AT ACG 2016

LAS VEGAS (FRONTLINE MEDICAL NEWS) – Pregabalin reduced abdominal pain in patients with irritable bowel syndrome (IBS) and moderate to severe abdominal pain, according to a study presented at the annual meeting of the American College of Gastroenterology.

Antispasmodics and neuromodulators are commonly used to treat such patients, but a significant number don’t respond to these agents, and opioids carry risks of addiction.

“It’s always very challenging to treat abdominal pain, and in general, gastroenterologists are not very comfortable treating with other agents like pregabalin. It’s important to study it,” said Lauren Gerson, MD , director of clinical research at California Pacific Medical Center, who attended the session.

The drug makes sense for IBS patients experiencing significant pain, according to Yuri Saito, MD, of the department of medicine and a consultant in the division of gastroenterology at the Mayo Clinic. Rochester, Minn., who presented the research. She noted that pregabalin is approved by the Food and Drug Administration for fibromyalgia, which occurs in many IBS patients. IBS patients also experience frequent anxiety, which can exacerbate symptoms. Pregabalin is not approved for anxiety, but is often prescribed off label. “We thought there were multiple reasons why pregabalin would potentially be effective in IBS,” Dr. Saito said in an interview.

Patients taking pregabalin (n = 41) had lower Bowel Symptom Scale (BSS) pain scores than did placebo (n = 44; 25 vs. 42; P =.008) and lower overall BSS severity scores at weeks 9-12 (26 vs. 42; P =.009). BSS diarrhea scores were lower in pregabalin (17 vs. 32; P = .049), as were bloating BSS scores (29 vs. 44; P =.016).

The study focused on patients with moderate to severe pain, who had experienced three or more pain attacks in a month, and at least one attack during a 2-week screening period. The pregabalin dosage began at 75 mg twice per day and was ramped up to 225 mg twice per day. That dosage was maintained from day 7 through week 12.

Somewhat disappointingly, the researchers found no difference in quality of life measures, but the presence of fibromyalgia may have complicated those measures, Dr. Gerson said.

Thirty-two percent of subjects in the pregabalin arm experienced dizziness, compared with 5% in the placebo group (P =.01). Other side effects included blurred vision (15% vs. 2%; P =.05) and feeling high or tipsy (10% vs. 0%; P =.05).

The results are encouraging and provide an additional treatment option. “I think it’s probably useful, but mainly in patients with diarrhea-prominent IBS,” said Dr. Gerson.

Dr. Saito was more effusive: “The take-home message is that, for patients with moderate to severe pain who have not responded to antispasmodics or other neuromodulators, Pregabalin may be useful as an alternate modality.”

Dr. Saito is an adviser or board member with Commonwealth Labs, Salix, and Synergy. Dr. Gerson is on Allergan’s speakers bureau.