Are Your Adult Patients With IBS-C Getting Adequate Relief?
IBS-C Symptoms Have a Significant and Negative Impact on Patients‘ Quality of Life1,2
Patients are willing to give up key aspects of their life in exchange for symptom relief1*
Responses to: What would patients be willing to give up for one month of IBS-C symptom relief?
A survey of 1,667 patients with IBS-C.
In an international survey of 1,966 adults diagnosed with IBS, patients reported they were willing to give up 15 years of their life to receive a treatment that would allow them to achieve perfect health2*
The Impact of IBS-C and Finding IBSRELA
Regina‘s IBS-C symptoms cause her to miss important events, impacting her relationships with friends and family.
Because IBS-C Has Multiple Underlying Causes, Treatment Is Not One Size Fits All3,4
IBS-C is a disorder of gut-brain interaction that results in constipation and abdominal symptoms3,5
Decreased colonic contractions and water imbalances, leading to hard stool and infrequent defecation6-8
Widened tight junctions that lead to the absorption of toxins and bacteria, resulting in an inflammatory response in proximity to nerve fibers throughout the gut epithelium9,10
Enhanced sensitization of afferent nerve pathways10,11
Additional causes may include changes in gut microbiota and other triggers of gut inflammation and immune activation9,10
A Significant Proportion of Patients May Not Have Found the Right Treatment for Them5
77% of patients taking a prescription IBS-C treatment continued to experience residual abdominal and stool-related symptoms when asked in a 2018 nationwide study of 1,311 adults with IBS-C5
Peer Perspectives
“It‘s important to explore the effectiveness of each treatment, and then to find out which one is effective for a given patient.”
—Dr Susan Lucak
Compensated advisor to Ardelyx View additional videos
References:
1. Ballou S, McMahon C, Lee H-N, et al. Effects of irritable bowel syndrome on daily activities vary among subtypes based on results from the IBS in America Survey. Clin Gastroenterol Hepatol. 2019;17(12):2471-2478. 2. Drossman DA, Morris CB, Schneck S, et al. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol. 2009;43(6):541-550. 3. Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014;20(22):6759-6773. 4. Carco C, Young W, Gearry RB, Talley NJ, McNabb WC, Roy NC. Increasing evidence that irritable bowel syndrome and functional gastrointestinal disorders have a microbial pathogenesis. Front Cell Infect Microbiol. 2020;10:468. 5. Quigley EMM, Horn J, Kissous-Hunt M, Crozier RA, Harris LA. Better understanding and recognition of the disconnects, experiences, and needs of patients with irritable bowel syndrome with constipation (BURDEN IBS-C) study: results of an online questionnaire. Adv Ther. 2018;35(7):967-980. 6. Camilleri M. Peripheral mechanisms in irritable bowel syndrome. N Engl J Med. 2012;367(17):1626-1635. 7. Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001;120(3):652-668. 8. Di Rosa C, Altomare A, Terrigno V, et al. Constipation-predominant irritable bowel syndrome (IBS-C): effects of different nutritional patterns on intestinal dysbiosis and symptoms. Nutrients. 2023;15(7):1647. 9. Camilleri M, Lasch K, Zhou W. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. The confluence of increased permeability, inflammation, and pain in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012;303(7):G775-G785. 10. Barbara G, Barbaro MR, Fuschi D, et al. Inflammatory and microbiota-related regulation of the intestinal epithelial barrier. Front Nutr. 2021;8:718356. 11. Farzaei MH, Bahramsoltani R, Abdollahi M, Rahimi R. The role of visceral hypersensitivity in irritable bowel syndrome: pharmacological targets and novel treatments. J Neurogastroenterol Motil. 2016;22(4):558-574.
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age.
CONTRAINDICATIONS
- IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
- IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).
