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University of Alabama at Birmingham—
The Long-Term Safety of NSAIDs and Coxibs: A Burning Question
The mission of the University of Alabama at Birmingham (UAB) CERTs is both to evaluate the effectiveness, safety, and impact on health-related quality of life (HRQOL) of musculoskeletal disorder therapeutics, and to guide and evaluate changes in the practice community based on new therapeutic knowledge.
In order to accomplish this, the UAB CERTS is working in collaboration with the UAB Center for Outcomes Effectiveness Research and Education, Center for Metabolic Bone Disease, Arthritis and Musculoskeletal Center, and the General Clinical Research Center to investigate innovative methods for effecting meaningful changes in provider behavior and patient-level outcomes.
Key projects:
- Pharmacoepidemiology and risk communication in biological therapeutics
- Quality indicators in both the management of gout and the use of analgesics for musculoskeletal disorders
- Impact of a multi-modal, provider-based intervention on the prevention and treatment of glucocorticoid-induced osteoporosis
Assessing drug safety often must start at the very beginning of the care process. The University of Alabama at Birmingham (UAB) CERTs is probing the patterns of drug prescription for musculoskeletal disorders, tracking some of the most common chronic diseases and the most frequently prescribed medications in the nation. The researchers hope to identify the best use of alternative drugs for these debilitating conditions, particularly arthritis, gout, and osteoporosis, and to find the perfect balance between benefit and risk.
For example, non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly prescribed medications in the world. They are used for pain and inflammation relief in a host of disorders, most commonly arthritis and back pain. Despite their popularity, they can have serious side effects, especially when not managed properly.
Chronic use of traditional NSAIDs has been linked to a variety of gastrointestinal (GI) problems, ranging from small ulcers to life-threatening perforations of the stomach wall. These GI complications result in over 100,000 hospitalizations and 16,500 deaths each year with annual healthcare costs in excess of $500 million. The GI effects can be suppressed, but this requires an additional prescription.
A new class of anti-inflammatory drugs called COX-2 enzyme inhibitors, or coxibs, has emerged to help solve this problem. The most well known of these are celecoxib (Celebrex™) and rofecoxib (Vioxx™), which are among the 10 most frequently prescribed drugs in the world. Research shows these drugs offer pain relief equal to traditional NSAIDs, but with fewer GI side effects.
The long-term safety of coxibs versus traditional NSAIDs, or NSAIDs plus Prilosec™, however, remains unknown. Using the collaborative power of CERTs, Dr. Saag and his colleagues are working on this problem with a regional managed care organization, United Healthcare of Alabama, Inc. (UHC), with the Veterans Administration and the Alabama Medicare Quality Improvement Organization (QIO). These studies are expected to lead to improved prescribing for millions of arthritis sufferers.
In addition, Dr. Saag and colleagues have recently completed a study of physicians' NSAID safety practices in comparison to published guidelines. The purpose of this study is to test an intervention that will lead to improved adherence to guidelines for NSAID toxicity monitoring and better patient outcomes. According to Dr. Sandra Nichols, senior medical director for United Healthcare of North Carolina, Inc., “the UAB CERTs method of translating current evidence-based guidelines into clinical practice may help managed care organizations to minimize practice-pattern variations.”
The practices will be improved by better monitoring of complications, avoiding use of unsafe combinations of drugs (both over-the-counter and prescribed), and by proper use of other medications to prevent complications.
As the cornerstone of this project, UAB investigators use their own innovative analytical method called Achievable Benchmarks of Care (ABCs). ABCs not only provide physicians feedback on their performance in relation to established guidelines, but also as compared with the best of their peers. Novel approaches such as ABCs allow CERTs research not only to improve clinical practice, but also refine policy and professional communication.
This past year, the UAB team worked with RAND and the National Committee for Quality Assurance (NCQA) to develop quality-of-care indicators for the management of patients with osteoporosis. Through NCQA, this work will be used nationwide by employer-based health plans to assure the quality of care for their beneficiaries with osteoporosis.
Related work in collaboration with the Arizona Medicare QIO and colleagues at the Duke CERTs will improve the care of nursing home residents who suffer from osteoporosis. This experimental intervention will ensure that nursing home residents receive state of the art care for this condition, which is common and associated with severe morbidity.
These projects demonstrate the impact on standard care that the CERTs can achieve. Not only are patients made less susceptible to unnecessary risks, but the very definition of “quality care” is changed by this evidence-based approach. The UAB CERTs melds research and education into a seamless quality-improvement mission.