Prucalopride in the treatment of chronic constipation in patients from the Asia-Pacific region: a randomized, double-blind, placebo-controlled study

被引:141
作者
Ke, M. [1 ]
Zou, D. [2 ]
Yuan, Y. [3 ]
Li, Y. [4 ]
Lin, L. [5 ]
Hao, J. [6 ]
Hou, X. [7 ]
Kim, H. J. [8 ]
机构
[1] Beijing Union Med Coll Hosp, Dept Gastroenterol, Clin & Res Ctr FGID & DGIM, Beijing 100070, Peoples R China
[2] Changhai Hosp Shanghai, Dept Gastroenterol, Shanghai, Peoples R China
[3] Shanghai Ruijin Hosp, Dept Gastroenterol, Shanghai, Peoples R China
[4] Capital Med Univ, Shangdong Univ, Qilu Hosp, Dept Gastroenterol, Jinan, Peoples R China
[5] Jiangsu Prov Hosp, Dept Gastroenterol, Nanjing, Jiangsu, Peoples R China
[6] Beijing Chaoyang Hosp, Dept Gastroenterol, Beijing, Peoples R China
[7] Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Gastroenterol, Wuhan 430074, Peoples R China
[8] Kyung Hee Univ Hosp, Dept Internal Med, Seoul, South Korea
关键词
Asian; Asia-Pacific; constipation; efficacy; prucalopride; safety; QUALITY-OF-LIFE; SELF-DEFINED CONSTIPATION; IRRITABLE-BOWEL-SYNDROME; MULTINATIONAL SURVEY; LAXATIVE USE; PHARMACOKINETICS; QUESTIONNAIRE; EPIDEMIOLOGY; VALIDATION; AMERICA;
D O I
10.1111/j.1365-2982.2012.01983.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
100201 [内科学];
摘要
Background The study evaluated efficacy and safety of the 2 mg dose of prucalopride compared to placebo in patients with chronic constipation (CC) from the Asia-Pacific region. Methods Randomized, placebo-controlled, parallel-group, phase III study with 2-week run-in, 12-week treatment phase, and 1-week follow-up. Adult patients with CC (=2 spontaneous bowel movements per week) received 2 mg prucalopride or placebo, once-daily, for 12 weeks. Primary efficacy measure was percentage of patients with average of =3 spontaneous complete bowel movements (SCBMs) per week (Responders) during the 12-week treatment. A key secondary endpoint was Responders during first 4 weeks of treatment. Other efficacy assessments were based on patient diaries, their assessments of symptoms and quality of life, and investigators assessment on efficacy of treatment. Safety assessments included adverse events, laboratory values, and cardiovascular events. Key Results Efficacy and safety were evaluated for 501 patients who received study drug. On the primary endpoint, prucalopride was significantly more effective than placebo with 83 (33.3%) vs 26 (10.3%) patients having a weekly average of =3 SCBMs during the 12-week treatment (P < 0.001). Respective percentages were 34.5%vs 11.1% over first 4 weeks (P < 0.001). On other secondary endpoints, clinical improvement was generally larger and statistically superior (P < 0.001) in the prucalopride group. Most frequently reported adverse events were diarrhea, nausea, abdominal pain, and headache. Conclusion & Inferences Prucalopride 2 mg given once-daily significantly improved bowel function, associated symptoms, and satisfaction in CC over a 12-week treatment period, and was safe and well tolerated by patients in the Asia-Pacific region.
引用
收藏
页码:999 / e541
页数:11
相关论文
共 30 条
[1]
[Anonymous], 2010, CONS GLOB PERSP
[2]
[Anonymous], 2011, RES PRUC
[3]
The treatment of chronic constipation in elderly people -: An update [J].
Bosshard, W ;
Dreher, R ;
Schnegg, JF ;
Büla, CJ .
DRUGS & AGING, 2004, 21 (14) :911-930
[4]
Selective stimulation of colonic transit by the benzofuran 5HT4 agonist, prucalopride, in healthy humans [J].
Bouras, EP ;
Camilleri, M ;
Burton, DD ;
McKinzie, S .
GUT, 1999, 44 (05) :682-686
[5]
Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies [J].
Camilleri, M. ;
Van Outryve, M. J. ;
Beyens, G. ;
Kerstens, R. ;
Robinson, P. ;
Vandeplassche, L. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2010, 32 (09) :1113-1123
[6]
Safety assessment of prucalopride in elderly patients with constipation: a double-blind, placebo-controlled study [J].
Camilleri, M. ;
Beyens, G. ;
Kerstens, R. ;
Robinson, P. ;
Vandeplassche, L. .
NEUROGASTROENTEROLOGY AND MOTILITY, 2009, 21 (12) :1256-1263+e117
[7]
A placebo-controlled trial of prucalopride for severe chronic constipation [J].
Camilleri, Michael ;
Kerstens, Rene ;
Rykx, An ;
Vandeplassche, Lieve .
NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (22) :2344-2354
[8]
Prucalopride for constipation [J].
Camilleri, Michael ;
Deiteren, Annemie .
EXPERT OPINION ON PHARMACOTHERAPY, 2010, 11 (03) :451-461
[9]
CHAPLIN S, 2010, PRESCRIBER, V5, P27
[10]
Ethnic or racial differences revisited - Impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics [J].
Chen, Mei-Ling .
CLINICAL PHARMACOKINETICS, 2006, 45 (10) :957-964