colesevelam / Generic mfg. - LARVOL DELTA

AGGRESSIVE LIPID LOWERING IN HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA: 29 YEARS EVENT-FREE SURVIVAL AFTER PREMATURE STEMI (ACC 2026) - "He began atorvastatin 20 mg plus ezetimibe 10 mg and colesevelam (6 × 625 mg daily)...In 2018, evolocumab 140 mg q2w was added and ezetimibe stopped, dropping LDL-C to 0-20 mg/dL... Intensive lipid lowering in HeFH can alter disease trajectory. In the pre-stent era, pharmacologic LDL-C reduction became a "revascularization strategy," providing nearly thee decades of event-free survival.Early and sustained LDL-C lowering in HeFH can prevent recurrent ischemic events and promote durable clinical stability, underscoring the critical role of aggressive lipid management in secondary prevention."

Coronary Artery Disease • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE) (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: University of California, San Francisco | Not yet recruiting ➔ Recruiting

Enrollment open

DETECTING SAFETY SIGNALS OF BILE ACID THERAPEUTICS: A FDA FAERS-BASED PHARMACOVIGILANCE STUDY (ISPOR 2026) - "Chenodiol (Ctexli), a synthetic bile acid, recently repurposed to treat cerebrotendinous xanthomatosis (CTX) in adults, has a limited well-defined real world safety data...Safety signals were evaluated using established criteria based on the reporting odds ratio (ROR) and proportional reporting ratio (PRR), each with 95% confidence intervals, along with the chi-square statistic (χ²) and p-values, with signals defined as ROR and PRR > 2, a lower 95% CI bound > 1, χ² ≥ 3, and p < 0.005. Disproportionality analysis identified potential safety signals associated with chenodiol, cholestyramine, colesevelam, and colestipol... Chenodiol's recent approval for cerebrotendinous xanthomatosis exemplifies how existing medications can be re-evaluated for new indications, and other therapeutic options. Integrating real-world safety data from post-marketing surveillance is crucial to supporting these repurposing efforts and ensuring patient safety."

Adverse events • Clinical

Lenalidomide-related diarrhea is associated with gut microbiota dysbiosis and disruption of the bile acid pool (ASH 2025) - P2 | "Symptom responsiveness to BA binders (colesevelam)has been described (PMID: 39300066), but the underlying mechanism of LRD is not known. We reveal primaryBA enrichment in patients with LRD, which correlated with disrupted microbial processing capacity. Thesedata suggest that beyond bile acid sequestration, strategies to improve gut microbial diversity andfunctional capacity may warrant further study for mitigation of LRD."

Dysbiosis • Gut Microbiota • Gastrointestinal Disorder • Hematological Malignancies • Multiple Myeloma

Lipid-Lowering Therapy Is Underutilized Across LDL-C Levels in Autoimmune Disease Compared to Diabetes: A Nationwide Analysis (AHA 2025) - "Statins included atorvastatin, rosuvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin. Non-statin therapies included icosapent ethyl, colesevelam, alirocumab, evolocumab, Bempedoic acid, cholestyramine, Inclisiran, colestipol, ezetimibe, gemfibrozil, omega-3 acid, fenofibrate...Non-statin lipid-lowering therapy use was significantly lower in autoimmune patients compared to those with diabetes across all LDL-C tertiles, with the largest differences observed at LDL <70 mg/dL (6.19% vs 10.24%, p<0.0001) and 70–99 mg/dL (4.05% vs 7.06%, p<0.0001).ConclusionDespite comparable ASCVD risk, patients with autoimmune disease are significantly less likely to receive statins or non-statin lipid-lowering therapy than those with DM across LDL-C levels. These findings show a need for improved cardiovascular prevention in this high-risk population."

Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Hepatology • Immunology • Inflammatory Arthritis • Lupus • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Bile Acid Binding Resins Improve Glucagon Receptor Agonist-Mediated Weight Loss in Diet-Induced Obese Mice. (PubMed, Obesity (Silver Spring)) - "Together, these studies suggest that BARs enhance the antiobesity effect of GCGR agonism in DIO mice, representing a novel antiobesity strategy."

Journal • Preclinical • Genetic Disorders • Obesity

Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE) (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: University of California, San Francisco

New P1/2 trial

Refractory Collagenous Colitis Requiring Inpatient Infliximab Infusion (ACG 2025) - "Multiple therapies, including loperamide, diphenoxylate-atropine, budesonide, bismuth subsalicylate, cholestyramine, colesevelam, mesalamine, gluten-free diet, and recent initiation of prednisone with azathioprine for the current flare have been ineffective. Attempts to initiate outpatient biologic therapy, with infliximab or vedolizumab, were unsuccessful due to insurance denial...TPN was started and trials of octreotide and rifaximin yielded no improvement...Severity and chronicity of microscopic colitis may mimic that of inflammatory bowel disease, and biologic therapy such as TNF-α inhibitors may be used for treatment, although current knowledge is based on case reports and studies. Further research is needed to investigate the role, safety and efficacy of biologics for treating microscopic colitis, which may help streamline off-label treatments, decrease morbidity, improve barriers for initiating such medications and resource utilization."

Clinical • Cardiovascular • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Renal Disease

Bile Acid Sequestrant-Induced Hypertriglyceridemia Leading to Acute Pancreatitis: A Case Report (ACG 2025) - "Although effective for gastrointestinal symptoms, they can affect lipid metabolism and pre-dispose one to consequences of hypertriglyceridemia.Case Description/ A 58-year-old Caucasian male with a history of ileocolonic Crohn's disease status post-surgical resection on ustekinumab was prescribed colesevelam for bile acid diarrhea which provided subsequent relief. Despite this, routine triglyceride screening is not standard before initiating bile acid sequestrant therapy for bile acid diarrhea. Given the prevalence of hypertriglyceridemia and reports of pancreatitis likely triggered by bile acid sequestrants, we recommend triglyceride screening in all patients with bile acid diarrhea prior to initiating bile acid sequestrant therapy."

Case report • Clinical • Cardiovascular • Crohn's disease • Dyslipidemia • Endocrine Cancer • Gastroenterology • Gastrointestinal Disorder • Hypertriglyceridemia • Immunology • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Pancreatitis • Severe Hypertriglyceridemia

ASSOCIATION BETWEEN PRURITUS AND HEALTHCARE UTILIZATION AND COSTS AMONG INDIVIDUALS WITH PRIMARY BILIARY CHOLANGITIS IN THE UNITED STATES (AASLD 2025) - "Subgroup analyses required pruritus treatment (sertraline, naltrexone, cholestyramine, cholestipol, rifampin, colesevelam, hydroxyzine or diphenhydramine) within ±90 days of the index date. Eligibility included age >=18, continuous enrollment for >=12 months pre- and post-index date, excluding patients receiving obeticholic acid during baseline... In a real-world study of patients with PBC, pruritus was a significant contributor to HCRU and costs. These findings highlight the need for effective management and novel therapies to alleviate pruritus and reduce its associated clinical burden and costs."

Clinical • HEOR • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus • Psychiatry • Sleep Disorder

A MULTI-SPECIALTY RETROSPECTIVE EVALUATION OF DIAGNOSTIC AND MANAGEMENT STRATEGIES FOR BILE ACID DIARRHOEA IN TERTIARY CARE HOSPITALS (UEGW 2025) - "Bile acid diarrhoea continues to be a prevalent factor contributing to chronic diarrhoea in healthcare. While existing treatment modalities have proven effective in managing this condition, they remain poorly tolerated. Our study confirms that colesevelam demonstrates improved tolerability compared to colestyramine."

Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

UTILIZATION OF SEHCAT [75SE-TAUROSELCHOLIC ACID] SCANNING FOR DIAGNOSING BILE ACID MALABSORPTION IN A UK TERTIARY REFERRAL CENTRE: AN UNDERUTILIZED DIAGNOSTIC TOOL FOR ENHANCING THE MANAGEMENT OF CHRONIC DIARRHOEA [WITHDRAWN] (UEGW 2025) - "SeHCAT scans demonstrated a diagnostic yield of 41.6% for BAM in a cohort of 334 patients, with 62.5% of assessed cases achieving a clinical response to bile acid sequestrant therapy (cholestyramine or colesevelam). These findings underscore the utility of SeHCAT scanning as a highly sensitive and specific tool for identifying BAM, a frequently underdiagnosed contributor to chronic diarrhea. Given the variability in current clinical practice and the underutilization of this diagnostic modality, integrating SeHCAT scans into standardized diagnostic algorithms for chronic diarrhea is recommended to enhance diagnostic accuracy and optimize patient outcomes."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

MANAGEMENT OF BILE ACID MALABSORPTION: INSIGHTS INTO TREATMENT AND PATIENT OUTCOMES (UEGW 2025) - "Current first-line treatment involves bile acid sequestrants (eg.cholestyramine, colesevelam). Our findings highlight critical gaps in the management of BAM. Poor compliance with cholestyramine, primarily due to side effects, underscores the importance of individualized treatment plans and patient education. Furthermore, inadequate follow-up care likely contributed to suboptimal treatment outcomes."

Clinical • Urology

Serum, urinary and fecal concentrations of perfluoroalkyl substances after interventions with cholestyramine/colesevelam and probenecid - cross-over trials in Ronneby, Sweden. (PubMed, Environ Int) - "Bile acid sequestrants could be used for accelerating PFAS excretion in highly PFAS exposed individuals. Studies are needed to evaluate the risks, costs and benefits of using it for this purpose."

Journal

Management of bile acid diarrhea in Italy: a survey. (PubMed, Intern Emerg Med) - "BAD diagnosis was assessed with 75SeHCAT (67.8% of gastroenterologists and 51.4% of other physicians), followed by a trial of cholestyramine (30.5% of gastroenterologists and 31.4% of other physicians)...75SeHCAT availability influences the awareness of this disease. Therapies currently are often not able to guarantee adequate symptom relief."

Journal • Gastrointestinal Disorder

Fecal and Clinical Profiles of Dogs With Chronic Enteropathies Treated With Bile Acid Sequestrants for 5-47 Months: A Retrospective Case Series. (PubMed, J Vet Intern Med) - "Treatment with BAS as adjunctive treatment potentially may benefit some dogs with nonresponsive or partially immunosuppressive-responsive enteropathy or CE dogs requiring high doses of corticosteroids."

Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders

IMpact of therapY using coleSevelam treatment reducing bile acids in patients with fonTan cIrCulation (MYSTIC): Rationale and Study Design. (PubMed, Am Heart J) - P1/2 | "Enrollment dates: September 2025 - August 2027 Trial Registration: NCT06197763 This manuscript describes the rationale and design of the MYSTIC study, which to our knowledge is the first interventional trial targeting a Fontan-specific metabolic derangement. The results will inform the feasibility of BA sequestration therapy in Fontan patients and guide future larger studies aimed at improving outcomes in this growing high-risk population."

Clinical • Journal • Metabolic Disorders

Update of safety profile of bile acid sequestrants: A real-world pharmacovigilance study of the FDA adverse event reporting system. (PubMed, PLoS One) - "This large-scale FAERS study updates the safety profiles of BASs, highlighting distinct risk patterns and delayed complications. The findings support personalized monitoring strategies that consider both drug-specific characteristics and temporal AE patterns."

Adverse events • Journal • Real-world evidence • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Developing a novel diagnostic method for bile acid malabsorption using liquid chromatography-mass spectrometry (BSG 2025) - "Whereas, in idiopathic BAM patients, levels of both lithocholic acid and chenodeoxycholic acid were significantly higher after treatment with colesevelam compared with those before treatment (p<0.01)...The significant differences in bile acid levels between disease groups suggest that the disease groups can be distinguished using their bile acid profiles, therefore providing a potential diagnostic tool for BAM. Ongoing research is focused on comparing the current bile acid data to the SeHCAT diagnostic data."

Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Bile acid malabsorption and treatment: an audit of real word practice from a UK tertiary referral centre (BSG 2025) - "Sex, age, the type of BAM and whether the treatment was colesevelam or cholestyramine were not significant predictors of clinical response (p>0.05).View this table:View inline View popup Abstract P112 Table 1 SeHCAT positivity by underlying diagnosisConclusions SeHCAT scans diagnosed BAM in 41.6% of patients with up to 62.5% responding to treatment. SeHCAT should be incorporated in the diagnostic pathway when assessing patients with chronic diarrhoea, a practice that is not well established currently and is generally variable."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

A retrospective study assessing the diagnosis and management strategies for bile acid diarrhoea across different specialties in tertiary care hospitals (BSG 2025) - "While existing treatment modalities have proven effective in managing this condition, they remain poorly tolerated. Our study confirms that colesevelam demonstrates improved tolerability compared to colestyramine"

Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

Management of bile acid malabsorption: insights into treatment and patient outcomes (BSG 2025) - "Current first-line treatment involves bile acid sequestrants (eg.cholestyramine, colesevelam). Co-prescribing antidiarrhoeals alongside sequestrants showed promising efficacy and tolerability, potentially reducing the need for higher doses of sequestrants and their associated side effects. These findings call for improved follow-up protocols, patient-centered approaches to medication management, and further exploration of combination therapies to enhance outcomes in BAM management."

Clinical • Gastroenterology • Pain • Urology

Bile Acid Binding Resins Improve Glucagon Receptor Agonist-Mediated Weight Loss in Diet-Induced Obese Mice (ADA 2025) - "These findings led us to hypothesize that BA-signaling is a key component of GCGR-stimulated weight loss and that BA sequestration may reduce this effect. To evaluate this hypothesis, we utilized BA-binding resins (BARS; Colesevelam (Colsv) and Cholestyramine (Cstyr)) to prevent intestinal BA re-uptake... Collectively, these studies suggest that BARS may enhance the anti-obesity effect of GCGR agonism and beneficially regulate feeding behavior in DIO mice. Furthermore, these studies argue that GCGR agonism combined with BARS treatment may represent a novel supplemental therapeutic approach for treatment of obesity."

Preclinical • Metabolic Disorders • Obesity

Global disparities in access to lipid-lowering therapies for patients with homozygous familial hypercholesterolemia - A physician survey. (PubMed, J Clin Lipidol) - P | "Our results confirm significant global disparities in LLT registration, reimbursement, and access between high-income and nonhigh-income countries. Improving LLT availability and accessibility, particularly in nonhigh-income countries, is essential to improve outcomes in patients with HoFH."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Treatment dilemmas faced by women of reproductive age with familial hypercholesterolemia: Case report (NLA 2025) - "Plasmapheresis was declined, and she started colesevelam...Conclusions Given the high prevalence of FH and the challenges posed by prolonged treatment interruptions during reproductive years, further studies are urgently needed to assess the risks and benefits of statin use during preconception, pregnancy, and breastfeeding. Such research will not only fill critical knowledge gaps but also support shared decision-making between patients and clinicians to optimize personalized care for affected individuals."

Case report • Clinical • Cardiovascular • Dyslipidemia • Endocrine Disorders • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders • Myocardial Infarction