- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Ibsrela (tenapanor) / Ardelyx, Kyowa Kirin, Knight Therap, Amitiza (lubiprostone) / Takeda, Mallinckrodt
[VIRTUAL] ABDOMINAL BLOATING IN IRRITABLE BOWEL SYNDROME WITH CONSTIPATION: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS OF FDA APPROVED MEDICATIONS (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_4094;
In a network analysis of RCTs evaluating the efficacy of secretagogues, tenapanor and tegaserod with abdominal bloating as the primary endpoint in patients with IBS-C, we found all drugs to be superior to placebo. Secretagogues appeared to be effective in relieving abdominal bloating especially linaclotide, however the long term efficacy is not known since most of the data were extracted at the 12-week time point.Key words: Rome IV, secretagogues, RCT, efficacy
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] COMPARISON OF 1-L PEG PLUS ASCORBIC ACID WITH LINACLOTIDE VERSUS SENNOSIDE FOR COLON CLEANING IN CONSTIPATED PATIENTS (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_1676;
Secretagogues appeared to be effective in relieving abdominal bloating especially linaclotide, however the long term efficacy is not known since most of the data were extracted at the 12-week time point.Key words: Rome IV, secretagogues, RCT, efficacy Linaclotide prior to 1-L PEG-Asc regimen significantly increased efficacy of bowel preparation and adenoma detection rate compared to sennoside regimen without reducing tolerability in constipated patients.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Trulance (plecanatide) / Bausch Health
Journal, IO biomarker: An update on guanylyl cyclase C in the diagnosis, chemoprevention, and treatment of colorectal cancer. (Pubmed Central) - Mar 12, 2021
Pre-clinical and clinical programs exploring these GUCY2C-targeting strategies will be reviewed. Recent mechanistic insights characterizing GUCY2C ligand loss early in tumorigenesis, coupled with results from the first clinical trials testing GUCY2C-targeting strategies, continue to elevate GUCY2C as an ideal target for prevention, detection, and therapy.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] 0 - AbbVie/Ironwood (LINZESS) Product Theater (DDW Virtual) - Mar 9, 2021 - Abstract #DDW2021DDW_234;
Recent mechanistic insights characterizing GUCY2C ligand loss early in tumorigenesis, coupled with results from the first clinical trials testing GUCY2C-targeting strategies, continue to elevate GUCY2C as an ideal target for prevention, detection, and therapy. Sponsor: Abbvie
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Assessment of Responsiveness to Treatment by Experience Sampling Method (clinicaltrials.gov) - Mar 3, 2021
P=N/A, N=30, Recruiting,
Sponsor: Abbvie Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Linzess DR (linaclotide DR) / Ironwood Pharma, AbbVie
Clinical, Journal: Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. (Pubmed Central) - Mar 2, 2021
Altering the site of drug delivery in the intestine might uncouple linaclotide's pain relief from secretory effects. Persistent, modest abdominal pain improvement with limited impact on bowel symptom parameters, as seen across MD-7246 doses, warrants further study of MD-7246 as a novel treatment for abdominal pain, regardless of IBS subtype.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer (clinicaltrials.gov) - Feb 23, 2021
P2, N=230, Recruiting,
Persistent, modest abdominal pain improvement with limited impact on bowel symptom parameters, as seen across MD-7246 doses, warrants further study of MD-7246 as a novel treatment for abdominal pain, regardless of IBS subtype. Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Oct 2021 --> Oct 2022
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion, Trial completion date, Trial primary completion date: The Psychosocial Effects of Systemic / Family Constellation (clinicaltrials.gov) - Feb 21, 2021
P=N/A, N=182, Completed,
Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Oct 2021 --> Oct 2022 Recruiting --> Completed | Trial completion date: Jun 2020 --> Oct 2020 | Trial primary completion date: Jun 2020 --> Oct 2020
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Amitiza (lubiprostone) / Takeda, Mallinckrodt
Journal: Medications for constipation in 2020. (Pubmed Central) - Feb 16, 2021
This review will help us identify and have a better understanding regarding what medications are available for use and the indications, so that we can better manage patients with chronic constipation. VIDEO ABSTRACT.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Trulance (plecanatide) / Bausch Health, Amitiza (lubiprostone) / Takeda, Mallinckrodt
Clinical: They compared linaclotide, lubiprostone, plecanatide, SSRI, Low FODMAP and CBT. Interesting to compare payer and patient perspective. (Twitter) - Feb 14, 2021
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Resolor (prucalopride) / J&J, Takeda, Amitiza (lubiprostone) / Takeda, Mallinckrodt
Clinical, Journal: European society of neurogastroenterology and motility guidelines on functional constipation in adults. (Pubmed Central) - Feb 11, 2021
European guidelines on chronic constipation, with recommendations and algorithms, were developed by experts. Despite the high level of agreement between the different experts, the level of scientific evidence for most recommendations was low, highlighting the need for future research to increase the evidence and improve treatment outcomes in these patients.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Julax (bisacodyl) / Shreya Life Sciences, Remedica
I've been living with #ovariancancer for 9 ys The Drs removed part of my bowel during my debulking surgery. I have a terrible time w/ constipation, have used everything fr sena, bisacodyl, lactolose, citro-mag, peg-lite, pico-salex,restorolax & constella Ppl still think they know (Twitter) - Feb 2, 2021
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Journal, HEOR: Pharmacologic, Dietary, and Psychological Treatments for Irritable Bowel Syndrome With Constipation: Cost Utility Analysis. (Pubmed Central) - Feb 2, 2021
From a patient perspective, on-label prescription drug treatment with linaclotide was the least expensive treatment strategy...Due mostly to prescription drug prices, neuromodulators, low FODMAP, and CBT appear cost-effective compared to on-label drug treatments from a payer perspective in cost-utility analysis. These findings may explain common treatment barriers in clinical practice.
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Clinical, Journal: An update on efficacy and safety considerations for the latest drugs used to treat irritable bowel syndrome. (Pubmed Central) - Jan 30, 2021
As second-line treatments, rifaximin is considered to be the best for IBS-D though it has lower efficacy than alosetron and eluxadoline.For IBS-C, linaclotide is the most effective and the safest second-line therapy, following laxatives/fibers, which may be replaced by tenapanor, in the future. When moderate to severe IBS is associated with severe pain or comorbid psychological disorders, gut-brain neuromodulators could also be prescribed.Regarding all this, there is still a paramount need to conduct careful clinical studies on efficacy, safety and cost-effectiveness of current approved and non-approved treatments.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial initiation date, Trial primary completion date: HygiRelief Procedure and HygiSample Evaluation for Functional Constipation (clinicaltrials.gov) - Jan 14, 2021
P=N/A, N=40, Not yet recruiting,
When moderate to severe IBS is associated with severe pain or comorbid psychological disorders, gut-brain neuromodulators could also be prescribed.Regarding all this, there is still a paramount need to conduct careful clinical studies on efficacy, safety and cost-effectiveness of current approved and non-approved treatments. Trial completion date: Jun 2021 --> Jun 2022 | Initiation date: Aug 2020 --> Mar 2021 | Trial primary completion date: Mar 2021 --> Mar 2022
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Ibsrela (tenapanor) / Ardelyx, Kyowa Hakko Kirin, Knight Therap
Preclinical, Journal: Deciphering ion transporters, kinases and PDZ-adaptor molecules that mediate guanylate cyclase C agonist-dependent intestinal fluid loss in vivo. (Pubmed Central) - Dec 16, 2020
The cGKII-NHERF1-CFTR and cGKII-NHERF2-NHE3 interactions are indeed major effectors of small intestinal fluid loss downstream of GCC activation in vitro and in vivo, but 50% of the linaclotide-induced fluid loss in vivo, while dependent on CFTR activation and NHE3 inhibition, does not involve cGKII, and 30% does not depend on NHERF1 or NHERF2. A combined NHERF1 and NHERF2 inhibition appears nevertheless a good pharmacological strategy against STa-mediated fluid loss.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial primary completion date: Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer (clinicaltrials.gov) - Dec 8, 2020
P2, N=230, Recruiting,
A combined NHERF1 and NHERF2 inhibition appears nevertheless a good pharmacological strategy against STa-mediated fluid loss. Trial primary completion date: Oct 2020 --> Oct 2021
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation (clinicaltrials.gov) - Nov 9, 2020
P2, N=30, Recruiting,
Linaclotide was safe and well tolerated and no new safety concerns were raised, supporting results from previous clinical trials. Trial completion date: Feb 2023 --> May 2021 | Trial primary completion date: Feb 2023 --> May 2021
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment open: Liberty: Evaluate the Safety of Linaclotide in IBS-C Patients in China (clinicaltrials.gov) - Nov 1, 2020
P=N/A, N=3000, Recruiting,
Trial completion date: Feb 2023 --> May 2021 | Trial primary completion date: Feb 2023 --> May 2021 Not yet recruiting --> Recruiting
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Enrollment closed: Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases) (clinicaltrials.gov) - Oct 19, 2020
P=N/A, N=2475, Active, not recruiting,
Therapeutic response in opioid-induced constipation is best achieved with the PAMORAs, methylnaltrexone, naloxegol and naldemidine, which are associated with low risk of serious adverse events. Recruiting --> Active, not recruiting
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Clinical, Journal: Contrasting Clinician and Insurer Perspectives to Managing Irritable Bowel Syndrome: Multilevel Modeling Analysis. (Pubmed Central) - Oct 11, 2020
From an insurer perspective, routine and algorithmic prescription drug coverage restrictions requiring failure of low-cost behavioral, dietary, and off-label treatments appear cost-effective. Efforts to address insurance coverage and drug pricing are needed so that healthcare providers can optimally care for patients with this common, heterogenous disorder.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] LINACLOTIDE AS A POTENTIAL BICARBONATE-CORRECTING THERAPY IN CF INTESTINE () - Oct 7, 2020 - Abstract #NACFC2020NACFC_623;
Ongoing experiments are using duodenal enteroids to determine the effect of linaclotide on human duodenal bicarbonate secretion and the involvement of CFTR. These experiments may provide insight into the therapeutic potential of linaclotide to correct defective intestinal bicarbonate secretion in CF patients, regardless of CFTR mutation.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Clinical, Journal, HEOR, Real-World Evidence: The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study. (Pubmed Central) - Oct 1, 2020
Overall, CONTOR participants were more likely to report BMs classified as LoWS or intermediate as satisfactory, versus HoLS. Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion date, Trial primary completion date: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (clinicaltrials.gov) - Oct 1, 2020
P3, N=120, Enrolling by invitation,
Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide. Trial completion date: Feb 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Dec 2023
- |||||||||| budesonide / Generic mfg.
[VIRTUAL] Unique Case of Gastroparesis in a Chronic Lyme Disease Patient () - Sep 15, 2020 - Abstract #ACG2020ACG_3307;
With dysmotility arises the opportunity for bacterial overgrowth. Therefore, the patient has been maintained on TPN and has been recommended treatment for small intestine bacterial overgrowth following completion of treatment for chronic lyme disease.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
[VIRTUAL] A Rare Case of Cecal Volvulus Associated With Linaclotide Use () - Sep 15, 2020 - Abstract #ACG2020ACG_1227;
Patient was informed about the possible association with linaclotide use and was advised to stop the medication to prevent any possible recurrence. Clinicians should be aware of this possible association with linaclotide use given that it can cause catastrophic complications.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Prialt (ziconotide) / Jazz
Journal: Directed Disulfide Pairing and Folding of Peptides for the De Novo Development of Multicyclic Peptide Libraries. (Pubmed Central) - Sep 12, 2020
As neither sequence manipulations nor unnatural amino acids are involved, the designed DRPs can be used as templates for the de novo development of biosynthetic multicyclic peptide libraries, enabling selection of DRPs with new functions directly from fully randomized sequences. We believe that this work represents as an important step toward the discovery and design of new multicyclic peptide ligands and therapeutics with structures not derived from natural scaffolds.
- |||||||||| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie, Trulance (plecanatide) / Bausch Health
Journal: Blunted Evoked Prouroguanylin Endocrine Secretion in Chronic Constipation. (Pubmed Central) - Sep 2, 2020
We believe that this work represents as an important step toward the discovery and design of new multicyclic peptide ligands and therapeutics with structures not derived from natural scaffolds. These observations support a novel pathophysiologic model in which CIC and IBS-C reflect a contribution of ProUGN insufficiency dysregulating intestinal fluid and electrolyte secretion.
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