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CardioBreak: PCSK9 Drug Cuts Apheresis, Novel Xa Drug Gets Complicated

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Posted: 3/28/2016 1:54:51 PM
Edited: 5/1/2022 11:12:11 AM (1)

CardioBreak: PCSK9 Drug Cuts Apheresis, Novel Xa Drug Gets Complicated

Recent developments of interest in cardiovascular medicine

Alirocumab (Praluent) reduced the frequency of apheresis by 75% compared with placebo and eliminated the need for apheresis for 63%, according to top-line results from the 62-patient phase III ODYSSEY ESCAPE trial in heterozygous familial hypercholesterolemia getting the treatments.

Novel factor Xa anticoagulant betrixaban missed its primary endpoint in the phase III APEX trial. The drug wasn’t better than enoxaparin (Lovenox) in preventing venous thromboembolism (VTE), pulmonary embolism, or VTE-related death in acute medically ill patients in the first trial cohort, a hurdle required in the protocol to move on to analysis of other cohorts.

"However, because the p-value was so close to the mark [in APEX], management still evaluated cohort 2 and the overall population and found that efficacy in those groups were backed up by p-values of 0.029 and 0.006, respectively," reported Motley Fool. "The company’s management plans to discuss the overall study results with the FDA soon and they remain undaunted in their plans to file a new drug application later this year."

The Impella line of implantable cardiac assist devices won’t need to undergo FDA advisory committee review for an expanded approval to patients with cardiogenic shock.

The Xeltis bioabsorbable cardiac pulmonary valve got humanitarian use device (HUD) designation by the FDA for treating children with a congenital obstruction.

The FDA warned Terumo about manufacturing flaws related to its carotid, peripheral, and renal guiding sheaths and said the company can’t get any premarket approval applications for related devices approved until resolved. The company detailed restricted access to its products here.

European regulators cleared the sirolimus-eluting, self-apposing Xposition S stent for use in unprotected left main coronary artery disease.

The U.K. National Institute for Health and Care Excellence (NICE) finalized approval of heart failure drug sacubitril/valsartan (Entresto).

The AHA/industry initiative to fund "One Brave Idea" to cure heart disease is now narrowing down applicants with the goal of announcing a winner this summer. See MedPage Today’s prior coverage here and here.

Meanwhile, heart disease mortality rates have declined over the past 4 decades overall, although some Southern areas haven’t kept pace.

CardioBreak is a guide to what’s new and interesting on the Web for cardiologists and other healthcare professionals with an interest in cardiovascular disease, powered by the MedPage Today community. Got a tip? Send it to us: