Abdominal pain prucalopride

Observational studies Prucalopride has been evaluated in an open long-term study in 1455 patients (90% women) with chronic constipation for up to 24 months 8% stopped taking prucalopride because of adverse events, mostly gastrointestinal events (3.3%) and headache (1%) [15 ]. During the first 3 months, the most frequent adverse events that led to prucalopride withdrawal were abdominal pain, diarrhea, nausea, and headache, which accounted for 74% of withdrawals because of adverse reactions (43 out of 58). Most of these events (30 out of 43) occurred in... 

In a phase II, double-blind, randomized, placebo-controlled study of prucalopride 2 or 4 mg/day for 4 weeks in 196 patients with non-cancer pain and opioid-induced constipation, prucalopride improved bowel function [17. The incidence of treatment-related adverse events was 49% with placebo (32/66), 58% with prucalopride 2 mg (38/66), and 50% with prucalopride 4 mg (32/64). The most common adverse events were related to the gastrointestinal system and included abdominal pain and nausea. Abdominal pain was more frequent with prucalopride 4 mg/day (16/64) compared with 2 mg/day (8/66) and placebo (6/66). Pain was the most frequently reported adverse event prucalopride 2 mg/day, 4/66 prucalopride 4 mg/day, 2/64 placebo 3/66. 

Headache was the most common nervous system disorder prucalopride 2 mg/day, 4/66 prucalopride 4 mg/day, 5/64 placebo 3/66. Severe abdominal pain and headache were slightly more common with prucalopride 4 mg/day than placebo. Abdominal pain was the most common reason for withdrawal in all groups. There were no consistent differences in electrocardiography, including heart rate, PR and QTc intervals, and QRS width. 

Placebo-controlled studies The efficacy and safety of prucalopride 2 or 4 mg/day for 12 weeks has been assessed in a double-blind, placebo-controlled trial in patients with severe chronic constipation [15 ]. The most common drug-related adverse events included headache, abdominal pain, nausea, and diarrhea (which occurred mainly on day 1 of treatment). However, there were no differences in the incidences of serious adverse effects or cardiovascular events compared with placebo. 

In a double-blind, randomized, placebo-controlled trial of prucalopride 2 or 4 mg/day for 12 weeks in 716 patients with chronic constipation, the most common drug-related adverse events were headache, nausea, abdominal pain, and diarrhea [16 "]. The overall incidence of prolongation of the QT interval was low and similar among all treatment groups. Withdrawals as a result of these adverse events accounted for a higher dropout rate in those who took prucalopride 4 mg/day (15%), than in the other treatment groups (6.3% and 6.7% with 2 mg/day and placebo respectively). 

In a phase II, double-blind, randomized, dose-escalation study of prucalopride 0.5, 1, and 2 mg/day for 28 days in 89 elderly chronically constipated patients in musing homes, the most common adverse events, which were probably related to prucalopride, were diarrhea and abdominal pain [17 ]. Relative to placebo, there were no differences in vital signs, electrocardiography, and the incidence of dysrhythmias. 

---