Search Results for: pcsk9

CANTOS Validates Role Of Inflammation In Heart Disease

–Modest treatment effect of canakinumab may limit clinical role in heart disease, but strong anti-cancer signal sparks interest. Despite questions about its clinical importance, the CANTOS trial is being hailed by experts for finally validating the role of inflammation in heart disease. The cardiovascular benefits in the trial were real but modest. Even more exciting,…

Click here to continue reading…

How Statins Make Some People Crazy

–Intelligent discussion about statins is threatened by zealous partisans. What is it about statins that causes so many people to go crazy? I’m not talking about any pharmacological effect of the drugs. Instead my focus here is on the zealous partisans— both against and in support of statins— who go off the deep end. Unfortunately…

Click here to continue reading…

Two NEJM Papers Spotlight Promising But Early New Cardio Drugs

Now that cardiologists and other doctors are comfortable talking about PCSK9 inhibitors they can start preparing to add a new mouthful of a therapeutic target to their vocabulary: angiopoietin-like-3 (ANGPTL3). Two papers published in the New England Journal of Medicine by industry researchers provide a snapshot of promising but still early research on two new drugs that target…

Click here to continue reading…

Ebbinghaus Study May Help Refute Doctor Google

–No neurocognitive adverse effects linked to very low LDL levels Reaching very low LDL levels with a PCSK9 inhibitor was not associated with any increase in neurocognitive adverse events, according to the largest and most rigorous study to assess the topic to date. Small and preliminary studies have raised concerns over the possibility of the…

Click here to continue reading…

Novel Drug Delivers Long Term Cholesterol Reduction

A novel drug that dramatically lowers LDL cholesterol and needs to be administered only a few times a year has reached a new milestone. Positive results from a phase II study with the drug, now known as inclisiran, were reported at the American College of Cardiology meeting in Washington, DC and published simultaneously in the…

Click here to continue reading…

FOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?

–Doctors and patients now must wrestle with a modestly effective but expensive drug. As it turns out the PCSK9 inhibitor saga ends not with a bang but a whimper. The results of the highly anticipated FOURIER trial show that the drugs work, though not as powerfully as many had hoped and expected. The question now…

Click here to continue reading…

Enormous Rivaroxaban Study Stopped Early For ‘Overwhelming Efficacy’

(Updated) –Oral anticoagulant reduced CV events in patients with coronary and peripheral disease. The very large COMPASS study has been stopped early for “overwhelming efficacy,” according to a press release issued by Bayer AG and Janssen, manufacturers of rivaroxaban (Xarelto). The phase 3 trial randomized 27,402 patients with coronary artery disease (CAD) and peripheral artery…

Click here to continue reading…

The GiveAway Act

The 21st Century Cures Act should be called the 21st Century GiveAway Act. The Act may not even deliver on its main attraction– the funding of new research– but will instantly definitely give a regulatory boost to a host of special interests, including drug and device makers. As Michael Hiltzik writes in the LA Times,…

Click here to continue reading…

Statin Nation ‘Census’ Highlights Major Disparities

–Women, minorities treated at significantly lower rates Anyone reading this is almost certainly aware of the enormous importance of statins in the current health scene. But until now they may have had a hard time to bring precise numbers and statistics to this all important story. Now data from a large federal survey confirm that…

Click here to continue reading…

Novel Cholesterol Therapy Flops And Company Ends Development

–13 years after ApoA-1 Milano sparked excitement the novel HDL therapy appears to be dead. After 13 years and despite the efforts of 3 separate companies, the novel cholesterol therapy known as ApoA-1 Milano appears to be dead. On Monday afternoon the Medicines Company announced that it had discontinued development of the drug and would…

Click here to continue reading…

Universal Child FH Screening Proposed

–Novel strategy would identify both children and adults at high risk for CV events. Doctors in the U.K. are proposing a novel strategy to identify very young children with familial hypercholesterolemia (FH). The strategy would also identify and help prevent events in the parents who also have FH. The new approach begins with a heel-stick…

Click here to continue reading…

Novel Cholesterol Drugs Move Forward In Clinical Trials

–New information about upcoming cholesterol drugs from the Medicines Company and Esperion Recently the makers of two novel cholesterol-lowering drugs in development provided important updates on their progress. On Tuesday, the Medicines Company announced positive top-line results for a trial of its unusual PCSK9 synthesis inhibitor scheduled to be presented in November. Last week Esperion…

Click here to continue reading…

LDL-Lowering Genetic Variants Linked to Diabetes Risk

–What can genetics tell us about diabetes incidence with cholesterol drugs? Editor’s note: The following guest post was contributed by Marilyn Mann, a well-known advocate for patients with familial hypercholesterolemia and a patient advisor to Circulation: Cardiovascular Quality and Outcomes. In a study published in the Journal of the American Medical Association, several LDL-lowering genetic…

Click here to continue reading…

Repatha Approved for Single Monthly Injection

–New hands-free system replaces three sequential shots The FDA has approved a device that can deliver a single monthly injection of evolocumab (Repatha), the cholesterol-lowering PCSK9 inhibitor manufactured by Amgen. Repatha is currently administered by subcutaneous injection in a 140-mg dose every 2 weeks or as a 420 mg monthly dose. Until now, the monthly…

Click here to continue reading…

FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug

Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within…

Click here to continue reading…

Time For Cardiologists To Start Prescribing Diabetes Drugs?

There’s an emerging consensus that now may be the time for cardiologists to start thinking seriously about prescribing diabetes drugs. Until now most cardiologists have not considered this to be part of their job description. But now new data from large cardiovascular outcome trials (CVOTs) shows that these drugs may one day become, like statins and…

Click here to continue reading…

ASGR1 Gene Tied to Heart Health

(Updated) –May have stronger impact than PCSK9 variants on disease risk A large new study from Iceland has identified variants in a gene that appear to have powerful cardioprotective effects, perhaps an first early step toward a novel therapy for heart disease prevention and treatment. The gene, ASGR1, was identified by the well known genetic…

Click here to continue reading…

New Cardio Drugs Off To Very Slow Start

–Heart failure experts divided over how and when to use Entresto To many long-time observers, the approval last year of two new cholesterol drugs and a heart failure drug appeared to herald a rebirth of the cardiovascular marketplace after a long period of dormancy. But so far in 2016, those new drugs have hardly made…

Click here to continue reading…

Not So Rare, FH Is Truly Risky Lipid Disorder

–Not all elevated is LDL is equally dangerous CHICAGO — Familial hypercholesterolemia (FH), a condition that has long been overshadowed by more common cardiovascular diagnoses, has now found the spotlight in the big tent as a hot and even controversial topic. The new interest is driven by important advances in understanding the genetics of the…

Click here to continue reading…

ACCELERATE Puts the Brake on CETP Inhibition

–No benefit with evacetrapib despite increase in HDL and decrease in LDL The fat lady hasn’t sung, the referee hasn’t counted up to 10, but it’s sure not looking good for the once highly promising class of drugs known as the CETP inhibitors. Bang the Drum Slowly, and Play the Fife Lowly Following the crash…

Click here to continue reading…

How Many People Really Have Familial Hypercholesterolemia– And Does It Matter?

A new study estimates that about 834,000 adults in the US have genetically high cholesterol levels, otherwise known as familial hypercholesterolemia (FH). The prevalence of FH, which the authors calculate as 1 in 250 American adults, is twice the size of earlier assumptions. But the authors acknowledge that the criteria for FH used in their…

Click here to continue reading…

Large Genetic Studies Support Role For Triglycerides In Cardiovascular Disease

Two  papers published in the New England Journal of Medicine offer new genetic evidence to support the increasingly accepted though still controversial view that triglycerides play an important causal role in cardiovascular disease. If fully validated the new findings could lead to new drugs to prevent and treat cardiovascular disease, though others caution that there…

Click here to continue reading…

Vulnerable Plaque: The Paradigm That Failed

Is it a hallowed paradigm or a hype-othesis? The “holy grail” of cardiology is to stop heart attacks before they happen by identifying– quickly, noninvasively, and specifically– those coronary artery lesions that result in heart attacks. The key theoretical underpinning driving this goal has been the vulnerable plaque hypothesis, which holds that the vast majority…

Click here to continue reading…

Slow Start For ‘Blockbuster’ Heart Failure Drug Entresto

Entresto, the new heart failure drug from Novartis that is widely expected to be a blockbuster, is off to an exceptionally slow start. Approved last July, the drug, formerly known as LCZ 696, had sales of only $21 million in 2015, only $5 million of which came in the fourth quarter. Despite low expectations in the early…

Click here to continue reading…

2015: The Year We Finally Cured Heart Disease!

Editor’s note: Larry was too depressed to write the 2015 yearly review. Veteran healthcare journalist and eternal optimist Candide Corn volunteered to take over the task this year. Candide’s motto is “all is for the best in the best of all possible worlds.” What a great year for cardiology! The year brought us an unending…

Click here to continue reading…