Plain language summary
Rofecoxib for osteoarthritis
Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. Further information is available at www.vioxx.com.
Does Rofecoxib work for treating osteoarthritis and how safe is it?
To answer this question, scientists found and analyzed 26 studies. These studies included over 20 000 people with osteoarthritis and lasted up to 1 year. Studies compared people taking rofecoxib at 12.5, 25 or 50 mg once a day to people taking a placebo (sugar pill) or other NSAIDs such as diclofenac, ibuprofen, naproxen, nimesulide, nabumetone, paracetamol (Tylenol), celecoxib or Arthrotec. These studies provide the best evidence we have today.
What is osteoarthritis and how could rofecoxib help?
Osteoarthritis (OA) is the most common form of arthritis that can affect the hands, hips, shoulders and knees. In OA, the cartilage that protects the ends of the bones breaks down and causes pain and swelling. Rofecoxib is often referred to as a 'COX II inhibitor' and is one of the new non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to decrease pain and inflammation. Other NSAIDS, such as naproxen (Naprosyn) are also prescribed but they come with warnings that they may cause stomach problems such as ulcers, bleeds and sores that can be serious. Rofecoxib is thought to be safer on the stomach than other NSAIDS.
Rofecoxib was taken off the market in October 2004. A study had shown that people taking rofecoxib to prevent colon cancer had more heart attacks and strokes than people taking a sugar pill.
What did studies testing rofecoxib in OA show?
Studies showed people taking rofecoxib improved more than people taking a sugar pill.
Three studies showed that
• 29 out of 100 people felt better overall with a sugar pill
• 53 out of 100 people felt better overall with rofecoxib at 12.5 mg per day.
Studies also showed that improvements were about the same whether people took rofecoxib or a different NSAID.
How safe was it in the studies?
Very few studies recorded and reported stomach problems. When rofecoxib was compared to a sugar pill, more people taking rofecoxib had kidney problems, water retention and high blood pressure but the number of people with stomach problems was about the same.
When compared to other NSAIDs, less people taking 25 or 50 mg rofecoxib had stomach problems than when taking ibuprofen (800 mg three times a day) or naproxen. Rofecoxib also caused less diarrhea than arthrotec.
What is the bottom line?
Rofecoxib was withdrawn from the world wide market in October 2004 and is no longer available.
When considering which non-steroidal anti-inflammatory drug (NSAID) to use, it must be remembered that the effects and safety of a drug is different among people and depends on the drug. The effect and safety also depends on the dose and how it acts in the body.
There are still questions about the effects and safety of other Cox-II inhibitors and more research is being done.