Blacks Face Higher Mortality from Heart Disease, Stroke

–CV disease accounts for large portion of health disparities. Cardiovascular disease led to the loss of more than 2 millions years of life in the African-American population between 1999 and 2010. A new scientific statement from the American Heart Association, Cardiovascular Health in African Americans, makes clear that, compared to whites, African Americans suffer disproportionately…

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Why Do Doctors Still Rely On LDL Instead Of Non-HDL Cholesterol?

–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….

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Merck Drops Development Of Once Promising CETP Inhibitor

–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…

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Side Effects In Drug Ads Don’t Add Up

–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…

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Upcoming US Guideline Will Likely Set 130/80 As New Blood Pressure Target

–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…

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Some Doctors Reluctant To Deactivate LVADs

–LVAD deactivation is not euthanasia or physician-assisted suicide. Left ventricular assist devices (LVADs) are used increasingly as destination therapy instead of as a temporary bridge until a donor heart becomes available for transplantation. Now patients, their families, and their caregivers are forced to confront the extremely difficult question of when and how to turn off…

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FDA’s Gottlieb Preparing To Lower The Bar To Approval

–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…

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Genotyping Reduces Adverse Events with Warfarin

–But still unclear whether benefit justifies the cost. Because its effects can be highly variable, warfarin is a notoriously difficult drug to administer. In recent years warfarin has resulted in more medication-related visits to emergency departments among older patients than any other drug. Researchers have long hoped that genotype-guided dosing of warfarin might reduce the…

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Stopping Aspirin Hikes CV risk

–37% increase in events seen after discontinuation in Sweden People who quit taking aspirin have an increased risk for a cardiovascular event, a large national registry has shown. The use of aspirin for primary prevention against cardiovascular disease has fallen from favor in recent years but aspirin for secondary prevention is still broadly popular and…

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Benefits Of Physical Activity Seen Worldwide

–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…

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Barely Half of Postmarket Studies Completed After 5 Years

–FDA fails to enforce requirements. Pharmaceutical and device companies are often taking advantage of a lenient (or, some would say, negligent) FDA to shirk their obligation to perform timely post-approval studies, a new Perspective published in the New England Journal of Medicine shows. The topic has gained increasing visibility and importance as the FDA has…

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What If PCI Is Just A Sham?

–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…

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Cardiac Stem Cell Therapies May Get Boost From New FDA

–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…

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Julio Palmaz Really Doesn’t Want You To Read This Story

—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…

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Cardiology Is Dead. Long Live Public Health.

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…

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SPRINT Substudy Detects Mortality Signal

–Aggressive blood pressure lowering may sometimes be deadly. BARCELONA — A new examination of data from the SPRINT trial raises the fear that adopting the aggressive blood pressure target of 120 mm Hg in some hypertensive patients with baseline BP of 160 mm Hg or more may increase the risk of death. Tzung-Dau Wang, MD,…

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REVEAL Revealed: A Slightly Positive CETP Inhibitor Trial

—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…

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Renal Denervation Resurrected With Modest BP Reduction

–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….

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New Economic Analyses Fail To Make Case For PCSK9 Inhibitors

(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…

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Big Mismatch In Risk Perception Between Heart Failure Patients and Their Physicians

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,…

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Off-Pump CABG Raises Long-Term Mortality Risk

–Significant risk over on-pump grafting found at 5 years in ROOBY trial. It seemed like a great idea. Perform coronary-artery bypass grafting (CABG) without stopping the heart and you can prevent the dangers of cardiopulmonary bypass. But it didn’t work out. After growing in popularity over the previous decade, in 2009 the first large, well-conducted…

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Renal Denervation: Back From The Dead Or Deja Vu All Over Again?

  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…

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Generic Atenolol in Short Supply

–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…

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Pharma Phantasy: The $30 Billion PCSK9 Inhibitor Market

–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….

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Ethical Questions Raised About NIH Blood Transfusion Trial

–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…

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