PMID- 34697276
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20211125
IS  - 2233-6869 (Electronic)
IS  - 1598-9992 (Linking)
VI  - 78
IP  - 4
DP  - 2021 Oct 25
TI  - Safety/Efficacy of Prucalopride in Korean Patients with Chronic Constipation: 
      Post-marketing Surveillance.
PG  - 219-226
LID - 10.4166/kjg.2021.099 [doi]
AB  - BACKGROUND/AIMS: Constipation is a common gastrointestinal disorder. Prucalopride 
      is a dihydrobenzofurancarboxamide derivative with gastrointestinal prokinetic 
      activities and is recommended as an appropriate choice in patients unresponsive 
      to laxatives. This study assessed the safety and efficacy of prucalopride in 
      Korean patients with chronic constipation, in whom laxatives were ineffective. 
      METHODS: This prospective, non-interventional post-marketing surveillance of 
      prucalopride was conducted from 2012 to 2018 at 28 hospitals in Korea. Adults who 
      received prucalopride for the symptomatic treatment of chronic constipation were 
      included. The patients received 2 mg of prucalopride once daily or 1 mg once 
      daily in patients older than 65 years. The baseline characteristics, adverse 
      events (AEs), and seven-point scale of Clinical Global Impression-Improvement 
      were collected. RESULTS: Of 601 patients, 67.7% were female, and the mean age was 
      62.3 years. Three hundred patients (49.9%) were older than 65 years. At the 
      baseline, 70.0% of patients reported less than two instances of spontaneous 
      complete bowel movements per week. AEs were reported in 107 patients (17.7%), 
      including headache (3.2%) and diarrhea (2.8%). Seven serious AEs (SAEs) were 
      reported in five patients (0.8%). The SAEs were resolved without complications; 
      there were no cases of death. All SAEs were assessed as 'unlikely' causality with 
      prucalopride. In 72.7% of patients, chronic constipation was improved by the 
      prucalopride treatment during the study period. CONCLUSIONS: This study 
      demonstrated the promising safety and efficacy profile of prucalopride in 
      clinical practice. Thus, prucalopride should be considered in patients with 
      chronic constipation when bowel symptoms are refractory to simple laxatives.
FAU - Yeon, Sang Eun
AU  - Yeon SE
AD  - Janssen Korea Ltd., Seoul, Korea.
FAU - Kim, Su Youn
AU  - Kim SY
AD  - Janssen Korea Ltd., Seoul, Korea.
AD  - Department of Biostatistics and Computing, Yonsei University College of Medicine, 
      Seoul, Korea.
FAU - Chung, Woo Chul
AU  - Chung WC
AD  - Division of Gastroenterology, Department of Internal Medicine, St. Vincent 
      Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.
FAU - Jeon, Seong Woo
AU  - Jeon SW
AD  - Department of Internal Medicine, School of Medicine, Kyungpook National 
      University, Daegu, Korea.
FAU - Park, Soo Jung
AU  - Park SJ
AD  - Department of Internal Medicine and Institute of Gastroenterology, Yonsei 
      University College of Medicine, Seoul, Korea.
FAU - Choi, Chang Hwan
AU  - Choi CH
AD  - Departmentof Internal Medicine, Chung-Ang University College of Medicine, Seoul, 
      Korea.
FAU - Choi, Myung Gyu
AU  - Choi MG
AUID- ORCID: 0000-0003-4083-5187
AD  - Division of Gastroenterology, Department of Internal Medicine, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea.
AD  - Catholic Photomedicine Research Institute, Seoul, Korea.
LA  - eng
PT  - Journal Article
PL  - Korea (South)
TA  - Korean J Gastroenterol
JT  - The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi
JID - 101189416
RN  - 0 (Benzofurans)
RN  - 0 (Laxatives)
RN  - 0A09IUW5TP (prucalopride)
SB  - IM
MH  - Adult
MH  - Benzofurans
MH  - Chronic Disease
MH  - *Constipation/drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Laxatives/therapeutic use
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Republic of Korea
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse events
OT  - Constipation
OT  - Korea
OT  - Prucalopride
OT  - Real clinical practice
EDAT- 2021/10/27 06:00
MHDA- 2021/11/26 06:00
CRDT- 2021/10/26 05:47
PHST- 2021/06/30 00:00 [received]
PHST- 2021/09/01 00:00 [revised]
PHST- 2021/09/03 00:00 [accepted]
PHST- 2021/10/26 05:47 [entrez]
PHST- 2021/10/27 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
AID - kjg.2021.099 [pii]
AID - 10.4166/kjg.2021.099 [doi]
PST - ppublish
SO  - Korean J Gastroenterol. 2021 Oct 25;78(4):219-226. doi: 10.4166/kjg.2021.099.