Better GI safety with celecoxib plus esomeprazole for arthritis pain

Reuters Health Information: Better GI safety with celecoxib plus esomeprazole for arthritis pain

Better GI safety with celecoxib plus esomeprazole for arthritis pain

Last Updated: 2018-05-02

By Rita Buckley

NEW YORK (Reuters Health) - Celecoxib has a better gastrointestinal safety profile in arthritis patients than ibuprofen or naproxen when all drugs are co-prescribed with esomeprazole, according to data from the PRECISION trial.

"The PRECISION trial found that the COX-2 inhibitor celecoxib does not carry any increased risk of heart attacks or strokes compared with two frequently used non-selective anti-inflammatory drugs or NSAIDS," said lead author Dr. Neville D. Yeomans from Austin Hospital, University of Melbourne, Australia.

"The present paper digs into the detail of the very large amount of information about gastrointestinal side effects of the drugs tested in that trial," he told Reuters Health by email.

PRECISION was a randomized, double-blind controlled trial including more than 24,000 adults with osteoarthritis or rheumatoid arthritis who needed daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for arthritis pain.

As described in Alimentary Pharmacology and Therapeutics, online April 17, patients received either celecoxib 100-200 mg b.i.d., ibuprofen 600-800 mg t.i.d., or naproxen 375-500 mg b.i.d. All patients received esomeprazole 20-40 mg daily, and low-dose aspirin or corticosteroids if already prescribed.

Adjudicators of clinically significant GI events (bleeding, obstruction, perforation from stomach downward or symptomatic ulcers) were blinded.

Mean treatment and follow-up durations were 20.3 and 34.1 months, respectively. While on treatment or 30 days after, clinically significant GI events occurred in 0.34%, 0.74% and 0.66% of those taking celecoxib, ibuprofen, and naproxen. Hazard ratios were 0.43 (P=0.0003) for celecoxib vs. ibuprofen and 0.51 (P=0.004) for celecoxib vs. naproxen.

Even taken with low-dose aspirin, fewer clinically significant GI events occurred on celecoxib than ibuprofen (HR, 0.52; P=0.03). Corticosteroid use increased total GI events and clinically significant GI events.

H. pylori serological status had no influence, an outcome that may be related to treatment with esomeprazole, Dr. Yeomans said.

"Celecoxib, the only COX-2 selective anti-inflammatory drug still on the market in many countries, produces fewer gastrointestinal complications than the older non-selective drugs, even when aspirin needs to be used concurrently to treat both heart disease and arthritis," he noted. "This combination of illnesses is common in our aging populations."

Dr. Yeomans said the findings should change patient management.

"Several international guidelines, based on older data, recommend avoiding a COX-2 inhibitor in patients with cardiac disease," he observed. "Now we know, with a high level of confidence, that when COX-2 inhibitors are used at the currently recommended dosage, they are less risky for the stomach and intestines. This should ease concerns about choosing a COX-2 inhibitor, especially in patients known to be at higher risk of a bleeding ulcer or anemia due to repeated gastrointestinal bleeding."

The study was funded by Pfizer. Several authors, including Dr. Yeomans, disclosed financial ties to the company.


Aliment Pharmacol Ther 2018.

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