The potential development of ulcers in patients who regularly take NSAIDs (nonsteroidal anti-inflammatory drugs) to relieve arthritis or other chronic pain is a known risk.
Study Shows Nexium Reduces Ulcer Risks
According to study results presented at the 68th Annual Scientific Meeting of the American College of Gastroenterology, Nexium (generic name esomeprazole), may significantly reduce the risk of ulcers. Nexium, a prescription heartburn medication marketed by AstraZeneca Pharmaceuticals LP, is a proton pump inhibitor (a class of drugs which blocks the production and secretion of gastric acid).
Nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen, aspirin and Celebrex (a COX-2 selective inhibitor), when taken regularly or at high doses quadruple the risk of gastric and duodenal (peptic) ulcers. Up to 30 percent of long-term NSAID users reportedly develop ulcers. Damage done to the stomach lining by NSAIDs depends on how much gastric acid is present. Drugs which suppress acid have been shown to reduce the risk of ulcers in previous studies. This study, which was funded by Astra Zeneca, was most promising since it evaluated a group of patients with a higher than average risk of developing ulcers.
About The Study
There were 585 participants involved in the international, multicenter, randomized, placebo-controlled study. All of the study participants were long-term painkiller users, taking an NSAID or COX-2 selective inhibitor for at least 5 days a week for 4 weeks. The participants were randomly assigned treatment with 20 mg. or 40 mg. Nexium (esomeprazole) or a placebo daily for 6 months.
- About 75 percent of the participants were women.
- About 26 percent had a history of previous ulcers.
- About 64 percent were over 64 years old.
- About 10 percent had both risk factors of being over 60 years old and having a previous ulcer.
- More than 80 percent of study participants were taking NSAIDs to treat one of the types of arthritis.
- 15 percent were taking COX-2 selective inhibitors.
- Some participants were taking aspirin at doses to protect their cardiovascular system.
- All participants screened negative for Heliobacter pylori at the beginning of the study. (H. pylori is a bacteria which causes ulcers.)
The Study Results
- 12.3 percent of participants who were given placebo instead of Nexium developed either a gastric or duodenal ulcer during the 6 month study.
- For the NSAID users (non-COX-2 inhibitor) who received 20 mg. or 40 mg. of Nexium daily, the ulcer rate was 5.2 percent and 4.4 percent respectively.
- Of the group taking COX-2 inhibitors, 17 percent taking placebo pills developed ulcers.
- None of the group taking COX-2 inhibitors and either dose of Nexium developed ulcers during the study. (This group was not large enough however to be statistically significant.)
The study results are encouraging. More studies will surely follow.
Sources: Painkiller Users: Heartburn Pill a Day Keeps Ulcers Away, NEWSWISE, October 14, 2003
Nexium combats ulcers caused by painkillers, Reuters Health, October 14, 2003
