Pharmaceutics

This page contains key pharmaceutical news on drug recalls, FDA clearance, safety communications and research. In cardiology, key pharmaceutic agents include antiplatelet therapies, anticoagulants, hypertension drugs, and drugs for heart failure and arrhythmias.

Dapagliflozin improves outcomes for elderly TAVR patients with heart failure
The positive data were presented as part of a late-breaking clinical trial at ACC.25 in Chicago. One cardiologist on stage for the presentation said these findings will impact the way he manages certain TAVR patients.
Oral semaglutide reduces heart risks while helping patients move past ‘fear of the needle’
Researchers still think patients should receive an injectable version of semaglutide when possible, but new data out of ACC.25 confirm that an oral formulation of the drug is associated with significant benefits.
‘A practice-changing trial’: Semaglutide linked to key benefits for PAD patients with diabetes
Patients who present with type 2 diabetes and PAD often face substantial mobility issues. According to new data presented at ACC.25, however, treatment with semaglutide could represent a major step forward for this high-risk population.
FDA chooses not to approve new nasal spray for heart rhythm issues
Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals.
Is statin therapy safe for pregnant women?
Laxmi Mehta, MD, explained that the use of statins when treating pregnant women is no longer forbidden. However, she added, cardiologists should always discuss it first with their patients.

FDA grants fast track designation to Bayer’s new drug for preventing stroke in AFib patients

The new drug, asundexian, is currently the subject of two multicenter Phase III studies—the OCEANIC-AF trial and OCEANIC-STROKE trial—focused on its safety and efficacy.

FDA expands dapagliflozin approval to cover all heart failure patients

The FDA has previously approved the SGLT2 inhibitor in patients with HFrEF, but not HFmrEF or HFpEF

Paul M. Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention, and the Eugene Braunwald Professor of Medicine, cardiovascular medicine, Brigham and Women's Hospital, who presented the results of late-breaking study on residual inflammatory risk in contemporary statin treated patients. The study used an analyses of 31,197 patients in the PROMINENT, REDUCE-IT and STRENGTH trials.

What new data can teach cardiologists about statin use and treating inflammation

"If we do not attack the inflammation, we just are not going to get the best outcomes for our patients," one researcher told Cardiovascular Business.

Marielle Scherrer Crosbie and Tomas Neilan explain the STOP-CA trial and how statins can help prevent cardiotoxicity from anthracycline chemo agents.

Statins may help prevent anthracycline cardiotoxicity in chemotherapy

The STOP-CA trial showed that statins can help chemotherapy patients avoid potential side effects related to anthracycline agents. Co-principal investigators Marielle Scherrer-Crosbie, MD, and Tomas Neilan, MD, discussed the details of that trial at ACC.23.

Clopidogrel linked to better long-term outcomes than aspirin in PCI patients with and without diabetes

Clopidogrel is especially effective at limiting major adverse cardiovascular events among PCI patients with diabetes, researchers found.

Antibiotic recalled due to risk of endocarditis, other life-threatening infections

According to an advisory on the FDA’s website, there is a “reasonable probability” that any immunocompromised patients exposed to the affected antibiotic could develop a life-threatening infection.

FDA approves drug for children with rare condition causing high LDL cholesterol

Evkeeza, which was previously approved for patients ages 12 and above, was shown to help lower cholesterol for children with homozygous familial hypercholesterolemia (HoFH), in conjunction with other therapies.

NASA astronaut Kate Rubins conducts research for the Effect of Microgravity on Drug Responses Using Engineered Heart Tissues (Cardinal Heart) investigation onboard the International Space Station, one of several cardiovascular experiments on the ISS in recent years. Two more cardiac experiements launched to the ISS in March 2023. NASA Image

Heart tissue heads to space for research on aging and impact of long spaceflights

These experiments, performed with help from NASA, are simply out of this world.

Pharmaceutics

Dapagliflozin improves outcomes for elderly TAVR patients with heart failure

Oral semaglutide reduces heart risks while helping patients move past ‘fear of the needle’

‘A practice-changing trial’: Semaglutide linked to key benefits for PAD patients with diabetes

FDA chooses not to approve new nasal spray for heart rhythm issues

Is statin therapy safe for pregnant women?