An Embargo Becomes A Public Relations Tool

In general I support embargoes in medical journalism. Although the current system is far from perfect and contains all sorts of wrinkles and unexpected consequences, I support the system because it allows journalists a bit more time to work on complicated stories and to try to get them right. This week, though, I came across…

Click here to continue reading…

FDA Warns Against Repackaging Dabigatran

The FDA has issued a safety communication regarding dabigatran (Pradaxa). Because the drug is subject to product breakdown and loss of potency due to moisture, the FDA recommends that it should be dispensed and stored in its original packaging and that consumers avoid using pill boxes or pill organizers with dabigatran….

Click here to continue reading…

PROTECT II: Who Will Protect Us From The Protectors?

PROTECT II is back, but you may need to bring your own protection. Last December I wrote about a press release issued by Abiomed containing the first results of the PROTECT II trial of the company’s Impella device. [The December press release has disappeared from the Abiomed website. It is reprinted at the bottom of…

Click here to continue reading…

Conflicts of Interest in Cardiovascular Guidelines

More than half of authors and reviewers of cardiovascular clinical practice guidelines have at least one conflict of interest (COI), according to a study in Archives of Internal Medicine. Todd Mendelson and colleagues analyzed the 17 most recent ACC/AHA guidelines through 2008 and found that 56% of the participants reported a COI. The most common…

Click here to continue reading…

Guest Post: Supermarket Chain Hawking Quaker Products & Free Cholesterol Screening

free cholesterol screen

Editor’s Note: The following guest post is reprinted with permission from Gary Schwitzer’s HealthNewsReview Blog. Supermarket Chain Hawking Quaker Products & Free Cholesterol Screening by Gary Schwitzer An online acquaintance in public health sent me this picture with this note: What’s next? Get your free PSA w/ 3 boxes of selenium? In the fine print…

Click here to continue reading…

FDA Approves Medtronic Protecta ICDs and CRT-Ds

The FDA has approved Medtronic’s family of Protecta ICDs and CRT-Ds, the company announced today. The Protecta devices employ new algorithms that the company claims will reduce the number of inappropriate shocks delivered by the devices….

Click here to continue reading…

Updated Unstable Angina/NSTEMI Guidelines Released by ACC & AHA

The AHA and ACC have released a focused update of the 2007 guidelines for the management of unstable angina and NSTEMI. The guidelines incorporate new information from recent clinical trials, and deal with controversial topics such as the timing and role of invasive therapy, the choice of antiplatelet agents, and the use of platelet-function and…

Click here to continue reading…

FDA Approves 2 New Cardiac Resynchronization Therapy-Pacemaker Systems From Medtronic

The FDA has approved two new cardiac resynchronization therapy-pacemaker (CRT-P) systems manufactured by Medtronic, the company announced. Both the Consulta® and Syncra™ CRT-P systems include an ECG reporting system, which works with the company’s network data monitoring system to offer remote follow-up of heart failure patients. In addition, the Consulta includes Medtronic’s fluid monitoring system…

Click here to continue reading…

Study Finds Pioglitazone Prevents Progression To Diabetes

Pioglitazone significantly reduces the development of type 2 diabetes in people with impaired glucose tolerance, according to the results of the ACT NOW study published in the New England Journal of Medicine. Ralph DeFronzo and colleagues randomized 602 patients with impaired glucose tolerance to pioglitazone or placebo. During a median followup of  2.4 years diabetes…

Click here to continue reading…

Merck Abandons Development of Factor Xa Inhibitor Betrixaban

detour

Merck announced today that it was ending development of the Factor Xa inhibitor betrixaban. The right to develop the drug will be returned to Portola Pharmaceuticals. Merck said its decision about the drug, which was poised to enter phase 3 trials, was “part of an ongoing prioritization of our late-stage pipeline.” William Lis, CEO of Portola,…

Click here to continue reading…

The French Set A New Roadblock For Ticagrelor

Arret sign

Another roadblock has popped up on what once had been thought to be a clear road to success for ticagrelor, AstraZeneca’s much discussed and anticipated antiplatelet agent. Although ticagrelor (Brilinta in the US, Brilique in France and elsewhere) received approval in Europe in December, the French health technology assessment agency, HAS (Haute Autorite de Sante) has raised…

Click here to continue reading…

New Protocol Identifies Low Risk Chest Pain Patients

Investigators in the Asia-Pacific region are proposing a “reliable, reproducible, and fast” 2-hour protocol to identify chest pain patients in the emergency department who have a low short-term risk of having a major adverse cardiac event and who may therefore be suitable for early discharge. The accelerated diagnosis protocol (ADP) consists of the TIMI score, ECG,…

Click here to continue reading…

Good News And Bad News About Physical And Sexual Activity and Cardiac Events

The bad news is that physical and sexual activity can trigger acute cardiac events. The good news is that the immediate increase in risk becomes much smaller with more frequent activity, and the long term overall benefits of activity remain unchallenged. These are the key findings of a meta-analysis by Issa Dahabreh and Jessica Paulus…

Click here to continue reading…

Fibrate Prescriptions: A Tale Of Two Countries

Despite the absence of supporting evidence, use of fibrates in the United States more than doubled between January 2002 and December 2009. By contrast, fibrate usage remained relatively stable in Canada during the same period. In a paper published in JAMA, Cynthia Jackevicius and colleagues report on their use of IMS Health data to compare trends in the use of the…

Click here to continue reading…

Study Explores Lowering the Troponin Diagnostic Threshold

Lowering the troponin diagnostic threshold can significantly improve outcomes after MI, claim Scottish investigators in a report published in JAMA. More than 2,000 patients with suspected ACS were studied. 64% of patients had troponin concentrations below 0.05 ng/mL, 8% had concentrations from 0.05 to 0.19 ng/mL, and 28% had concentrations 0.20 ng/mL or higher. By…

Click here to continue reading…

AHA Releases New Recommendations For Management Of Acute VTE

The AHA is offering new guidance for the management of patients with pulmonary embolism,  iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension. The scientific statement is published online in Circulation. In addition to advice about anticoagulant therapy, the statement offers extensive recommendations about the appropriate use of fibrinolytic agents, catheter-based and surgical interventions, and…

Click here to continue reading…

PROTECT Compares Unfractionated Heparin And Dalteparin In Critically Ill Patients

ICU patients are at high risk to develop venous thromboembolism. Published in NEJM, PROTECT (the Prophylaxis for Thromboembolism in Critical Care Trial) compared the effects of the low-molecular-weight heparin dalteparin with unfractionated heparin (UFH) in 3746 critically-ill patients….

Click here to continue reading…

Stent Company Sues Investigator Over Trial Conduct

Medical device company OrbusNeich said today that it had filed a lawsuit against Pavel Cervinka, the principal investigator of a clinical trial comparing the company’s Genous stent with a bare metal stent. The trial was initially presented at the ACC in March 2009 (as reported on Heartwire here) and was subsequently published in Catheterization & Cardiovascular…

Click here to continue reading…

Lilly and Daiichi Sankyo Pull The Trigger and Kill Prasugrel Study

Daiichi Sankyo and  Lilly said today that they had discontinued the TRIGGER-PCI (Testing Platelet Reactivity in Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy with Prasugrel) study  due to a lower than anticipated rate of primary endpoints (MI or cardiovascular death) in patients enrolled in the study. Taken in combination with the publication…

Click here to continue reading…

Meta-Analysis of Observational Studies Finds Worse Outcomes For Rosiglitazone Compared To Pioglitazone

There are no long term trials directly comparing rosiglitazone and pioglitazone. In an article published in BMJ, Yoon Kong Loke and colleagues perform a systematic review and meta-analysis of 16 observational studies with more than 800,000 thiazolidnedione users in an attempt to assess the relative cardiovascular effects of the two drugs. When compared with pioglitazone,…

Click here to continue reading…

Small Study May Help Revive Hopes For Stem Cell Therapy

Stem cell therapy may help reverse long-term damage after MI, according to a small, preliminary study by a group led by Joshua Hare published in Circulation: Research. 8  patients with LV dysfunction after MI received injections of autologous bone marrow progenitor cells in the LV scar and surrounding area. At one year, as assessed by cardiac MRI,…

Click here to continue reading…

ACC and MedPage Will Provide Enhanced News Coverage From 20 Cardiology Meetings

As first reported here in December, Medpage Today and the ACC have announced an alliance to provide enhanced coverage of more than 20 cardiology meetings each year. The new partnership will be in place next month at the ACC annual meeting in New Orleans. Medpage Today editorial director Peggy Peck told CardioBrief in December that the…

Click here to continue reading…

SYNTAX Quality of Life Substudy Finds Small Benefit for CABG in Angina Relief

The newest findings from the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) study finds a small benefit for CABG over PCI in relieving angina. The results of the SYNTAX quality of life substudy are published in the New England Journal of Medicine. Previous results from the SYNTAX trial, in which 1800 patients with 3-vessel…

Click here to continue reading…

GRAVITAS Published: Who Gets To Weigh In On the Results?

When a major trial is published in a top clinical journal, the accompanying editorial often serves to set the agenda for discussion about the trial. With the publication in JAMA of the GRAVITAS (Gauging Responsiveness With A VerifyNow Assay– Impact on Thrombosis and Safety) trial, presented last November at the American Heart Association meeting, fresh questions…

Click here to continue reading…

AHA Offers Qualified Endorsement Of Weight Loss Surgery

For the first time, the AHA has offered a qualified endorsement of bariatric surgery. The scientific statement, published in Circulation, states that bariatric surgery is a relatively safe procedure that can lead to long-term weight loss and significantly improve health in appropriately selected obese patients who have been unable to lose weight nonsurgically….

Click here to continue reading…