December 13, 2005
The Cleveland Clinic announced today that its Cardiovascular Coordinating Center will direct a worldwide clinical trial involving approximately 20,000 patients to study the safety of pain relievers used by millions of patients with arthritis.
The trial will assess the relative safety of three of the most commonly used pain relievers in the treatment of arthritis patients: ibuprofen (Motrin™), naproxen (Naprosyn™ or Aleve™) and celecoxib (Celebrex™). These drugs, known as Cox-2 inhibitors (or coxibs) and non-steroidal anti-inflammatory drugs (NSAIDS), have received considerable attention recently for their potential link to cardiovascular conditions.
The trial’s lead investigator is cardiologist Steven E. Nissen, M.D., Medical Director of The Cleveland Clinic Cardiovascular Coordinating Center (C5). Dr. Nissen is also President-Elect of the American College of Cardiology, the professional society representing 33,000 cardiovascular specialists.
The worldwide study has been named the PRECISION Trial – Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen. The study will enroll patients with osteoarthritis, the most common form of arthritis, who have known coronary heart disease or who have multiple risk factors for heart disease. Some patients with rheumatoid arthritis also will be included.
This is the first large-scale trial of the popular pain relievers to exclusively study patients with heart disease or those at high risk for heart disease. Trial participants will be randomly assigned to receive one of the three drugs. Neither the patients, nor their physicians, will be aware of which drug they are actually receiving. All patients will receive a low dose of aspirin if indicated by current guidelines.
“Prior trials of pain relievers have not focused on these high-risk patients,” Dr. Nissen said. “Since so many arthritis patients are at risk for heart disease, it is critically important to understand the cardiovascular safety of these drugs. Currently available information is insufficient to determine whether typical dosages of celecoxib and other popular pain relievers are linked to an increased risk of heart disease.”
Enrollment in the trial, which is expected to take 18 months, will begin in 2006. Patients will be followed for an average of two years. The study will track the occurrence of serious cardiovascular events including death, heart attack and stroke.
“The trial seeks to provide definitive information for patients who need to know the safest approach for relieving arthritis pain,” Dr. Nissen said. “We are committed to conducting this trial using the best scientific methods to answer a critically important public health question.”
Dr. Nissen and Eric Topol, M.D. were among the first to highlight the potential risks associated with Vioxx™, a type of pain reliever that was pulled off the market in September 2004 after it was linked to adverse cardiovascular conditions. Drs. Nissen and Topol first suggested that COX-2 medicines had the potential to cause heart disease and stroke in an article published in the Journal of the American Medical Association in 2001.
Although the PRECISION trial will be funded by Pfizer Inc., makers of celecoxib, Dr. Nissen emphasizes that the leadership and conduct of the trial will be directed independently by the Cardiovascular Coordinating Center at The Cleveland Clinic. The trial will be governed by an executive committee consisting of leaders in cardiovascular medicine, rheumatology and gastroenterology, including a staff member from the National Heart, Lung and Blood Institute of the National Institutes of Health.
The study leadership will insist that none of the members of the executive committee accept honoraria or any other compensation from makers of any drugs in this class. “We recognize the importance of conducting this trial according to the highest standards of integrity,” Dr. Nissen said.
©Cleveland Clinic Foundation 12/05
