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.

FDA approves Bayer's finerenone to treat wide range of heart failure patients
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
Statin use may protect patients from subarachnoid hemorrhages
Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.
FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy
The new drug, LX2006, has already received the FDA's fast track designation. This latest distinction was based on early data from two separate clinical trials.
FDA finalizes new heart warnings for COVID-19 vaccines
The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines.
New report raises questions about data that helped heart drug gain FDA approval
Ticagrelor, an antiplatelet medication from AstraZeneca commonly prescribed by cardiologists, gained FDA approval back in 2011. The author of a new investigative report, however, is raising several concerns about the data used to secure that approval.

Bertram Pitt, MD, a professor of medicine emeritus at the University of Michigan School of Medicine, explains the role of sodium–glucose co-transporter-2 (SGLT-2) inhibitors for heart failure (HF). Initially developed to treat diabetes, these drugs have been shown to improve HF outcomes in HF in several large, randomized trials over the past few years, including SOLOIST-WHF, DAPA-HF, EMPEROR-Preserved, and the DELIVER trials. The positive results earned their inclusion in the 2022 AHA/ACC/HFSA Guideline for

What clinical research tells us about sotagliflozin and heart failure

Some SGLT2 inhibitors have been linked to significant improvements in HF outcomes, but what about sotagliflozin? We spoke with Bertram Pitt, MD, to learn more.

Vericiguat consistently linked to positive outcomes, limited side effects among heart failure patients

Reviewing data from several studies, researchers wrote that vericiguat (Verquvo) could potentially "become a breakthrough in the treatment of heart failure."

FDA calls out weight loss pills for ‘hidden’ ingredient that puts health of heart patients at risk

The agency’s own analysis confirmed that these capsules contain sibutramine, which was removed from the market back in 2010 due to safety concerns

CardiacSense, an Israel-based healthcare technology company, gained FDA clearance for its CSF-3 medical watch

Regulatory Roundup: FDA clears new medical watch, considers empagliflozin for CKD and much more

Our monthly review of FDA-related news items in the world of cardiology includes updates from CardiacSense, MedAlliance, Lupin, Realize Medical and Eli Lilly and Company.

FDA approves new medication for type 2 diabetes

The newly approved SGLT2 inhibitor, bexagliflozin, is marketed under the name Brenzavvy. It is not recommended for patients with type 1 diabetes.

Peter Libby, MD, a cardiovascular medicine specialist, Brigham and Women’s Hospital, and Mallinckrodt Professor of Medicine, Harvard Medical School, explains the take aways from the PROMINENT trial using pemafibrate to lower cardiovascular risks. The trial, presented at the American Heart Association (AHA) 2022 meeting, did not show reduction in the incidence of cardiovascular events among those who received pemafibrate than among those who received placebo. #AHA #AHA22

VIDEO: Pemafibrate does not lower cardiovascular risks in the PROMINENT trial

Peter Libby, MD, a cardiovascular medicine specialist with Brigham and Women’s Hospital and Harvard Medical School, explained some key takeaways from the PROMINENT trial.

How cardiologists can improve in-hospital outcomes after PCI

Researchers evaluated if two recently developed risk scores can anticipate adverse in-hospital outcomes after PCI, sharing their findings in the American Journal of Cardiology.

A new antiplatelet strategy for treating diabetic PCI patients

Clopidogrel monotherapy after just one month of DAPT was associated with promising outcomes, including a reduction in bleeding events.

Pharmaceutics

FDA approves Bayer's finerenone to treat wide range of heart failure patients

Statin use may protect patients from subarachnoid hemorrhages

FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy

FDA finalizes new heart warnings for COVID-19 vaccines

New report raises questions about data that helped heart drug gain FDA approval