Public HealthMovetis Releases New Data That Support Prucalopride's Favourable And Differentiated Efficacy And Cardiovascular Safety Profile
Data from 7 prucalopride trials are being presented at the Digestive
Disease Week (DDW) in Chicago. They confirm the consistent and predictable
efficacy of prucalopride across different patient groups and add more
evidence to its favourable cardiovascular and overall safety profile. The
data also support the longer term efficacy of the drug in adults and elderly
with chronic constipation (cc) and demonstrate a significant improvement in
Quality of Life (QOL) across different trials. These data are part of the
extensive prucalopride dataset (83 clinical trials) that is currently under
review by the European health authorities.
The results from two randomized, double-blind, placebo controlled,
cross-over safety trials that investigated the cardiovascular safety of
prucalopride in 56 healthy subjects showed no clinically relevant differences
in blood pressure and heart rhythm between treatment groups. Furthermore,
extensive ECG monitoring did not reveal any significant findings on specific
QT related endpoints. Lieve Vandeplassche[1], VP clinical development at
Movetis and author of the abstract concluded: "This data is reassuring with
regard to the lack of significant QT effects, even up to repeated
supratherapeutic doses of 20mg daily, which is 10 times the recommended
dose."
At the congress Prof Michael Camilleri[2], MD, USA, presented data from a
long term follow-up study with prucalopride that support both efficacy
(expressed as overall patient satisfaction with bowel movements) and a
favourable safety profile are maintained during treatment for up to 24
months. The same author[3] presented data from a double-blind,
placebo-controlled study which evaluated the safety and tolerability of
prucalopride in frail constipated elderly patients in nursing homes. He
concluded that prucalopride up to 2mg once daily for a 4 week treatment
period showed a good safety profile and was well tolerated by these
constipated elderly of which the vast majority had underlying cardiovascular
diseases. No differences versus placebo were noted during continuous
measurement of both a variety of general cardiovascular and specific
pro-arrhythmogenic or QT endpoints.
Prof Dr Jan Tack[4] from the University Hospital Gasthuisberg in Leuven
authored an abstract that investigated the effect of prucalopride on health
related QOL. The data showed that 36.5% of patients (of which the majority
was dissatisfied with previous laxative treatment and had a long standing
history of severe constipation) had an improvement of more than or equal to 1
point on the validated PAC-QOL scale at the recommended 2mg dose of
prucalopride compared to 18.6% of placebo patients.
On the data presented at DDW, Dirk Reyn, CEO of Movetis, commented: "The
seven studies presented at DDW are part of what is undoubtedly one of the
most extensive product dataset available in chronic constipation. The
efficacy, safety, tolerability and QOL data itself confirm that prucalopride
is a promising new drug for a patient population in need of new treatment
alternatives. Especially the 2 specifically designed QT studies and the
cardiovascular (CV) safety study in frail elderly, provide reassuring
evidence in support of a more favourable and different CV safety profile of
prucalopride versus any of the older prokinetic drugs."
About prucalopride
Prucalopride is the first compound of a new class of highly selective
serotonin (5HT4) receptor agonists with strong enterokinetic activity
especially on the colon. It is indicated for the treatment of chronic
constipation in adults and elderly for whom laxatives provide inadequate
relief. Prucalopride is currently under review by the European Medicines
Evaluation Agency (EMEA) and Swissmedic.
The drug has been tested in 2752 patients (including elderly) in
double-blind randomized placebo-controlled studies up to 12 weeks of
treatment. Patients included in three identically designed pivotal phase III
studies showed a baseline value of References
[1] Cardiovascular safety of prucalopride in healthy subjects: results
from two randomized, double-blind, placebo-controlled, cross-over trials.
Authors: Malcolm J. Boyce; Renç© Kerstens; Greet Beyens; Jannie Ausma; Lieve
Vandeplassche.
[2] Long-term follow-up of safety and satisfaction with bowel function in
response to oral prucalopride in patients with chronic constipation. Authors:
Michael Camilleri; Greet Beyens; Renç© Kerstens; Lieve Vandeplassche.
[3] A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and
Tolerability of Prucalopride Oral Solution in Constipated Elderly Patients
Living in a Nursing Facility. Authors: Michael Camilleri; Renç© Kerstens;
Greet Beyens; Patricia Robinson; Lieve Vandeplassche.
[4] PAC-QOL results from 3 identical randomized placebo-controlled trials
with prucalopride in patients with severe chronic constipation. Authors: Jan
Tack;Dominique Dubois; Renç© Kerstens; Greet Beyens; Lieve Vandeplassche;
Jannie Ausma.
Movetis NV