- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
[VIRTUAL] MOBILIZATION OF ENDOGENOUS HEMATOPOIETIC SYSTEM FOR TREATMENT OF ALZHEIMER’S DISEASE (Hall E) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_281; The combination of AMD31100 -lactate have a beneficial effect by improving cognitive deficit, reducing Tau and APP pathologies and lead to shift in microglia to anti-inflammatory status Conclusions The combination of AMD3100 and lactate down regulate CXCR4/CXCL12 interaction, shift the neuroinflammation from a neurotoxic profile to a neuroprotective one. This shift attenuated pathological features of AD and ameliorate the cognitive functions .
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood Pharma
Journal: Chronic linaclotide treatment reduces colitis-induced neuroplasticity and reverses persistent bladder dysfunction. (Pubmed Central) - Dec 21, 2019 Linaclotide itself does not inhibit bladder afferents, rather normalization of bladder function by daily linaclotide treatment occurs via indirect inhibition of bladder afferents via reduced nociceptive signaling from the colon. These data support the concepts that cross-organ sensitization underlies the development and maintenance of visceral comorbidities, while pharmaceutical treatments that inhibit colonic afferents may also improve urological symptoms through common sensory pathways.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment open: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (clinicaltrials.gov) - Nov 28, 2019 P3, N=120, Recruiting, These data support the concepts that cross-organ sensitization underlies the development and maintenance of visceral comorbidities, while pharmaceutical treatments that inhibit colonic afferents may also improve urological symptoms through common sensory pathways. Not yet recruiting --> Recruiting
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood
Clinical, P2 data, Journal: Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study. (Pubmed Central) - Nov 6, 2019 P2 Our results suggest that 0.0625, 0.125, 0.25, and 0.5 mg/d are effective doses of linaclotide for treating CC in Japanese patients. ClinicalTrials.gov: NCT02425722, supported by Astellas Pharma, Inc.
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Review, Journal: Update on Pharmacotherapy for Irritable Bowel Syndrome. (Pubmed Central) - Oct 29, 2019 Tenapanor, a sodium/hydrogen exchanger 3 inhibitor, appears to be a promising treatment option in the pipeline...There are no established pharmacologic agents for IBS with a mixed bowel pattern. There is a promising pipeline for additional novel therapies for IBS.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood
A Guanylate Cyclase C Agonist Linaclotide Reduces Trimethylamine N-Oxide in an Adenine-Induced CKD Model (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_3776; By metagenome analysis, microbial order Clostridiales may have been responsible for the change in TMAO. Conclusion Linaclotide reduced TMAO and uremic toxin levelsand be a potent tool for the cardio-renal syndrome by modification of the “gut-cardiorenal axis” gut-cardiorenal axis Funding Government Support - Non-U.S.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion: Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes (clinicaltrials.gov) - Oct 10, 2019 P=N/A, N=29, Completed, Conclusion Linaclotide reduced TMAO and uremic toxin levelsand be a potent tool for the cardio-renal syndrome by modification of the “gut-cardiorenal axis” gut-cardiorenal axis Funding Government Support - Non-U.S. Active, not recruiting --> Completed
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood, Resolor (prucalopride) / J&J, Takeda, relamorelin (RM-131) / Allergan
Journal: Gastrointestinal involvement in systemic sclerosis: diagnosis and management. (Pubmed Central) - Oct 8, 2019 Combination therapies are also under study. Electroacupuncture, dietary intervention (e.g. medical nutrition therapy, low FODmap diet), and medical cannibus may also play a role in alleviating patient symptoms; however, more data are needed to define the role of these interventions in SSc.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood
Linaclotide for the Treatment of Gastrointestinal Symptoms in Systemic Sclerosis (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2706; Linaclotide is a well-tolerated and efficacious prosecretory agent that can be used to manage refractory constipation in who have failed management with over the counter laxatives and/or stool softeners. We find that low-dose treatments with linaclotide are an effective option with a lower side effect profile than high-dose treatment regimens, though high doses are required for optimal symptom control in some patients.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood, Resolor (prucalopride) / J&J, Takeda, Amitiza (lubiprostone) / Takeda, Mallinckrodt
Review, Journal, HEOR: Cost Effectiveness of Treatments for Chronic Constipation: A Systematic Review. (Pubmed Central) - Sep 26, 2019 Further analysis is needed comparing all available treatments for patients who have not responded to laxatives. Overall, results from economic evaluations appear to align with stepwise practice guidelines.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: LIN-MD-63: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (clinicaltrials.gov) - Sep 15, 2019 P2, N=101, Terminated, Overall, results from economic evaluations appear to align with stepwise practice guidelines. N=260 --> 101 | Trial completion date: Oct 2020 --> Aug 2019 | Recruiting --> Terminated | Trial primary completion date: Oct 2020 --> Aug 2019
- |||||||||| Gattex (teduglutide) / Takeda
Teduglutide Therapy for a Patient With Chronic Intestinal Failure Following Multi-Visceral Transplantation (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2210; Loperamide and Diphenoxylate were also trialed...She was placed on Linaclotide in addition to Teduglutide with the need to maximize TPN requirements...Research is ongoing to discover pharmacologic treatment options that significantly decrease the necessity of TPN and IVF. HGH and GLP-2 agonists are options at this time, however remain in question if they are effective long term.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood
Linaclotide Safety and Efficacy in Children Aged 6 to 17 Years With Functional Constipation (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2154; For the primary endpoint, or the secondary efficacy endpoints, none of the LIN doses (A, B, C) led to a clear improvement over PBO (p ≥ 0.1502) in the ITT population. A trend toward improved efficacy at the high LIN dose vs.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood, Linzess DR (linaclotide DR) / Allergan, Ironwood
MD-7246, a Delayed-Release Formulation of Linaclotide Targeting Visceral Pain Associated With IBS-D, Does Not Impact Bowel Frequency or Stool Consistency in Healthy Volunteers: Results From Phase I Trial (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1726; Neither LIN nor its active metabolite were detected in plasma after 7 days of oral administration and no intact tablets were discovered in any subject’s stool. The median and interquartile range (IQR) for change from baseline (CFB) in SBM and BSFS were similar and overlapping for placebo and all 3 MD-7246 dose groups (median (IQR) CFB: SBM: -2.6 (-4.6, 2.9), -1.9 (-4.4, -1.4), -1.3 (-2.0, 0.0), and 0.0 (‑7.7, 0.9); BSFS: 0.4 (-0.2, 1.0), 0.2 (-1.0, 0.9), 0.2 (-0.4, 1.0) and 0.4 (-0.3, 1.8) in placebo and low, mid, and high MD-7246 doses, respectively).
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood, Trulance (plecanatide) / Synergy Pharmaceuticals Inc., Amitiza (lubiprostone) / Takeda, Mallinckrodt
The Fragility Index of the Randomized Trials for Irritable Bowel Syndrome With Constipation (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_812; studying lubiprostone since the study itself reported a nonsignificant outcome, as well as Novick at al. studying tegaserod (Table 1).
- |||||||||| Resolor (prucalopride) / J&J, Takeda
Journal: Prucalopride (Motegrity) for chronic idiopathic constipation. (Pubmed Central) - Aug 6, 2019 Our findings suggest a novel treatment paradigm for GC-C agonism in IBS-C and BPS mediated through visceral organ crosstalk, a mechanism not previously linked to linaclotide. No abstract available
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Review, Journal: New treatments and therapeutic targets for IBS and other functional bowel disorders. (Pubmed Central) - Jul 17, 2019 The current development of new treatment alternatives is focusing on different aspects of the complex pathophysiology of IBS and other FBDs: gut microenvironment (via diet and modulation of gut microbiota), enterohepatic circulation of bile acids, gastrointestinal secretion, motility and sensation, gut-brain interactions, gut barrier function and the immune system within the gastrointestinal tract. Studies also suggest that personalized treatment of IBS and other FBDs is possible using various diagnostic markers.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial termination: Efficacy of Linaclotide to Senna for CIC (clinicaltrials.gov) - Jul 2, 2019 P=N/A, N=9, Terminated, Patients with IBS may benefit from a multipronged, individualized approach to treatment, including dietary modifications, psychological and pharmacological therapies. Completed --> Terminated; Not sufficient recruitment
- |||||||||| Resolor (prucalopride) / J&J, Takeda
Clinical, Review, Journal: Clinical Efficacy and Safety Profile of Prucalopride in Chronic Idiopathic Constipation. (Pubmed Central) - Jun 21, 2019 The most frequent adverse events were headaches and problems related to the gastrointestinal tract. Caution should be taken when using prucalopride in patients with impaired liver and renal function. In Canada, prucalopride has been approved for treatment of female patients with chronic idiopathic constipation who have failed therapy with at least two laxatives from different classes over a six-month period.
- |||||||||| Linzess (linaclotide) / Allergan, Astellas, Ironwood
Journal: Long-term treatment with linaclotide of intestinal pseudo-obstruction secondary to Ehlers-Danlos syndrome. (Pubmed Central) - Jun 15, 2019 Caution should be taken when using prucalopride in patients with impaired liver and renal function. In Canada, prucalopride has been approved for treatment of female patients with chronic idiopathic constipation who have failed therapy with at least two laxatives from different classes over a six-month period. No abstract available
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