ECMO).

Joe Cleveland
Pal takes over as surgical director of the Mechanical Circulatory Support Program from Joseph Cleveland, MD, who remains active with the CT team as a surgeon and research leader.

These and other skills strengthen not only the cardiothoracic (CT) surgery team but also the Heart Failure Program at CU and UCHealth University of Colorado Hospital. They also contributed to Pal’s selection as surgical director of CU’s Mechanical Circulatory Support Program. He takes over from Joseph Cleveland, MD, who has headed the program since its inception in 2001.

Don’t expect Pal to focus on these accomplishments when he talks about what motivates him, though.

“As a surgeon, caring for patients with heart failure requires good collaboration with management by my cardiology colleagues,” Pal said. “Physicians tend to work in silos, but heart failure requires multispecialty care by skilled specialists and nurses in the ORs, ICUs and clinics. That reflects my personality. I have something to learn from everyone. It’s foolish to think I can do anything alone.”

New shoes

Pal’s arrival fills a vacancy created about a year and a half ago with the departure of Ashok Babu, MD, for Saint Thomas Heart in Nashville. With last year’s addition of Muhammad Aftab, MD, the CT surgery team is positioned to rebuild its annual LVAD volume to its past peak of 50 or so, Cleveland said. It performed 36 such procedures last year.

Amrut Ambardekar
Cardiac Transplantation Program Director Amrut Ambardekar, MD, welcomes the experience and expertise that Pal brings to CU and University of Colorado Hospital.

“The number of cardiac surgeries we do has been increasing generally,” added Amrut Ambardekar, MD, director of CU’s Cardiac Transplantation Program. “Jay not only fills a void in staffing but will allow us to grow to the next level.”

With Pal taking on the surgical director’s administrative duties, Cleveland will also have more time to pursue his research interests while maintaining his surgical schedule. He’s principal investigator for the clinical trial of the HeartMate 3 LVAD, which in late August received FDA approval as a short-term LVAD for patients awaiting heart transplant. Cleveland said he also plans to increase the CT surgery team’s involvement with CU’s Structural Heart Program, which offers minimally invasive procedures that are increasingly in demand, such as transcatheter aortic valve replacement (TAVR).

Cleveland said he’s confident that he can take on these new challenges, thanks to Pal’s mix of experience in areas both familiar and new to the CU program.

“We wanted someone who is mid-career who can, at the same time, bring outside ideas and help to make us better,” Cleveland said. “Jay also impressed us as thoughtful and collaborative, someone who would be a good colleague.”

Extending ECMO

The ECMO program promises to be another beneficiary. The technique involves providing mechanical circulation support for patients with acute heart and/or lung damage from heart attacks, arrhythmias, or viral infections, for example. The machine boosts circulation and breathing, giving injured organs a chance to rest and heal, sometimes as a bridge to an LVAD or transplant.

“There is an urgent need in Denver and beyond for care for people who get very sick, very quickly,” Pal said. “These patients would otherwise die. With aggressive care, we can salvage their organs and their lives.”

Ambardekar said the number of ECMO cases grew from 40 in fiscal year 2016 (which ended June 30, 2016) to 50 in fiscal year 2017. The program also earned the ELSO Gold Level Award of Excellence for excellence in patient care, training, education and other criteria for measuring and evaluating organizations that use ECMO to treat patients.

Longer reach

Pal also promises to help the Transplant Program extend its reach in retrieving donor hearts for patients on its waiting list. The traditional “upper limit” for bringing a heart from the field to the surgical table is four hours, Pal said. But he and his colleagues at the University of Washington often pushed beyond that boundary, sometimes flying from Seattle to deep into the Alaskan interior or far down the coast to Southern California to get and bring back a lifesaving heart. They regularly kept the organs viable for six hours and more, he said.

One key to the success was a new technique that keeps the donor heart perfused with warm blood during transport. Even more important, Pal said, was donor selection and timing. “It’s important to have healthy young donors,” he noted. “The surgery must also then be expeditious. The distance should be a minor factor in our decision making.”

His experience should help the CU team expand the area it travels for donor organs, Ambardekar said. “We’ve generally not gone more than 1,000 miles, but Jay is used to traveling longer distances,” he said. “For our patients waiting for a transplant, the farther we can go for organs, the better.”

That capability also promises to be important because the United Network for Organ Sharing (UNOS) is preparing to implement changes to its adult heart allocation system. One of them will expand the geographic area available to institutions to procure hearts for its sickest patients.

As Pal put it, “The number of people with heart failure is growing, but the donor population is still relatively fixed. That means our ability to get hearts to those who will benefit the most is paramount.”

Cutting down on cutting open

Meanwhile, Pal also has experience with surgical alternatives to opening the sternum for implantation of LVADs. Instead, surgeons make a much smaller incision in the chest wall. The idea isn’t about saving time – in fact, the procedure is more difficult and takes longer than opening the chest, Pal said. It’s aimed at sparing patients who get LVADs as a bridge to heart transplant a second sternotomy when they receive their new hearts, he said.

Cleveland said he’s done one of the less-invasive procedures, but having it more available as an option for patients is important for the CT surgery team as a whole. “We want to bring in new techniques as we move forward,” he said.

A considerable number of patients at UCH stand to benefit from having the choice. Half of the patients who received heart transplants in 2016 were those who received LVADs as a bridge, Ambardekar noted.

“Ultimately the transplants for those patients could be better, safer, faster and involve less bleeding” if they have a minimally invasive procedure to implant their LVADs, he said.

In touch with outreach

The ultimate goal all these procedures is to help patients live better lives, and that requires educating and staying connected, not only with them, but with their providers. University of Washington is in a bigger and more competitive market than Denver – at least in terms of the availability of tertiary and quaternary care – but like their Denver colleagues, Seattle specialists serve patients from a large swath of thinly populated rural communities in the eastern portion of Washington. Pal is familiar with the importance of reaching out to community cardiologists to help them care for their heart failure patients and keep them close to home as much as possible.

Pal plans to join Cleveland, Ambardekar and others on trips to places like Greeley and Cheyenne, Wyoming to meet with primary care providers and cardiologists. They offer tips on treating heart failure and explain the basics of operating, monitoring and maintaining LVADs. Cleveland said he and his team have also hosted groups of community cardiologists at UCH to observe how patients are selected to receive LVADs and transplants. Community providers with questions can also call in to a 24-hour help line staffed by the hospital’s Mechanical Circulatory Support Program coordinators.

“It’s two-way communication,” Cleveland said. “Patients know we are not here to supplant their community providers. We’re here to help manage complex medical situations.”

“My goal is to help patients not just live longer, but to go back to doing the things they want,” Pal said. “It’s not about our program getting all the patients. It’s about serving as a resource for patients and their providers.”

Still a relative newcomer to the Rocky Mountain region, Pal said he looks forward to skiing, camping and hiking with twin daughters Aliana and Isabella (not quite 3 years old) and wife, Angela. While he points to the similarities between the clinical programs in Washington and Colorado, he’s looking forward to experiencing one difference as autumn in Seattle and Denver approaches.

“The sunshine here is quite nice,” he said.

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