Very low LDL + normal BP = good (IVUS) outcome

Patients with coronary artery disease who have very low LDL levels and normal blood pressure have slower progression of atherosclerosis, as measured by IVUS, according to an analysis of more than 3,400 patients published in the Journal of the American College of Cardiology. But in an accompanying editorial, Jonathan Tobis and Alice Perlowski warn against…

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JAMA editors take strong stance against conflict of interest and free speech

In an editorial posted online in JAMA, the editors Catherine DeAngelis and Phil Fontanarosa have taken a strong stance against both conflict of interest and free speech. According to the editorial, it’s ok to accuse JAMA authors of conflict of interest, but you can’t tell anyone except the journal editors until the editors themselves report…

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A SHAPE board member responds to critical editorial

In response to a CardioBrief editorial posted earlier this week that was highly critical of SHAPE, I received a letter from a lawyer who is  a member of SHAPE’s board of directors. Although I disagree with her views, her position is worthy of respect. With her permission I have posted her letter, followed by my…

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FDA panel turns down TherOx Aqueous Oxygen System in 9-5 vote

The FDA’s Circulatory System Devices Advisory Panel has voted 9-5 against the TherO Aqueous Oxygen System (AO System), intended for use in acuteMI patients who have undergone successful revascularization less than or equal to 6 hours from symptom onset. You can read a report of the panel on TCTMD by Brian Vastag….

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FDA panel votes 15-2 in favor of rivaroxaban

The FDA’s Cardiovascular and Renal Advisory committee voted 15-2 in favor of rivaroxaban. At least two Wall Street analysts have suggested, however, that the FDA may delay approval until it receives more data, pushing final approval into next year. CardioBrief received detailed comments on the meeting from two panel members, Darren McGuire and Sanjay Kaul….

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Meta-analysis: CABG beats PCI in diabetics and elderly

Overall, CABG and PCI have similar death rates in patients with multivessel disease, but the results heavily favor CABG when it comes to diabetics and elderly patients, according to a new meta-analysis led by Mark Hlatky published in the Lancet. The reasons for CABG’s better outcome are unclear, but “intuitively such mechanisms are most likely…

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Dronedarone gets cautious nod from FDA advisory panel

The FDA’s Cardiovascular and Renal Advisory Committee voted 10 to 3 in favor of approval for Sanofi’s dronedarone. By all accounts it was a difficult decision for the committee. CardioBrief has received statements from panel members Sanjay Kaul (yes, he did make it to the meeting) and Darren McGuire….

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Cardiovascular research: does pharma see a future?

Pfizer’s decision to abandon research in cardiovascular drugs is the occasion for a perspective by Alan Garber in the New England Journal of Medicine. Garber asks: “Did the decision reflect only the strengths and weaknesses of Pfizer’s pipeline, or have the commercial prospects soured so much that we can expect an industrywide decline in innovation…

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Young blacks more likely to develop heart failure

Blacks younger than 30 years old are 20 times more likely to develop heart failure over the next 20 years than whites, according to a new study published in the New England Journal of Medicine. Hypertension, obesity, and systolic dysfunction were significant predictors of heart failure. The study, write Clyde Yancy and Eric Peterson in…

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Have the results of the AURORA study been leaked?

Although the AURORA study, which is comparing rosuvastatin  to placebo in hemodialysis patients, is not scheduled to be  presented until March 30 at the ACC scientific sessions in Orlando, at least one analyst is claiming he “understands” that the results are negative, according to a Reuters story by Ben Hirschler. Here is what Hirschler writes:…

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Editorial: SHAPE is skating on thin ice

It’s hard to argue with a concept like heart attack prevention. So when an organization like SHAPE (The Society for Heart Attack Prevention and Eradication) comes along, it’s easy to overlook some of the troubling details of the group in the interest of the greater common good. When SHAPE published its own guidelines independent of…

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Rivaroxaban may face tough questions about bleeding risk

The bleeding risk of rivaroxaban may be a significant focus of the FDA’s Cardiovascular and Renal Advisory Committee when it meets on Thursday. Briefing documents for the meeting posted this morning on the FDA website indicate that the FDA has significant safety concerns about the bleeding risk of rivaroxaban….

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No surprise: ACAT inhibitor fails again

Almost 4 years after its specatacular crash and burn in the ACTIVATE trial, pactimibe has once again failed to live up to its much earlier promise.  In the CAPTIVATE trial, published today in JAMA, pactimibe not only failed to prevent atherosclerotic progression in patients with familial hypercholesterolemia, as assessed by CIMT, but also caused an…

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Normal ABI isn’t really normal

Patients who have borderline or low normal ankle-brachial index (ABI) ratios are nevertheless at elevated risk for functional decline and disability, according to a new study appearing online in JACC. The 5 year, prospective, observational study found that patients with ABI values between 0.90 and 1.09 “appear to be at significantly greater risk of functional…

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Exercise: don’t stop or you just might drop

A new study published online in Circulation provides further evidence that exercise after MI is benefical, improving endothelial function as measured by flow mediated dilation, but also shows that the benefits drop rapidly after exercise is stopped. The results were the same whether patients took up aerobic training, resistance training , or a combination regimen. “This…

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FDA reviewers give green light for dronedarone

Ahead of Wednesday’s meeting of the Cardiovascular and Renal Advisory Committee meeting, FDA reviewers have recommended approval of Sanofi’s dronedarone to delay recurrence of and hospitalization for atrial fibrillation. FDA  observers will be pleased to learn that Sanjay Kaul is listed on the roster as a committee member. CardioBrief is willing to bet that Sanjay…

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Statins may help fight severe asthma attacks

A retrospective analysis of more than 12 million people in an insurance database has provided evidence that the anti-inflammatory effects of statins may help reduce the severity of asthma attacks, according to a new study presented at the 2009 Annual Meeting of the American Academy of Asthma, Allergy and Immunology (AAAAI). (You can find the…

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Number of deaths linked to Sprint Fidelis leads rises to 13

Late on Friday the 13th Medtronic sent a letter to physicians saying that the number of deaths in which its Sprint Fidelis leads may have played a role has climbed to 13. Earlier this week we reported that the judge who had dismissed the lawsuits against the company would not step down from the case…

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Demolition derby: JAMA, BMJ, and Wall Street Journal health blog

It’s not a cardiology issue, but we can’t help being amazed at some of the “frank” talk and raw emotions on display in a new post by David Armstrong in the Wall Street Journal health blog. Armstrong recounts what happens when he spoke to JAMA editors about a letter that appeared on the British Medical…

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NYC $$$ (cont’d): Rose gets a raise at Mt Sinai

Cardiac surgeon Eric Rose can hold his head up high: at $2.75 million his salary is the same as Mt Sinai’s top interventional cardiologist, Samin Sharma.  By moving from Columbia to Mt Sinai last fall, Rose apparently increased his compensation from a mere $2.2 million at Columbia. According to an article in Crain‘s, Rose brought…

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New diabetes drugs juggled by FDA

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review BMS’s saxagliptin tablet and Novo Nordisk’s liraglutide injection on April 1-2. Saxagliptin is a DPP-4 inhibitor, liraglutide is a long-acting form of GLP-1. Click here for the FDA webpage for the advisory committee meeting. Noticeably absent from the advisory committee meeting is Takeda’s alogliptin, another…

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Europe losing battle against heart disease

Europe is losing the battle against heart disease, according to the latest report from EUROSPIRE III published in the Lancet. Among patients with heart disease, there has been no improvement in rates of smoking, hypertension, obesity, and diabetes, although patients are receiving more drugs. Real progress will require lifestyle programs and comprehensive, multidisciplinary approaches, write…

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ABSORB this: bioabsorbable stent remains promising at 2 years

Two year results from the ABSORB trial continue to show promising results for bioabsorbable polymer drug-eluting stents (BVS), according to a new paper published in the Lancet. Results are hard to interpret given that only 30 patients were enrolled in the trial, but the researchers, led by Patrick Serruys, were encouraged by the fact that…

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PCI: no impact on mortality or MI, no surprise

To no one’s surprise except all the patients who are convinced that their cardiologists saved their lives, elective PCI over the last 20 years has had no discernible effect on mortlaity or MI when compared to medical therapy, according to a new network meta-analysis by Thomas Trikalinos and colleagues in the Lancet. (The beneficial effects…

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Phase 2 data on Schering’s TRA published in the Lancet

Two years after its initial presentation at the ACC in 2007, the promising phase 2 results on Schering’s novel thrombin receptor antagonist (TRA) in the setting of elective PCI have been published in the Lancet. (You can see the slide set from the initial presentation at clinicaltrialresults.com.) The results were promising enough– good efficacy and…

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