FDA advisory panel backs expanded indication for Crestor (rosuvastatin) 1

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 12-4 today in favor of an expanded indication for rosuvastatin (Crestor). According to an FDA analysis, the expanded indication means an additional 6.5 million people would be eligible to take the drug.
Click to continue reading, including commentary from panel member Sanjay Kaul…

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Review finds “no consistent or reproducible treatment effect” for serial calcium scans 2

There is no evidence to support annual coronary artery calcium (CAC) screening to measure atherosclerosis progression, according to a systematic review in Archives of Internal Medicine by Peter McCullough and Kavitha Chinnaiyan. Further, an accompanying editorial by Patrick O’Malley argues that “the answer to the problem of rescanning in the community… is to stop the current practice of initial screening first.”
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Are CT scans the wild west of today’s medicine? Reply

Are CT scans the wild west of today’s medicine, with little sense of law or regulation and a heightened expectation of premature death? Two new studies appearing in the Archives of Internal Medicine suggest the analogy might not be entirely inappropriate. More than 70 million CT scans are performed each year, representing a tripling of usage since 1993, yet there is little standardization in utilization patterns or radiation doses, and the consequence may be a much higher rate than expected of cancer and death in the coming decades.

“15,000 persons may die as a direct result of CT scans physicians had ordered in 2007 alone,” writes Rita Redberg, in an accompanying editorial.

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Wired: David Eddy’s efforts to replace human trials with computer models 1

We’re a little behind in our reading so we didn’t notice until now a fascinating feature article by Jennifer Kahn in the December Wired that’s likely to be of significant interest to many CardioBrief readers. The article provides an in-depth look at the efforts of David Eddy to develop highly sophisticated computer models to diminish the need for human clinical trials. Eddy is a polymath who had originally planned to be a  cardiovascular surgeon and was training at Stanford before deciding to restart his career. For the last 30 years he’s held a wide variety of jobs, including a long-term postion as Chief Scientist of the Blue Cross Blue Shield Association/Kaiser Permanente Technology Evaluation and Coverage (TEC) Program.

As often happens in Wired articles, the first half of the article is guilty of untempered enthusiasm for new technology, and naive readers might think that clinical trials with actual human subjects are about to go on the endangered species list, but the second half of the article adds some much-needed balance and perspective, and the final product offers a provocative insight into Eddy’s quixotic efforts to replace or augment in vivo studies with in silico studies.

Kahn starts her article with the story of Eddy’s efforts in 2004 to use Archimedes, his computer model, to replicate the Collaborative Atorvastatin Diabetes Study (CARDS) months before the results of the study became known. Here is Kahn’s description of what happened:
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Many dialysis patients undergoing PCI receive contraindicated antithrombotics Reply

More than a fifth of dialysis patients undergoing PCI receive the antithrombotic drugs enoxaparin and/or eptifibatide, which are cleared renally. These drugs are contraindicated in this population, and their use is associated with a significantly increased risk of major bleeding and death, according to a new report appearing in JAMA.
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New MRI technique shows– finally– that men and women have different hearts Reply

It won’t solve the age-old questions about the deeper differences between men and women, but  a new MRI imaging technique is revealing fundamental differences between the movement of men’s hearts and women’s hearts. The technique also found movement differences between young and old hearts. Ultimately, the new technique might aid in the earlier diagnosis of heart disease, say the authors.
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Rivaroxaban: EINSTEIN at ASH and another rock on the road to approval 1

The presentation of the EINSTEIN-Extension trial of rivaroxaban for VTE at the American Society of Hematology meeting in New Orleans on Tuesday was overshadowed by the drug’s developer’s disclosure of a new rock on rivaroxaban’s road to FDA approval.

The company developing rivaroxaban, Bayer, said in a press release that it would not respond to an FDA Complete Response Letter this year, as it had previously stated, but would instead “communicate an updated filing strategy in its Annual Press Conference on February 28, 2010,” according to a Bayer press release.
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RE-COVER at ASH: Dabigatran equals warfarin for VTE treatment Reply

Dabigatran (Pradaxa) is as effective as warfarin for the treatment of VTE, according to results of the RE-COVER study presented today at the American Society of Hematology meeting today and published online in the New England Journal of Medicine.

Sam Schulman and colleagues randomized 2539 patients with acute VTE to warfarin or dabigatran (150 mg twice daily) for 6 months. Patients were initially treated with heparin for 5 to 11 days. At 6 months the incidence of recurrent VTE was 2.2% (27 patients) in the warfarin group versus 2.4% (30 patients) in the dabigatran group, a difference which fell within the prespecified margin for noninferiority (p<0.0001). Major bleeding occurred in 20 dabigatran-treated patients and 24 warfarin-treated patients. There were no significant differences in mortality, ACS, or liver function test abnormalities.

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Industry, academic researchers, and clinical trials: the slippery slope Reply

Ed Silverman’s venerable Pharmalot blog recently posted a useful summary of some of the conflict of interest problems that come up when physicians enroll their patients in clinical trials. The basis for the article was a 62-page paper from the  Center for Health & Pharmaceutical Law & Policy at the Seton Hall Law School.

But what really caught our eye was a detailed comment at the bottom of the post by “Pharmavet,” who is, apparently, a pharmaceutical executive with extensive experience in the clinical trials arena. You should read his entire comment, filled with insights gained from years of daily battle in the trenches, but here are a few highlights:
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BMJ: risk of VTE after surgery is higher and lasts longer than expected Reply

The risk of VTE after surgery is higher and lasts longer than expected, according to an article in the BMJ by Valerie Beral and colleagues on behalf of the Million Women Study collaborators. Using data from nearly 1 million women admitted to the hospital in the UK and nearly a quarter of a million admissions for surgery, the study found that women who had surgery were 70 times more likely to have VTE than women not having surgery. For outpatient procedures the risk was increased 10 times.
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BMJ: Large observational study finds excess CV risk with sulphonylureas, but benign outcomes with TZDs Reply

In recent years the debate over the proper use  and relative benefits of diabetes drugs has been unceasing. The significance of the controversy has been elevated due to the rising tide of diabetes and the commercial importance of many of these drugs. Now a new and very large observational study from the UK may help shed light on the real world impact of these drugs, but the more difficult decisions relating to these drugs surely will not be settled by studies of this nature.
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Roche’s taspoglutide beats sitagliptin in phase III trial 2

Two phase III trials with taspoglutide have met their primary endpoint, according to an announcement by Roche. Taspoglutide is under development by Roche as a once-weekly GLP-1 inhibitor for use in type 2 diabetics.

In the T-emerge 4 trial, taspoglutide was superior to sitagliptin in reducing HbA1c levels in 636 patients who had failed to reach treatment targets with metformin. The trial also included a placebo arm, but the press release did not give results for this part of the trial. (CardioBrief has asked Roche for clarification about this point.)
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JAMA: It’s hard to beat Framingham; beware the meta-analysis Reply

Don’t believe the hype about new risk factors, or other attempts to modify the Framingham Risk Score (FRS). That’s the message of Ioanna Tzoulaki, George Liberopoulos, and John Ioannidis in a JAMA review article assessing claims of improvements to the FRS. The same issue contains a commentary by Charles Hennekens and David DeMets warning against the dangers of small trials, meta-analyses, and subgroup analyses.
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Circulation: exercise may help slow aging process by protecting telomeres 1

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 stabilizes the telomere,” said Ulrich Laufs, the study’s lead author from Saarland University in Homburg, Germany, in an AHA press release.
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Dronedarone (Multaq) gains EU approval for atrial fibrillation Reply

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 against its use in patients with LVEF below 35%.

Click here to read the press release from Sanofi-aventis…

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

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 in the study. The results appear in a report in the New England Journal of Medicine by Torbjørn Omaland and other PEACE Trial investigators, led by Eugene Braunwald.
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