Sanofi and Regeneron achieved a modest victory with the much anticipated ODYSSEY Outcomes trial of its cholesterol lowering drug Praluent (alirocumab). The trial met its primary endpoint and even reported a significant improvement in all-cause mortality. But the mortality finding has an asterisk attached to it and it is far from clear whether the overall…
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)…
Moment Of Truth For Struggling And Expensive Cholesterol Drugs
February 15, 2018 by 7 Comments
It will be the moment of truth for the expensive new cholesterol drugs known as PCSK9 inhibitors. Next month we will learn much more about the PCSK9 inhibitor class of cholesterol drugs. A lot of the remaining uncertainty about the efficacy— or lack of efficacy— of these drugs will be resolved when a large cardiovascular…
Statin Critic Accused Of Image Manipulation In Earlier Research
February 8, 2018 by 7 Comments
A journalist who has been a frequent critic of statins has been publicly accused of scientific misconduct involving image manipulation in an earlier research paper. Maryanne Demasi is an Australian journalist who has a PhD in Rheumatology from the Royal Adelaide Hospital in South Australia. She has been a frequent critic of statins, a proponent of…
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…
Forthcoming Expert Guideline May Upgrade PCSK9 Inhibitors
July 21, 2017 by 1 Comment
Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial…
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…
Merck Reveals Positive Findings For Its CETP Inhibitor
June 27, 2017 by 2 Comments
–Surprising success after 3 previous drugs in the class failed. Merck announced on Tuesday that the REVEAL trial with anacetrapib had met its primary endpoint, significantly reducing the rate of coronary death, MI, and coronary revascularization in high risk patients already taking statins. Full results of REVEAL will be presented on August 29 at the European…
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…
Study Fuels Debate Over When to Start Cholesterol Screening
May 15, 2017 by 3 Comments
–For younger adults, study finds low yield of 10-year risk-based screening A new study provides ammunition to supporters of a conservative approach to initiating cholesterol tests in younger adults. But proponents of a more aggressive approach argue that the interpretation does not take into account the enormous burden of cardiovascular disease as people grow older….
Another HDL Therapy Crashes and Burns
March 19, 2017 by 3 Comments
–Failure of pre-beta HDL mimetic puts another nail in the HDL coffin Once again, an HDL-inspired therapy has failed when put to the test in a clinical trial. Although there are still ongoing trials with other HDL-related therapies, most experts now feel that it is time for the field to turn its attention elsewhere and…
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…
27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints
February 2, 2017 by 3 Comments
(Updated) –Cardiovascular outcomes finally available for PCSK9 inhibitors. Amgen announced on Thursday afternoon that the FOURIER trial had met both its primary composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the even more rigorous key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). The company…
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…
Saturated Fats Linked To Heart Disease Once Again
November 27, 2016 by 10 Comments
–But critics say that observational studies can’t establish causal relationship. A prominent group of nutrition researchers have once again linked saturated fats to increased coronary heart disease. The new paper, published in BMJ, is the third paper in the past year to decry saturated fats. Along with the previous two papers, published in JACC and JAMA Internal…
Mixed Results For ApoA-1 Therapies
November 16, 2016 by Leave a Comment
–It’s still not time to write the obituary for all HDL therapies. There was good news and bad news for a category of experimental drugs that attempt to mimic the putative beneficial effect of HDL at the American Heart Association meeting in New Orleans. Thirteen years after setting the field on fire with a promising…
Pfizer Ends Development Of Its PCSK9 Inhibitor
November 1, 2016 by 1 Comment
–Immune issues and diminishing efficacy doomed the new drug. Pfizer announced on Tuesday that it was discontinuing development of bococizumab, its cholesterol-lowering PCSK9 inhibitor under development. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide…
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…
Novel Cholesterol Drugs Move Forward In Clinical Trials
October 18, 2016 by 1 Comment
–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…
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…
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