CardioExchange Archive

September 8th, 2011

FDA Advisory Panel Gives Yellow Light to Rivaroxaban

Larry Husten, PHD

The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers, […]

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September 8th, 2011

When Is the Patient “Too Old” for an ICD?

Tariq Ahmad, MD, MPH and James Fang, MD

Discuss whether to implant an ICD near the end of a patient’s life.

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September 6th, 2011

FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

Larry Husten, PHD

FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers is […]

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August 29th, 2011

Not Shocking: French Studies Evaluate Remote Monitoring of ICDs

Larry Husten, PHD

Remote monitoring of ICDs can reduce inappropriate shocks, but the overall clinical benefit and cost-effectiveness of the technology has not yet been demonstrated, according to two new studies presented at the ESC meeting in Paris. Salem Kacet presented the ECOST (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) study in which 433 ICD patients were […]

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August 17th, 2011

E-doctoring?

Heather M Johnson, MD, MS

The possibilities — and the limits — of giving medical advice online

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August 10th, 2011

Rivaroxaban Compared with Warfarin in 14,000 AF Patients

Larry Husten, PHD

In ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), researchers tested rivaroxaban (20 mg/day) against warfarin in 14,264 patients with nonvalvular atrial fibrillation (AF). The results of the trial, which were first presented last November at the American […]

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August 4th, 2011

Easy Come, Easy Go? ESC to Review Dronedarone’s Role in AF Guidelines

Larry Husten, PHD

Less than a year after speeding into the European Society of Cardiology’s atrial fibrillation guidelines with a class 1 recommendation, the role of dronedarone (Multaq, Sanofi) in the treatment of AF will be reconsidered. “The ESC will produce a focused update of the AF Guidelines when the full results of PALLAS have been published and regulatory authorities […]

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July 29th, 2011

Controversial IOM Report Highly Critical of 510(k) Process

Larry Husten, PHD

The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The […]

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July 28th, 2011

When Will Palliative Care and Hospice Discussions Be Considered Normal?

Heather M Johnson, MD, MS

Guest blogger John Mandrola shares a clinical anecdote that gets to the heart of the matter on this delicate issue.

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July 21st, 2011

FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone

Larry Husten, PHD

The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis), and the European Medicines Agency (EMA) has updated its reviews of dronedarone and 2 other drugs that also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer). The FDA and dronedarone: The FDA issued a safety communication about […]

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