More than 5 years after Vioxx was withdrawn from the market, and more than 3 years after the US General Accounting Office (GAO) recommended major changes at the FDA to enhance the safety monitoring of approved drugs, the FDA has failed to make adequate improvements, according to a new GAO report.
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Monthly Archives: December 2009
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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Cardiorenal advisory panel to take up nebivolol for heart failure in January Reply
The FDA Cardiovascular and Renal Drugs Advisory Committee will meet on January 11 to consider the supplemental drug application of nebivolol (Bystolic) for the proposed indication of chronic heart failure. Two years ago the drug received its initial approval for the treatment of hypertension.
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.
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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US Justice Dep’t weighing criminal charges against J&J over Natrecor marketing Reply
The US Department of Justice is nearing a decision whether to file criminal charges against Johnson & Johnson for illegally marketing Natrecor (nesiritide), according to an article by Dan Levine on Law.Com. The government has been investigating J&J’s marketing of nesiritide since 2005.
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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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Susan Shurin to serve as acting director of NHLBI Reply
The NIH has announced that Susan Shurin will serve as acting director of the NHLBI, replacing Elizabeth Nabel. In October Nabel announced her resignation after being named the next president of Brigham and Women’s Hospital.
