–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….
Merck Drops Development Of Once Promising CETP Inhibitor
October 11, 2017 by 1 Comment
–Despite positive results in the REVEAL trial anacetrapib is dead. Merck announced on Wednesday that it would not seek regulatory approval for its cholesterol drug anacetrapib. The decision did not surprise most observers, despite the fact that investigators recently reported positive results for the drug in the enormous 30,000+ patient REVEAL trial. The trial was…
Side Effects In Drug Ads Don’t Add Up
October 10, 2017 by 4 Comments
–The long recitation of all possible side effects dilutes the perception of risk. One of the most perplexing aspects of the ubiquitous direct to consumer (DTC) prescription drug advertisements is the seemingly endless recitation of side effects in drug ads. The list is, alternatively, horrifying, boring, concerning, and silly. It is reasonable to wonder how these…
Upcoming US Guideline Will Likely Set 130/80 As New Blood Pressure Target
October 6, 2017 by 1 Comment
–The highly anticipated AHA/ACC BP guideline will be published in November. The new magic number will be 130 over 80 mm Hg. That’s the new blood pressure goal that many hypertension experts say will be the centerpiece of the new US blood pressure guidelines. The new guideline will be introduced next month in Anaheim during the…
FDA’s Gottlieb Preparing To Lower The Bar To Approval
September 28, 2017 by 3 Comments
–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…
Benefits Of Physical Activity Seen Worldwide
September 21, 2017 by 1 Comment
–Latest findings from the influential PURE study Observational studies have consistently established a link connecting physical activity and cardiovascular health, but the vast majority of this research has occurred in high-income countries, where physical activity is often recreational. Now the latest report from an enormous worldwide observational study offers powerful evidence that the connection exists…
What If PCI Is Just A Sham?
September 18, 2017 by 3 Comments
–A small study might upset assumptions about the benefits of stent. What if PCI for stable ischemic heart disease (SIHD) is just a big lie? That is, what if it’s no better than a sham procedure? This may seem like a crazy proposition, but there’s at least an outside chance that a small trial coming…
Cardiac Stem Cell Therapies May Get Boost From New FDA
September 14, 2017 by 1 Comment
–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…
Julio Palmaz Really Doesn’t Want You To Read This Story
September 11, 2017 by 8 Comments
—Raising questions about a trial provokes a ‘cease-and-desist’ letter. The world stent pioneer Julio Palmaz really doesn’t want you to read this post. After I raised questions about a recent paper involving Palmaz I received a “cease-and-desist” letter from his lawyer. Here is the background to this story: Last year I wrote a brief post…
Cardiology Is Dead. Long Live Public Health.
September 7, 2017 by 8 Comments
Cardiology is dead. Here’s two new important pieces of evidence: The FDA’s Cardiovascular and Renal Drugs Advisory Committee hasn’t met since April 2015, and even then it was for the decidedly uninspiring drug cangrelor. And the committee has no meetings scheduled for the rest of this year. Take a look at the list of late-breaking…
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…
Renal Denervation Resurrected With Modest BP Reduction
August 28, 2017 by Leave a Comment
–Preliminary results from SPYRAL HTN-Off Med BARCELONA – Renal denervation is back from the dead, but only as a faint shadow of its former self. Initial interim results of the SPYRAL HTN-Off Med study suggest that the new and improved version of renal denervation (RDN) produces a real but very modest reduction in blood pressure….
CANTOS Validates Role Of Inflammation In Heart Disease
August 27, 2017 by 8 Comments
–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,…
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…
Big Mismatch In Risk Perception Between Heart Failure Patients and Their Physicians
August 17, 2017 by 4 Comments
There’s a big discrepancy between the way patients with “advanced” heart failure view themselves and the way their doctors view them, a new study published in JACC: Heart Failure shows. In a cohort of 161 ambulatory patients with advanced heart failure, physicians categorized 111 patients (69%) as being at high risk for urgent transplant, LVAD,…
Renal Denervation: Back From The Dead Or Deja Vu All Over Again?
August 14, 2017 by 1 Comment
Renal denervation is back. Or not. The failure of renal denervation (RDN) was one of the most spectacular failures in cardiovascular medicine in recent years. Great expectations for RDN appeared to die with the Simplicity-3 HTN trial, the first rigorous test of the technology, which showed that it was ineffective in the treatment of resistant…
Generic Atenolol in Short Supply
August 10, 2017 by 1 Comment
–The latest sign of turmoil in the generic drug marketplace. The widely prescribed beta-blocker atenolol is in short supply around the country. The FDA first reported an atenolol shortage on July 26. According to the FDA website, three companies that manufacture generic atenolol — Mylan, Sandoz, and Teva — say that the cause is a…
Pharma Phantasy: The $30 Billion PCSK9 Inhibitor Market
August 8, 2017 by 2 Comments
–Drug company dreams up a study showing all the benefits and none of the costs or risks of PCSK9 inhibitors. Here’s a pro tip for pushing a drug (or, indeed, any aggressive treatment or screening strategy): focus exclusively on the benefits, even if they are modest at best, and completely ignore side effects and costs….
Ethical Questions Raised About NIH Blood Transfusion Trial
August 4, 2017 by Leave a Comment
–Public Citizen says the MINT trial comparing blood transfusion strategies after MI should be halted. Public Citizen is calling for the immediate suspension of a large NIH-sponsored trial comparing blood transfusion strategies after heart attacks. The Myocardial Ischemia and Transfusion (MINT) trial should be halted “because of potentially serious ethical violations,” said the consumer advocacy…
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…
Nissen Calls Statin Denialism A Deadly Internet-Driven Cult
July 24, 2017 by 15 Comments
–“We are losing the battle for the hearts and minds of our patients.” A leading cardiologist has unleashed a blistering attack on “statin denial,” which he calls “an internet-driven cult with deadly consequences.” In an editorial in Annals of Internal Medicine, Steve Nissen (Cleveland Clinic) expresses grave concerns over statistics showing that only 61% of…
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…
Questions Raised About Trump’s New CDC Boss
July 11, 2017 by 3 Comments
–Fitzgerald championed Coke-backed obesity program and practiced ‘anti-aging medicine’ Serious questions are being raised about Brenda Fitzgerald, MD, the Georgia doctor who Trump is appointing to be the new head of the CDC. Fitzgerald is an ob/gyn with long involvement in Republican politics in her state. She currently serves as the Commissioner of the Georgia…
Labscam: Rogue Laboratory Testing At Center Of Addiction Treatment Scandal
July 3, 2017 by 1 Comment
–‘Sober homes’ in Florida are just the tip of the iceberg. A massive scandal involving fraudulent addiction treatment centers and rogue laboratories has recently surfaced. Several recent news reports have focused on the scandal’s epicenter in Florida, but industry observers say that the scandal is the tip of an iceberg of corruption, abuse, and fraud…
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