Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting – results from a German noninterventional study

2018 ◽  
Vol 56 (07) ◽  
pp. 738-744 ◽  
Author(s):  
Viola Andresen ◽  
Stephan Miehlke ◽  
Elmar Beck ◽  
Gwen Wiseman ◽  
Peter Layer
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Clinical Practice ◽  
Real World ◽  
Common Adverse Event ◽  
Routine Clinical Practice ◽  
Guanylate Cyclase C ◽  
Bowel Movements ◽  
Irritable Bowel ◽  
Noninterventional Study

Abstract Background Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolerability of linaclotide in IBS-C in routine clinical practice in Germany. Methods This was a 52-week, noninterventional study of linaclotide in patients aged ≥ 18 years with moderate to severe IBS-C. Severity of abdominal pain and bloating and frequency of bowel movements were assessed over 5 study visits. Treatment-related adverse events were recorded. Results The study enrolled 375 patients; the mean observation duration was 4.4 months. Linaclotide marketing was halted during the study period for economic reasons, accounting for low patient numbers and short observation duration. Linaclotide significantly reduced mean (standard deviation [SD]) scores between treatment start (visit 1) and study end (visit 5) for abdominal pain intensity (visit 1: 4.87 [2.63] vs. visit 5: 2.40 [2.20], p < 0.0001), mean [SD] bloating intensity (visit 1: 5.30 [2.70] vs. visit 5: 2.86 [2.34], p < 0.0001), and increased mean [SD] bowel movement frequency (visit 1: 2.71 [1.80] vs. 4.38 [1.86], p < 0.0001). Diarrhea, occurring in 5.1 % of patients, was the most common adverse event. Conclusion Linaclotide is effective in improving the major symptoms of IBS-C and demonstrates a favorable safety profile in the real-world environment of routine clinical practice. DRKS (www.drks.de/): DRKS00005088.

scholarly journals Multicentre, non-interventional study of the efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in primary, secondary and tertiary centres: the Alpine study

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e025627 ◽  
Author(s):  
Daniel Pohl ◽  
Michael Fried ◽  
Dominic Lawrance ◽  
Elmar Beck ◽  
Heinz F. Hammer
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Secondary Outcome ◽  
Interventional Study ◽  
Intensity Score ◽  
Bowel Movements ◽  
The Mean ◽  
Irritable Bowel

ObjectivesWe evaluated the effectiveness and tolerability of linaclotide, a minimally absorbed guanylate cyclase-C agonist, in patients with irritable bowel syndrome with constipation (IBS-C) in routine clinical practice.SettingA multicentre, non-interventional study conducted between December 2013 and November 2015 across 31 primary, secondary and tertiary centres in Austria and Switzerland.ParticipantsThe study enrolled 138 patients aged ≥18 years with moderate-to-severe IBS-C. Treatment decision was at the physician’s discretion. Patients with known hypersensitivity to the study drug or suspected mechanical obstruction were excluded. The mean age of participants was 50 years, and >75% of the patients were women. 128 patients completed the study.Primary and secondary outcome measuresData were collected at weeks 0 and 4 in Austria and weeks 0, 4 and 16 in Switzerland. The primary effectiveness endpoints included severity of abdominal pain and bloating (11-point numerical rating scale [0=no pain/bloating to 10=worst possible pain/bloating]), frequency of bowel movements and physicians’ global effectiveness of linaclotide. Treatment-related adverse events (AEs) were recorded.ResultsFollowing a 4-week treatment period, the mean intensity score of abdominal pain was reduced from 5.8 at baseline to 2.7, while the bloating intensity score was reduced from 5.8 at baseline to 3.1e (both indices p<0.001). The frequency of mean weekly bowel movements increased from 2.1 at baseline to 4.5 at week 4 (p<0.001). Global effectiveness and tolerability of linaclotide were assessed by the treating physicians as ‘good’ or ‘excellent’ in >70% of patients. In total, 31 AEs were reported in 22 patients, the most common being diarrhoea, reported by 6 (7%) and 8 (15.4%) patients in Austria and Switzerland, respectively.ConclusionsPatients with IBS-C receiving linaclotide experienced effective treatment of moderate-to-severe symptoms in routine clinical practice. Linaclotide was safe and well tolerated and no new safety concerns were raised, supporting results from previous clinical trials.

Mo1635 Efficacy of Linaclotide in Constipation-Predominant Irritable Bowel Syndrome in Routine Clinical Practice: A Multicentre Experience

2016 ◽  
Vol 150 (4) ◽  
pp. S737-S738
Author(s):  
Jessica Shearer ◽  
Peter Paine ◽  
Anupam Rej ◽  
Anurag Agrawal ◽  
Alexander C. Ford
Keyword(s):  
Irritable Bowel Syndrome ◽  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Irritable Bowel

scholarly journals Abnormal Uroguanylin Immunoreactive Cells Density in the Duodenum of Patients with Diarrhea-Predominant Irritable Bowel Syndrome Changes following Fecal Microbiota Transplantation

2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
Tarek Mazzawi ◽  
Øystein Eikrem ◽  
Gülen Arslan Lied ◽  
Trygve Hausken
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Total Group ◽  
Guanylate Cyclase C ◽  
Rome Iii ◽  
Fresh Feces ◽  
Cell Densities ◽  
Irritable Bowel

Altered densities of enteroendocrine cells play an important role in patients with irritable bowel syndrome (IBS). Uroguanylin activates guanylate cyclase-C to regulate intestinal electrolyte and water transport. Aim. To quantify uroguanylin immunoreactive cells density in the duodenum of diarrhea-predominant IBS (IBS-D) patients compared to controls and to investigate the effect of fecal microbiota transplantation (FMT) on these cell densities. Method. Twelve patients with IBS-D according to Rome III criteria were included. The cause was identified as post infectious (PI, n=6) or idiopathic (n=6). They completed the IBS-symptom questionnaire before and 3 weeks after FMT. Thirty grams of fresh feces donated from healthy relatives were diluted with 60 ml normal saline and instilled via endoscope into the duodenum. Biopsies were taken from the patients’ duodenum before and 3 weeks after FMT. Duodenal biopsies taken from eight healthy controls were also included. The biopsies were immunostained for uroguanylin and quantified using computerized image analysis. Results. Uroguanylin immunoreactive cells were found both in duodenal villi and crypts in both controls and IBS-D patients. The densities of uroguanylin immunoreactive cells were significantly lower in the villi (P<0.0001) and higher in the crypts (P<0.0001) for the patients than the controls. Following FMT, the densities of uroguanylin immunoreactive cells for the total group and idiopathic subgroup decreased significantly in the duodenal crypts (P=0.049 and 0.04, respectively) but not in the villi. No significant changes were shown in the PI-IBS subgroups. The cells density in only the crypts correlated with diarrhea (r=0.97, P=0.001) and bloating (r=–0.91, P=0.01) in the PI-IBS subgroup before FMT and with abdominal pain (r=0.63, P=0.03) in the total group of IBS-D patients after FMT. Conclusion. Altered uroguanylin immunoreactive cells density was found in IBS-D patients compared to controls. Changes in these cells density following FMT correlated with IBS symptoms (diarrhea, bloating, and abdominal pain).

Effectiveness of rifaximin in the treatment of abdominal pain at irritable bowel syndrome

2020 ◽  
Vol 0 (4) ◽  
pp. 22-28
Author(s):  
S. M. Tkach ◽  
A. E. Dorofeev ◽  
N. M. Mirzabaeva
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Irritable Bowel
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