番茄社区

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BARCELONA -- Relieving pain is essential to management of patients with rheumatoid or osteoarthritis, and NSAIDS are often the go-to first choice. But choosing the wrong NSAID can increase patients systolic blood pressure by 3.7 mm Hg, thus increasing the risk of stroke.

The wrong NSAID? Ibuprofen. The right NSAID? Celecoxib (Celebrex), so said Frank Ruschitzka, MD, of the University Heart Centre in Zurich, who reported the findings from the PRECISION-ABPM study in a Hot Line session at the European Society of Cardiology meeting here. The findings were simultaneously published in the .

The analysis was a pre-specified substudy of the PRECISION study -- the longtime-in-the-making cardiovascular safety study of celecoxib that was reported at the 2016 American Heart Association meeting.

Celecoxib and other cyclooxygenase (COX)-2 inhibitors came under a cloud in 2004 when a cancer chemoprevention study of rofecoxib (Vioxx) was halted due to excess thrombotic events. In the aftermath, Vioxx was pulled from the market, development of COX-2 inhibitors stopped and, in April 2005, .

PRECISION confirmed that celecoxib use did not increase the risk of heart attack or stroke compared with ibuprofen or naproxen, but there was a surprise -- naproxen was not as heart safe as previously believed.

And in this substudy using 24-hour ambulatory blood pressure monitoring, naproxen use was associated with a modest, non-significant 1.6 mm Hg increase in systolic pressure. Celecoxib, by contrast, decreased the average systolic blood pressure measured over 24 hours by -0.3 mm Hg, to produce a significant -3.9 mm Hg difference compared with ibuprofen, which raised blood pressure by 3.7 mm Hg (P=0.009).

Ruschitzka said the finding is clinically significant because NSAIDs are so widely used and because both ibuprofen and naproxen are available over-the-counter. He urged physicians to consider blood pressure when discussing NSAIDs with patients.

PRECISION-ABPM was a prospective, double-blind, randomized, non-inferiority cardiovascular safety trial. The study was conducted at 60 sites in the U.S. and included 444 patients, of whom 408 (92%) had osteoarthritis and 36 (8%) had rheumatoid arthritis. All patients had evidence of, or were at increased risk for, coronary artery disease.

Patients were randomized in a 1:1:1 fashion to receive celecoxib (100–200 mg twice a day), ibuprofen (600–800 mg three times a day), or naproxen (375–500 mg twice a day) with matching placebos. The primary endpoint was the change from baseline in 24-hour ambulatory blood pressure after 4 months.