Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation

Digestive Diseases and Sciences

Volumn 56, Issue 9, 2011, Pages 2639-2645

  Lembo, Anthony J ^a   Johanson, John F ^b   Parkman, Henry P ^c   Rao, Satish S ^d   Miner Jr , Philip B ^e   Ueno, Ryuji ^f  

^a HARVARD MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF ILLINOIS   (United States)

^c TEMPLE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF IOWA   (United States)

^e Oklahoma Foundation for Digestive Research   (United States)

^f Sucampo Pharmaceuticals Inc   (United States)

Author keywords

Chronic idiopathic constipation; Effectiveness; Long term safety; Lubiprostone

Indexed keywords

LUBIPROSTONE;

ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; ARTICLE; BLOATING; CHRONIC IDIOPATHIC CONSTIPATION; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; SYMPTOM; TREATMENT DURATION; TREATMENT RESPONSE; URINARY TRACT INFECTION; VOMITING;

ADULT; ALPROSTADIL; CATHARTICS; CHLORIDE CHANNELS; CHRONIC DISEASE; CONSTIPATION; DRUG ADMINISTRATION SCHEDULE; FEMALE; HISTORY, 18TH CENTURY; HUMANS; MALE; MIDDLE AGED;

EID: 80054746486     PISSN: 01632116     EISSN: 15732568     Source Type: Journal    
DOI: 10.1007/s10620-011-1801-0     Document Type: Article

References (22)

1. A Sonnenberg TR Koch 1989 Epidemiology of constipation in the United States Dis Colon Rectum 32 1 8 2910654 10.1007/BF02554713 1:STN:280: DyaL1M%2FptVOntQ%3D%3D (Pubitemid 19041870)
2. W Stewart J Liberman RS Sandler, et al. 1999 Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features Am J Gastroenterol 94 3530 3540 10606315 10.1111/j.1572-0241.1999.01642.x 1:STN:280:DC%2BD3c%2Fnt1egsw%3D%3D
3. PD Higgins JF Johanson 2004 Epidemiology of constipation in North America: a systematic review Am J Gastroenterol 99 750 759 15089911 10.1111/j.1572-0241.2004.04114.x (Pubitemid 38612817)
4. BC Martin 2004 National estimates of office and emergency room constipation-related visits in the United States Am J Gastroenterol 99 S244 10.1111/j.1572-0241.2004.04058.x Abstract (Pubitemid 38279863)
5. NJ Talley AR Zinsmeister C Van Dyke LJ Melton III 1991 Epidemiology of colonic symptoms and the irritable bowel syndrome Gastroenterology 101 927 934 1889716 1:STN:280:DyaK3MzmsFWqug%3D%3D
6. NJ Talley 2005 : Differentiating functional constipation from constipation-predominant irritable bowel syndrome: management implications Rev Gastroenterol Disord 5 1 9 15741927 (Pubitemid 40443991)
7. SA Muller-Lissner MA Kamm C Scarpignato, et al. 2005 Myths and misconceptions about chronic constipation Am J Gastroenterol 100 232 242 15654804 10.1111/j.1572-0241.2005.40885.x (Pubitemid 41623292)
8. JH Xing EE Soffer 2001 Adverse effects of laxatives Dis Colon Rectum 44 1201 1209 11535863 10.1007/BF02234645 1:STN:280:DC%2BD3MvptFOiuw%3D%3D (Pubitemid 32758279)
9. LJ Brandt CM Prather EM Quigley LR Schiller P Schoenfeld NJ Talley 2005 Systematic review on the management of chronic constipation in North America Am J Gastroenterol 100 S5 S21 16008641 10.1111/j.1572-0241.2005.50613-2.x (Pubitemid 41038422)
10. BE Lacy WD Chey 2009 Lubiprostone: Chronic constipation and irritable bowel syndrome with constipation Expert Opin Pharmacother 10 143 152 19236188 10.1517/14656560802631319 1:CAS:528:DC%2BD1cXhsFSmtbrL
11. MiraLAX. Package insert, Schering-Plough HealthCare Products Inc. 2011.
12. TJ Jentsch M Poet JC Fuhrmann AA Zdebik 2005 Physiological functions of ClC Cl- channels gleaned from human genetic disease and mouse models Annu Rev Physiol 67 779 807 15709978 10.1146/annurev.physiol.67.032003.153245 1:CAS:528:DC%2BD2MXjsFeks7Y%3D (Pubitemid 40404510)
13. J Cuppoletti DH Malinowska KP Tewari, et al. 2004 SPI-0211 activates T84 cell chloride transport and recombinant human ClC-2 chloride currents Am J Physiol Cell Physiol 287 C1178 C1183 10.1152/ajpcell.00528.2003 (Pubitemid 39382875)
14. R Ueno H Osama T Habe, et al. 2004 Oral spi-0211 increases intestinal fluid secretion and chloride concentration without altering serum electrolyte levels (abstract) Gastroenterology 126 A-100
15. M Camilleri AE Bharucha R Ueno, et al. 2006 Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers Am J Physiol Gastrointes Liver Physiol 290 G942 G947 10.1152/ajpgi.00264.2005 1:CAS:528: DC%2BD28Xlt1ehsLY%3D
16. JF Johanson D Morton J Geenen R Ueno 2008 Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally acting type-2 chloride channel activator, in patients with chronic constipation Am J Gastroenterol 103 170 177 17916109 10.1111/j.1572-0241.2007.01772-4.x 1:CAS:528:DC%2BD1cXhsVyjt7g%3D (Pubitemid 351501102)
17. CF Barish D Drossman JF Johanson R Ueno 2010 Efficacy and safety of lubiprostone in patients with chronic constipation Dig Dis Sci 55 1090 1097 20012484 10.1007/s10620-009-1068-x 1:CAS:528:DC%2BC3cXjtlahtro%3D
18. JF Johanson MA Gargano PC Holland, et al. 2004 Phase III, randomized withdrawal study of RU-0211, a novel chloride channel activator for the treatment of constipation Gastroenterology 126 A-100 Abstract
19. International Conference on Harmonization. The extent of population exposure to assess clinical safety for drugs for long-term treatment of non-life-threatening conditions. 1994. Available at: http://wwwichorg/cache/ compo/475-272-1html#E1.
20. E Rivera A Wahle TR Joswick, et al. 2007 Lubiprostone, a novel type-2 chloride channel (ClC-2) activator, does not affect serum electrolyte balance in elderly and non-elderly patients with chronic idiopathic constipation Gastroenterology 132 A191 A192 Abstract
21. C Sprenger A Copa J Morganroth, et al. 2007 Effect of lubiprostone, a unique agent for the treatment of chronic idiopathic constipation, on clinical electrocardiographic results Gastroenterology 132 A325 Abstract
22. E Corazziari D Badiali G Bazzocchi, et al. 2000 Long-term efficacy, safety, and tolerability of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation Gut 46 522 526 10716682 10.1136/gut.46.4.522 1:CAS:528: DC%2BD3cXis1ems7w%3D (Pubitemid 30305817)