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Octatropine methyl bromide and diazepam combination (Valpinax) in patients with irritable bowel syndrome: a multicentre, randomized, placebo-controlled trial.
Eur Rev Med Pharmacol Sci 2010; 14(3):155-62ER

Abstract

OBJECTIVE

To investigate the efficacy and tolerability of octatropine methyl bromide plus diazepam (Valpinax) in patients with irritable bowel syndrome (IBS).

MATERIALS AND METHODS

We conducted a randomized, double-blind, multicentre study in 186 patients aged 18-65 years with IBS diagnosed according to Rome II criteria. Following a 2-week washout period, patients received octatropine plus diazepam 40 mg/2.5 mg twice daily or placebo for 6 weeks. The primary efficacy endpoint was response to a weekly question: "did you have satisfactory relief of your abdominal pain and discomfort during the last week?" Other endpoints included abdominal swelling, abdominal pain and discomfort, symptom severity, and the number of bowel movements. A prespecified subgroup analysis was conducted in patients with an abdominal pain and discomfort score > or = 3.

RESULTS

The primary efficacy endpoint showed a tendency towards a statistically significant benefit for octatropine plus diazepam over placebo among patients with a baseline abdominal pain and discomfort score of > or = 3 (3 vs. 0 patients; p = 0.059). Octatropine plus diazepam demonstrated significant improvements from baseline in all parameters assessed, but not compared with placebo. Adverse events were reported in 15.1% of patients receiving octatropine plus diazepam.

CONCLUSIONS

Patients with IBS and an abdominal pain and discomfort score of > or = 3, who may be considered in the active phase of the disease, may derive some benefits from octatropine plus diazepam. This study highlights that Rome II criteria should be considered with particular care in the design of a clinical trial, since it does not consider disease activity level on admission.

Authors+Show Affiliations

lnstitute of Gastroenterology, School of Medicine, "Luigi Sacco" Hospital, University of Milan, Italy. fabio.pace@unimi.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20391952

Citation

Pace, F, et al. "Octatropine Methyl Bromide and Diazepam Combination (Valpinax) in Patients With Irritable Bowel Syndrome: a Multicentre, Randomized, Placebo-controlled Trial." European Review for Medical and Pharmacological Sciences, vol. 14, no. 3, 2010, pp. 155-62.
Pace F, Maurano A, Ciacci C, et al. Octatropine methyl bromide and diazepam combination (Valpinax) in patients with irritable bowel syndrome: a multicentre, randomized, placebo-controlled trial. Eur Rev Med Pharmacol Sci. 2010;14(3):155-62.
Pace, F., Maurano, A., Ciacci, C., Savarino, V., Attili, A., Iaquinto, G., ... Porro, G. B. (2010). Octatropine methyl bromide and diazepam combination (Valpinax) in patients with irritable bowel syndrome: a multicentre, randomized, placebo-controlled trial. European Review for Medical and Pharmacological Sciences, 14(3), pp. 155-62.
Pace F, et al. Octatropine Methyl Bromide and Diazepam Combination (Valpinax) in Patients With Irritable Bowel Syndrome: a Multicentre, Randomized, Placebo-controlled Trial. Eur Rev Med Pharmacol Sci. 2010;14(3):155-62. PubMed PMID: 20391952.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Octatropine methyl bromide and diazepam combination (Valpinax) in patients with irritable bowel syndrome: a multicentre, randomized, placebo-controlled trial. AU - Pace,F, AU - Maurano,A, AU - Ciacci,C, AU - Savarino,V, AU - Attili,A, AU - Iaquinto,G, AU - Magni,E, AU - Porro,G Bianchi, PY - 2010/4/16/entrez PY - 2010/4/16/pubmed PY - 2010/4/30/medline SP - 155 EP - 62 JF - European review for medical and pharmacological sciences JO - Eur Rev Med Pharmacol Sci VL - 14 IS - 3 N2 - OBJECTIVE: To investigate the efficacy and tolerability of octatropine methyl bromide plus diazepam (Valpinax) in patients with irritable bowel syndrome (IBS). MATERIALS AND METHODS: We conducted a randomized, double-blind, multicentre study in 186 patients aged 18-65 years with IBS diagnosed according to Rome II criteria. Following a 2-week washout period, patients received octatropine plus diazepam 40 mg/2.5 mg twice daily or placebo for 6 weeks. The primary efficacy endpoint was response to a weekly question: "did you have satisfactory relief of your abdominal pain and discomfort during the last week?" Other endpoints included abdominal swelling, abdominal pain and discomfort, symptom severity, and the number of bowel movements. A prespecified subgroup analysis was conducted in patients with an abdominal pain and discomfort score > or = 3. RESULTS: The primary efficacy endpoint showed a tendency towards a statistically significant benefit for octatropine plus diazepam over placebo among patients with a baseline abdominal pain and discomfort score of > or = 3 (3 vs. 0 patients; p = 0.059). Octatropine plus diazepam demonstrated significant improvements from baseline in all parameters assessed, but not compared with placebo. Adverse events were reported in 15.1% of patients receiving octatropine plus diazepam. CONCLUSIONS: Patients with IBS and an abdominal pain and discomfort score of > or = 3, who may be considered in the active phase of the disease, may derive some benefits from octatropine plus diazepam. This study highlights that Rome II criteria should be considered with particular care in the design of a clinical trial, since it does not consider disease activity level on admission. SN - 1128-3602 UR - https://www.unboundmedicine.com/medline/citation/20391952/Octatropine_methyl_bromide_and_diazepam_combination__Valpinax__in_patients_with_irritable_bowel_syndrome:_a_multicentre_randomized_placebo_controlled_trial_ L2 - http://www.diseaseinfosearch.org/result/3876 DB - PRIME DP - Unbound Medicine ER -