06 May Trulance® (plecanatide) For Chronic Idiopathic Constipation and Irritable Bowel Syndrome-C
MedicalResearch.com Interview with:
Gregory S. Sayuk, MD, MPH
John T. Milliken Department of Medicine
Division of Gastroenterology
Associate Professor of Medicine and Psychiatry
Associate Director, Fellowship Training Program
Washington University School of Medicine
MedicalResearch.com: What is the background for this study?
Response: The primary objective of this analysis, “Plecanatide for Patients with Chronic Idiopathic Constipation and Irritable Bowel Syndrome‒Constipation: Analysis of Abdominal Pain from Four Randomized Phase 3 Clinical Trials,” was to determine the impact of plecanatide on abdominal pain in patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), in addition to comparing efficacy results in patient populations with minimal to mild pain versus moderate to severe pain at baseline. This was a post hoc analysis of data from the four large, phase 3 plecanatide pivotal trials in CIC and IBS-C.
MedicalResearch.com: What are the main findings?
Response: Overall, the analysis showed that CIC and IBS-C patients treated with plecanatide had a significant improvement in abdominal pain with plecanatide treatment, beginning at 1 week for IBS-C and at 2 weeks for CIC. Baseline abdominal pain scores were relatively higher for patients with IBS-C than for those with CIC.
Stratifying by baseline abdominal pain severity, CIC and IBS-C patients with moderate to severe pain at baseline treated with plecanatide had a significant improvement in abdominal pain for most weeks, beginning at 1 week for CIC and at 2 weeks for IBS-C. This effect continued to the end of the 12-week study period.
The observed differences between treatment arms in the follow-up period were not significant, supporting the consistent, ongoing use of plecanatide by the patient to sustain improvements in IBS-C and CIC symptoms, including abdominal pain, over time
MedicalResearch.com: What should readers take away from your report?
Response: These data emphasize the overlapping features in IBS-C and CIC of not only bowel symptoms (constipation, hard stools, and infrequent stools) but also abdominal pain. Plecanatide is approved for the treatment of both IBS-C and CIC at the 3 mg once daily dose and was shown effective in managing the constipation symptoms. This analysis showed that, plecanatide was effective in reducing abdominal pain in patients with both conditions as well.
MedicalResearch.com: How is plecanatide different from other treatments for Irritable Bowel Syndrome?
Response: Plecanatide works by activating guanylate cyclase C (GCC) receptors in the gut, which results in increased intestinal fluid and transit and has been shown in animal models to reduce pain by blocking pain signaling nerves in the intestines. Plecanatide is unique in that it is a close analog of uroguanylin, a protein that our body produces naturally to regulate fluid balance in the gut. Plecanatide activates the GCC receptors in a pH-dependent fashion, and as a result its secretory effects occur preferentially in the proximal small bowel (duodenum and jejunum), thereby increasing water content in the intestinal tract.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Given the wide spectrum of severity and frequency of abdominal pain experiences in both CIC and IBS-C, ongoing research is being conducted to better understand the physiological mechanisms underlying these pain experiences in both CIC and IBS-C, and with the effect of plecanatide on them. We are also very interested in learning more about the effects of plecanatide on other abdominal sensory symptoms, such as bloating, discomfort and straining, and furthermore, whether improvements in these symptoms translate into measurable benefits in the quality of life and healthcare utilization for the patient.
MedicalResearch.com: Is there anything else you would like to add?
Response: I would encourage the interested reader to also review DDW poster #3342696 with Dr. Darren Brenner as the lead author, where we analyzed the phase 3 plecanatide IBS-C and CIC data for efficacy in bloating symptoms, finding in an integrated analysis that plecanatide significantly improved bloating symptoms compared to placebo.
Disclosures: A.E. Bharucha has filed for/been awarded patents jointly with Medspira, Medtronic, and Minnesota Medical Technologies. G.S. Sayuk is a consultant and speaker for Salix Pharmaceuticals, Inc., and for Allergan/Ironwood Pharmaceuticals, and a consultant for the GI Health Foundation. J. Rosenberg participated in speakers bureaus for Allergan, Salix, and Takeda. R. Patel is an employee and stockholder at Bausch Health. Acknowledgments: Funding for this study and poster support was provided by Salix Pharmaceuticals Inc. (Bridgewater, NJ, USA). Medical writing and editorial support was provided by The Medicine Group (New Hope, PA, USA), in accordance with Good Publication Practice guidelines.
Trulance ® (Plecanadite) is FDA approved for the treatment of IBS-C and CIC and may improve abdominal and stool symptoms as early as the first 1-2 weeks; however, the maximal effect on pain can take longer. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age. Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration. Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. The most common side-effects experienced by individuals taking plecanatide include diarrhea. This drug has minimal absorption, with minimal drug-drug interactions.
Citation: DDW2020 ePoster:
Plecanatide for Patients with Chronic Idiopathic Constipation and Irritable Bowel Syndrome-Constipation: Analysis of Abdominal Pain from Four Randomized Phase 3 Clinical Trials
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