Amitiza (lubiprostone) / Takeda, Mallinckrodt - LARVOL DELTA

PROVISIONAL EXPERT RECOMMENDATIONS FOR THE MANAGEMENT OF FECAL INCONTINENCE IN SYSTEMIC SCLEROSIS: A REPORT FROM WORLD SCLERODERMA FOUNDATION (WSF) GASTROINTESTINAL "AD HOC COMMITTEE" (EULAR 2025) - "(100%) Consider and prioritize pelvic physical therapy upfront for SSc-FI attributable to pelvic floor weakness before testing, as patients often improve and risk is minimal (if any) (100%) If overflow diarrhea is the issue and slow colonic transit is present, consider a trial of prokinetics (e.g., prucalopride or pyridostigmine). (83.3%) If slow colonic transit is not an issue, consider a trial of other medications (e.g., secretagogues, such as linaclotide, lubiprostone, plecanatide) to help alleviate stool burden... We present provisional recommendations for the evaluation and management of fecal incontinence in SSc. Only minimal refinement and voting is required to finalize these practical recommendations. Our collegiate approach will provide guidance for clinical practice and also inform a future research agenda."

Gastroenterology • Immunology • Rheumatology • Scleroderma • Systemic Sclerosis

Evaluation of post-market adverse events of lubiprostone: a real-world adverse event analysis from the FAERS database. (PubMed, BMC Gastroenterol) - "Our study comprehensively evaluated the safety of lubiprostone in the post-marketing setting. Despite its therapeutic advantages, there is a potential for various systemic adverse effects. In addition to adverse events consistent with information from existing clinical trials and the insert, we discovered several serious localized adverse reactions and previously unreported systemic adverse reactions. These may be potentially associated with lubiprostone, but are not confirmed adverse effects. This will provide valuable evidence for future studies and further prospective clinical trials to confirm these results and elucidate the relationship between them, thus better guiding the clinical practice of lubiprostone."

Adverse events • Journal • P4 data • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology

ANALYSES OF THE SOCIOECONOMIC VALUES OF TREATMENTS FOR CHRONIC CONSTIPATION IN JAPAN (DDW 2025) - "Methods Using data from clinical trials of Lubiprostone, Linaclotide, and Elobixibat conducted in Japan, changes in the number of spontaneous bowel movements (SBM) were synthesized using network meta-analysis (NMA), with placebo results set at zero for comparison. Sensitivity Analysis: The results were sensitive to the effectiveness of Elobixibat, but the trend remained consistent with the base case analysis for the other costs. Conclusions When selecting constipation treatment drugs, it is essential to consider not only their efficacy and cost but also their potential to reduce the socioeconomic burden associated with chronic constipation."

Constipation • Gastroenterology • Gastrointestinal Disorder

EVALUATING THE SAFETY OF PHARMACOTHERAPY FOR IRRITABLE BOWEL SYNDROME: A META-ANALYSIS (DDW 2025) - "AEs were more varied for tricyclics (indicated for IBS global symptoms); for example, compared to placebo the three most common AEs with associated risk increases were drowsiness (14%), dry mouth (12%), and weight gain (9%) for amitriptyline, dry mouth (22%), flushing (18%), and constipation (17%) for desipramine, and fatigue (15%), dry mouth (3%) and blurry vision (1.5%) for doxepin...The NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor (indicated for IBS-C) was 27 (p < 0.01), 53 (p = 0.59), 58 (p < 0.01), 59 (p = 0.03), and 17 (p <0.01) respectively. The NNH for alosetron and eluxadoline (indicated for IBS-D) was 16 (p < 0.01) and 32 (p < 0.01). Ramosetron and rifaximin (indicated for IBS-D) had a negative risk difference, with the rate of withdrawal due to AEs higher in the placebo arm, so NNH was a negative, although statistically insignificant, value... Tricyclics, alosetron, and tenapanor are associated with a higher..."

Retrospective data • Constipation • Fatigue • Gastrointestinal Disorder • Xerostomia

IBS-C PATIENT EXPERIENCES WITH PHARMACOLOGIC THERAPIES: QUALITATIVE ANALYSIS OF ONLINE POSTS FROM (TWITTER) AND E-HEALTH FORUMS (DDW 2025) - "To find relevant posts from IBS-specific subforums, we applied filters targeting FDA-approved IBS-C medications (linaclotide, lubiprostone, plecanatide, tegaserod, tenapanor). Discussions : Our study highlights the diverse real-world experiences of IBS-C patients with FDA-approved therapies, revealing variability in both efficacy and the biopsychosocial impacts associated with each medication. These findings highlight the importance of shared decision making in selecting an IBS-C treatment, including evaluating the need to switch medications or classes, as well as addressing barriers such as cost and side effects to improve adherence and patient outcomes."

Clinical • CNS Disorders • Constipation • Gastrointestinal Disorder • Mood Disorders • Psychiatry

Assessment of Lubiprostone as an Adjunct Therapy for Bowel Preparation in Colonoscopy: A Meta-Analysis of Randomized Controlled Trials. (PubMed, JGH Open) - "It also did not affect procedure time [MD = -0.74, 95% CI: -2.91-1.43; p = 0.50], polyp detection rate [RR = 1.07, 95% CI: 0.90-1.26; p = 0.45], or adenoma detection rate [RR = 1.09, 95% CI: 0.75-1.57; p = 0.66]. Our meta-analysis found that LBP, explored as an adjunct to PEG-E solutions for bowel preparation, offers no significant additive effect on preparation quality before colonoscopy."

Journal • Retrospective data • Review • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Pharmacologic Treatment of Irritable Bowel Syndrome with Predominant Constipation (PubMed, Korean J Gastroenterol) - "Guanylate cyclase-C agonists (linaclotide and plecanatide) enhance intestinal fluid secretion and motility, normalize bowel movements, and reduce abdominal pain. Na+/H+ exchanger inhibitors (e.g., tenapanor) decrease sodium absorption, increase fluid secretion, and alleviate visceral pain. Lubiprostone activates the chloride channels to facilitate bowel movements, while polyethylene glycol laxatives regulate osmotic pressure to improve stool consistency and ease defecation. Highly selective 5-HT4 agonists, such as prucalopride, accelerate gastrointestinal and colonic transit and improve stool frequency and consistency without increasing the cardiovascular risks raised in earlier agents such as tegaserod...These pharmacology agents have shown efficacy and safety in clinical studies, but drug availability, adverse effects, and variable patient responses are still challenging. Effective strategies to manage IBS-C require a personalized approach, considering the..."

Journal • Review • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain

Evaluation study on the effectiveness and safety of Lubiprostone combined with magnesium sulfate in bowel preparation for elderly patients with constipation (ChiCTR) - P=N/A | N=100 | Recruiting | Sponsor: Shanghai Geriatric Medical Center; Shanghai Geriatric Medical Center

New trial • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and safety of a polyethylene glycol electrolyte solution combined with lubiprostone for bowel preparation in type 2 diabetes patients using GLP-1 receptor agonists: a prospective, multicenter, randomized, open-label, blinded endpoint trial (ChiCTR) - P=N/A | N=216 | Not yet recruiting | Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Letter: Lubiprostone Treatment for MASLD-Gender Imbalance and Blinding Considerations. Authors' Reply. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Letter: Lubiprostone Treatment for MASLD-Gender Imbalance and Blinding Considerations. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Metabolic Dysfunction-Associated Steatotic Liver Disease

Healthcare Utilization and Costs of Care in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation After Initiating Oral Therapies: Real-World Analysis in the US Medicare Population. (PubMed, Adv Ther) - "These findings suggest that linaclotide treatment may be associated with lower total healthcare costs compared to lubiprostone and plecanatide for patients initiating IBS-C/CIC-related drugs in Medicare populations."

HEOR • Journal • Medicare • Real-world evidence • Reimbursement • US reimbursement • Constipation • Gastroenterology • Gastrointestinal Disorder

Letter: Lubiprostone-A Novel Therapeutic Avenue for Gastrointestinal Complications in MASLD. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Gastrointestinal Disorder • Metabolic Dysfunction-Associated Steatotic Liver Disease

Letter: Lubiprostone-A Novel Therapeutic Avenue for Gastrointestinal Complications in MASLD. Authors' Reply. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Gastrointestinal Disorder • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database. (PubMed, Expert Opin Drug Saf) - "We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone."

Adverse events • Journal • P4 data • Real-world evidence • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Comparison chart: Safety of drugs for IBS in pregnancy and lactation. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastrointestinal Disorder

Drugs for irritable bowel syndrome. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Figure 1: Treatments for irritable bowel syndrome (IBS) in adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Comparison chart: Some drugs for irritable bowel syndrome with constipation (IBS-C). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial. (PubMed, Aliment Pharmacol Ther) - P3 | "Lubiprostone was well tolerated and reduced liver fat content as measured by MRI-PDFF in patients with MASLD over 48 weeks. Lubiprostone appears promising to treat MASLD and warrants more extensive studies to confirm such efficacy."

Clinical • Journal • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Lubiprostone for Long-term Efficacy and Safety in Elderly Patients with Chronic Constipation: An Open-Label, Multicenter Clinical Study (ChiCTR) - P4 | N=260 | Recruiting | Sponsor: Peking University People's Hospital; Peking University People's Hospital

New P4 trial • Constipation • Gastroenterology • Gastrointestinal Disorder

A multicenter, observational study on the efficacy of lubiprostone in the treatment of adult chronic constipation in an ethnic region (ChiCTR) - P=N/A | N=1000 | Sponsor: The First Affiliated Hospital of Kunming Medical University; The First Affiliated Hospital of Kunming Medical University

New trial • Constipation • Gastroenterology • Gastrointestinal Disorder

The Efficacy of Lubiprostone in Patients of Constipation: An Updated Systematic Review and Meta-Analysis. (PubMed, JGH Open) - "Lubiprostone significantly improves all SBM-related outcomes. Owing to its good safety and efficacy profile, lubiprostone can be used in the combination regimens for management of CIC, IBS-C, and OIC."

Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Single-Center Experience with Concomitant Use of Novel and Off-Label Prescriptions for Chronic Constipation (ACG 2024) - "Charts were reviewed for prescriptions of at least 1 of 8 pharmacotherapies: linaclotide, lubiprostone , plecanatide , prucalopride, tenapanor , tegaserod, pyridostigmine, and colchicine. 405 patients were evaluated for chronic constipation, of which 138 (34%) received one or more prescription-based therapies. The most common diagnoses supporting these prescriptions are listed in Table 1. 110 patients (79.7%) were prescribed monotherapy, 23 (16.67%) given dual therapy simultaneously, 4 (2.8%) given three agents simultaneously, and only 1 (0.7%) given four agents simultaneously."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

Comparative Efficacy and Safety of Lubiprostone and Osmotic Laxatives in Chronic Idiopathic Constipation: A Systematic Review and Network Meta-Analysis. (PubMed, J Gastroenterol Hepatol) - "Lubiprostone is more effective than PEG and Lactulose for treating CIC, with comparable safety profiles. However, this conclusion requires further validation through large-scale, high-quality studies."

Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder