Experimental Drug May Treat Chronic Constipation
Studies Show Linoclotide Is an Effective Treatment for Long-Term Constipation
Investigating a New Medication for Chronic Constipation continued...
In the first study, 21% of the patients on the low dose of the drug and 19% of patients on the high dose of the drug achieved that goal, compared to 3% who were taking the placebo.
In the second study, 16% on the low dose and 21% on the higher dose met that target, compared to 6% who were taking the placebo.
Stated another way, about six to 10 people would need to take the drug for one person to see a benefit.
The most commonly reported side effect was diarrhea, which affected 14% to 16% of patients on the high and low doses and about 5% who were taking the placebo.
Researchers said most of the diarrhea reported in the study occurred early on and went away as people got used to the medication.
But for about 5% of people, it was a side effect that was bothersome enough to cause them to drop out of the study.
The studies were sponsored by Ironwood Pharmaceuticals and Forest Research Institute, the companies that are developing the drug.
Experts said the studies were welcome news since few therapies have been proven to be safe or effective for a condition that can make people miserable.
"If you're constipated, you become uncomfortable," says Anthony Starpoli, MD, a gastroenterologist at Lenox Hill Hospital in New York City. "You have bloating, distention, all of these sorts of things."
"I think this is great, and the safety profile is terrific from everything that they're showing," says Starpoli, who was not involved in the research. "Of course, once this is implemented in clinical practice, sometimes the picture changes."
The drug isn't yet available to patients. The drug's manufacturer has applied for FDA approval. A decision isn't expected until next year.
"Linoclotide is actually quite promising," says Lawrence Leung, MBBChir, an assistant professor in the department of family medicine at Queens University in Kingston, Ontario, Canada.
"My concern is that it could be pretty expensive," says Leung, who recently reviewed the evidence behind treatments for chronic constipation but was not involved in the current research.
Because the elderly suffer from chronic constipation in disproportionate numbers, he thinks it will fall on public programs like Medicare to pay for the drug.
"The cost will be a concern, and I'm not sure whether governments will like to bear the cost for a drug that should be used every day," he says.