Aspirin is the most familiar non-steroidal anti-inflammatory drug, or NSAID. Another frequently used, non-prescription NSAID is ibuprofen, available under the brand names of Motrin, Advil, Nuprin and others. In addition, many non-steroidals are available by prescription.
Because NSAIDs suppress the body's defenses against ulcers, about 130,000 habitual users develop complications each year. Of these, 10,000 to 20,000 die.
In the last year, the Food and Drug Administration has approved the first
drug designed to prevent the ulcers induced by these pain-killers.
The prescription drug, misoprostol, is manufactured under the trade name Cytotec by G.D. Searle of Skokie, Ill. The company, which has exclusive rights to the drug until 1993, has budgeted millions to promote it. Although it accounted for only $20 million in sales last year, a company spokesman has predicted it could earn $200 to $250 million a year by 1992.
Cytotec is a man-made prostaglandin, a look-alike of a group of fatty acids, some of which stimulate a protective mechanism for certain organs, including the stomach.
The drug was so effective in its clinical trials, which began last
December, that the FDA suspended the trials after only three months. Of the 427 osteoarthritic patients studied, only 1.4 percent of those who took Cytotec with their regular pain-killer developed ulcers, compared to 21.7 percent of those who took the pain-killers alone.
The drug, which is usually taken four times a day and costs about $2 a day, has received the endorsement of the Arthritis Foundation. "When used appropriately, Cytotec reduces the possibility of stomach ulcers significantly," said Floyd Pennington, Arthritis Foundation group vice president for education.
Until Cytotec's development, coated aspirin and certain prescription NSAIDs were recommended to minimize gastrointestinal damage. But they are generally regarded as less effective in fighting arthritis pain.
Aspirin has been viewed as the chief ulcer-causing culprit and "probably still is more likely to cause ulcers," said Dr. Eric Boyce of the Philadelphia College of Pharmacy and Science. But as more people begin using the other NSAIDS, doctors are seeing ulcers in these patients, too.
In addition to arthritis sufferers, people with chronic headaches depend on these same pain-killers for relief. They, too, are at risk of developing stomach ulcers.
Unfortunately, doctors can't always predict which patients are at risk of developing ulcers and, therefore, are candidates for Cytotec. Ulcers can be ''silent" until a life-threatening complication develops.
"Some people have no symptoms of ulcers, and then they're throwing up blood. Others have the ulcer symptoms, like pain, but have no ulcer," said Dr. Doug Conaway, a Temple University rheumatologist. "We are reduced to identifying high-risk groups who could benefit from this protective drug."
Those patients considered most at risk are:
* Those over 60 years old.
* Alcohol and tobacco users.
* Persons with a history of a peptic ulcer.
* Persons with another complicating ailment, like heart disease, diabetes or kidney disease.
Doctors won't prescribe Cytotec for all patients taking pain-killers, regardless of their ulcer risk, because it has its own side-effects, including diarrhea, cramping and, in pregnant women, miscarriage. For this reason, women are advised to have a pregnancy test done before beginning Cytotec and are urged to practice effective birth control while taking it.
Although several simple tests exist to see if a person is losing blood
internally, which may indicate an ulcer is present, they don't detect the problem early enough, according to Conaway.
Once an ulcer is diagnosed, many drugs are available to treat it, although in the past that meant the patient had to halt the arthritis medication. ''People would yo-yo between ulcer medication and arthritis medication," said Pennington of the Arthritis Foundation.
For most who suspend their arthritis medication temporarily, there is no long-term loss in mobility, said Conaway. But if the arthritis pain is severe, each day without medication may mean a day lost at work, or a day spent in bed.
"NSAIDs are absolutely essential for arthritis treatment," said Pennington. "We must inform those at high risk for ulcers that Cytotec may help them, so they don't have to stop taking NSAIDs and can live a higher quality of life."
The Arthritis Foundation has a toll-free hotline (1-800-283-7800) and medicals experts will be answering questions tomorrow from 9 a.m.-7 p.m. about aspirin use and other methods of pain relief. Information packets will be mailed upon request.
Arthritis sufferers often take aspirin in much higher doses than those recommended for occasional headaches and pain. Tomorrow's hotline program is being funded by the Aspirin Foundation of America. Physicians, as well as Arthritis Foundation information specialists, will be answering questions. The hotline regularly operates Monday-Friday, 9 a.m.-7 p.m. with Arthritis Foundation operators.