Many at risk for stomach damage
Millions of people are taking aspirin on a daily basis, largely because the drug has been shown to significantly reduce the risk of heart attack and stroke. But for all its benefits, aspirin can also damage the lining of the gastrointestinal tract.
Many people also take anti-inflammatory drugs called cox-2 inhibitors for arthritis. Cox-2 inhibitors can exacerbate stomach damage caused by regular aspirin.
Forty to 50 percent of patients with rheumatoid or osteoarthritis are also at risk for cardiovascular disease, says Stefano Fiorucci, lead author of a study appearing in the current issue of the Proceedings of the National Academy of Sciences and professor of gastroenterology at the University of Perugia in Italy. Millions of people are exposed simultaneously to cox-2 inhibitors plus aspirin, which significantly increases the risk [of stomach damage].
Adds Dr Brett Bernstein, director of ambulatory services in the division of digestive disease at Beth Israel Medical Center in New York City, Many people now are on both aspirin and anti-inflammatories or cox-2 inhibitors, which are good for arthritis conditions but don't have a cardiac benefit.
Aspirin, stomach cancer link checked out
To see if the new aspirin could prevent stomach damage from cox-2 inhibitors, Fiorucci and his colleagues recruited 32 healthy volunteers. Half received the new drug, called NCX-4016, plus the cox-2 inhibitor celecoxib, sold under the brand name Celebrex. The other half got regular aspirin (100 milligrams) along with celecoxib.
The situation we were trying to simulate was a patient with rheumatoid arthritis who had cardiovascular risk factors and was taking cox-2 inhibitors, Fiorucci explains.
At the end of the trial, participants in the regular aspirin group suffered about twice the level of stomach damage as volunteers in the NCX-4016 group. In other words, NCX-4016 could represent a safer alternative to regular aspirin for patients who are also taking cox-2 inhibitors.
How it differs from the old version
The new aspirin differs from the old version in that it releases nitric oxide, which works to increase blood flow into different parts of the body. One reason traditional aspirin may cause damage to the stomach is that it may decrease blood flow to the lining of the stomach, Bernstein explains. As a result, substances that normally protect it can't get to it, he says. Nitric oxide opens up the blood flow, and therefore could protect the lining.
This is the third or fourth study to look at the effects of NCX-4016 in humans, says Fiorucci, who was involved in some of those studies. NCX-4016 is now in phase 2 studies in Europe.
Most of the phase 2 trials will be finished one year from now, and the company which is actually marketing it is looking for some strategic alliance with some giant to move in phase 3, Fiorucci says. It's on the way. It's not very close to the market, likely two to three years. Phase 3 is the final phase of a trial that tests the safety and efficacy of a product on a large pool of patients. - (HealthDayNews)