Gastroenterology & Hepatology

July 2024 - Volume 20, Issue 7, Supplement 4

Highlights in IBS-C From Digestive Disease Week 2024

With Expert Comments by:
Darren M. Brenner, MD
Professor of Medicine (Gastroenterology and Hepatology) and Surgery
Northwestern Medicine
Northwestern University
Feinberg School of Medicine
Chicago, Illinois

A Review of Selected Posters and CME Symposium
From DDW 2024
May 18-21, 2024    Washington, DC

Efficacy of Tenapanor in Patients With IBS-C: A Post Hoc Analysis of Patients With and Without Prior Use of Other IBS-C Prescription Medications From the Phase 3 T3MPO-1 and T3MPO-2 Studies

Irritable bowel syndrome (IBS) is commonly accompanied by diarrhea but may instead be marked by constipation (IBS-C).1 IBS-C affects approximately 29% of the population and can cause severe deterioration in quality of life. Tenapanor is a first-in-class locally acting inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3).2 The drug received approval by the US Food and Drug Administration (FDA) for the treatment of patients with IBS-C, based on the double-blind, multicenter, phase 3 T3MPO-1 and T3MPO-2 trials.3-5 T3MPO-1 enrolled 1599 adults for a 12-week treatment period, and T3MPO-2 enrolled 1461 adults for a 26-week treatment period. Patients in both trials were evenly randomized to receive tenapanor (50 mg, twice daily) versus placebo. The trials demonstrated improvements in IBS symptoms, including significant increases in the frequency of complete spontaneous bowel movements (CSBM) and decreased pain compared with baseline values. 

Both the T3MPO-1 and T3MPO-2 trials allowed the enrollment of patients who had previously used other prescription medications, as long as their use had stopped within 30 days of trial enrollment. Therefore, a post hoc analysis was performed to evaluate the effect of prior medication use on the clinical response to tenapanor, using pooled patient data from the 2 trials.6 A CSBM response was defined as an increase of 1 or more weekly CSBM from baseline, and abdominal pain response was defined as a decrease of at least 30% in average weekly worst abdominal pain from baseline. The FDA composite response was defined as having both a CSBM response and an abdominal pain response in the same week for at least 6 of the 12 weeks of study treatment. The post hoc analysis included 58 patients with prior prescription medication use for their IBS-C (tenapanor, n=26; placebo, n=32) and 1145 patients with no prior prescription medication use for their IBS-C (tenapanor, n=576; placebo, n=569). The most common prior prescription medication was linaclotide (61.5%-59.4%), followed by lubiprostone (38.5%-37.5%). Both linaclotide and lubiprostone had been previously used by 3.1% of patients in the placebo cohort versus 0% in the tenapanor cohort. 

Among patients with prior exposure to prescription medication for their IBS-C, the composite response rate was significantly higher with tenapanor versus placebo (42.3% vs 18.8%; P=.038). The composite response rate was also higher with tenapanor versus placebo among patients without prior exposure to prescription medication for their IBS-C (31.2% vs 21.3%; P<.0001). Among patients with prior exposure to prescription medication for IBS-C, tenapanor was associated with a higher rate of CSBM response versus placebo (46.2% vs 25.0%; Figure 1), whereas the abdominal pain response was similar for tenapanor and placebo (46.2% vs 43.8%, respectively). Among the cohort of patients without prior exposure to prescription medication for their IBS-C, tenapanor was superior to placebo based on both the CSBM rate (40.2% vs 31.7%; P=.002) and reduction in abdominal pain (46.9% vs 35.3%; P<.001). 

Tenapanor was generally well tolerated. Treatment-emergent adverse events (AEs) were more common among patients with prior exposure to prescription medication for their IBS-C compared with patients without (59% vs 36%). During the randomized treatment period, the most common treatment-emergent AE was diarrhea, in patients with (26.9%) and those without (14.8%) prior IBS-C prescription medication use.

References

1. Singh P, Sayuk GS, Rosenbaum DP, Edelstein S, Kozuka K, Chang L. An overview of the effects of tenapanor on visceral hypersensitivity in the treatment of irritable bowel syndrome with constipation. Clin Exp Gastroenterol. 2024;17:87-96.

2. Herekar A, Shimoga D, Jehangir A, et al. Tenapanor in the treatment of irritable bowel syndrome with constipation: discovery, efficacy, and role in management. Clin Exp Gastroenterol. 2023;16:79-85.

3. Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281-293.

4. Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294-1303.

5. Ibsrela (tenapanor) [package insert]. Freemont, CA: Ardelyx, Inc.; April 2022.

6. Shah E, Lacy B, Yang Y, et al. Efficacy of tenapanor in patients with irritable bowel syndrome with constipation: a post hoc analysis of patients with and without prior use of other IBS-C prescription medications from the phase 3 T3MPO-1 and T3MPO-2 studies [DDW abstract Tu1658]. Gastroenterol. 2024;166 (6 [suppl 1]).

Comparing the Efficacy of Tenapanor in IBS-C in Hispanic Versus Non-Hispanic Patients: A Post Hoc Analysis of Patients in the Phase 3 T3MPO-1 and T3MPO-2 Studies

Studies suggest that there may be differences between Hispanic and non-Hispanic adults with IBS, in terms of health-care–seeking behaviors, internalized stigma, and the time spent attending to bowel function.1-3 Hispanic people comprise the second largest ethnic population in the United States, at approximately 65 million or nearly 20% of the entire US population; however, Hispanic patients only represent approximately 11% of clinical trial participants.3-5 A post hoc study evaluated outcomes in Hispanic versus non-Hispanic patients in the T3MPO-1 and T3MPO-2 studies, whose study populations included 28% Hispanic patients.6-8

The multicenter, double-blind, phase 3 T3MPO-1 and T3MPO-2 studies enrolled adults with IBS-C. Patients were randomized to treatment with tenapanor (50 mg, twice daily) versus placebo for 12 weeks (T3MPO-1) or 26 weeks (T3MPO-2).9 The pooled analysis of the current study included 600 patients who were treated with tenapanor (175 Hispanic and 425 non-Hispanic patients) and 599 patients who received placebo (161 Hispanic and 438 non-Hispanic) from the intention-to-treat population. 

The response to tenapanor versus placebo was defined as follows. A 6- of 12-week overall response was defined as achieving a CSBM response and an abdominal pain response in the same week for at least 6 of the first 12 weeks of treatment. A 9- of 12-week overall response was defined as achieving a CSBM response, an abdominal pain response, plus at least 3 CSBMs in the same week for at least 9 of the first 12 weeks of treatment. A 9- of 12-week durable overall response was defined as achieving a CSBM response, an abdominal pain response, and at least 3 CSBM in the same week for at least 9 of the 12 weeks of treatment plus 3 of the 4 final weeks of treatment (during weeks 9-12 of treatment). 

All three of the efficacy outcomes showed superior results with tenapanor versus placebo in both the Hispanic and non-Hispanic cohorts from the pooled analysis, and outcomes were generally comparable between the 2 ethnic subgroups of patients. The 6- of 12-week overall response rate was 30.86% with tenapanor versus 18.01% with placebo (∆=12.84%; P=.006) in the Hispanic cohort and was 32.00% versus 22.37%, respectively, in the non-Hispanic cohort (∆=9.63%; P=.002; Figure 2). The 9- of 12-week overall response rate was 18.29% with tenapanor versus 6.21% with placebo in the Hispanic cohort (∆=12.07%; P<.001) and was 15.06% versus 3.65%, respectively, in the non-Hispanic cohort (∆=11.41%; P<.001). The 9- of 12-week durable overall response rate was 17.71% with tenapanor versus 6.21% with placebo in the Hispanic cohort (∆=11.50%; P<.001) and was 14.59% versus 3.42% in the non-Hispanic cohort (∆=11.16%; P<.001).

Treatment-related AEs were reported by 26.9% of Hispanic patients versus 48.2% of non-Hispanic patients; however, the difference between the 2 cohorts was attributed to random factors. Diarrhea was the most common treatment-emergent AE of any grade in both the Hispanic (8.6%) and non-Hispanic (18.0%) cohorts. Other treatment-emergent AEs included nausea, nasopharyngitis, flatulence, headache, and urinary tract infection.

References

1. Almario CV, Sharabi E, Chey WD, Lauzon M, Higgins CS, Spiegel BMR. Prevalence and burden of illness of Rome IV irritable bowel syndrome in the United States: results from a nationwide cross-sectional study. Gastroenterol. 2023;165(6):1475-1487.

2. Taft TH, Riehl ME, Dowjotas KL, Keefer L. Moving beyond perceptions: internalized stigma in the irritable bowel syndrome. Neurogastroenterol Motil. 2014;26(7):1026-1035.

3. Zuckerman MJ, Guerra LG, Drossman DA, Foland JA, Gregory GG. Health-care-seeking behaviors related to bowel complaints. Hispanics versus non-Hispanic whites. Dig Dis Sci. 1996;41(1):77-82.

4. US Census Bureau. Profile of general population and housing characteristics. http://data.census.gov/. Accessed June 10, 2024.

5. US Food & Drug Administration. 2020 Drug Trials Snapshots Summary Report. https://www.fda.gov/media/145718/download. Accessed June 10, 2024.

6. Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281-293.

7. Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294-1303.

8. Frazier R, Hasler W, Yang Y, Zhao S, Edelstein S, Rosenbaum DP. Comparing the efficacy of tenapanor in irritable bowel syndrome with constipation in Hispanic vs non-Hispanic patients: a post hoc analysis of patients in the phase 3 T3MPO-1 and T3MPO-2 studies [DDW abstract Tu1663]. Gastroenterol. 2024;166(6 [suppl 1]).

9. Ibsrela (tenapanor) [package insert]. Freemont, CA: Ardelyx, Inc.; April 2022.

Efficacy, Safety, and Time to Response of Linaclotide in Patients ≥65 With IBS-C

Linaclotide is a guanylate cyclase-C agonist that is approved by the FDA for the treatment of adults with IBS-C.1 Despite the high incidence of IBS-C in the overall population, few studies have focused specifically on elderly patients. A Japanese study suggested that IBS-C symptoms may differ among patients in different age groups.2 To evaluate the effects of linaclotide therapy in older patients, a post hoc analysis evaluated the safety, efficacy, and time to response in patients with IBS-C based on age.3 Patient data were pooled from 3 phase 3 trials that compared daily linaclotide (290 μg) versus placebo for 12 weeks: LIN-MD-31, MCP-103-302, and MCP-103-312.4-6 All of the trials included patients who met the modified Rome II or Rome III criteria for IBS-C and had a mean baseline abdominal pain score of at least 3.

The post hoc subgroup analysis included 2044 patients aged less than 65 years (linaclotide, n=1028; placebo, n=1016) and 152 patients aged 65 years or greater (linaclotide, n=73; placebo, n=79). Patients in the younger subgroup had a mean age of 42.8±11.8 years and 89% were female. Patients in the older subgroup had a mean age of 70.6±5.2 years and 72% were female. Baseline characteristics were similar across the 4 subgroups, including mean body mass index (27.7-28.5 kg/m2), abdominal pain score (5.3-5.8), and CSBM frequency (0.2-0.4). In both the younger and older subgroups, linaclotide yielded significant improvements in IBS-C–related symptoms compared with placebo, based on abdominal pain, abdominal discomfort, abdominal bloating, and CSBM frequency (Figure 3).

Linaclotide also yielded a superior median time to response compared with placebo based on abdominal symptoms and CSBM frequency in both cohorts based on age. In the older subgroup of patients, linaclotide significantly improved the median time to response based on abdominal pain (3 vs 6 weeks; P=.0106), abdominal discomfort (3 vs 8 weeks; P=.0054), abdominal bloating (3 vs 9 weeks; P=.0005), and CSBM frequency (2 vs 3 weeks; P=.0165). In the younger subgroup of patients, linaclotide again showed a significant improvement in time to response based on abdominal pain (3 vs 6 weeks; P<.0001), abdominal discomfort (3 vs 7 weeks; P<.0001), abdominal bloating (4 vs 8 weeks; P<.0001), and CSBM frequency (2 vs 4 months; P<.0001). 

The most common treatment-emergent AE in both linaclotide-treated subgroups was diarrhea of any grade, affecting 15% to 16% of patients. The majority of treatment-emergent diarrhea was mild to moderate in severity. In patients aged 65 years or greater, treatment-emergent diarrhea led to discontinuation in 5.3% of patients; in patients less than 65 years of age, treatment-emergent diarrhea led to discontinuation in 3.9% of patients. Among patients treated with placebo, the rate of treatment discontinuation owing to treatment-emergent diarrhea was 2.5% in the older versus 0% in the younger patients. In summary, linaclotide demonstrated acceptable safety and efficacy outcomes for the treatment of IBS-C in both younger and older patient subgroups from 3 phase 3 trials.

References

1. Linzess (linaclotide) [package insert]. North Chicago, IL: AbbVie, Inc.; June2023.

2. Kosako M, Akiho H, Miwa H, Kanazawa M, Fukudo S. Influence of the requirement for abdominal pain in the diagnosis of irritable bowel syndrome with constipation (IBS-C) under the Rome IV criteria using data from a large Japanese population-based internet survey. Biopsychosoc Med. 2018;12:18.

3. Chang L, Brenner DM, Chen W, et al. Efficacy, safety, and time to response of linaclotide in patients ≥65 with irritable bowel syndrome with constipation [DDW abstract Tu1653]. Gastroenterol. 2024;166(6 [suppl 1]).

4. Chang L, Lacy BE, Moshiree B, et al. Efficacy of linaclotide in reducing abdominal symptoms of bloating, discomfort, and pain: a phase 3b trial using a novel abdominal scoring system. Am J Gastroenterol. 2021;116(9):1929-1937.

5. Chey WD, Lembo AJ, Lavins BJ, et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol. 2012;107(11):1702-1712.

6. Rao S, Lembo AJ, Shiff SJ, et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am J Gastroenterol. 2012;107(11):1714-1724.

One Size Does NOT Fit All: Improving Patient Care in IBS-C

An Interview With Darren M. Brenner, MD

This interview is based on the presentations and discussion at the CME symposium “One Size Does NOT Fit All: Improving Patient Care in IBS-C,” which was planned and implemented by Medical Education Resources and GI Health Foundation. Presenters at the symposium included Darren M. Brenner, MD, Christina Hansen, FNP-C, and Gregory Sayuk, MD.

G&H What are the typical symptoms that patients with IBS-C experience?

DMB In clinical practice, there is often a convergence of symptoms between IBS-C and chronic idiopathic constipation (CIC). IBS-C manifests with abdominal pain along with symptoms of constipation. Additionally, many patients with IBS-C also experience abdominal discomfort and bloating, hence the importance of assessing each of these symptoms in clinical trials. Regarding bowel symptoms, patients commonly report decreased stool frequency and/or the passage of hard stools (Bristol Stool Form Scale [BSFS] 1-2) as well as sensations of straining and/or incomplete evacuation. When evaluating a patient with IBS-C, it is crucial to thoroughly investigate all functional constipation symptoms.

G&H What are the social and economic burdens associated with IBS-C? 

DMB IBS-C imposes substantial economic burdens, estimated in the billions per annum in the United States alone. These costs encompass both direct expenses and indirect losses, with the latter stemming from reduced work productivity in the forms of absenteeism and presenteeism, and the excessive utilization of unnecessary diagnostic procedures. Surprisingly, despite both the American Gastroenterological Association (AGA) and American College of Gastroenterology (ACG) advocating for the use of a positive diagnostic strategy minimizing testing, extensive testing remains the norm.

Beyond financial ramifications, IBS-C profoundly affects patients’ quality of life, with the majority experiencing significant distress from their symptoms. Depression and anxiety rates are elevated among patients along with constraints on physical and social activities. One study revealed the staggering extent of this impact, with patients expressing a willingness to sacrifice one-quarter of their remaining life expectancy (averaging 15 years) for a treatment guaranteeing symptom relief.

Despite its debilitating nature, a troubling 75% of individuals with IBS remain undiagnosed. Early, accurate diagnosis is thus paramount to initiating timely treatment interventions.

G&H Why is making an IBS-C diagnosis important?

DMB Making a definitive diagnosis of IBS-C is important for many reasons. First, it validates the patient’s symptoms and acknowledges that their condition is real. This is crucial for fostering open communication between the patient and the health care provider, enabling a more effective dialogue regarding treatment strategies.

Moreover, a formal diagnosis reduces unnecessary testing and increases the likelihood of the patient being offered evidence-based treatment options tailored to address the spectrum of symptoms associated with IBS-C. By acknowledging the multifaceted nature of the condition, health care providers can offer comprehensive treatment plans aimed at alleviating the various symptoms that contribute to its debilitating impact on patients’ lives.

G&H Do the AGA and the ACG guidelines recommend any particular diagnostic strategy?

DMB Both the AGA and ACG guidelines emphasize the adoption of a positive diagnostic strategy for IBS, which stands in contrast to a diagnostic approach of exclusion involving extensive testing. Several studies have compared these 2 approaches, consistently demonstrating that extensive testing only leads to increased costs. Importantly, increased testing has not correlated with improved symptomatic or quality of life outcomes for individuals with IBS-C. In essence, the positive IBS diagnostic strategy has been proven to be noninferior to the diagnostic approach of exclusion. 

G&H How can clinicians make a positive IBS-C diagnosis? 

DMB Because of the absence of validated diagnostic tests or biomarkers for IBS-C, clinicians rely on a comprehensive assessment involving medical history, physical examination, and adherence to diagnostic criteria. The Rome IV criteria, established in 2016, serve as a cornerstone for diagnosis, supplemented by the BSFS.

According to the Rome IV criteria, a definitive diagnosis of IBS requires recurrent abdominal pain occurring at least once weekly along with 2 or more of the following criteria: association with defecation, altered stool frequency, or changes in stool appearance. Furthermore, the presence of more than 25% of bowel movements categorized as BSFS types 1 or 2, and less than 25% as types 6 or 7, supports the diagnosis of IBS-C.

Recognizing the challenges in applying stringent criteria in clinical practice, the Rome Foundation has modified these diagnostic criteria to enhance clinical utility. These modifications allow for a clinical diagnosis of IBS if symptoms align with Rome IV criteria and significantly impact daily activities or quality of life, and alternative diagnoses have been reasonably ruled out by the practitioner.

G&H How accurate is this positive diagnostic strategy? When is additional testing warranted?

DMB The reliability of the Rome criteria alongside limited diagnostic testing has been extensively validated, dating back to the utilization of Rome II criteria nearly 3 decades ago. Remarkably, diagnosis based solely on symptoms has demonstrated accuracy in up to 98% of patients.

However, the presence of alarm signs, such as new symptoms in patients over 50 years old, unintended weight loss, hematochezia, nocturnal awakening owing to symptoms, acute or rapidly progressing symptoms, and a family history of colorectal cancer, celiac disease, or inflammatory bowel disease, indicates a need for further investigation to rule out alternative diagnoses. 

To ensure accuracy in diagnosis, I adhere to 8 straightforward rules, which help guide clinical decision-making and ensure comprehensive evaluation when necessary.

G&H Why is treating IBS-C a “one size does not fit all” approach?

DMB The symptom profile of IBS-C can arise from various underlying etiopathogenic mechanisms, including disruptions in guanylate cyclase-C receptors, chloride channels, or sodium hydrogen exchangers. However, pinpointing the specific cause for an individual patient is challenging, given the complexity and variability of these mechanisms. Consequently, recommending therapy often relies on an empirical approach.

Owing to the multifactorial pathophysiology of IBS-C, treatment response can vary among patients. Thus, if a patient proves unresponsive to one therapy, there is potential for positive outcomes with an alternative approach. This underscores the importance of flexibility and adaptability in treatment strategies, tailoring interventions to each patient’s unique presentation and response.

G&H What are the available FDA-approved therapies and how do their mechanisms of action differ?

DMB There are currently 4 FDA-approved options available for treating IBS-C: the secretagogues lubiprostone, linaclotide, and plecanatide, as well as the retainagogue tenapanor. Lubiprostone gained FDA approval in 2006, followed by linaclotide in 2012, plecanatide in 2017, and tenapanor in 2019 (with its US market launch in 2022).

Secretagogues function by increasing luminal fluid secretion and promoting intestinal transit. Tenapanor is a first-in-class locally acting inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3). Tenapanor-mediated NHE3 inhibition results in several effects: reduced dietary sodium absorption, leading to water retention in the intestinal lumen and accelerated intestinal transit; decreased intestinal permeability; and diminished visceral hypersensitivity.

Although all 4 therapies accelerate intestinal transit, their distinct mechanisms of action play a crucial role in addressing abdominal sensory symptoms such as pain, discomfort, and bloating. These differences are particularly significant in tailoring treatment to individual needs. Given the multifaceted nature of IBS-C, it is essential to target both abdominal and bowel symptoms comprehensively. Should one class of agents fail to address both abdominal and bowel symptoms, utilizing a therapeutic agent from an alternative class is advisable. 

G&H How effective and safe are these therapies in managing both the bowel and abdominal symptoms? 

DMB All 4 currently available FDA-approved agents were evaluated in large, pivotal, phase 3 randomized controlled trials. All 4 agents significantly outperformed placebo in terms of overall response and improvement in individual symptoms. 

For lubiprostone, an overall responder was defined as a monthly responder for at least 2 of 3 months, with monthly responder defined as a patient who rated their IBS symptoms as being at least moderately relieved for all 4 weeks of the month or significantly relieved for at least 2 weeks of the month, with no ratings of moderately or severely worse. For linaclotide, plecanatide, and tenapanor, overall response was defined as at least a 30% improvement from baseline in average daily worst abdominal pain score plus an increase of at least 1 CSBM from baseline, both in the same week for 6 or more of 12 weeks of treatment. 

All 4 agents are associated with common gastrointestinal adverse effects. For lubiprostone, the most common side effect was nausea. For linaclotide, plecanatide, and tenapanor, it was diarrhea. 

G&H Are there any predictors of therapy discontinuation/continuation?

DMB A recent study by Shah and colleagues examined the predictors for discontinuation of drug therapy in individuals with IBS-C. Multiple factors were assessed, and overall women and individuals with at least 1 chronic pain condition were less likely to discontinue linaclotide. 

G&H Do the AGA and ACG agree on treatment recommendations for IBS-C? 

DMB In general, both guidelines align on the use of therapies for IBS-C, but differences arise in the strength of their recommendations. Notably, discrepancies exist regarding PEG laxatives and antispasmodics, with the ACG advising against their use.

The variance in recommendations stems from the methodologies employed in guideline development. The ACG guidelines rely on global symptom response assessments, whereas the AGA guidelines base recommendations on comparisons with no pharmaceutical treatment intervention.

G&H What makes the choice of treatment difficult? 

DMB Choosing the right treatment for IBS-C presents numerous challenges owing to several factors. First, our current understanding of IBS-C does not allow for precise targeting of patient symptoms, making it difficult to predict the most effective treatment. Additionally, the lack of head-to-head trials comparing available therapies means we have limited knowledge of their comparative efficacies.

Although network meta-analyses have demonstrated the superiority of all agents over placebo for treating global IBS-C symptoms and abdominal bloating, indirect comparisons have not revealed significant differences between drugs. When treating individual patients, factors such as time to response and side effect profiles must be carefully considered.

Furthermore, personalized treatment plans should take into account the patient’s preferences and biases. Some patients may prefer food-based interventions, behavior-based therapies, alternative medicine approaches, or pharmaceutical treatments. Considering these preferences alongside clinical evidence is crucial for developing effective and patient-centered management plans for IBS-C.

G&H We are seeing increasing incorporation of APPs (advanced practice providers) in provision of care for patients with IBS. What are the drivers of this growth?

DMB The increased demand for services from APPs in providing care for patients with IBS can be attributed to several factors. These include a shortage of physicians, the rising prevalence of gastrointestinal diseases, an aging population with multiple comorbidities, the introduction of new therapies, procedures, and medications, and a greater number of insured patients seeking health care services.

G&H How can integrating APPs in clinical practice improve the care of patients with IBS?

DMB Multidisciplinary care involving APPs has demonstrated significant benefits for individuals with IBS, driven by several key factors. First, patients with IBS often require dedicated time and compassionate listening, especially when discussing social situations and factors that may exacerbate their anxiety. APPs, with their ability to spend more time with individual patients compared with gastroenterologists, are well suited to provide this personalized attention and support.

Moreover, involving APPs in the care of patients with IBS enhances access to care, improves continuity of care, and reduces wait times for consultations and follow-up visits. This streamlined approach not only ensures that patients receive timely and comprehensive care but also alleviates the burden on gastroenterologists, allowing them to focus on procedures and more complex cases.

By enabling APPs to take on a greater role in patient management, physicians can better meet the increasing demands for endoscopic procedures while also reducing burnout among the entire health care team. This collaborative model of care not only improves patient outcomes but also enhances overall health care delivery by maximizing resources and promoting a more efficient health care system.

G&H Are there any APP collaborative models that can be employed in the clinic?

DMB APPs can play various roles in team-based care for patients with IBS, depending on the clinic or practice model and the needs of the patient population. Some potential roles include follow-up visits, collaborative consultations, and independent consultations. 

APPs can conduct follow-up visits with patients after the initial diagnosis is made by a physician. These visits can involve monitoring treatment progress, addressing any concerns or questions the patient may have, and making adjustments to the treatment plan as needed. 

APPs and physicians can work together to meet with patients during appointments. This collaborative approach allows for comprehensive assessments and treatment discussions, drawing on the expertise of both health care providers. 

Experienced APPs may be capable of conducting initial consultations and follow-up visits independently, assessing patient symptoms, providing education, and implementing treatment plans. They can determine if a referral to a physician is necessary based on the patient’s clinical presentation.

The specific model of care may vary between community-based and academic-based institutions, as well as among individual clinics or practices. Each entity should define a model that aligns with their resources, patient population, and organizational goals. 

G&H How can we successfully integrate APPs in our clinical practice? 

DMB Successful integration of APPs into clinical practice requires comprehensive training and experience. This includes exposure to various aspects of patient care, interdisciplinary collaboration, and opportunities for professional development. 

Upfront training for APPs should encompass not only patient interaction skills but also exposure to different specialties involved in the care of patients with IBS. This may include spending time in clinics with gastroenterologists, dieticians, and behavioral therapists to gain a deeper understanding of their roles and how they contribute to patient care.

APPs should have opportunities to collaborate with other health care professionals involved in the management of IBS. This collaboration allows them to better understand the roles of each practitioner, the tools they utilize, and how they approach patient care. This knowledge enables APPs to effectively communicate with patients about what to expect during consultations with different practitioners and to make appropriate referrals based on patient needs.

Engaging APPs in academic settings, such as through organizations like Gastroenterology and Hepatology Advanced Practice Provider (GHAPP), provides opportunities for professional growth and development. This may include participating in lectures, advisory committees, and collaborative research projects with physicians. By contributing to presentations and publications, APPs can enhance their understanding of IBS and contribute to advancements in the field.

G&H Do you have any overall take-home message from this symposium for clinicians? 

DMB Interdisciplinary and integrative care is essential for optimizing outcomes in patients with IBS-C, benefiting both the patients and the health care system as a whole. IBS-C management is inherently complex and multifaceted, requiring a personalized approach tailored to each individual’s unique needs and preferences.

Given the multifactorial pathophysiology of IBS-C and the variability in patient presentations, a one-size-fits-all approach is not effective. Instead, a comprehensive care plan that integrates dietary, behavioral, and pharmaceutical interventions offers a more holistic and effective approach to managing symptoms and improving quality of life for patients with IBS-C. This approach not only maximizes treatment efficacy but also enhances patient satisfaction and engagement in their care.

Disclosures

Dr Brenner is a speaker, advisor, and consultant and has participated in educational programs for American Gastroenterological Association (AGA), Anji Pharmaceuticals, Ardelyx, Inc., Continuing Education Alliance, LLC, Continuing Education Company, Inc., Elsevier, Inc., Enova International, Focus Medical Communications, LLC, GI Health Foundation, Gemelli Biotech, Ironwood Pharmaceuticals, Inc., Mahana Therapeutics, Inc., MedForce, Inc., Meetings & Events International, Pri-Med Institute, LLC, Primary Care Education Consortium, RedHill Biopharma Ltd, Salix Pharmaceuticals, Inc., Tactical Advantage Group, University of California, Los Angeles (UCLA), and WebMD, LLC.

Millennium Medical Publishing, Inc