Circulation: exercise may help slow aging process by protecting telomeres

Intensive exercise protects against telomere shortening, according to an intriguing new study appearing in Circulation. German researchers studied young professional runners, middle-aged athletes, and age-matched controls who did not exercise regularly. “The most significant finding of this study is that physical exercise of the professional athletes leads to activation of the important enzyme telomerase and…

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Dronedarone (Multaq) gains EU approval for atrial fibrillation

Sanofi-aventis announced today that dronedarone (Multaq) received approval for the indication of atrial fibrillation in the European Union. Dronedarone was approved in the US last July. (Click here for our previous coverage of dronedarone.) The approval comes with a contraindication for use in unstable patients with class III and IV heart failure, and a recommendation…

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NEJM: very low troponin T levels in stable CAD associated with death and HF, but not MI

Using a new, highly sensitive assay for cardiac troponin T, investigators from the PEACE trial have been able to demonstrate that nearly all patients with stable CAD have detectable levels of troponin T, and that these levels may predict death and heart failure. Somewhat surprisingly, however, troponin T levels were not significantly associated with MI…

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Report: New niacin scrips rise 41% in week following ARBITER 6

Following the release of ARBITER 6 last Sunday, new prescriptions for Niaspan (extended-release niacin, Abbott) rose 41% over the week before, according to SDI, a market research firm that tracks prescriptions….

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JAMA: high primary PCI volume doesn’t translate into lower mortality

High volume primary PCI centers are faster and deliver more evidence-based care than their lower-volume counterparts, but in recent years there is no discernible difference in mortality, according to a new study from the Get With the Guidelines Program appearing in JAMA….

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Did Medicaid pay for all those Plavix ads on the news?

Direct-to-consumer (DTC) advertising doesn’t increase drug usage but it does raise the cost of drugs, according to an article by Michael Law and colleagues in Archives of Internal Medicine. Using Plavix (clopidogrel) as a case study, the researchers studied pharmacy data from Medicaid programs from 1999 through 2005. Plavix did not begin DTC advertising until…

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Vioxx: what did Merck know and when did it know it?

Merck may have been aware of the heightened cardiovascular risk of rofecoxib (Vioxx) years before it withdrew the drug from the market in 2004, according to an article appearing in the Archives of Internal Medicine. Joseph Ross and colleagues analyzed data available to the manufacturer from 30 randomized trials and enrolling over 20,000 subjects. As early…

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One week later: the ARBITER 6 aftermath

One week after the slightly premature release of ARBITER 6, the most important clinical trial in the history of medicine a small surrogate endpoint trial, the medical experts, Wall Street analysts, and the media have declared that nothing really changed because of the trial….

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FDA also announces safety review of sibutramine (Meridia)

Following a similar earlier communication today from the European Medicines Agency, the FDA late this afternoon announced an ongoing safety review of Meridia (sibutramine). The FDA announcement includes some details not contained in the EMEA communication. According to the FDA announcement (see below), preliminary data from the SCOUT trial (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight…

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EMEA investigating increased cardiovascular risk with sibutramine

The European Medicines Agency (EMEA) said that it’s Committee for Medicinal Products for Human Use (CHMP) has started a review of sibutramine (Meridia) to investigate data from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial) suggesting a possible increased risk of serious cardiovascular events….

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EINSTEIN at ASH: rivaroxaban (Xarelto) prevents recurrent VTE, but bleeding may be a concern

EINSTEIN-Extension, which will be presented as a late-breaking clinical trial at the American Society of Hematology meeting in New Orleans on December 8, demonstrates that rivaroxaban (Xarelto), the direct oral factor Xa inhibitor, is effective in the long-term prevention of recurrent venous thromboembolism. But a high bleeding rate may dampen enthusiasm for the new oral anticoagulant….

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AstraZeneca submits NDA to the FDA for Brilinta (ticagrelor) and fills in details about how it works

AstraZeneca has submitted its new drug application to the FDA for its highly promising new antiplatelet agent, ticagrelor (Brilinta). (See press release below.) Two phase II studies presented at the AHA earlier this week shed more light on the drug….

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AHA/ACC/SCAI release updated STEMI and PCI guidelines

The AHA, ACC, and SCAI have released focused updates to existing STEMI and PCI guidelines. New to the guidelines are recommendations regarding prasugrel, left main stenting, and DES vs BMS for primary PCI, among others. Here are some of the highlights:…

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AHA: Ken Baughman dies after a traffic accident in Orlando

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Ken Baughman, 63, has died as a result of a traffic accident on Monday in Orlando, FL. Baughman, the former head of the division of cardiology at Johns Hopkins, was the Director of the Advanced Heart Disease Program at Brigham & Women’s Hospital. The Boston Globe reports that Baughman was hit by a car at…

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FDA issues public health advisory on interaction between clopidogrel and omeprazole

Updated: The FDA has issued a public health advisory to highlight updated safety information regarding an interaction between clopidogrel (Plavix) and omeprazole. The label change, which was made on Friday, was reported first by CardioBrief yesterday. An FDA official explained that the label changes were based on data from a new study performed by the…

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AHA: 58% survival rate at 2 years with HeartMate II continuous flow LVAD

The HeartMate II continuous flow LVAD outperformed its older cousin, the HeartMate XVE pulsatile flow LVAD, according to the results of the HeartMate II Destination Therapy Trial presented today at the AHA and published online in the New England Journal of Medicine. The trial randomized 200 patients with advanced heart failure who were not eligible for…

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AHA: early repolarization on ECG associated with increased risk of cardiac death

Early repolarization, long thought to be benign, is associated with an increased risk of death from cardiac causes, according to a new study presented here at the AHA and published online in the New England Journal of Medicine. Finnish investigators examined the ECGs of 1,864 middle-aged people to assess the prognostic significance over 30 years of…

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New warnings added to Plavix (clopidogrel) label

Several new warnings have been added to the Plavix (clopidogrel) label. The new warnings are for reduced effectiveness due to impaired CYP2C19 function and for co-adminstration of the drug with omeprazole, which can reduce the pharmacologic activity of clopidogrel….

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Sunday at the AHA: ARBITER’s wild roller coaster ride in Orlando

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[Updated. See bottom of story for postscript on CNBC TV reporter Mike Huckman’s embargo break.] The early release of the ARBITER 6 trial on Sunday was a roller coaster ride in more ways than one. In addition to the drama in the newsroom at the AHA as the embargo was lifted, the hastily assembled news…

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AHA: Niacin to take center stage as it beats ezetimibe in ARBITER 6

Following a frenzied build-up (on Wall Street, at least– not so much in the medical community) the results of ARBITER 6 have now been presented at the AHA and published online in the New England Journal of Medicine. The bottom line: niacin but not ezetimibe caused a significant reduction in CIMT. Although its HDL raising…

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AHA: Biventricular pacing preserves LV shape and function

Biventricular pacing may prevent the adverse left ventricular modeling and reduction in LV function often seen with RV pacing, according to results of the PACE Trial presented at the AHA and published online in the New England Journal of Medicine. Chinese investigators randomized 177 patients with bradycardia and preserved LV function to biventricular pacing or…

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AHA: cangrelor fails to find a championship season

Negative results of the CHAMPION PCI and CHAMPION PLATFORM trials have put a damper on hopes for cangrelor, the potent intravenous, reversible platelet blocker under development by the Medicines Company. But investigators say the drug might not have been used properly in the trials, and say they hope to find ways to make use of the…

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AHA: Ticagrelor found beneficial in STEMI subset of PLATO

Results from the 8,430 STEMI patients enrolled in the PLATO trial (presented last summer at the ESC and published simultaneously in the Lancet) are consistent with the main 18,000 patient trial and show that ticagrelor reduced the primary endpoint of MI, stroke or vascular death without causing an increase in major bleeding complications when compared…

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The empire strikes back: Merck’s Richard Pasternak downgrades ARBITER 6

In response to the growing frenzy on Wall Street and in the media over the upcoming presentation of ARBITER 6 on Monday morning, Merck’s Richard Pasternak (formerly a cardiologist at Massachusetts General Hospital) sent a lengthy critique of the trial to CardioBrief (see below). Pasternak also wrote a detailed response to an article about ARBITER 6…

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Editorial: Why ARBITER 6 is important– and not important

Arbiter-6 is big news. CNBC will be reporting live from the convention hall on Monday when the results are released. Just in the last day or so the New York Times and the Wall Street Journal have discussed the significance– or lack of it– of the trial. On the one hand, most cardiologists I speak…

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