May 17th, 2012
FDA Approves Generic Clopidogrel as Plavix Loses Patent Protection
Larry Husten, PHD
For the second time in the past 6 months, a cardiology mainstay drug has lost patent protection and gone generic. Today, the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November, the best-selling drug of all time, […]
April 19th, 2012
Should We Pull the Trigger on Platelet Reactivity Testing (and Put It out of Its Misery)?
Richard A. Lange, MD, MBA and L. David Hillis, MD
“We said it before, and we’ll say it again: an assessment of platelet reactivity by this method doesn’t effectively identify individuals at high risk for a cardiovascular event following PCI.”
March 28th, 2012
Proof-of-Concept for Bedside Rapid Genotyping Test of CYP2C19
Larry Husten, PHD
A new point-of-care test can rapidly identify people with a common genetic variant associated with impaired clopidogrel function. The authors claim that this is the first study to demonstrate the feasibility of delivering a genetic test at bedside. In an article published online in the Lancet, Jason Roberts and colleagues report on a new point-of-care test that can identify […]
September 21st, 2011
More Data but No Answers About Platelet Function Testing
Larry Husten, PHD
The RECLOSE 2–ACS (Responsiveness to Clopidogrel and Stent Thrombosis 2–ACS) trial from Italy provides new information about platelet reactivity but doesn’t answer any of the key questions about the possible role of platelet function testing in clinical practice. In a paper published in JAMA, Guido Parodi and colleagues report on 1,789 ACS patients who underwent PCI and who […]
July 28th, 2011
AstraZeneca Sets Premium Price for Ticagrelor
Larry Husten, PHD
AstraZeneca will be charging a premium price for its new antiplatelet drug ticagrelor (Brilinta). Wall Street analyst Timothy Anderson reports that the daily treatment cost for the drug will be $7.24 on a wholesaler acquisition cost (WAC) basis, which is approximately 20% higher than the daily cost of $6.08 for clopidogrel (Plavix) and about 25% […]
March 28th, 2011
Updated Unstable Angina/Non-STEMI Guidelines Released by ACC & AHA
Larry Husten, PHD
The AHA and ACC have released a focused update of the 2007 guidelines for the management of unstable angina and non-STEMI. The guidelines incorporate new information from recent clinical trials, and deal with controversial topics such as the choice of antiplatelet agents, the use of platelet-function and genetic tests with antiplatelet agents, and the timing […]
February 27th, 2011
Examining an Ad for a Platelet-Inhibition Test
Harlan M. Krumholz, MD, SM
I’ve recently seen in medical journals an advertisement that features an image of a clot within a stent and this headline in all capital letters: “Low Levels of Platelet Inhibition May Have Significant Consequences.” The final two words, “Significant Consequences,” are in a very large font, and the entire ad has an ominous black background. Below […]
November 3rd, 2010
Do Your Patients Wait to Fill Their Plavix and Effient Prescriptions After Drug-Eluting Stent Implantation?
Chris Smith, RN
I recently read an article in the journal Circulation that contained an alarming finding about patients who receive drug-eluting stents. Apparently, 1 in 6 did not fill their clopidogrel prescriptions immediately after discharge from a hospital in one of three large integrated health care systems. The median delay was 3 days. Furthermore, during a median follow-up […]
October 1st, 2010
A Case of Exuberance About a Subgroup in a Clinical Trial
Harlan M. Krumholz, MD, SM
In many clinical trials, researchers investigate whether an overall effect of an intervention is consistent across various subgroups, as I discussed in this Journal Club Series last week. Such subgroup analyses require assessment of what is called an interaction — that is, whether the effect in one group differs from that in another. Do the benefits differ, […]
August 29th, 2010
Genetic Substudies of Large Trials Question Value of Clopidogrel Genotyping
Larry Husten, PHD
Genetic substudies across a broad range of large clinical trials that used clopidogrel raise questions about the clinical utility of clopidogrel genotyping. The substudies come from large and important trials like PLATO, TRITON-TIMI 38, CURE, and ACTIVE A. A genetic substudy of PLATO finds that ticagrelor is superior to clopidogrel irrespective of genetic subtype. Therefore, according […]