TY - JOUR
T1 - Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation
AU - Lembo, Anthony J.
AU - Johanson, John F.
AU - Parkman, Henry P.
AU - Rao, Satish S.
AU - Miner, Philip B.
AU - Ueno, Ryuji
N1 - Funding Information:
Acknowledgments Writing and editorial support in the preparation of the manuscript draft and subsequent revisions was provided by Brian G. Shearer, PhD, Takeda Pharmaceuticals North America, Inc. Editorial assistance was also provided by Susan Ruffalo, PharmD of MedWrite, Inc. Newport Coast, California. Amitiza® is a registered trademark of Sucampo Pharma Americas, Inc. Dulcolax® is a registered trademark of Boehringer Ingelheim GmbH. Fleet Enema® is a registered trademark of C. B. Fleet Company. SAS® is a registered trademark of SAS Institute Inc. Research supported by Sucampo Pharma Americas Inc., 4520 East–West Highway, Bethesda, Maryland, USA.
PY - 2011/9
Y1 - 2011/9
N2 - Background: Lubiprostone helps relieve constipation in short-term 4-week studies. There are limited data on long-term pharmacological treatment with lubiprostone for chronic idiopathic constipation. Aims: To examine the long-term safety and effectiveness of lubiprostone in patients with chronic idiopathic constipation. Methods: In this prospective, multicenter, open-labeled trial, 248 patients aged ≥18 years with chronic idiopathic constipation were directed to take lubiprostone 24 mcg BID as needed for 48 weeks. Patients were allowed to decrease the dose in response to the perceived severity of constipation and need for relief. Hematology and chemistry profiles and assessment of constipation symptoms and its severity were performed at all visits. Adverse events (AEs) were recorded. Results: Of the 248 patients who entered the trial, 127 (51%) completed the trial. A dose reduction was observed in 17% of the patients, resulting in an average study medication exposure across the study of approximately 1.7 capsules (or approximately 40.8 mcg) per day. The most common treatment-related AEs were nausea (19.8%), diarrhea (9.7%), abdominal distension (6.9%), headache (6.9%), and abdominal pain (5.2%). No deaths were reported and of the 16 reported serious AEs, one was considered possibly treatment related. Average changes in serum electrolytes were not clinically relevant at any time point during the study. On average, lubiprostone significantly (p < 0.0001) reduced patient-reported constipation severity, abdominal bloating, and abdominal discomfort across 48 weeks when compared to baseline. Conclusions: During this 48-week open-label study, lubiprostone was well tolerated. Bowel symptoms consistently improved over 48 weeks in adult patients with chronic idiopathic constipation.
AB - Background: Lubiprostone helps relieve constipation in short-term 4-week studies. There are limited data on long-term pharmacological treatment with lubiprostone for chronic idiopathic constipation. Aims: To examine the long-term safety and effectiveness of lubiprostone in patients with chronic idiopathic constipation. Methods: In this prospective, multicenter, open-labeled trial, 248 patients aged ≥18 years with chronic idiopathic constipation were directed to take lubiprostone 24 mcg BID as needed for 48 weeks. Patients were allowed to decrease the dose in response to the perceived severity of constipation and need for relief. Hematology and chemistry profiles and assessment of constipation symptoms and its severity were performed at all visits. Adverse events (AEs) were recorded. Results: Of the 248 patients who entered the trial, 127 (51%) completed the trial. A dose reduction was observed in 17% of the patients, resulting in an average study medication exposure across the study of approximately 1.7 capsules (or approximately 40.8 mcg) per day. The most common treatment-related AEs were nausea (19.8%), diarrhea (9.7%), abdominal distension (6.9%), headache (6.9%), and abdominal pain (5.2%). No deaths were reported and of the 16 reported serious AEs, one was considered possibly treatment related. Average changes in serum electrolytes were not clinically relevant at any time point during the study. On average, lubiprostone significantly (p < 0.0001) reduced patient-reported constipation severity, abdominal bloating, and abdominal discomfort across 48 weeks when compared to baseline. Conclusions: During this 48-week open-label study, lubiprostone was well tolerated. Bowel symptoms consistently improved over 48 weeks in adult patients with chronic idiopathic constipation.
KW - Chronic idiopathic constipation
KW - Effectiveness
KW - Long-term safety
KW - Lubiprostone
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U2 - 10.1007/s10620-011-1801-0
DO - 10.1007/s10620-011-1801-0
M3 - Article
C2 - 21769655
AN - SCOPUS:80054746486
SN - 0163-2116
VL - 56
SP - 2639
EP - 2645
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 9
ER -