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Viberzi improves symptoms of IBS-D
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Viberzi safely and effectively reduced symptoms of irritable bowel syndrome with diarrhea, according to the results of two phase 3 trials.
“IBS-D is a chronic condition that affects millions of Americans that has limited treatment options,” Anthony J. Lembo, MD, from Harvard Medical School, told Healio Gastroenterology. Viberzi (eluxadoline, Allergan) “is a novel mixed mu-opioid agonist and a delta-opioid antagonist that is administered orally. In the phase 3 clinical trials eluxadoline improved IBS-D symptoms.”
Anthony J. Lembo
In previous trials, a 200-mg twice-daily dose was not more efficacious than a 100-mg dose and resulted in more adverse events. Lembo and colleagues therefore randomly assigned a total of 2,427 adults with IBS-D from multiple centers in the U.S., Canada and UK, to receive 75-mg or 100-mg eluxadoline or placebo twice daily for 26 weeks in the IBS-3002 trial (n = 1,146), and for 52 weeks in the IBS-3001 trial (n = 1,280). The percentage of patients with a composite response of reduced abdominal pain and improved stool consistency on the same day for at least half of the days from weeks 1 through 12 and 1 through 26 served as primary endpoints.
“A greater percentage of eluxadoline treated patients met the primary efficacy endpoint defined by FDA as simultaneous reductions in the daily worst abdominal pain score by ≥30% as compared to the baseline weekly average and a reduction in the Bristol Stool Scale … to < 5 (1-7 scale where 7 is consistent with loose watery stools), on at least 50% of the days within a 12-week treatment interval,” Lembo said.
In the IBS-3001 trial, 23.9% of patients who received 75 mg and 25.1% of patients who received 100 mg achieved the primary endpoint in weeks 1 through 12 compared with 17.1% of those who received placebo (P = .01 and P = .004, respectively). For weeks 1 through 26, 23.4% of the 75-mg group and 29.3% of the 100-mg group achieved the primary endpoint compared with 19% of the placebo group (P = .11 and P < .001, respectively).
In the IBS-3002 trial, 28.9% of the 75-mg group and 29.6% of the 100-mg group achieved the primary endpoint in weeks 1 through 12 compared with 16.2% of the placebo group (both P < .001). For weeks 1 through 26, 30.4% of the 75-mg group and 32.7% of the 100-mg group achieved the primary endpoint compared with 20.2% of the placebo group (P = .001 and P < .001, respectively).
“The most common side effects reported were nausea and constipation,” Lembo said.
Nausea affected 8.1%, 7.5% and 5.1% of the 75-mg, 100-mg and placebo groups, respectively, while constipation affected 7.4%, 8.6% and 2.5%, respectively, and abdominal pain affected 5.8%, 7.2% and 4.1%, respectively.
“There were a limited number of cases of pancreatitis and sphincter of oddi dysfunction occurring almost exclusively in patients who consumed an increased amount of alcohol,” Lembo said.
Overall, 0.3% of the safety population (n = 1,666) developed pancreatitis and 0.5% developed abdominal pain with elevated hepatic-enzyme levels.
Eluxadoline was shown to decrease symptoms of IBS-D in both men and women in both trials, Lembo and colleagues concluded. “Future studies should be aimed at identifying subpopulations of patients with IBS with diarrhea who may best benefit from eluxadoline,” they wrote. – by Adam Leitenberger
Disclosure: Lembo reports he has received fees for serving on advisory boards for Allergan, Furiex, Prometheus, Salix, Valeant, Forest Laboratories, Alkermes, AstraZeneca and Ironwood. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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