One of our goals at Mayo Clinic is to improve the way patients experience health care. We established the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery to investigate ways to improve across the continuum of health care delivery. In the center, we look at systems engineering, care experience, and ways to improve population health and surgical outcomes. We also identify ways to increase value and manage costs of care – imperatives in today’s health care environment.
The center collaborates with a number of organizations to build the evidence base in health care delivery. Several colleagues and I recently published a study in the BMJ that illustrates the value that big data can add to the practice of medicine – enabling us to much more precisely treat individuals based on their personal characteristics. This study shows that we can, and should, dig deeper into treatment options based on more precise factors – in this case, an age difference of as little as 10 years. (Read full news release here).
Using the Optum Labs Data Warehouse, we determined that for older patients, particularly individuals greater than 75 years of age, the risk of gastrointestinal (GI) bleeding is 3 to 5 times higher when taking newer anticoagulant medications dabigatran or rivaroxaban compared to when using warfarin. This risk was less for users of the newer medications when younger than 65, but began to increase between age 65 and 75.
Warfarin has been in use since the 1950s, and is an effective anticoagulant. Because it is so powerful and long acting, users are required to have regular blood tests to monitor the effects. The newer medications dabigatran and rivaroxaban are as effective as warfarin at preventing blood clots and reducing the risk of stroke and clotting complications, do not require the regular monitoring and have predictable, regular single or twice daily dosing. This convenience factor has fueled the popularity of the newer medications as a replacement for warfarin.
With so many treatment choices available, doctors and patients may have difficulty narrowing them down to ‘the right choice.’ This study helps pinpoint what appears to be a better choice for older individuals. We were able to show that the risk of GI bleeding changes with patient age, and thus enable physicians to choose a safer anticoagulant option for their patients.
This study highlights the importance of post-marketing studies of drug safety using large, population-based datasets, such as Optum Labs Data Warehouse. These “real-world” studies highlight safety concerns that would not have been discovered in the environment of randomized controlled trials where patients are carefully selected to ensure adverse events do not occur. This new evidence merits consideration when physicians tailor drug regimens for their patients.
Age matters in the choice of anticoagulant. For patients younger than 65 years, the new oral anticoagulants are a safe and convenient choice. However, the risk-benefit is not favorable as the patient ages beyond 65 years.
Neena S. Abraham, M.D., is Associate Medical Director for the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. She is a Professor of Medicine, a gastroenterologist, and the director of the Mayo Clinic Cardiogastroenterology Program. She sees patients and conducts her research on the Arizona campus.