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DAPA-HF, REWIND, other cardiometabolic science highlighted at CMHC
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CHICAGO — Healio presents live updates from the late-breaking trials session at the Cardiometabolic Health Congress.
Presenters highlighted notable recent research involving drugs to address diabetes and cardiometabolic health, including DECLARE-TIMI 58, REWIND, GLP-1 receptor agonist and SGLT2 inhibitor meta-analyses and DAPA-HF.
DECLARE-TIMI 58 trial
Beyond improved cardiovascular outcomes, the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) may also offer adults with type 2 diabetes the potential to prevent and treat kidney disease, according to findings published in The Lancet Diabetes & Endocrinology.
“The DECLARE-TIMI 58 trial had appeared since last CMHC,” Jay S. Skyler, MD, MACP, professor of medicine in the division of endocrinology, diabetes and metabolism at the University of Miami Leonard M. Miller School of Medicine, said during his presentation. “This was an interestingly designed study and had two primary endpoints. One was a CV death or hospitalization for heart failure. Researchers found that dapagliflozin beat placebo with a 17% risk reduction that was statistically significant. So, for HF it had a beneficial effect. For the other primary endpoint, which was standard MACE, you can see that there was no statistical difference between the two. That led to a little bit of confusion, but then the DECLARE-TIMI 58 study had included a lot of people who did not previously have CVD, unlike many of the other trials.”
Healio had previously reported on the results of DECLARE-TIMI 58 trial at the American Diabetes Association Scientific Sessions. Read more
REWIND trial
Among a large cohort of adults with type 2 diabetes with and without established CVD, the once-weekly GLP-1 receptor agonist dulaglutide (Trulicity, Eli Lilly) reduced the risk for nonfatal myocardial infarction, nonfatal stroke and CV death by 12% compared with placebo, according to findings published in The Lancet.
“REWIND was another very interesting study. This was done with dulaglutide, another GLP-1 receptor agonist, and as we reported at ADA in June,” Skyler said during his presentation. “This study was highly anticipated because it’s the first GLP-1 receptor agonist that also had a significantly large portion of people without previous CVD. As you saw in the DECLARE-TIMI 58 study, that prevented the endpoint. With the primary outcome of both REWIND and DECLARE-TIMI 58 that does make statistical significance, researchers observed a 12% risk reduction in the primary outcome of MACE.”
Healio previously reported on the findings of REWIND at the American Diabetes Association Scientific Sessions. Read more
In a related commentary published in Cardiology Today and on Healio, Bolanle Akinyele, MD, a general cardiology fellow at Johns Hopkins Hospital, Roger S. Blumenthal, MD, director of the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease and editor of the Cardiology Today Prevention section and Sudipa Sarkar, MD, MSCI, assistant professor of medicine in the division of endocrinology, diabetes and metabolism at Johns Hopkins University School of Medicine, discussed the role of dulaglutide for primary prevention of CVD. Read more
GLP - 1 meta-analysis
A meta-analysis of seven large CV outcomes trials suggests that treatment with GLP-1 receptor agonists reduces major adverse CV events by 12%, all-cause mortality by 12% and hospitalization for HF by 9% among adults with type 2 diabetes when compared with placebo, according to findings published in The Lancet Diabetes & Endocrinology.
“The GLP-1 receptor agonist meta-analysis for MACE was one that was presented during the REWIND presentation at ADA where they took a previously published one from Circulation [and] added REWIND to it,” Skyler said during his presentation. “They all trend in the direction of showing the beneficial effect.”
Healio previously reported on the GLP-1 meta-analysis. Read more
SGLT2 meta-analysis
A meta-analysis of four recent CV and kidney outcomes trials assessing the use of SGLT2 inhibitors among patients with type 2 diabetes suggests that the drug class offers nephroprotective benefits across all levels of kidney function, regardless of albuminuria status, according to findings published in The Lancet Diabetes & Endocrinology.
“This meta-analysis of SGLT2 consisted of CREDENCE, DECLARE-TIMI 58, CANVAS and EMPA-REG Outcome,” Skyler said. “You can see, overall, there’s a 33% benefit in terms of dialysis transplant or renal death, separating that out as the outcome measure. If you look at substantial loss and kidney function, end-stage kidney disease, CV renal death, it’s a 29% overall risk reduction.”
Healio had previously reported on this SGLT2 meta-analysis. Read more
DAPA-HF trial
Among patients with HF, with and without diabetes, treatment with dapagliflozin reduced risk for worsening HF and CV death when added to standard therapy, according to anticipated results of the DAPA-HF trial.
“This was the first study, not for prevention of HF, but for patients who already had HF with reduced ejection fraction,” Cardiology Today Editorial Board Member Keith C. Ferdinand, MD, FACC, FAHA, FASH, FNLA, professor of medicine at Tulane University School of Medicine in New Orleans, said during a presentation. “The entry ejection fraction was 30% to 31%. These were patients who had functional class III or IV HF, symptomatic HF. The question to be answered was will SGLT2 inhibition help patients who already have HFrEF, and the answer is yes, there was a lower risk of worsening HF or death from CV causes and better quality of life.”
Healio previously covered the presentation of the results of the DAPA-HF trial at the European Society of Cardiology Scientific Congress. Read more
Reference:
Skyler JS, et al. FDA Updates and Late Breaking Trials. Presented at: Cardiometabolic Health Congress; Oct. 10-13, 2019; Chicago.
Disclosures: Ferdinand reports he consulted for Amgen, Boehringer Ingelheim, Eli Lilly, Novartis, Quantum Genomics, Regeneron and Sanofi. Skyler reports he has financial ties with multiple pharmaceutical and device companies.