This excerpt taken from the NVS 6-K filed Nov 2, 2005.
Geneva, October 19, 2005 Results of the PROGIS study released at the European Society for Organ Transplant (ESOT) meeting showed that 66% of patients who suffered gastrointestinal (GI) complaints while on mycophenolate mofetil (MMF) following kidney transplantation surgery reported an overall improvement in GI symptoms when converted to Myfortic® (enteric coated mycophenolate sodium).
Data from PROGIS (Patient Reported Outcomes in renal transplant patients with or without Gastro-Intestinal Symptoms) also showed that converting MMF patients who experienced GI problems to Myfortic significantly reduced their symptom burden while significantly improving their gastrointestinal and general well-being (p < 0.001).
These findings provide for the first time in transplantation insight into the value of patient-reported measurement tools as a way of differentiating the impact of adverse events with immunosuppressive therapies. This study also confirmed that MMF-associated gastro-intestinal effects had a significant impact on the health-related quality of life and psychological well-being of the study patients.
Patient Reported Quality of Life measurements have been used successfully in other treatment areas such as oncology, said Professor Paul Keown, MD, Director of Immunology and Head of Nephrology at the University of British Columbia. This is the right time to apply these assessment tools to transplant patients to further our understanding of how to improve care in patients who have gone through very intensive medical management.
Dr Shamkant Mulgoankar, Chief of the Division of Transplantation for the St Barnabas Health Care System and one of the leading investigators in the study, said: These first data are very encouraging results for the transplant community as this is the first study to evaluate patient functioning and well-being among patients converted from MMF to Myfortic because of GI complaints. Clinicians can now use these results to guide their considerations of treatment options for patients with GI complaints.
PROGIS is an open-label, multicenter, longitudinal study that utilised four different patient-reported Quality of Life questionnaires to identify the burden of gastrointestinal symptoms related to the two mycophenolic acid formulations (Myfortic and MMF) in kidney transplanted patients.
Changes in GI-specific symptoms burden from baseline were reported by patients using the Gastrointestinal Symptoms Rating Scale (GSRS) as well as the Overall Treatment Effect (OTE) scale after four to six weeks of treatment. Other scales used were GIQLI (GI Quality of Life Index) and PGWBI (Psychological Well-Being Index).
Myfortic is an enteric-coated formulation of mycophenolic acid and is approved in over 50 countries, including the US and major European countries. Myfortic is indicated for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants in combination with ciclosporin for microemulsion and corticosteroids.
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