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…
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,…
Huge Diet Study Questions Conventional Wisdom About Carbs And Fats
–But PURE also challenges belief that more is better for fruits and vegetables. BARCELONA — An enormous prospective study of food intake in adults, reported here, challenges several staunchly held beliefs about dietary components and their association with health risks: finding, for example that diets rich in fats, including saturated fats, don’t increase mortality risk,…
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…
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….
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,…
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…
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,…
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…
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…
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…
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….
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…
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…
Nissen Calls Statin Denialism A Deadly Internet-Driven Cult
–“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…
Potential Benefits And Dangers of New Troponin Tests
–What does it mean when 80% of people have detectable levels without CVD? As many as four out of five people without known heart disease will have detectable levels of cardiac troponins with the new high-sensitivity tests, according to a new meta-analysis. Even very low levels within the normal range indicated increased cardiovascular risk, but…
Forthcoming Expert Guideline May Upgrade PCSK9 Inhibitors
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
–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…
Aggressive BP Targets Will Hike Falling Risk in Older Patients
–Another paper raises new questions about applying SPRINT in the real world Applying the intense blood pressure goals used in SPRINT in a real world elderly population might lead to a dramatic increase in injurious falls, according to a new study from Ireland published in JAMA Internal Medicine. The Systolic Blood Pressure Intervention Trial (SPRINT)…
Coronary Artery Calcium Rises With Intense Exercise
–But the lesions observed are more likely to appear stable. Exercise is good for you, but is there a point at which more exercise is either no longer beneficial or perhaps even harmful? Two new studies now help clarify — albeit not resolve — the issue. The studies offer evidence that people who exercise for…
Questions Raised About Trump’s New CDC Boss
–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…
New Studies Reassure on Coffee Safety, Suggest Survival Bump
–Benefits of coffee now apparent in non-white and European populations. Two large new observational studies appearing Monday in Annals of Internal Medicine strengthened the association between higher coffee consumption and longer life. In the wake of earlier studies pointing to the potential benefits of coffee, the two new papers extend those benefits to new populations,…
Sudden Death Declining in Heart Failure
–Does the trend mean that ICDs are indicated less often? The incidence of sudden death in heart failure patients with reduced ejection fraction, in clinical trials, has declined significantly in the last 20 years, according to a new study published in the New England Journal of Medicine that may impact inclination to recommend implantable cardioverter-defibrillators…
Labscam: Rogue Laboratory Testing At Center Of Addiction Treatment Scandal
–‘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…
Merck Reveals Positive Findings For Its CETP Inhibitor
–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…
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