VIDEO: Trulance improves patient-assessed symptom, QOL scores
SAN ANTONIO — In this exclusive video from the American College of Gastroenterology Annual Meeting, Darren M. Brenner, MD, associate professor of medicine and surgery at Northwestern University Feinberg School of Medicine, discusses the results of a study on Trulance, which validated previous phase 3 safety and efficacy data in patients with chronic idiopathic constipation.
“The data we are presenting at this meeting is a presidential poster looking at some other domains in terms of symptom benefits and health-related quality of life, specifically using two validated scales,” Brenner told Healio Gastroenterology and Liver Disease.
The current study, according to Brenner, evaluated the patient assessment of constipation symptom scale (PAC-SYM) and patient assessment of constipation quality of life scale (PAC-QOL).
“To break down these scales a little bit further, the PAC-SYM scale is a 12-question scale that works through domains; abdominal pain, rectal pain and stool symptoms,” Brenner said. “The PAC-QOL is a 28-question survey that looks at multiple domains as well, looking at health worries and concerns, physical symptoms, psychosocial components and satisfaction with constipation-related symptoms.”
The study was a post-hoc analysis of the previous phase 3 data.
As Brenner noted, plecanatide (Trulance, Salix Pharmaceuticals) significantly improved both PAC-SYM scores and PAC-QOL scores compared with placebo.
“This new data ... validates what we saw in the original phase 3 trials looking at different endpoints showing that this can be a very effective treatment for ... patients with chronic constipation both in terms of their symptoms and the way they perceive these symptoms and their quality of life after taking this medication,” he said. – by Ryan McDonald
Brenner DM, et al. P0341. Presented at: American College of Gastroenterology Annual Meeting; Oct. 25-30, 2019; San Antonio.
Disclosure: Brenner reports serving as a speaker, advisor and consultant for Salix Pharmaceuticals.