No, CRISPR gene editing technology is not going to “cure” heart disease. But a New York Times story by Gina Kolata on an extremely early study in animals prominently plays up just this extremely unlikely claim. The Times story is based on a press release issued by Verve Therapeutics, a new biotechnology company founded by Sekar Kathiresan, an influential cardiologist and genomic…
Esperion Releases Top Line Results For First Pivotal Phase 3 Study
March 7, 2018 by 4 Comments
Esperion announced positive results today for the first in a series of pivotal phase 3 studies of its cholesterol lowering drug. The trial (Study 4, or 1002-048) compared bempedoic acid to placebo in 269 patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD who have high LDL cholesterol levels (100 mg/dl or greater)…
New And Improved LDL Lab Numbers
October 27, 2017 by 5 Comments
–Lab companies start reporting more accurate LDL cholesterol measurements. The LDL cholesterol number, which has been the obsessive focus of physicians and patients for several decades now, is getting a major upgrade. A new and improved method to calculate the LDL cholesterol number is starting to filter into standard laboratory reports. Until now LDL cholesterol,…
Why Do Doctors Still Rely On LDL Instead Of Non-HDL Cholesterol?
October 15, 2017 by 4 Comments
–There’s broad agreement that non-HDL is a better measure than LDL. For decades lipid experts have been saying that non-HDL is preferable to LDL cholesterol in the assessment of cardiovascular risk. The subject is not controversial. Although they may disagree about its precise significance, every expert I contacted agreed that non-HDL is superior to LDL….
REVEAL Revealed: A Slightly Positive CETP Inhibitor Trial
August 29, 2017 by 3 Comments
—After 3 strikes a CETP inhibitor finally scores. BARCELONA — Finally there is a CETP inhibitor that actually confers more benefit than risk: anacetrapib. The benefit emerged from the Randomized EValuation of the Effects of Anacetrapib through Lipid-modification (HPS3/TIMI55-REVEAL) trial which was presented here at the European Society of Cardiology meeting and published simultaneously in…
New Economic Analyses Fail To Make Case For PCSK9 Inhibitors
August 23, 2017 by 1 Comment
(Updated) –PCSK9 inhibitors have ‘the dubious distinction of being the most expensive preventive therapies by far in the history of cardiovascular medicine’ Two new economic analyses conclude that PCSK9 inhibitors are far too expensive to be cost effective. Both studies incorporate data from FOURIER, the first and still the only large cardiovascular outcomes trial with…
How Statins Make Some People Crazy
July 30, 2017 by 21 Comments
–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…
Study Estimates Benefits Of Broad Primary Prevention Strategies With Statins
July 20, 2017 by 9 Comments
–But the benefits may be substantially diminished when patient preferences are considered. A new analysis provides staunch support for the use of statins for the primary prevention of cardiovascular disease. But the same analysis also emphasizes that this support varies dramatically based on the values and concerns of individual patients. Kirsten Bibbins-Domingo (UCSF) led a…
End of the Road for CETP Inhibitors?
May 17, 2017 by 1 Comment
With the publication of the ACCELERATE trial in the New England Journal of Medicine the long train of bad and disappointing news for the once-promising approach of CETP inhibition remains unbroken. More than 12,000 high-risk patients were randomized in ACCELERATE to evacetrapib or placebo. In 2015 the trial was prematurely terminated for futility; the main…
Novel Drug Delivers Long Term Cholesterol Reduction
March 17, 2017 by 1 Comment
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…
FOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?
March 17, 2017 by 6 Comments
–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…
Genetic Studies Offer Hint Of Clinical Benefits-And Risks- of PCSK9 Inhibitors
November 30, 2016 by 2 Comments
–Both cardiovascular benefits and increase in diabetes seem likely. There is no more eagerly awaited question in cardiovascular medicine than the clinical role of the PCSK9 inhibitors. The first reports from a series of outcomes trials are not due until next year. But two large genetic studies published this week deliver strong indirect evidence that…
Universal Child FH Screening Proposed
October 26, 2016 by 1 Comment
–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…
LDL-Lowering Genetic Variants Linked to Diabetes Risk
October 6, 2016 by 1 Comment
–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…
FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug
June 30, 2016 by Leave a Comment
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…
Study Questions ‘Lower Is Better’ For Cholesterol
June 20, 2016 by 3 Comments
–No added benefit for statin patients who reached very low LDL levels A large observational study suggests that moderate lowering of LDL may be just as effective as intensive lowering. “Our results do not provide support for a blanket principle that lower LDL cholesterol is better for all patients in secondary prevention,” the authors conclude….
Not So Rare, FH Is Truly Risky Lipid Disorder
April 3, 2016 by Leave a Comment
–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…
ACCELERATE Puts the Brake on CETP Inhibition
April 3, 2016 by Leave a Comment
–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…
Rat Study Links Neural Tube Defects To Lower PCSK9 Levels
January 3, 2016 by Leave a Comment
(Updated) PCSK9 may play an important role in neural tube development (NTD), a new study in rats suggests. The study, published in Scientific Reports, found that PCSK9 levels were significantly reduced in rat embryos with NTDs. The main focus of the paper was to identify biomarkers that could be used for the prenatal detection of NTDs, since there are now…
New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs
November 5, 2015 by 4 Comments
More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…
Third Strike For CETP Inhibitors: Lilly Halts Big Evacetrapib Trial
October 12, 2015 by 2 Comments
For the third time a large trial testing a CETP inhibitor drug has gone down the tubes. On Monday morning Eli Lilly announced that it had terminated ACCELERATE, its large phase 3 trial of the drug evacetrapib. The company said the trial was stopped “due to insufficient efficacy” and that the company planned to discontinue…
Report Concludes That PCSK9 Inhibitors Are Effective But Very Expensive
September 8, 2015 by 1 Comment
The new PCSK9 inhibitors– with an annual cost of over $14,000 a year– are far too expensive to be broadly used in eligible populations without restrictions, according to a draft report from the Institute for Clinical and Economic Review (ICER). The price of the new drugs would need to fall to nearly $2,000 in order for the drugs to…
IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics
August 31, 2015 by 1 Comment
The beneficial effects of ezetimibe are found almost exclusively in patients with diabetes, according to an update of the influential IMPROVE-IT trial presented on Sunday at the European Society of Cardiology meeting in London. The new finding may lead to questions about the widely accepted interpretation of the main finding of the trial, which is that it provided strong support for…
Novel Drug Could Cut LDL With Just 2 Or 4 Shots A Year
August 30, 2015 by Leave a Comment
A novel drug still in phase 1 studies could dramatically lower cholesterol with only a few injections each year. Because the drug could be given during regular visits to the doctor it might help solve the thorny problem of drug compliance and adherence. Like the recently approved monoclonal antibodies alirocumab and evolocumab, the drug targets PCSK9 to lower LDL,…
Cholesterol Wars: The Reimbursement Battle Begins
August 28, 2015 by 1 Comment
(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…
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