Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck Drug?

Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the…

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TACT Principal Investigator Reflects On A Long And Contentious Journey

gervasio-lamas

In a fascinating and important blog post, Gervasio Lamas offers a deeply personal perspective on the long and contentious journey of the Trial to Assess Chelation Therapy (TACT), for which he was the principal investigator. Here are a few quotes from his post, but I can’t urge you strongly enough to read the entire post over…

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Flu Vaccine May Help Prevent Cardiovascular Events

A new meta-analysis published in JAMA offers the best evidence yet that the flu vaccine may help prevent cardiovascular events. Jacob  Udell and colleagues analyzed data from 5 published clinical trials in which 6,469 patients were randomized. People who received the flu vaccine had a significantly lower risk of cardiovascular events. The protective effect was largely restricted to…

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New Questions Raised About Italian Cardiologists Already Under Cloud Of Suspicion

(This story was updated on Friday, October 4 with a response from Dr. Modena.) New questions are being raised about the integrity and reliability of research published by a prominent Italian cardiologist and her colleagues. Last November, as previous reported here, Maria Grazia Modena, a former president of the Italian Society of Cardiology, and 8 other…

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Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology

Early trials of renal denervation, the innovative new catheter-based blood pressure lowering technology,  have resulted in extremely impressive drops in systolic blood pressure in the range of 30 mm Hg. These results have sparked a great deal of excitement in the hypertension community and stirred the interest of a multitude of medical device companies. Some…

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New Actelion Drug Found Safe And Effective In Pulmonary Arterial Hypertension– But Does It Save Lives?

Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs.  The drug, a dual endothelin-receptor antagonist, is under development from Actelion as an enhanced version of bosentan (Tracleer). The results of a phase 3 trial, SERAPHIN (Study with an Endothelin…

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American Heart Association Announces Late-Breaking Clinical Trials

AHA 2013 logo

There are still a few days left in August and the European Society of Cardiology meeting doesn’t start until this weekend in Amsterdam. Nevertheless, the American Heart Association has released the list of late-breaking clinical trials for the annual meeting in November. Late-Breaking Clinical Trials 1: Acute Cardiovascular and Cerebrovascular Care Sunday, Nov 17, 2013, 4:00 PM –…

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Faint PRAISE: 13 Year Delay In Publication Of A Major Clinical Trial Sparks Criticism

Milton Packer

13 years after first being presented the results of the PRAISE-2 trial finally have been published in JACC: Heart Failure. The trial itself is now largely irrelevant to current clinical practice, as the hypothesis it tested has long been abandoned, but the long delay in publication may serve to bring even more awareness to the…

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Recent €23 Million Biotech IPO Relied Heavily On Questionable Research

A successful €23 million initial public offering  (IPO) last week was based on highly questionable research, according to a group of UK physicians who have scrutinized the available data. In addition, one of the researchers, a prominent European cardiologist, failed to disclose in a key paper that he helped to start, and held a significant interest…

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Paper Raises Hundreds Of Questions About The Integrity Of Stem Cell Research Group

Bodo-Eckehard Strauer

Serious questions have been raised about the integrity and validity of research performed by a well-established German stem cell research group. A paper published in the International Journal of Cardiology exhaustively details a multitude of discrepancies and contradictions in papers from the researcher’s group. Further, the revelation of such widespread misconduct may lead to broader disturbing questions about…

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New Anticoagulant Found Safe And Effective In Acute Venous Thromboembolism

In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism. The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented on Monday at…

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Novartis Acknowledges Employees Participated In ‘Independent’ Trials

Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five…

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Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients

  The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said  the trial had failed to meet its primary endpoint.   The RED-HF…

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