10-year study eases concerns about Celebrex, heart risk

(CNN)Over the past decade, doctors have suspected that celecoxib, a pain-relieving nonsteroidal anti-inflammatory drug, or NSAID, increases heart risks more than older NSAIDs. But a new study, published Sunday in the New England Journal of Medicine, lays those fears to rest.

A three-way comparison of prescription doses of Celebrex (celecoxib), Naprosyn (naproxen) and Motrin (ibuprofen) showed little difference in arthritis patients' risk of heart failure, heart attack or stroke, with Celebrex proving marginally safer than the others.
    "In 2013, there were 100 million prescriptions written for NSAIDs, so these results affect almost everybody," said Dr. Steve Nissen, lead investigator of the new study and chairman of the department of cardiovascular medicine at the Cleveland Clinic. He presented his findings at the American Heart Association's annual scientific meeting in New Orleans Sunday.
    The study began 10 years ago and involved nearly 1,000 medical centers around the world. The researchers equally divided more than 24,000 osteoarthritis or rheumatoid arthritis patients into three groups. Each group was assigned prescription doses of either celecoxib, naproxen or ibuprofen.
    More than half (64%) of the participants were women. The average age of participants was 64. All had been diagnosed with heart disease or had an increased risk for developing cardiovascular problems along with their arthritis condition.
    Though the main purpose of the study was to see whether celecoxib raised the risk of heart problems in this group of patients, Nissen and his colleagues also assessed whether all or any of the three drugs were associated with serious gastrointestinal upset, kidney complications or death.
    "Until you do the studies, you can make bad judgments about what is safe and effective," Nissen said, adding that the new study "didn't show what we thought."

    Heart risks

    Celebrex did not prove more risky than the two older drugs. In fact, heart attack, stroke or cardiovascular death occurred in 2.3% of the patients taking celecoxib, 2.5% of those taking naproxen and 2.7% of those taking ibuprofen.
    An unrelated 2004 study raised questions about the potential risks of prescription-strength celecoxib. In 2005, the FDA responded to this news by advising Pfizer that Celebrex could stay on the market if the company continued to study potential heart risks associated with the drug.
    A year later, Nissen and Pfizer began the specially designed study of arthritic patients at high cardiovascular risk to comply with the FDA advisory.
    Importantly, Celebrex went off-patent in the United States and Europe two years ago, so the generic can now be produced by competitors. However, Pfizer retains the patent in Japan until 2016.
    "This was never about the patent -- this was about patient safety," said Pressler, who explained Pfizer carries out studies to validate the safety of its products all the time. Asked if Pfizer is hoping to create an over-the-counter version of Celebrex, which is a prescription drug, he said it's under consideration andwill ultimately be for the FDA to decide.
    Nissen said the new results prove that previous assumptions about Celebrex based on Vioxx are simply incorrect.
    "I've been telling my patients for 10 years that if they have arthritis and have to take a drug, naproxen is safest," said Nissen, who presented the research Sunday at the American Heart Association conference in New Orleans. "I've been wrong. I drank the Kool-Aid."

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    Steinbaum agreed. "As a cardiologist and as a patient," Celebrex can be considered a safe option for pain relief -- "and it might be better in terms of side effects."
    However, Nissen and his co-authors concluded that their results do not tell us about the effects of the more than two dozen other NSAIDs marketed in the United States.
    "At the end of the day, NSAIDs are not great for us. There are side effects to every medication," Steinbaum said. "What I tell people is, the lowest dose you can get away with, the better it is."

    Read more: http://www.cnn.com/2016/11/13/health/nsaid-pain-reliever-safety/index.html