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 end-points 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 ≥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 ≥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 ≥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.
| Original language | English |
|---|---|
| Pages (from-to) | 155-162 |
| Number of pages | 8 |
| Journal | European Review for Medical and Pharmacological Sciences |
| Volume | 14 |
| Issue number | 3 |
| Publication status | Published - Mar 2010 |
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Keywords
- Diazepam
- Irritable bowel syndrome
- Octatropine
- Tropanes
ASJC Scopus subject areas
- Medicine(all)
- Pharmacology (medical)
Cite this
Octatropine methyl bromide and diazepam combination (Valpinax®) in patients with irritable bowel syndrome : A multicentre, randomized, placebo-controlled trial. / Pace, Fabio; Maurano, A.; Ciacci, C.; Savarino, V.; Attili, A.; Iaquinto, G.; Magni, E.; Bianchi Porro, G.
In: European Review for Medical and Pharmacological Sciences, Vol. 14, No. 3, 03.2010, p. 155-162.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Octatropine methyl bromide and diazepam combination (Valpinax®) in patients with irritable bowel syndrome
T2 - A multicentre, randomized, placebo-controlled trial
AU - Pace, Fabio
AU - Maurano, A.
AU - Ciacci, C.
AU - Savarino, V.
AU - Attili, A.
AU - Iaquinto, G.
AU - Magni, E.
AU - Bianchi Porro, G.
PY - 2010/3
Y1 - 2010/3
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 end-points 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 ≥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 ≥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 ≥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.
AB - 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 end-points 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 ≥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 ≥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 ≥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.
KW - Diazepam
KW - Irritable bowel syndrome
KW - Octatropine
KW - Tropanes
UR - http://www.scopus.com/inward/record.url?scp=77951633814&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77951633814&partnerID=8YFLogxK
M3 - Article
C2 - 20391952
AN - SCOPUS:77951633814
VL - 14
SP - 155
EP - 162
JO - European Review for Medical and Pharmacological Sciences
JF - European Review for Medical and Pharmacological Sciences
SN - 1128-3602
IS - 3
ER -