Editor's Note: In March 2007 the FDA asked Novartis -- the maker of Zelnorm -- to pull the drug from the market because of evidence that it raises the risk of heart attacks and stroke. But in July 2007 the FDA ruled that Zelnorm may be used by some patients in critical need of the drug who do not have heart problems.
May 21, 2004 -- A drug now prescribed for women with irritable bowel syndrome (IBS) may prove to be an effective and novel treatment for people with severe heartburn who respond poorly to existing therapies, according to new research presented this week at a large digestive disease conference.
Investigators say the findings may help in understanding the pain involved with gastroesophageal reflux disease, or GERD, and could have major implications for the future treatment GERD.
[The heartburn drugs Prilosec and Nexium] work like magic in patients whose GERD is driven by acid exposure, but as many as a third of patients don't respond well to acid suppression," study author Philip B. Miner Jr., MD, tells WebMD. "This study provides new insights and a possible new treatment strategy."
Forty two patients whose GERD was poorly controlled by a class of drugs called proton pump inhibitors (including Prilosec and Nexium) were treated with either placebo or the IBS drug Zelnorm -- the first approved drug to mimic the effects of the hormone serotonin in the intestine. This naturally occurring hormone works to regulate the intestinal tract.
In the study, the drug was found to have no impact on the amount of acid secreted by the stomach, yet patients reported less heartburn and regurgitation while taking Zelnorm. Roughly two-thirds of the patients in the study said the drug controlled their pain better than placebo, despite the drug having little or no effect on the amount of acid secreted.
"This particular drug may end up being the best drug for this purpose or it may not," Miner says. "But the most important thing is that this research adds to our understanding of what is happening in people with GERD."
Expert Not Impressed
GERD researcher Joel Richter, MD, says he doesn't buy the argument that a third of patients cannot be adequately treated with currently approved medications like Prilosec and Nexium.
"I think the number is much lower than that," he tells WebMD. "But billions are spent each year in the treatment of GERD, so all the drug companies want to get into the heartburn business."
The chairman of the gastroenterology department at The Cleveland Clinic, Richter says he has used Zelnorm to treat roughly a dozen of his GERD patients. Only one or two responded, he says, and a side effect - diarrhea -- was a big problem.
Zelnorm is approved for the treatment of constipation-related irritable bowel syndrome (IBS). Although diarrhea was also reported as a side effect in the study, none of the patients stopped taking the drug because of it.
"The one thing this drug is good at is making stools loose," Richter says. "This research suggests some reason for enthusiasm, but I certainly didn't see it in my patients."
Zelnorm manufacturer Novartis Pharmaceuticals paid for the study and is a WebMD sponsor.