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Lyrica may improve IBS symptoms
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LAS VEGAS — Lyrica may improve symptoms of irritable bowel syndrome, including overall symptoms, abdominal pain and potentially bloating and diarrhea, according to the results of a pilot randomized controlled trial presented at ACG 2016.
Lyrica (pregabalin, Pfizer) is a structural derivative of gamma-aminobutyric acid (GABA), and a calcium channel alpha 2 delta-subunit ligand with known analgesic and anxiolytic activity. It is FDA approved for fibromyalgia and various forms of neuropathic pain ... and also has several non-FDA uses including generalized anxiety disorder and restless leg syndrome.
“The rationale for pregabalin in IBS was several-fold,” Yuri A. Saito, MD, MPH, associate professor of medicine at the Mayo Clinic in Rochester, Minn., said during her presentation.
“First of all, there have been studies that document that fibromyalgia is common in IBS patients, and conversely, there have been studies that report among fibromyalgia patients, IBS is common. We also know that anxiety is common in IBS patients.” Moreover, a previous study has shown pregabalin modifies visceral hypersensitivity in IBS patients, she noted.
To obtain preliminary clinical data on the effect of pregabalin on gastrointestinal IBS symptoms,
Saito and colleagues randomly assigned 85 adults with IBS (mean age, 39.4 years; 86% women) who had baseline pain scores greater than 50/100 to receive 225 mg pregabalin or placebo twice daily for 12 weeks. Twenty-one percent of patients had IBS-C, 35% had IBS-M, 44% had IBS-D, and 20% also had fibromyalgia.
Average pain/discomfort scores on the Bowel Symptom Scale during the last 4 weeks of treatment served as the primary endpoint, and these were significantly lower in the treatment vs. placebo arm (25 vs. 42; P = .008).
Average overall BSS severity scores were also lower in the treatment arm during the same period (26 vs. 42; P = .009), as were BSS diarrhea scores (P = .049) and BSS bloating scores (P = .044), but there was no difference in BSS constipation scores. Findings were similar during the last week of treatment.
In terms of secondary endpoints, there was no significant difference in adequate relief at week 12 between groups (46% vs. 36%; P = .35). In addition, 63% of the treatment group vs. 45% of the placebo group had changes of 3 or greater from baseline pain scores during the last week of treatment (P = .1). IBS-related quality of life was also comparable between groups at the end of treatment.
“In conclusion, this pilot study suggests that pregabalin may show beneficial effects on the symptoms of IBS, including overall IBS symptoms and abdominal pain, but also potentially bloating and diarrhea, and additional studies are warranted to determine whether these findings can be replicated in a larger sample,” Saito said. – by Adam Leitenberger
Reference:
Saito YA, et al. Abstract #9. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 17-19, 2016; Las Vegas, NV.
Disclosures: Saito reports advisory committee or board membership for Commonwealth Labs, Salix and Synergy.
Perspective
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William D. Chey, MD
I think this is a very exciting study. The idea of identifying alternative pain modulators for patients with IBS is an incredibly hot topic of tremendous clinical relevance.
Pain is the unifying clinical feature in patients with IBS. Obviously, patients with IBS have a broad range of clinical phenotypes in regards to their bowel habits, but all patients have pain. When looking broadly at populations of IBS and asking them about their most bothersome symptom, it’s almost universally pain in the studies that have been conducted. So the idea of identifying drugs that have before this time not been utilized for pain in patients with IBS is really exciting.
A lot of people in clinical practice are already experimenting with drugs that effect gabalin or pregabalin, so seeing data from an actual randomized controlled trial is reassuring. This should really stimulate the design and conduct of larger trials that can give us greater confidence about the benefits of this drug for IBS.
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