PRECISION Trial Highlights Importance of Clinician Counselling on Combination Therapy
Following the 2004 withdrawal of rofecoxib (Vioxx) from the market, the FDA mandated a clinical trial to determine if celecoxib (Celebrex) shared a similar elevated risk of heart-related complications. The decade long PRECISION trial (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen) studied patients with osteoarthritis or rheumatoid arthritis and concluded that celecoxib demonstrated comparable cardiovascular safety and better gastrointestinal and kidney safety in comparison to either ibuprofen or naproxen. A new substudy of outcomes from the PRECISON trial analyses patient outcomes from taking aspirin in combination with the studied NSAIDs. Principal investigator Steve Nissen, MD, chairman of cardiovascular medicine at Cleveland Clinic, commented, “NSAIDS are some of the most widely used drugs in the world with more than 100 million prescriptions issued annually in the United States. Past studies have reported conflicting results regarding using NSAIDs together with aspirin, but we know that many patients do combine the medications, so it was vital to understand the risks and differences among the drugs.”
The substudy evaluated records of almost 24,000 patents who had taken daily prescription does of celecoxib, naproxen, or ibuprofen for at least 18 months. 11,000 of these took aspirin in addition. Researchers found that the addition of aspirin diminished the original safety advantages observed for celecoxib, but that overall, patients taking a combination of celecoxib and aspirin experienced fewer adverse outcomes than did those taking both ibuprofen and aspirin. First author Grant Reed, MD, an interventional cariology fellow at Cleveland Clinic, concluded, “Our findings underscore how important it is that physicians counsel their patients when starting them on an NSAID and consider the potential effects of use together with aspirin.” The substudy was reported earlier this week in the Journal of the American College of Cardiology.
Read a news story about the findings.
The journal abstract may be read here.
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