August 12, 2011
Linaclotide is Safe and Effective for Chronic Constipation
Chronic constipation affects about one in six people in the U.S. and is a problem that primary care doctors hear about very frequently. Symptoms include infrequent bowel movements, hard stools, straining, abdominal bloating and discomfort, and a sense of incomplete evacuation. It’s not a dangerous problem, but it causes plenty of misery for lots of people. Though doctors have a few remedies for chronic constipation (which I’ll list at the end of this post) they are only temporarily and modestly effective.
This week’s New England Journal of Medicine publishes the results of two trials testing a new medication, linaclotide, for chronic constipation. Linaclotide is taken orally as a capsule once a day. The two studies together randomized over two thousand patients with chronic constipation to linaclotide or placebo. The patients were followed for 12 weeks to assess improvement in their symptoms.
The patients taking linaclotide had significant relief of their symptoms. (The specifics are detailed in horrifying clarity in the article.) Unlike laxatives which lose effectiveness with repeated use, linaclotide continued to be as effective at the end of the trial as at the beginning. There is also a rebound effect with the chronic use of laxatives in which after stopping the medication patients are more constipated than before they started. This rebound effect was not observed with linaclotide.
Linaclotide also appears to be safe. The most common side-effect, as you would expect, was diarrhea.
Linaclotide is not yet available to patients. It has yet to go through the FDA approval process. I suspect a few patients will be emailing me daily to check if it’s on the market yet. In the meantime, our advice to patients with chronic constipation remains the following.
WebMD also has a very informative slideshow about constipation.
No more laxative? The drug linaclotide helps relieve constipation (LA Times Booster Shots)
Experimental Drug May Treat Chronic Constipation (WebMD article)
Myths and Facts About Constipation (WebMD slideshow)
Two Randomized Trials of Linaclotide for Chronic Constipation (New England Journal of Medicine article. Summary available without subscription.)
Important legal mumbo jumbo: