Anti-inflammatory medications and the risk for cardiovascular disease: A new study, a new perspective

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Information final week about celecoxib reveals how difficult it may be to grasp the dangers and advantages of newly developed medicine. That is notably true when the findings of 1 examine contradict these of previous research. And that’s precisely what has occurred with celecoxib.

Anti-inflammatory drugs: execs and cons

The FDA accredited celecoxib (Celebrex) in 1999. This anti-inflammatory remedy could be a extremely efficient therapy for arthritis and different painful circumstances. It was developed with the hope that it will be not less than as efficient as different anti-inflammatory drugs (reminiscent of ibuprofen or naproxen) however trigger much less abdomen irritation. Growing a safer anti-inflammatory remedy is a worthy objective, since abdomen irritation can’t solely trigger annoying ache or nausea, however it could possibly additionally result in ulcers, bleeding, or perforation. These drugs may also improve blood strain and trigger kidney issues.

Celecoxib is named a COX-2 inhibitor — that’s as a result of it targets an enzyme (COX-2) concerned in irritation. Ibuprofen and naproxen (and lots of different anti-inflammatories) goal COX-1 and COX-2. They’re referred to as “non-selective” anti-inflammatory medicine. Due to the place these enzymes are discovered within the physique, the COX-2 selective drugs appeared able to dampening down irritation whereas going simpler on the abdomen.

And that was true. Celecoxib — and different COX-2 inhibitors, reminiscent of rofecoxib (Vioxx) — did trigger much less abdomen bother. However quickly after its approval, research steered different considerations: an elevated danger of coronary heart assault and stroke. Rofecoxib was faraway from the market in 2004. And whereas the FDA allowed celecoxib to stay in the marketplace, it required the producer to subject extra warnings to sufferers. It additionally required extra examine. And that’s why celecoxib is again within the information this week. The outcomes of the PRECISION (Potential Randomized Analysis of Celecoxib Built-in Security versus Ibuprofen or Naproxen) trial had been launched. And the information is nice for celecoxib.

Outcomes suggests decrease heart problems danger — and fewer uncomfortable side effects — than anticipated

The PRECISION trial is a rigorously designed and highly effective examine that analyzed the impression of celecoxib on heart problems. The examine spanned 926 medical facilities in 13 nations and enrolled greater than 24,000 sufferers with two of the commonest varieties of arthritis (osteoarthritis and rheumatoid arthritis). Every examine topic had a better than common danger for heart problems because of a historical past of hypertension or excessive ldl cholesterol.

Examine topics had been divided into three teams who took anti-inflammatory drugs each day: one group took celecoxib, one group took ibuprofen, and the final group took naproxen.

Examine topics taking celecoxib in average doses had been

  • no extra possible than these taking ibuprofen or naproxen to have a deadly or non-fatal coronary heart assault or stroke
  • much less possible than these taking ibuprofen or naproxen to have vital gastrointestinal issues, reminiscent of critical bleeding
  • much less possible than these taking ibuprofen to have kidney issues or hospital admission for hypertension.

What does this imply for you?

It’s uncommon {that a} single examine offers a definitive reply or adjustments observe in a single day. However this was a big, well-designed, and costly examine that’s unlikely to be repeated any time quickly. And, one other examine of lower-risk folks got here to an identical conclusion simply final yr.

Nonetheless, questions might but come up concerning:

  • The dearth of a placebo group. As steered by some prior analysis, it’s attainable that every one three of the medicine used on this examine improve the danger of cardiovascular issues; with no management group, it’s unattainable to say.
  • Dosing. Examine topics had been allowed to take as much as 400 mg/day of celecoxib if that they had rheumatoid arthritis however solely 200 mg/day if that they had osteoarthritis. In actual life docs might prescribe a wider vary of doses.
  • Cause for therapy. This examine solely included folks with rheumatoid arthritis or osteoarthritis. The outcomes could be totally different if folks with different circumstances had been included.
  • Different medical issues. The dangers and advantages of celecoxib in folks with different medical issues (reminiscent of vital kidney illness) are unsure as a result of this examine excluded them.
  • Different medical therapies. All sufferers on this examine took a medicine to guard the abdomen; exterior of research, that’s not at all times the case.

Whereas these points are legitimate, I feel this examine does present a big measure of reassurance concerning the cardiovascular dangers of celecoxib. And it could encourage docs who thought the drug was too dangerous to prescribe it extra usually.

This new analysis reveals in a dramatic approach why “extra analysis is required” isn’t just a tagline on the finish of so many medical information tales. And within the case of celecoxib, the results of the extra analysis is nice information certainly.

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