E. Coss-Adame , J.M. Remes-Troche , R. Flores Rendón , J.L. Tamayo de la Cuesta , M.A. Valdovinos Díaz
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引用次数: 0
Abstract
Introduction
Chronic idiopathic constipation (CIC) negatively impacts quality of life and increases healthcare costs. Lubiprostone stimulates the secretion of intestinal fluid, in turn facilitating the passage of stools and alleviating associated symptoms. Lubiprostone has been available in Mexico since 2018, but its clinical efficacy has not been studied in a Mexican population.
Aim
To evaluate the efficacy of lubiprostone, assessed by changes in spontaneous bowel movement (SBM) frequency after one week of treatment with 24 μg oral lubiprostone (b.i.d.), as well as its safety, over four weeks of treatment.
Study
Randomized, double-blind, placebo-controlled study on 211 adults with CIC in Mexico.
Results
The increase in SBM frequency, after one week of treatment, was significantly higher in the lubiprostone group than in the placebo group (mean: 4.9 [SD: 4.45] vs. 3.0 [3.14], P = .020). Secondary efficacy endpoints revealed a significantly higher proportion of SBM frequency/week in the lubiprostone group at weeks 2, 3, and 4. There was a better response within 24 hours after the first dose with lubiprostone vs. placebo (60.0% vs. 41.5%; OR: 2.08, [95% CI: 1.19, 3.62], P = .009) and the lubiprostone group also had significant improvement, with respect to straining, stool consistency, abdominal bloating, and satisfaction index. The main adverse events were gastrointestinal disorders in 13 (12.4%) lubiprostone-treated subjects and 4 (3.8%) control subjects.
Conclusions
Our data confirm the efficacy and safety of lubiprostone for the treatment of CIC in a Mexican population. Lubiprostone treatment induces relief from the most bothersome symptoms associated with constipation.
期刊介绍:
La Revista de Gastroenterología de México es el órgano oficial de la Asociación Mexicana de Gastroenterología. Sus espacios están abiertos a los miembros de la Asociación como a todo miembro de la comunidad médica que manifieste interés por utilizar este foro para publicar sus trabajos, cumpliendo con las políticas editoriales que a continuación se mencionan. El objetivo principal de la Revista de Gastroenterología de México, es publicar trabajos originales del amplio campo de la gastroenterología, así como proporcionar información actualizada y relevante para el área de la especialidad y áreas afines. Los trabajos científicos incluyen las áreas de Gastroenterología clínica, endoscópica, quirúrgica y pediátrica.