Biomarkers: Don’t Believe the Hype

Watch out for hype when examining the biomarker literature, a new study published in JAMA suggests. John Ioannidis and Orestis Panagiotou first searched the literature  and identified  highly cited studies of biomarkers that included a relative risk calculation of effect size on a particular outcome. Most of the 35 studies reported cancer- or cardiovascular-related outcomes….

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Comment: Abbott & Costello Weigh In On Niacin

Editor’s note: Here’s a great comment from a reader on the previous post about the NLA and AIM-HIGH: I am a patient and policy prof who turned down niaspan because there was no scientific evidence of benefit relative to risk, which is not trivial. There still isn’t, unless having more sexy numbers is considered a…

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National Lipid Association: AIM-HIGH Results “Disappointing” But Prescribing Practices Should Not Change

The National Lipid Association has issued a statement to its members about the AIM-HIGH Study. The NLA acknowledges that the “findings are disappointing since clinicians have used extended-release niacin to treat patients with low HDL-C” but urges its members to “await full availability and review of the trial before integrating this information into clinical practice.”…

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NHLBI Stops the AIM-HIGH Trial of Niacin

(Updated with comments from William Boden, Sanjay Kaul, James Stein, Monty Krieger, and Allen Taylor)– The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health) trial of niacin has been stopped early by the NHLBI. The trial was designed to test the addition of high dose, extended-release niacin (Niaspan) to statins…

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Senate Report Uncovers Sanofi Attempts to Stifle Generic Lovenox

A report issued by the US Senate today contains numerous documents demonstrating attempts by Sanofi to orchestrate a negative perspective on generic Lovenox by the FDA. The documents outline Sanofi’s relationships with the North American Thrombosis Forum (NATF), the Society of Hospital Medicine (SHM), and a Duke University pulmonologist, Dr. Victor Tapson. A Sanofi slide…

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FDA Approves Xience Nano for Small Vessels

The FDA has approved the Xience Nano everolimus-eluting stent, Abbott has announced. The stent is based on the same platform as the popular Xience V stent, and can be used in vessels as small as 2.25 mm. The approval was based on results from the SPIRIT Small Vessel clinical trial. The rate of target lesion…

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Pictures At An Exhibition

HRS facebook

Click one link and you’ll see nothing but thoughtful scientists earnestly advancing the state of electrophysiology in surroundings completely devoid of all commercial influence. Click another link and you’ll find a very different perspective on the same meeting.  …

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New Onset AF Linked To Increase in Death and CV Events

In the Women’s Health Study, which followed nearly 35,000 women for more than 15 years, mortality was significantly higher in the 1011 women who developed AF than in the women who did not, according to a report by David Conen and colleagues published in JAMA. Here is the incidence rate (per 1000 person-years of followup)…

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Copeptin May Help Predict CV Death in Elderly HF Patients

The biomarker copeptin, which is a surrogate marker of vasopressin, may help predict the risk of death in elderly HF patients, according to a new study in JAMA. Urban Alehagen and colleagues followed 470 elderly HF patients from 1996 through 2009, during which time there were 226 deaths from any cause and 146 deaths from…

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What Is the Impact of Screening Low Risk Patients with CT Angiography?

In a study published online in Archives of Internal Medicine, John McEvoy and colleagues examine the impact of screening low risk patients with coronary CT angiography (CTA). They compared 1000 South Korean patients who underwent CTA and compared them to 1000 matched controls. CTA identified 215 people with coronary atherosclerosis. At 90 days and at…

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Eplerenone Found To Also Reduce AF in HF Patients

Results from EMPHASIS-HF (Eplerenone and Atrial Fibrillation in Patients with Systolic Heart Failure and Mild Symptoms) previously showed that adding the aldosterone antagonist eplerenone to standard therapy in patients with NYHA class II heart failure resulted in the reduction of the composite endpoint of death from cardiovascular causes or hospitalization for heart failure. Now, a…

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Annuloplasty Rings, Edwards, and the FDA: More Details Emerge

The routine approval of implanted medical devices via the 510(k) premarket notification process, and in particular the controversy over Edwards’ Myxo Etlogix annuloplasty ring, get new scrutiny in an article in the Chicago Tribune by Jason Grotto and Deborah Shelton. The Myxo controversy began in 2008 when a patient who received the device had a poor outcome after…

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FDA Panel Delivers Mixed Verdict on Trilipix (Fenofibrate)

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee delivered a mixed verdict on fenofibrate (Trilipix, Abbott). On the one hand, the panel agreed unanimously that the FDA should require Abbott to perform a large clinical trial in high risk patients with elevated triglyceride levels and low HDL levels who nevertheless have achieved target LDL cholesterol…

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ProPublica: Medical Schools Plug Holes in Conflict-of-Interest Policies

ProPublica icon

Editor’s note: The following post is reprinted with permission from ProPublica. It is the latest installment in ProPublica’s Dollars for Doctors: How Industry Money Reaches Physicians, an ongoing investigation. Medical Schools Plug Holes in Conflict-of-Interest Policies by Charles Ornstein and Tracy Weber ProPublica, May 19, 2011, 1:01 p.m. Stanford University has taken disciplinary action against five faculty…

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FDA Announces Details of Severe New Restrictions on Rosiglitazone

The FDA has announced the details of the updated REMS (risk evaluation and mitigation strategy) for rosiglitazone, the embattled and highly controversial diabetes drug. The new REMS will sharply restrict access to and distribution of drugs containing rosiglitazone (Avandia, Avandamet, Avandaryl)….

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Part 3: The NLA Responds To Questions

Editor’s Note: This is the final installment of a three-part series on the National Lipid Association. The first part focused on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia, and raised questions about the role of industry in the documents. The second part explored additional questions about the NLA’s relationships…

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Part 2: The National Lipid Association And Industry

NLA Marketing & Sponsorship brochure

Editor’s Note: This is the second of a three-part series on the National Lipid Association. The first part focused on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia, and raised questions about the role of industry in the documents. This second part explores additional questions about the NLA’s relationships with…

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Part 1: The National Lipid Association and the FH Guidelines

NLA FH Guidelines author disclosures

Editor’s Note: This is the first of a three-part series on the National Lipid Association. This first part focuses on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia (FH) and raises serious questions about the role of industry in the documents. The second part explores additional questions about the…

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The Curse of the Egyptian Mummy: Coronary Artery Disease?

Mummy head

Could the real curse of the mummy be coronary artery disease? Despite strict adherence to the original Mediterranean diet and a complete lack of tobacco, trans-fats, and refined sugars, an Egyptian princess who died around 1550 BC is the first person in history to receive a diagnosis of coronary artery disease. A CT scan of…

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FDA Reviewers Scrutinize ACCORD and Trilipix

The FDA has released the agenda, questions, roster, and briefing materials  for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee in which the ACCORD trial and the fate of Abbott’s Trilipix (fenofibric acid) will be discussed. The key questions on which that the advisory committee members will be asked to vote are:…

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Sleep Deprivation and the Cardiac Surgeon

Sleep deprivation in cardiac surgeons does not lead to worse surgical outcomes, according to a study published in the Archives of Surgery. Michael Chu and colleagues collected sleep information from 6 consultant surgeons working at a large hospital in Ontario, Canada and outcome data from their 4,047 patients who underwent cardiac surgery from 2004 through…

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ProPublica: Cardiac Society Draws Bulk of Funding From Stent Makers

Editor’s note: The following post is reprinted with permission from ProPublica. It is the latest installment in ProPublica’s Dollars for Doctors: How Industry Money Reaches Physicians, an ongoing investigation. Cardiac Society Draws Bulk of Funding From Stent Makers by Charles Ornstein, ProPublica, May 13, 2011, 1:27 p.m. A Pittsburgh hospital informed 141 patients [1] earlier this year…

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TAVI & Stroke: More Details Surface About PARTNER A

In the past year transcatheter aortic valve implantation (TAVI) has emerged as a possible new treatment for  patients with aortic valve disease who are not surgical candidates (the PARTNER B study) and for some patients as a viable alternative to surgery (the PARTNER A study). A major lingering question about the PARTNER A study was…

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Study Finds Little Effect of COURAGE On Adoption of Optimal Medical Therapy

Optimal medical therapy (OMT) for patients with coronary artery disease (CAD) was not significantly boosted by the publication of the COURAGE trial, despite the clear message from that trial showing the benefits of OMT, according to a new study published in JAMA. William Borden and colleagues used data from 467,211 patients in the National Cardiovascular…

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Trial REVEALs No Benefit And Some Concerns With EPO After Primary PCI

Erythropoietin alfa failed to reduce infarct size and was associated with more cardiovascular events when given after successful PCI in STEMI patients, according to results of the REVEAL (Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction) trial published in JAMA. In a study with a dose-escalation safety phase and a…

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