After 10 years of research, scientists have affirmed the heart safety of Pfizer Inc.'s arthritis drug Celebrex (celecoxib), providing evidence that it is no more likely to cause stroke or heart attacks than its rivals.
The arthritis drugs Celebrex, Ibuprofen and Naproxen are part of a group of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDS). All pain killers work by preventing the production of the enzyme that triggers inflammation.
In 2004, concerns toward the safety of Celebrex for the heart emerged when another pain killer named Vioxx was pulled off the market by pharmaceutical company Merck. Back then, evidence suggested that Vioxx had increased the likelihood of heart attacks among patients with arthritis.
Safe For Heart Health
Now, a large-scale study discovered that Celebrex does not pose higher risk of stroke, heart attack or other cardiovascular problems compared to Ibuprofen and Naproxen.
Dr. Steven Nissen, lead researcher of the report and a cardiologist at Cleveland Clinic, said findings indicate that Celebrex is less likely to cause side effects such as gastrointestinal or kidney problems than its rivals.
The 10-year clinical trial involved around 24,000 patients who took Celebrex, Ibuprofen or Naproxen for 20 months on average, and were followed for the next 14 months. All arthritis patients either had existing cardiovascular disease or were at greater risk.
About a third of the participants were given 100 milligrams of Celebrex twice per day, a third received 600 milligrams of ibuprofen thrice a day, and the rest received 375 milligrams of naproxen twice per day.
Nissen and his colleagues affirmed that those on Celebrex fared no worse than those on naproxen and ibuprofen when heart disease complications are considered.
"These findings challenge the widely held view that naproxen provides superior cardiovascular safety," said Nissen.
Limitations Of The Study
The results of the research may help patients reconsider their NSAID pain relievers, particularly for those who take arthritis drugs more frequently and in larger doses, authors of the study said.
Nissen advised arthritis patients with severe pain to weigh the benefits of pain relievers versus the potential hazards. He said users should take the lowest possible dosage to avoid side effects.
"Everyone on the planet takes these drugs," said Nissen. In fact, at least 70 percent of elderly in the United States take NSAIDS once a week.
Meanwhile, the research does contain several limitations. For instance, about 27 percent of patients left the trial before it was determined whether they experienced side effects, and another 68 percent discontinued the use of Celebrex.
Additionally, the dose of Celebrex given to patients because of countries' regulations is lower than the amount that patients in other studies have received. Past studies have shown the cardiovascular complications increase along with the dosage.
Details of the report are published in the New England Journal of Medicine.
