Generic Atorvastatin Hits the Market

The first generic version of Lipitor (atorvastatin) became available today as the exclusive patent held by Pfizer finally expired. Lipitor was by far the most successful prescription drug in history. Watson Pharmaceuticals announced an authorized generic version. One other company, Ranbaxy, has been authorized to market atorvastatin, but has struggled to gain FDA approval of its manufacturing plant….

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Apixaban Gains Priority FDA Review for Stroke and VTE Prevention in AF

Bristol-Myers Squibb and Pfizer announced today that the FDA will give a priority-review to the new drug application (NDA) for apixaban (Eliquis) for the prevention of stroke and systemic embolism in AF patients. The FDA said a decision would be reached by March 28, 2012. The NDA is based on results from the large phase…

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Study Finds 10% of PCI Patients Readmitted to Hospital Within 30 Days

One in 10 PCI patients is readmitted to the hospital within 30 days, according to a new study published in the Archives of Internal Medicine. The study is a good example of the increased focus on rehospitalization, which is being used more frequently as a key measure of outcome. Farhan Khawaja and colleagues analyzed data…

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Long Transfer Delays for STEMI Patients at Most Hospitals Without Primary PCI

Fewer than 10% of STEMI patients eligible for PCI who arrive at a hospital without PCI capability are transferred within the recommended times, according to a new study published in Archives of Internal Medicine. Although dramatic improvements in door-to-balloon times have been achieved in recent years in PCI-capable hospitals, the new report suggests that hospitals without…

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CardioMEMS CHAMPION Trial Undergoes Scrutiny From Wall Street Ahead of Next Month’s FDA Panel

CHAMPION blinding

Note to readers: An earlier version of this story stated that the FDA may be concerned about the conduct of the CHAMPION trial. This statement could be construed as an implication of ethical misconduct or negligence on the part of the trial sponsors or investigators. I apologize if I conveyed this impression in the earlier story….

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ESC May Re-Examine Guidelines in Wake of Poldermans Dismissal

In the wake of the dismissal of Don Poldermans from the Erasmus Medical Center due to scientific misconduct (for background see this and this) the European Society of Cardiology has announced that Poldermans has resigned from his position as chairperson of the task force that created the ESC practice guidelines for preoperative cardiac risk assessment and…

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Long Term Followup of HPS Shows Extended Benefits of Statins

Long-term followup of patients enrolled in the Heart Protection Study (HPS) demonstrates continued benefits in the group originally randomized to receive simvastatin instead of placebo. The main results of the HPS, published in 2002, showed a significant 23% reduction at 5.3 years in major vascular events associated with simvastatin treatment among the 20,536 patients with…

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Merck Pleads Guilty and Pays $950 Million for Illegal Promotion of Vioxx

Vioxx

The US Department of Justice announced today that Merck, Sharp & Dohme will plead guilty to illegal promotion of Vioxx (rofecoxib) and will pay a $950 million in fines and penalties to the US government and individual states. The criminal plea is tied to Merck’s off-label promotion of rofecoxib for rheumatoid arthritis (RA) from 1999…

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More Details Emerge About the Dutch Research Scandal

Erasmus MC

More details have emerged about the research scandal in the Netherlands, in which prominent Erasmus Medical Center cardiovascular researcher Don Poldermans was fired for scientific misconduct. Anonymously leaked portions of a report from the Erasmus Medical Center investigation first appeared on Scribd over the weekend [Editor’s note: the Scribd link is no longer working]. Later an executive…

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Prominent Dutch Cardiovascular Researcher Fired for Scientific Misconduct

Poldermans

Updated– Don Poldermans, a well-known researcher in cardiovascular medicine in the Netherlands, has been fired for scientific misconduct by the Erasmus Medical Center in Rotterdam. According to a statement from Erasmus Medical center, an investigation found that Poldermans was careless in collecting the data for his research. In one study it was found that he used patient…

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ELEVATE TIMI 56: One New Piece of the Clopidogrel Puzzle

Jessica Mega AHA

Tripling the maintenance dose of clopidogrel in most but not all patients with a common genetic variation will lower platelet reactivity to levels achieved in patients without the variation, according to results of the ELEVATE TIMI 56 trial. The finding helps solve one piece of the clopidogrel puzzle, but does not provide a path to…

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Experts Clash Over Interpretation and Value of AIM-HIGH

Philip Barter

Sparks flew at the AHA press conference this morning when the designated discussant for the AIM-HIGH trial, Australia’s Philip Barter, said that “the design was such that in no way could it test the hypothesis” that niacin therapy may be beneficial. “This trial disturbs me greatly,” he said. The trial co-principle investigator, William Boden, defended his trial,…

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Hype Aside, Hope for Stem Cell Therapy May Be Emerging From Hibernation

Two small studies of cardiac stem cells for the treatment of heart failure have shown promise, but ABC News, CBS News and other media outlets are throwing around words like “medical breakthrough” and “heart failure cure.” ABC News correspondent Richard Besser was so enthusiastic that anchor Diane Sawyer commented that she had never seen him “so…

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SATURN Regression Trial: Gorilla Statin and Statin King Battle to a Draw

An epic battle comparing the two most potent statins– the reigning king atorvastatin versus “gorilla statin” rosuvastatin– ended with a quiet draw. Results of SATURN (Study of CoronaryAtheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) were presented at the AHA and published simultaneously in the New England Journal of Medicine….

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AIM-HIGH: No Benefit for Niacin on Top of Statins

The AIM-HIGH investigators aimed for the lofty target of proving the beneficial effects of niacin therapy. They did not succeed. The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes) investigators randomized 3414 patients with CV disease, low HDL and elevated triglycerides to extended-release niacin or placebo in addition to…

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PALLAS: Poor Results for Dronedarone in Permanent AF

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After a brief announcement earlier this year that the trial had been terminated early, the full results of PALLAS  (Permanent Atrial Fibrillation Outcomes Study Using Dronedarone on Top of Standard Therapy) have now been presented at the AHA and  published simultaneously in the New England Journal of Medicine. PALLAS shows that dronedarone (Multaq, Sanofi)  should not be used…

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MI FREEE: How Much Do Free Medications Really Cost?

heart

Could getting rid of co-payments improve adherence to post-discharge medications, leading to better  outcomes and reduced costs? That’s the theory tested by the MI FREEE (Post-Myocardial Infarction Free Rx Event and Economic Evaluation) trial, which was presented at the AHA and  published simultaneously in the New England Journal of Medicine. Niteesh Choudhry and colleagues randomized 5855…

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ATLAS ACS 2-TIMI 51: Rivaroxaban Beneficial in Low-Risk ACS Population

Results of the highly anticipated ATLAS-ACS 2–TIMI 51 demonstrate that ACS patients receiving standard therapy, including dual antiplatelet therapy, may benefit from the addition of the factor Xa inhibitor rivaroxaban, although at the cost of some additional bleeding complications. The Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary…

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ADOPT Fails to Support Extended Oral Anticoagulation with Apixaban in High Risk Post-Discharge Patients

Although medically ill patients remain at risk for VTE after hospital discharge, a strategy of extended oral anticoagulation with apixaban did not prove successful in the ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial, which was presented by Samuel Z Goldhaber at the American Heart Association and published simultaneously in the New England Journal of…

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TRACER: Novel Antiplatelet Vorapaxar Runs Into Trouble in ACS

The novel antiplatelet vorapaxar, which blocks the thrombin receptor to inhibit platelet activation, ran into trouble in the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial, which was stopped prematurely earlier this year due to safety concerns….

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The AHA Starts on Sunday

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Look for AHA coverage from Orlando starting Sunday morning at 8 AM….

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Controversy Over Cholesterol Testing for Children

New guidelines from the NHLBI and the American Academy of Pediatrics recommend that all children between the age of 9 and 11 should undergo cholesterol screening. Screening should then be repeated at 17 and 21 years of age. The new guidelines are scheduled to be officially introduced by panel member Patrick McBride at the AHA…

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TAVI at TCT: Enthusiasm Tempered by Poor Transapical Outcomes

Continued enthusiasm for transcatheter aortic valve implantation (TAVI) with the Edwards’ Sapien device was tempered somewhat by poor outcomes observed in the group of patients for whom the procedure was performed through the transapical instead of the transfemoral approach. Results of 3 new studies from the PARTNER trials and a controversial new trial, STACCATO, were…

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CardioBrief Poll: Should the ACC Train Industry Reps?

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The American College of Cardiology has announced a new series of education programs for industry employees. The ACC claims that the program will provide “a comprehensive, thorough and non-biased education in the field of cardiology” so that the employees “can become partners to health care providers — supporting positive health outcomes for patients.” …graduates of…

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Obstructive Lesions Found in Patients with Calcium Score of Zero

A small but significant number of symptomatic patients with calcium scores of zero have obstructive coronary artery disease (CAD), according to a new study published in the Journal of the American College of Cardiology. Todd Villines and colleagues studied 10,037 symptomatic patients without known CAD enrolled in the CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An…

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