PMID- 31892640
OWN - NLM
STAT- MEDLINE
DCOM- 20201110
LR  - 20201110
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 9
IP  - 12
DP  - 2019 Dec 30
TI  - 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.
PG  - e025627
LID - 10.1136/bmjopen-2018-025627 [doi]
LID - e025627
AB  - OBJECTIVES: We 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. SETTING: A 
      multicentre, non-interventional study conducted between December 2013 and 
      November 2015 across 31 primary, secondary and tertiary centres in Austria and 
      Switzerland. PARTICIPANTS: The 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 MEASURES: Data 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. RESULTS: Following 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. CONCLUSIONS: Patients 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.
CI  - (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Pohl, Daniel
AU  - Pohl D
AUID- ORCID: 0000-0002-0855-1152
AD  - Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, 
      Switzerland.
FAU - Fried, Michael
AU  - Fried M
AD  - Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, 
      Switzerland.
FAU - Lawrance, Dominic
AU  - Lawrance D
AD  - Allergan Limited, Marlow, Buckinghamshire, UK.
FAU - Beck, Elmar
AU  - Beck E
AD  - Anfomed Gesellschaft fur Angewandte Forschung in der Medizin mbH, Mohrendorf, 
      Bayern, Germany.
FAU - Hammer, Heinz F
AU  - Hammer HF
AD  - Division of Gastroenterology and Hepatology, Medical University Graz, Graz, 
      Austria heinz.hammer@medunigraz.at.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20191230
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Peptides)
RN  - N0TXR0XR5X (linaclotide)
SB  - IM
MH  - Abdominal Pain/drug therapy
MH  - Austria
MH  - Constipation/drug therapy
MH  - Diarrhea/etiology
MH  - Female
MH  - Humans
MH  - Irritable Bowel Syndrome/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Peptides/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Switzerland
MH  - Tertiary Care Centers
MH  - Treatment Outcome
PMC - PMC6955540
OTO - NOTNLM
OT  - abdominal pain
OT  - bloating
OT  - irritable bowel syndrome-constipation
OT  - linaclotide
OT  - non-interventional study
OT  - real-world evidence
COIS- Competing interests: Writing and editorial assistance was provided to the authors 
      by Germaine D. Agollah, PhD of Allergan. Editorial assistance was also provided 
      to the authors by Complete HealthVizion, Inc., funded by Allergan plc, Dublin, 
      Ireland. All authors met the ICMJE authorship criteria.
EDAT- 2020/01/02 06:00
MHDA- 2020/11/11 06:00
PMCR- 2019/12/30
CRDT- 2020/01/02 06:00
PHST- 2020/01/02 06:00 [entrez]
PHST- 2020/01/02 06:00 [pubmed]
PHST- 2020/11/11 06:00 [medline]
PHST- 2019/12/30 00:00 [pmc-release]
AID - bmjopen-2018-025627 [pii]
AID - 10.1136/bmjopen-2018-025627 [doi]
PST - epublish
SO  - BMJ Open. 2019 Dec 30;9(12):e025627. doi: 10.1136/bmjopen-2018-025627.