CHICAGO, June 2 /PRNewswire/ -- 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, 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, 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 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 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.
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 0.5 spontaneous complete bowel movements (SCBM)/week in the drug-free 2 weeks run-in period and showed an average history of 20 years of chronic constipation.
In contrast to laxatives, prucalopride triggers a physiological and peristaltic reflex in the colon through stimulation of the 5HT4-receptors on the intramural nerves. This accelerates overall transit along the GI tract, induces colonic mass movement and significantly enhances colonic emptying. Prucalopride stimulates normal bowel function by specifically targeting the underlying impaired motility and as a result it alleviates a broad range of chronic constipation symptoms and improves patient satisfaction.
Through a clear focus on gastroenterology (GI), Movetis seeks to improve the lives of millions of patients - both adults and children - by discovering, developing and ultimately commercializing innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV - founded in Belgium in December 2006 - aims to become a leading European specialty pharmaceutical organization focused on GI diseases.
 Cardiovascular safety of prucalopride in healthy subjects: results from two randomized, double-blind, placebo-controlled, cross-over trials. Authors: Malcolm J. Boyce; René Kerstens; Greet Beyens; Jannie Ausma; Lieve Vandeplassche.
 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; René Kerstens; Lieve Vandeplassche.
 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; René Kerstens; Greet Beyens; Patricia Robinson; Lieve Vandeplassche.
 PAC-QOL results from 3 identical randomized placebo-controlled trials with prucalopride in patients with severe chronic constipation. Authors: Jan Tack;Dominique Dubois; René Kerstens; Greet Beyens; Lieve Vandeplassche; Jannie Ausma.
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