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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ACC survey finds critical shortage of cardiologists now and in the future 1

Updated: A critical shortage of cardiologists exists today, and will only grow more severe in the future, according to a new report from the American College of Cardiology. The report finds a current shortage of more than 1,600 general cardiologists and nearly 2,000 interventional cardiologists. By 2025 the shortage of general cardiologists could grow to 16,000, and by 2050 the number of practicing cardiologists will need to double.

But not all experts agree that simply increasing the number of cardiologists is the best way to address the underlying problem, and several experts expressed skepticism about the finding that there is currently a shortage in interventional cardiologists.
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Phentermine and topiramate: a slimming combination 1

The combination of phentermine and topiramate resulted in substantial weight loss and good tolerability, according to a press release from Vivus Inc, the manufacturer of the combination drug called Qnexa.

Vivus announced today positive results from two pivotal phase 3 studies, EQUIP and CONQUER, in more than 3,750 patients. The company said the studies met their primary enpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes, the company reported.
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Lifetime exposure to lead linked to increased CV risk Reply

Lifetime cumulative exposure to lead is associated with significant increases in cardiovascular mortality, according to a new study in Circulation.

By measuring lead concentrations in the bone, the researchers, led by Marc Weisskopf, were able to asess long term exposure to lead. People with patella bone lead levels in the highest tertile were more than five times as likely to die of cardiovascular causes as people in the lowest tertile.
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“Dr Nobody” in JAMA editors flap speaks his mind 1

Jonathan Leo, the “Dr. Nobody” in the JAMA editors flap, has delivered a long and thoughtful response to the entire sorry episode in an article in the journal Society.

Among many issues, Leo discusses the academic freedom concerns raised by the case. (Recall that the JAMA editors initially demanded that Leo– along with any other JAMA letter writers– had no right to publish without permission from the editors.) Here is what Leo has to say:
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Are low-carb, high fat diets “fads”? 4

Should low-carb, high fat diets be considered “fad diets”? A Comment by Mann and Nye published in the Lancet simply assumes that these diets don’t have any scientific credibility, but we’ve seen a number of important studies in major publications, including recent trials in the NEJM by Shai et al and in JAMA, by Gardner et al, to suggest that these diets are very far from being dismissed as mere fads. In fact, there’s plenty of evidence to suggest that they should be taken very seriously indeed. (In fact, as any expert will reluctantly concede, there’s almost no good randomized, controlled data to conclusively demonstrate that any diet is better than any other.)
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