Statement from AHA, ACC, and ACG Reaffirms Use of PPIs with Antiplatelet Therapy

Despite recent warnings by the FDA, an Expert Consensus Document released jointly by the AHA, the ACC, and the American College of Gastroenterology states that it is acceptable to use proton pump inhibitors (PPIs) with thienopyridines like clopidogrel in patients at high risk for upper GI bleeds. The statement does not recommend routine use of PPIs…

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New Safety Questions Raised About Multaq

The Institute for Safe Medication Practices has identified a potential drug safety signal for dronedarone (Multaq, Sanofi-Aventis). The potential problem is outlined in QuarterWatch: 2010 Quarter 1, a publication of the ISMP that monitors FDA MedWatch reports, and was written about on the Pharmalot blog. The report concludes: Evidence is accumulating that the risks of the…

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RE-LY Substudy Finds Dabigatran Effective in Secondary Stroke Prevention

A substudy of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrates that dabigatran is as effective in AF patients for secondary stroke prevention as it is for overall stroke prevention. In their paper in the Lancet Neurology, Hans-Christoph Diener and the RE-LY study group report the results of the trial in the predefined subset of…

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Guest Post: New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?

Editor’s Note: The following guest post by John Mack is reprinted with permission from Pharma Marketing Blog. by John Mack In its most recent TV and print ads for Lipitor, Pfizer highlights a middle-aged man working out in a gym. In bold text and voice overs, the ad asks “Are You Kidding Yourself?” The print…

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Meta-Analysis Turns Up Mixed Results for Vitamin E on Stroke Subtypes

In a meta-analysis appearing in BMJ, vitamin E supplements had no effect on the overall rate of stroke but were associated with a small reduction in the risk of ischemic stroke and a slightly larger increase in the risk of hemorrhagic stroke. Markus Schürks and colleagues analyzed data from 9 trials including 118,765 subjects. Although the…

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Cardiology and the Qur’an: Controversy Erupts Over Paper Published in the International Journal of Cardiology

A paper published in the International Journal of Cardiology has provoked criticism for mixing religion and science. The paper, “The heart and cardiovascular system in the Qur-an and Hadeeth,” asserts that modern scientific understanding of the heart  can be found in key Islamic texts. In his popular blog Pharyngula PZ Myers, biologist and debunker, writes:…

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Is Dabigatran (Pradaxa) More Cost-Effective Than Warfarin in AF?

Dabigatran (Pradaxa), newly approved by the FDA to prevent stroke in patients with atrial fibrillation (AF), might turn out to be a cost-effective alternative to warfarin, according to an Annals of Internal Medicine study. Using data from the RE-LY trial, James Freeman and colleagues modeled the quality-adjusted survival and cost-effectiveness of dabigatran compared with high- or low-dose warfarin…

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Pradaxa (dabigatran) Goes On Sale Wednesday, November 3

Dabigatran (Pradaxa, Boehringer Ingelheim) will go on sale in drugstores on Wednesday, November 3, according to a press release issued by Boehringer Ingelheim. The press release confirms the previously reported wholesale acquisition price of $6.75 a day for two capsules. Knowledgeable experts estimate that therefore the retail price of Pradaxa will likely be $7.90 per day, or…

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Bayer says rivaroxaban meets primary endpoint in ROCKET AF

Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the scheduled presentation of the trial at the AHA on November 15….

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Paper on Cardiopulmonary Bypass Priming Retracted; 200 Additional Papers Under Question

The journal Anesthesia & Analgesia, which calls itself “The Gold Standard in Anesthesiology,” has retracted a paper on cardiopulmonary bypass priming and has raised questions about 200 additional published papers by the author, Joachim Boldt, the head of the Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Bremserstr, Germany. A detailed report about the retraction was…

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Meta-Analysis Examines Risk Associated with CYP2C19 Genotypes

There has been widespread debate and disagreement over the clinical significance of people with reduced function CYP2C19 genotypes who take clopidogrel. In an effort to shed light on the topic, Jessica Mega and colleagues analyzed data from 9685 patients enrolled in nine clinical trials. Some 26% of patients had 1 reduced-function allele, and 2% had 2…

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Pradaxa (dabigatran) Pricing Starts to Emerge

It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative told CardioBrief that the wholesale acquisition cost (WAC) of the drug will be $6.75 per day for 2 pills. The price will apply to both the 150 mg and the 75 mg capsules.  According to knowledgeable experts,…

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Can Barbers Help Fight High Blood Pressure in Black Men?

A very long time ago, barbers performed surgical procedures. Now, once again, barbers may have a role to play in the health care of their community….

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Top New York City Interventional Cardiologists Now Making $3 Million a Year

There’s no recession for top interventional cardiologists in New York City. Mt. Sinai’s Samin Sharma and New York-Presbyterian’s Jeffrey Moses now make at least $3 million a year, Sharma told CardioBrief. Sharma will make his money staying in one place at Mt. Sinai. Moses, however, will have to travel between New York-Presbyterian’s uptown (Columbia University Medical…

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News Briefs: Recurrent Stroke Prevention Guidelines, Vernakalant Trial Suspended, GSK Investigated, Generic Enoxaparin Takes Off, Kaul Speaks, Midei Sues

The American Heart Association published revised recurrent stroke prevention guidelines. The new guidelines state that recurrent stroke may be prevented by carotid angioplasty or by treating metabolic syndrome….

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Some Remaining Questions About Dabigatran

Yesterday’s approval of dabigatran (Pradaxa) has been long awaited in the cardiology community. Although just about everyone agrees that a good alternative to warfarin is highly desirable, there are many remaining questions about the drug as it prepares to enter the marketplace. Here are a few questions raised by electrophysiologist John Mandrola on his blog:…

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FDA Issues Complete Response Letter for Bydureon (extended-release exenatide)

The approval of Bydureon (extended-release exenatide), which had been widely anticipated, now will be delayed until 2012. The sponsoring companies (Amylin, Lilly, and Alkermes) announced on Tuesday that they had received a complete response letter from the FDA in response to the NDA for the drug. According to the companies, the FDA has requested a…

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Dabigatran Gains FDA Approval

The FDA has approved dabigatran (Pradaxa) for the prevention of stroke and blood clots in patients with atrial fibrillation. Boehringer Ingelheim first announced the approval in a tweet (of all places). The FDA says the drug will be available in 75 mg and 150 mg capsules. (In its review of the drug the FDA had been critical of data…

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FDA Won’t Soften Clopidogrel-Omeprazole Warning

The FDA has no plans to withdraw or soften its warning about a possible interaction between clopidogrel (Plavix) and omeprazole (Prilosec), according to an article in the Wall Street Journal. Despite the recent publication of the COGENT study which found no evidence for an adverse clinical interaction, the FDA is standing by the advisory it…

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A ProPublica Investigation: Docs on Pharma Payroll Have Blemished Records, Limited Credentials

Editor’s Note: The following article is reprinted with permission from ProPublica, the “independent, non-profit newsroom that produces investigative journalism in the public interest.” This is the first installment of an ongoing investigation titled “Dollars for Doctors.” For more information and resources about the investigation, including a tool to look up drug company money paid to…

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FDA Advisors Go Easy on Aranesp (darbepoetin alfa)

The FDA Cardiovascular and Renal Advisory Committee went easy today on Aranesp (darbepoetin alfa), the embattled erythropoeisis-stimulating agent (ESA).  After considering the implications of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), the committee recommended that no additional restrictions or label changes be made for the drug. However, the vote hardly represents a ringing endorsement…

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Guest Post: My Journey with Heart Failure

Editor’s note: I am very pleased to welcome Mary Knudson to the blogosphere and to introduce CardioBrief readers to Heart Sense: A Blog About Heart Failure. Knudson’s blog will undoubtedly prove to be an invaluable resource to heart failure patients, their family members, and the health care professionals who treat people with heart failure. As…

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Is the Time Right for a Preprint Archive for Clinical Trials?

Here’s a great idea: a preprint archive for clinical trials. Taking inspiration from the well-established use of preprint archives in physics, math, and other scholarly areas, Martin Fenner, a cancer researcher, proposes the establishment of a preprint archive for clinical trial research papers. Fenner points out that “the results of clinical trials are rarely first…

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Meta-Analysis Lends More Support to Compression-Only CPR

There’s new evidence supporting the movement away from traditional bystander CPR in favor of chest-compression-only CPR. In a paper appearing online in the Lancet, Michael Hüpfl, Harald F Selig, and Peter Nagele report the results of two separate meta-analyses. In the first meta-analysis, the investigators combined data from 3 randomized trials comparing compression-only CPR to standard CPR…

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Trick or TREAT? FDA Staff Highly Critical of Aranesp Trial

Update: 6:00 PM: The FDA has posted the roster for Monday’s meeting. Committee members include Henry Black, Jonathan Halperin, Judith Hochman, Sanjay Kaul, Mori Krantz, and Darren McGuire. The questions for the committee will not be posted before the meeting. An FDA official told CardioBrief that the FDA is not required to post questions. Halloween…

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