BackgroundThe 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.MethodsRandomized, 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 investigator’s assessment on efficacy of treatment. Safety assessments included adverse events, laboratory values, and cardiovascular events.Key ResultsEfficacy 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 & InferencesPrucalopride 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.

The aim of this study was to record gastric myoelectric activity using multichannel electrogastrography (EGG) and to determine if there are differences due to age, gender, body mass, and study location. In 61 normal subjects from four centers, fasting multichannel EGG was recorded for 1 h, followed by two 1-h postprandial recordings after a test meal. Variables assessed included dominant frequency (DF) and its power, percentage time in 2- to 4-cpm frequency, and percentage slow-wave coupling (%SWC). There were no significant differences in EGG parameters with respect to gender or age. Subjects with a BMI > 25 had a decrease in the absolute DF power but a similar increase in the postprandial DF power. Subjects with a BMI > 25 had a postprandial decrease in the %SWC compared to those with a BMI < 25. There was a decrease in postprandial %SWC in European/Asian centers compared to American centers. In conclusion, multichannel EGG provides assessment of electrical slow-wave coupling in addition to determining dominant frequency, power, and percentage normal rhythm. This multicenter study of normal subjects shows similar multichannel EGG values among different genders and ages. Body mass and ethnicity may impact on some of the EGG values.

BackgroundPrucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated.AimTo evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials.MethodsData were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials.ResultsOverall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women.ConclusionThe integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.