Extreme cardiology culture: Califf, Harrington, Topol & Teirstein

Two new audio programs posted recently on TheHeart.Org provide a fascinating snapshot of the extremes of contemporary cardiology….

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FDA approves saxagliptin (Onglyza)

The FDA announced today that it had approved saxagliptin (Onglyza) to treat type 2 diabetes in adults….

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Senate hearings lay groundwork for assault on CME

On Wednesday the glaring deficiencies of CME were put on display during the Senate Special Committee on Aging hearing on “Medical Research and Education: Higher Learning or Higher Earning?” Committee Chairman Herb Kohl opened the hearing by noting that over the last decade industry funding of CME has quadrupled and now totals over $1 billion…

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FDA advisory panel gives mixed response to telmisartan

The FDA Cardiovascular and Renal Drugs Advisory Committee turned down the proposed indication for telmisartan to reduce risk of myocardial infarction (MI) but did recommend a more narrow indication in patients who are intolerant of an ACE inhibitor….

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FDA cardiorenal panel votes against binodenoson

The FDA’s Cardiovascular and Renal Drugs advisory committee voted 11-5 against binodenoson (CorVue, King Pharmaceuticals), saying the data presented to them did not prove the drug was as effective as adenosine. The FDA is evaluating the NDA for binodenoson as a pharmacologic stress agent used as an adjunct to non-invasive myocardial perfusion imaging (MPI) tests to…

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Senate committee to hold hearings on CME

The Senate Special Committee on Aging will hold a hearing on “Medical Research and Education: Higher Learning or Higher Earning?” on Wednesday afternoon. CardioBrief has learned that one major focus of the hearing will be CME, and that Steve Nissen will be testifying. The hearing will be webcast at 2 PM ET. Click here to…

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DES usage plunged immediately following warnings at ESC 2006

Following the presentation at ESC 2006 in Stockholm of studies questioning the safety of drug-eluting stents (DES), usage of DES in NSTEMI patients plunged almost immediately from 90% to below 60%, according to a new report in Circulation: Cardiovascular Quality and Outcomes based on data from the CRUSADE and ACTION-GWTG registries. “We were interested in whether…

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Dronedarone (Multaq) to cost $9/day

Dronedarone (Multaq) is now available in US pharmacies at a typical retail cost of $9 per day ($4.50 per pill). The drug’s price is significantly higher than earlier Wall Street estimates, according to news stories on Dow Jones and Reuters. Wall Street analysts are now raising their estimates of the drug’s anticipated revenue….

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FDA review raises questions about expanded indication for telmisartan

FDA reviewers have raised a number of serious issues about the telmisartan application for an expanded indication. Telmisartan is now approved for the treatment of hypertension. The FDA Cardiovascular and Renal Drugs Advisory Committee will meet on Wednesday to evaluate the proposed indication for telmisartan to reduce risk of myocardial infarction (MI), stroke, cardiovascular (CV)…

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FDA briefing documents: binodenoson in for some tough questions

The FDA has posted briefing materials for the July 29 meeting of the Cardiovascular and Renal Drugs advisory committee to assess the NDA for binodenoson (CorVue, King Pharmaceuticals) as a pharmacologic stress agent used as an adjunct to non-invasive myocardial perfusion imaging (MPI) tests to detect perfusion abnormalities in patients with known or suspected coronary…

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Best-selling cardiovascular drugs of 2008

Med Ad News has published its annual list of the top 200 best-selling medicines of the year. As in recent years, Lipitor was by the far the best selling drug of the year. Here are the top cardiovascular drugs with sales over $2 billion and their sales (in billions of dollars) last year:…

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FDA panel recommends approval of Medtronic’s Melody transcatheter pulmonary valve

The FDA’s Circulatory System Devices panel voted unanimously to approve the humanitarian device exemption for Medtronic’s Melody transcatheter pulmonary valve. A Reuters news story quoted panel member William Maisel, who said “there is room for improvement for the device” but the company “demonstrated safety and probable benefit.”…

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Cardiology strikes back: Bove, Lewin, Weber & Black defend ties to industry

In the wake of numerous congressional investigations,  an influential report on conflict of interest from the IOM, a JAMA special communication by Rothman et al advocating that medical groups sever most of their ties to industry, and many other calls for wholesale reform, several groups of influential and powerful physicians are striking back and defending…

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Shocking studies in JAMA show benefits of healthy lifestyles

Findings from two large new studies from the Nurses Health Study and the Physicians Health Study should surprise no one except investors in tobacco and fast food companies. A report from the Nurse’s Health Study found that hypertension could be significantly reduced by adherence to modifiable lifestyle and dietary factors including maintaining normal weight, daily…

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FDA posts briefing documents on Medtronic transcatheter pulmonary valve

The FDA has posted its briefing documents for Wednesday’s meeting of the Circulatory System Devices Panel advisory committee meeting to assess the HDE application for Medtronic’s Melody transcatheter pulmonary valve and delivery system. The briefing documents say that the device met its primary efficacy and safety endpoints, but go on to raise questions about the…

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2 studies show benefits of lowering salt

High-salt diets contribute to resistant hypertension, and modest reductions in salt can help reduce blood pressure in black, Asian, and white populations, according to two new studies published today in Hypertension. In the first study, a randomized, cross-over study of a high-salt versus a low-salt diet in 12 patients with resistant hypertension, systolic blood pressure…

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COURAGE fortified by angiography study and Califf editorial

No study in recent years has provoked as much intense reaction– both positive and negative– as COURAGE. In particular, critics from the interventional community have argued that the results did not apply to a large percentage of their patients. Now a new analysis of angiographic data from COURAGE, published in Circulation: Cardiovascular Quality and Outcomes,…

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Cleveland Clinic again leads US News & World Report list for heart hospitals

US News & World Report has released its 2009 list of hospital rankings. Once again Cleveland Clinic leads the list of top hospitals for heart and heart surgery hospitals. Here’s the top 25 Heart and Heart Surgery Hospital rankings:…

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Prasugrel priced 18% more than clopidogrel in US by Lilly/Daiichi Sankyo

Effient (prasugrel) will cost 18% more than Plavix (clopidogrel) in the US, according to a Dow Jones newswire story yesterday by Peter Loftus. The cost for Effient will be $5.45 per pill, compared to $4.60 for Plavix. Loftus spoke with Javan Collins, vice president of Lilly’s U.S. cardiovascular business, who also said that the drug…

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NEJM: Bhatt editorial evaluates prasugrel in clinical practice

Only days after the FDA approval of prasugrel, the New England Journal of Medicine has published an editorial by Deepak Bhatt on “Prasugrel in Clinical Practice.” Bhatt writes that because prasugrel is a more potent inhibitor of the platelet receptor than previously available theinopyridines it can cause “a greater reduction in ischemic events– but it…

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NEJM: open vein-graft harvesting preferable to endoscopic harvesting

Defying conventional wisdom and commonly accepted clinical practice, vein-grafts obtained through open harvesting outperformed endoscopically-obtained vein grafts, according to an analysis of data from the PREVENT IV trial published in the New England Journal of Medicine….

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Approval aftermath: now the real prasugrel battle begins

Following last Friday’s much anticipated approval of prasugrel, the consensus among observers and analysts is that there is no consensus about the ultimate fate of prasugrel. Given the boxed warning and limited indication, prasugrel will have a hard time capturing the enormous market currently dominated by clopidogrel. Following clopidogrel’s patent expiration prasugrel will then have…

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Teenage girl thriving after late donor cardiectomy 10 years after heterotopic transplant

hannahhearts

In 1994, at the age of two years, Hannah Clark, suffering from severe heart failure, underwent a heterotopic cardiac transplantation. More than ten years later the donor heart was removed, following many episodes of post-transplant lymphoproliferative disorder and recovery of her native heart. Now, more than 3 years after the second operation, Hannah’s remarkable story…

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Study estimates cancer risks for widespread calcium screening

Calcium artery calcium (CAC) screening might cause 42 and 62 excess cases of cancer per 100,000 men and women respectively, according to a new study in the Archives of Internal Medicine. The study by Kim and colleagues also found a more than 10-fold variation in radiation dose. The investigators note that the potential impact of…

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Barcelona: List of ESC Hot Lines, Clinical Trial Updates, and Science Hot Lines

Updated and Corrected: The ESC has posted the complete scientific program for the ESC Congress 2009 in Barcelona. Here are the details for Hot Line, Clinical Trial Update, and Science Hot line  sessions. You can access the complete program at this link….

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