A multicenter examine led by Vanderbilt College Medical Heart (VUMC) and Lipscomb College School of Pharmacy in Nashville has recognized a possible new therapy for acute coronary heart failure, a number one explanation for hospitalization and demise.
The drug, dapagliflozin, was initially authorised for the therapy of Kind 2 diabetes, nevertheless it since has been proven to scale back the danger of hospitalization for coronary heart failure and demise in sufferers with severe well being issues that embrace coronary heart and power kidney illness and heightened cardiovascular danger.
Reporting this month within the Journal of the American School of Cardiology, the researchers discovered that dapagliflozin additionally advantages sufferers after admission to the hospital for acute coronary heart failure. The drug improves diuresis, the elimination of extra fluid from the lungs, thereby relieving congestion, and it could scale back hospital stays.
“We demonstrated security and efficacy of initiating dapagliflozin inside the first day of hospitalization for acute coronary heart failure,” mentioned the paper’s first writer, Zachary Cox, PharmD, professor of Pharmacy Apply at Lipscomb College. This “can have worldwide influence on the therapy of acute coronary heart failure.”
Every year 800,000 sufferers with acute coronary heart failure are admitted to U.S. hospitals from emergency rooms. These sufferers are at excessive danger for extended hospital stays and demise. The annual value of treating acute coronary heart failure in the US is estimated to exceed $34 billion.
Diuretics are administered to most sufferers with acute coronary heart failure to enhance signs and lung congestion brought on by fluid buildup. Nevertheless, the optimum method to diuretic remedy in sufferers hospitalized for acute coronary heart failure stays poorly outlined and contributes to extended inpatient stays and excessive demise and readmission charges.
Moreover, many sufferers don’t reply to diuretics, and about half of sufferers are discharged with persistent congestion. This can lead to sufferers returning to the hospital quickly after discharge and being readmitted for additional coronary heart failure remedy.
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that acts on the kidneys to extend the removing of sodium and glucose from the physique. In April 2020, VUMC started a randomized, medical trial of the drug in sufferers hospitalized with acute coronary heart failure.
The examine was designed by VUMC’s JoAnn Lindenfeld, MD, and Sean Collins, MD, MSc, and by Cox, a member of VUMC’s coronary heart failure analysis crew.
Lindenfeld, professor of Drugs within the Division of Cardiology, is nationally identified for her progressive contributions to the sphere of coronary heart failure.
Collins, professor of Emergency Drugs, directs the Heart for Emergency Care Analysis and Innovation (CERI), a nationwide chief in emergency care analysis, co-directs the Vanderbilt Coordinating Heart, which helps VUMC-led medical analysis, and is affiliate director for medical trials analysis within the Vanderbilt Institute for Drugs and Public Well being.
Cox is a fellow of the Coronary heart Failure Society of America who has revealed extensively within the discipline.
Regardless of the COVID-19 pandemic, which reached its crescendo in the course of the examine, the researchers have been in a position to enroll 240 sufferers and full the trial, “due to the diligent effort and collaboration between the CERI analysis crew, and … the departments of emergency drugs and cardiology,” Cox mentioned.
“This distinctive partnership permits VUMC to conduct trials in acute coronary heart failure which are solely doable in a small variety of medical facilities the world over,” he mentioned.
The trial “actually highlights the novelty of our Emergency Drugs infrastructure, and why we’re a frontrunner in designing and conducting extremely impactful medical trials reminiscent of this one,” Collins added.
Sufferers have been enrolled at 5 websites along with VUMC: TriStar Centennial Medical Heart and Ascension St. Thomas Hospital West in Nashville, the College of North Carolina at Chapel Hill, the College of Mississippi Medical Heart in Jackson, and INTEGRIS Well being Baptist Medical Heart in Oklahoma Metropolis.
Inside 24 hours of admission for acute coronary heart failure, sufferers have been randomized to obtain both dapagliflozin or typical diuretic therapy.
Whereas early administration of dapagliflozin didn’t enhance weight-based diuretic effectivity in comparison with typical therapy, sufferers who acquired the drug skilled no improve in opposed occasions, required shorter durations of IV diuresis, and have been discharged sooner throughout the five-day examine interval.
The trial demonstrated the protection and efficacy of beginning a drug throughout early hospitalization that may proceed to be prescribed upon discharge to assist obtain optimum outpatient remedy and scale back the chance of readmission.
“It’s a technique to each enhance diuresis AND get a head begin on implementing Guideline Directed Medical Remedy in sufferers with acute coronary heart failure,” Lindenfeld mentioned.
Different VUMC co-authors are Cathy Jenkins, MS, and Frank Harrell Jr., PhD, Division of Biostatistics, and Christina Kampe, MAcc, Karen Miller, RN, MPA, and William Stubblefield, MD, MPH, Division of Emergency Drugs.
The examine was an investigator-initiated trial funded by AstraZeneca however independently carried out by VUMC investigators. Dapagliflozin is marketed below the model identify FARXIGA. Acute coronary heart failure analysis at VUMC is supported partly by the Nationwide Coronary heart, Lung and Blood Institute of the Nationwide Institutes of Well being.
