CV impact of diabetes drugs, reduction of residual risk among news highlighted at CMHC
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In the past year, numerous drugs and interventions have addressed diabetes, obesity, and cardiometabolic health, according to presentations at the virtual Cardiometabolic Health Congress.
Presenters discussed notable trials including EMPEROR-Reduced, AWARD-11, THEMIS, the ORION program and PROPEL.
EMPEROR-Reduced
The SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) lowered risk for CV death and hospitalization for heart failure compared with placebo, regardless of the presence or absence of diabetes, according to findings from the EMPEROR-Reduced trial published in The New England Journal of Medicine.
“There was a lower risk in CV death or hospitalization with HF with reduced ejection fraction, both the primary outcomes and the outcomes related to first and recurrent hospitalization for heart failure, both statistically significant,” Keith C. Ferdinand, MD, FACC, FAHA, FASPC, Gerald S. Berenson Chair in Preventive Cardiology, professor of medicine at Tulane University School of Medicine and Cardiology Today Editorial Board Member, said during the presentation. “Another endpoint was a benefit in terms of slowing the reduction in estimated glomerular filtration rate in these patients. The important thing was we had another study called DAPA-HF with dapagliflozin (Farxiga, AstraZeneca), another SGLT2 inhibitor that actually had shown similar results. It hasn’t made its way to the guidelines yet; guideline committees take a little time to integrate some of these findings. The data do suggest, however, in patients with mild to moderate HF with reduced ejection fraction, with an ejection fraction of 40% or lower, that SGLT2 inhibitors appear to improve symptoms and quality of life, and reduce the risk of hospitalization and CV mortality.”
Healio previously reported on the findings of the EMPEROR-Reduced trial during coverage of the virtual European Society of Cardiology Congress in August. Read more.
AWARD-11
Larger doses of 3 mg and 4.5 mg of the GLP-1 receptor dulaglutide (Trulicity, Eli Lilly) led to decreased HbA1c levels and weight loss in a cohort of adults with poorly controlled type 2 diabetes, according to findings from the AWARD-11 study published in the Journal of the Endocrine Society. The FDA approved 3 mg and 4.5 doses of dulaglutide in September.
“According to their results, at the higher doses, you have a greater A1c reduction, 1.5% [at 1.5 mg] compared to 1.9% at the highest dose, and there was a weight loss of 10.4 pounds,” Anne Peters, MD, director of the University of Southern California clinical diabetes programs and professor at the USC Keck School of Medicine, said during the presentation.
“The way they did this in the clinical trial, which is the way I do it because I want to mitigate gastrointestinal side effects, was they start out at the 0.75 mg dose for one month, they get it once a week for a month,” Peters continued. “Then if there are no side effects, go up to 1.5 mg, do that for a month, then 3 mg for a month, then 4.5 mg. You don’t necessarily have to go to the highest dose if you’re getting to whatever your target is at the lowest dose.”
Healio previously reported on the findings from AWARD-11. Read more.
Pooled ORION analysis
Inclisiran (Novartis) was found to lower LDL levels by more than 50% in patients with atherosclerotic CVD, heterozygous familial hypercholesterolemia and ASCVD risk equivalents, according to data from three ORION trials published in the New England Journal of Medicine.
“This is quite unique. You give a dose [at baseline], then the second dose at 3 months, and then every six months, so twice a year dosing, and you get a 50% or more LDL reduction,” Christie M. Ballantyne, MD, professor at the Center for Cardiovascular Disease Prevention at the Baylor College of Medicine, said during the presentation. “It’s a very different concept for what this might accomplish. Thus far, with this new technology, there is a long biological half-life of the agent. But the safety looked good overall. Numerically, there was some reduction, if you pool all three (ORION trials), in CV events. And there is a large outcome study in progress.”
Healio previously reported on the findings on the ORION trials during a presentation at the virtual American College of Cardiology Scientific Session in March. Read more.
THEMIS trial update
New data from the THEMIS trial showed participants with diabetes and stable CAD had fewer ischemic limb events when prescribed ticagrelor (Brilinta, AstraZeneca) and aspirin compared with those only prescribed aspirin, according to findings originally presented at the ESC Congress.
“Peripheral ischemic events data from THEMIS showed that in that stable CAD diabetes population, there were significant reductions in peripheral ischemic events,” Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center and professor of medicine at Harvard Medical School, said during the presentation.
According to the data, patients with stable CAD and diabetes without a history of MI or stroke experienced a reduction in ischemic events when prescribed ticagrelor with aspirin compared with those prescribed only aspirin. In June, the FDA approved ticagrelor to reduce risk for first MI or stroke in high-risk individuals with CAD.
Healio previously reported on the new THEMIS trial findings at the virtual ESC Congress in August. Read more.
PROPEL
Low-income individuals with obesity had a nearly 5% average weight loss after participating in a high-intensity, lifestyle-based treatment plan in a primary care setting, according to PROPEL trial data published in The New England Journal of Medicine.
“The clinics were randomly assigned to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or standard of care,” Robert H. Eckel, MD, professor of medicine, emeritus, in the division of endocrinology, metabolism and diabetes and division of cardiology; and professor of physiology and biophysics, emeritus; and the Charles A. Boettcher II Chair in atherosclerosis at the University of Colorado Anschutz Medical Campus, said during the presentation. “Patients in the intensive lifestyle group participated in a high-intensity program delivered by health coaches embedded in these clinics. Their program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months.
“A high-intensity based treatment program for obesity delivered in an underserved population resulted in clinically significant weight loss at 24 months,” Eckel added. “Cardiometabolic medicine is really an area that overlaps between not only physicians and other health care providers such as physician’s assistants and nurse practitioners, but also the overall team approach in terms of the nutritional impact that we can have in underserved populations.”
Healio previously reported on the findings from PROPEL. Read more.
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Ballantyne CM, et al. FDA update and late breaking trials. Presented at: Cardiometabolic Health Congress; Oct. 21-24, 2020 (virtual meeting).
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