After researchers from the United States, France and Germany reported clopidogrel is less effective in some patients, the Food and Drug Administration (FDA) in the United States issued a black box warning to physicians on the drug's package insert.
"(Our findings) add a further layer of complexity to the FDA 'black box' warning and show that reported genetic variants have no effect in certain patient populations," said Dr. Guillaume Paré, lead researcher and assistant professor of pathology and molecular medicine at the Michael G. DeGroote School of Medicine.
Clopidogrel is the world's second best-selling prescription drug with global sales of more than $6 billion annually. It is used in 110 countries by millions of people to reduce the risk of heart attack and stroke.
Following the FDA's warning, clopidogrel became the focus of on-going debates within cardiology circles. Some American cardiologists initially called the FDA's actions irresponsible. Others complained they were left without any appropriate direction on how to manage their patients.
About 20 per cent of the population carry the loss-of-function version of the gene involved in the clopidogrel controversy.
To assess the influence genetics might have on patients prescribed clopidogrel, Paré and colleagues from McMaster University conducted a genetic sub-study of 6,000 participants from two major clinical trials (CURE and ACTIVE). The CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events) trial of 12,562 patients with acute coronary syndrome in 28 countries found clopidogrel significantly reduces the risk of heart attack stroke and dying. The ACTIVE (Atrial Fibrillation Clopidogrel Trial with Irbesartan for the Prevention of Vascular Events) trial of 7,554 patients with atrial fibrillation in 30 countries found clopidogrel added to Aspirin significantly reduced the risk of cardiovascular events, and particularly stroke. Both trials were supported by Sanofi-Aventis and Bristol-Myers Squibb.
"We found the previously reported genetic variants had no effect at all (for patients) in either the CURE or ACTIVE trials," said Paré. He will present these findings at the European Cardiovascular Society Congress meeting in Stockholm, Sweden, on August 29. The study will also be simultaneously published online in the New England Journal of Medicine.
Paré said the positive results from McMaster's genetic sub-study come from studying different patient populations. "Also, our study design was a bit stronger from an epidemiology point of view."
Beyond clopidogrel, he said there is a broader message of the need for cautiousness as genetics becomes more and more integrated into patient care.
Laura Thompson | EurekAlert!
Rutgers-led innovation could spur faster, cheaper, nano-based manufacturing
14.02.2018 | Rutgers University
New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg
Quantum computers may one day solve algorithmic problems which even the biggest supercomputers today can’t manage. But how do you test a quantum computer to...
For the first time, a team of researchers at the Max-Planck Institute (MPI) for Polymer Research in Mainz, Germany, has succeeded in making an integrated circuit (IC) from just a monolayer of a semiconducting polymer via a bottom-up, self-assembly approach.
In the self-assembly process, the semiconducting polymer arranges itself into an ordered monolayer in a transistor. The transistors are binary switches used...
Breakthrough provides a new concept of the design of molecular motors, sensors and electricity generators at nanoscale
Researchers from the Institute of Organic Chemistry and Biochemistry of the CAS (IOCB Prague), Institute of Physics of the CAS (IP CAS) and Palacký University...
For photographers and scientists, lenses are lifesavers. They reflect and refract light, making possible the imaging systems that drive discovery through the microscope and preserve history through cameras.
But today's glass-based lenses are bulky and resist miniaturization. Next-generation technologies, such as ultrathin cameras or tiny microscopes, require...
Scientists from the University of Zurich have succeeded for the first time in tracking individual stem cells and their neuronal progeny over months within the intact adult brain. This study sheds light on how new neurons are produced throughout life.
The generation of new nerve cells was once thought to taper off at the end of embryonic development. However, recent research has shown that the adult brain...
15.02.2018 | Event News
13.02.2018 | Event News
12.02.2018 | Event News
22.02.2018 | Life Sciences
22.02.2018 | Physics and Astronomy
22.02.2018 | Earth Sciences