Baylor College. US: The illness known as non-valvular atrial fibrillation has serious
consequences but these can be managed. However, for years, the only
treatments to reduce the risk of stroke, had side effects such as
intracranial and/or gastrointestinal bleeding. Novel drugs are now being
used and showing safer outcomes.
A group of researchers, including some from Baylor College of
Medicine, reviewed more than 27,000 patients’ outcomes after being
treated with this drug, providing additional supportive and valuable
safety data on major bleeding and related outcomes in routine clinical
practice.
The findings appear in Clinical Cardiology.
Non-valvular atrial fibrillation is the most common cardiac
arrhythmia. It can cause heart failure, stroke, poor mental health,
reduced quality of life and death.
“Non-valvular atrial fibrillation can have severe outcomes, and the
limited treatments we had contain their own set of side effects that can
also be deadly,” said Dr. W. Frank Peacock, professor of emergency
medicine and research director at Ben Taub Hospital. “We were basically
trading a probable outcome of stroke or death for a less certain outcome
of death due to internal bleeding. The newer drugs we are using to
treat this disorder have been shown to be safer, but still have similar
side effects albeit at lower rates, so we need to keep evaluating to
find the most effective use.”
Peacock and his colleagues reviewed 27,467 patient records from the
U.S. Department of Defense who had received rivaroxaban. They found that
less 2 percent of people experienced major bleeding events with the
majority of those being gastrointestinal and not the more serious
intracranial type. Out of those who did suffer major bleeding, less than
3 percent ended in death. With past treatments such as warfarin, much
higher numbers of patients would have suffered intracranial bleeding
with a higher chance of dying.
“Overall, there was a low rate of bleeding events The majority of
bleeding events were gastrointestinal, which is less deadly than
intracranial bleeding, therefore the mortality rate was low,” Peacock
said.
Peacock added that with past drugs there were also lifestyle restrictions that are not needed when taking rivaroxaban.
“Patients couldn’t eat certain foods such as spinach. While these
restrictions might not seem dramatic, making sure our patients have a
good quality of life is very important to overall wellbeing and health.”
Peacock added that these results were consistent with past studies
but continued review of patient outcomes helps doctors weigh the
benefits of certain types of treatments, learn who is most at risk for
side effects, and allows them to educate the patient on all options.
Others who took part in the study include: Dr. Sally Tamayo, Naval
Medical Center, Portsmouth, Virginia; Dr. Manesh Patel, Duke University
Health System and Duke Clinical Research Institute, Durham, North
Carolina; Nicholas Sicignano and Kathleen P. Hopf, Clinical
Epidemiology, Health ResearchTx, Trevose, Pennsylvania; Dr. Larry Fields
and Dr. Daniel Yannicelli, Janssen Scientific Affairs, LLC, Raritan,
New Jersey; Dr.Troy Sarich, Janssen Scientific Affairs, LLC, Titusville,
New Jersey; Dr. Shujian Wu, Janssen Research and Development, LLC,
Raritan, New Jersey; and Dr. Zhong Yuan, Janssen Research and
Development, LLC, Titusville, New Jersey.