REVERSE at 2 years: CRT may help prevent progression in early HF Reply

Two-year results from the REVERSE trial help support the proposition that cardiac resynchronization therapy may be beneficial in patients with class 1 and 2 heart failure. The results, which were presented initially last March at the American College of Cardiology meeting, have been published online as an expedited paper in the Journal of the American College of Cardiology. The major findings from the trial, the one year results, had been presented a year earlier at the ACC, and failed to demonstrate a benefit for CRT in this population, though trial investigators pointed to signs of reverse ventricular remodeling as an important hint of benefit.
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Invitation to Readers: My Mighty Team Reply

Dear CardioBrief Reader,

I am pleased to invite you to become one of the first users of an innovative new website, My Mighty Team, that has just entered beta testing. MIGHTY is a completely free social networking site designed to help people achieve goals such as losing weight, quitting smoking, or exercising more, by using small, focused teams to support and track their progress.
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FDA adds pancreatitis warning to Januvia label Reply

The FDA has revised the prescribing information for Januvia (sitagliptin) and Janumet  (sitagliptin/metformin), adding information about reported cases of acute pancreatitis in 88 cases. The FDA recommends that doctors monitor patients  for acute pancreatitis after initiating sitagliptin or increasing the dose.

Merck, which manufactures sitagliptin, released a statement saying it “believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis.”
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Cholesterol prescriptions from Senators Schumer, Grassley, and Nelson 2

It’s only a very small moment within the enormous ongoing debate over health care reform, but a recent exchange in the US Senate over cholesterol remedies highlights the potential pitfalls when politicians talk about medicine.

As reported by David Herzenhorn in the New York Times, New York’s Senator Charles Schumer “said his doctor had directed him to take Lipitor… and then, after his cholesterol levels had dropped, suggested that he try a less expensive, generic medication instead. But he switched back after his cholesterol levels went back up. ‘I’m taking Lipitor even though it’s more expensive.’”
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TCT: Ticagrelor again shows benefits in PLATO invasive substudy 4

New results from a subset of the PLATO trial show that ticagrelor was more effective than clopidogrel in preventing events in ACS patients undergoing an invasive strategy.

Under development as Brilinta by AstraZeneca, ticagrelor is an oral, reversible antiplatelet drug with a rapid onset of action. The main results of PLATO in 18,624 ACS patients were presented last month at the ESC and published simultaneously in the New England Journal of Medicine. At TCT today, Chris Cannon presented results of the very large, planned substudy of the 72% of PLATO patients for whom an invasive strategy was intended.

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Gregg Stone no longer chairman of Cardiovascular Research Foundation Reply

UpdatedAccording to the website of the Cardiovascular Research Foundation, Gregg Stone is no longer the chairman of CRF. In addition, Stone is identified as the “immediate past chairman” of CRF in the press release for the SPIRIT IV trial issued by Abbott.

As CardioBrief reported yesterday, Stone’s predecessor as chairman, and the founder of the CRF, Martin Leon, was the subject of a letter from Senators Herb Kohl and Charles Grassley regarding potentially undisclosed conflict of interest statements.
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TCT: Xience outperforms Taxus in SPIRIT IV, but no difference in diabetics Reply

The Xience V outperformed the Taxus Express 2 in the SPIRIT IV Trial, but didn’t do any better or worse in the highly anticipated subset of diabetic patients. The results were presented at TCT 2009 during the Late Breaking Trials session on Wednesday by Gregg Stone.

At one year, the trial’s primary endpoint– the rate of target lesion failure (TLF)– in the 3,690 patients enrolled in the trial was 4.2% in the Xience V group versus 6.8% in the Taxus group, a highly significant difference. TLF is a combined endpoint of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven TLR (ID-TLR).
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Senators ask Columbia: did Martin Leon fail to disclose millions of dollars received from industry? 1

Updated– Senators Herb Kohl and Charles Grassley have once again raised the issue of potentially undisclosed conflicts of interest involving Martin Leon and the Cardiovascular Research Foundation he founded. The senators’ letter coincided with TCT 2009, the group’s well-known annual meeting for interventional cardiologists, which is now taking place in San Francisco.

The senators’ letter to Columbia University was first reported by Barry Meier in a story in the New York Times. Based on their review of information received in their investigation of medical device makers, the senators state that “Dr. Leon appears to have failed to report millions of dollars that he has received in outside income.” The senate letter is based on discrepancies between information received from industry and from the disclosure statements submitted by Leon.
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ACC/AHA publish new performance measures to prevent CV disease Reply

The ACC and the AHA have produced a joint scientific statment containing 13 key aspects of cardiovascular disease prevention. The statement is published simultaneously in Circulation and the Journal of the American College of Cardiology.

The performance measures translate existing guidelines, or principles important to disease prevention, into practical steps for healthcare providers, said Rita Redberg, the chair of the writing group, in an ACC/AHA press release.

Here are the 13 performance measures:
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Wall Street analyst calls prasugrel launch “muted” 1

It may be too soon for reliable predictions, but one Wall Street analyst sees signs of weakness in Lilly’s launch of Effient (prasugrel).

Seamus Fernandez, a Leerink Swann analyst, wrote in a research note that the number of new prescriptions for prasugrel were below the numbers observed during a similar period in successful new drug launches in recent years.
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Company and Wall Street disagree over trial results of diet drug lorcaserin Reply

If you only read the press release issued by Arena Pharmaceuticals you would think the results of BLOSSOM, the highly anticipated phase 3 trial of the diet drug locaserin, were overwhelmingly positive. But Wall Street has a different view of the trial and drove the stock price of the company down more than 10%. Update: By Friday afternoon Wall Street appeared to change its mind. By the end of the day the stock was up 5.5%.

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UK study: high risk associated with 10-15 year cut in life expectancy Reply

50-year-old men who smoked and had hypertension and hypercholesterolemia had a dramatic 10 year reduction in their life expectancy, according to a report in BMJ on long term followup of 19,000 men enrolled in the Whitehall Study. Even worse, men in the study with risk factor scores in the top 5% had a 15 year reduction in their life expectancy compared to men in the bottom 5%.
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Senate investigation uncovers huge expenditures for Vytorin CME 3

As part of its investigation into continuing medical education (CME), the Senate Special Committee on Aging has uncovered extensive records of the vast sums of money spent by Merck/Schering Plough on CME programs for Vytorin from 2004 through 2007. The document, which was first reported by Jared A. Favole on Dow Jones newswires, provide a fascinating glimpse into the $60 million CME program. The documents also shed light on company expenditures for academic physicians serving as advisory board members to the companies.

CardioBrief has been able to view the document submitted to the senate committee. The document is over 100 pages in length and contains detailed lists of the thousands of CME grants made by the companies. The vast majority of the grants are relatively small– in the $1,000 – 5,000 range– and generally cover grand rounds and other similar activities. But a substantial number of the grants are breathtaking in their size.
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Study sheds light on stroke following cardiac surgery Reply

Stroke following cardiac surgery occurs in about 2% of cases but does not necessarily occur  more frequently in patients with significant carotid stenosis, according to a single center study appearing in the Archives of Neurology.

Yuebing Li and colleagues followed 4335 patients undergoing coronary artery bypass grafting, aortic valve replacement, or both at Lehigh Valley Hospital and Health Network. More than three-quarters of the strokes occurred in patients with significant carotid stenosis. However, patients who underwent combined carotid and cardiac operations had a much higher risk of stroke (15%)  than patients with a similar degree of carotid stenosis who only had cardiac surgery (0%).
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ICDs in women? A new meta-analysis sparks criticism Reply

A new meta-analysis finds that ICDs are not associated with a mortality benefit in women. The study, by Ghanbari and colleagues, appears in the Archives of Internal Medicine.

934 women and 3,810 men were randomized in the 5 trials included in the meta-analysis. For men, the trials, both individually and in the combined analysis, resulted in a statistically significant overall reduction in mortality.
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Everybody in the (risk) pool! Survey finds frightening increase in CV risk 1

Fewer and fewer Americans are at low risk for cardiovascular disease, according to an important and frightening new report on long term trends from the National Health and Nutrition Examination Surveys (NHANES) of adults 25-74 years of age.

In the most recent survey (1999-2004) only about 8% of US adults had a low risk profile, despite favorable trends in reducing smoking and cutting cholesterol. The  overall increase in risk was due to the increased prevalence of diabetes, obesity, and hypertension, said the CDC’s Earl Ford, and his colleagues, in their report in Circulation.
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Editor insists prasugrel ghostwriter go public 1

You don’t need a medium or a seance to find a ghost. All it takes is a sharp-eyed editor.

According to a Reuters story by Brendan Borrell, the editor of the Journal of Managed Care Pharmacy,  Frederic Curtiss, insisted that a reluctant medical writer be listed as an author on a prasugrel article. The article, “Pharmacy Benefit Spending Poised to Increase for Antithrombotic Drug Therapy– Prasugrel Versus Clopidogrel,” appeared in the June  2009 issue of JMCP.

Curtiss insists that “all authors who contribute more than 1% to the manuscript” be disclosed, according to the Reuters report. Curtiss uses forensic methods, such as examining metadata in Word documents, to uncover hidden authors.
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