New data submitted at the 15th United European Gastroenterology Week congress
PARIS, October 30, 2007 - For the first time a once daily dosing regime of mesalazine (Pentasa® granules) has proven to be statistically superior to twice daily dosing for the effective maintenance of remission in patients suffering from mild to moderate ulcerative colitis (UC), finds a trial presented at the 15th United European Gastroenterology Week (UEGW) congress.
The primary objective of the 12-month multi-centre, randomised controlled, investigator blinded PODIUM trial, was to demonstrate equal efficacy of a single 2g sachet taken once daily compared to two separate 1g sachets per day. However, in a surprisingly strong result, of the 362 UC patients in remission who had relapsed within the past year, 73.8% of once daily patients were in clinical and endoscopic remission compared with 63.6% in the twice daily group (P=0.024).
"Once-daily studies conducted with other mesalazine drugs have focused on acute disease where compliance isn't so much of a problem. None of them suggested superior efficacy compared to multiple doses. It is therefore particularly interesting that this trial of Pentasa® sachets focuses on maintenance and has shown superior efficacy for the once-daily, single sachet regime", said co-ordinating investigator, Prof Dr. Axel U. Dignass, Markus Hospital, Frankfurt, Germany.
At the end of the PODIUM trial, once daily dosing had a higher compliance than twice daily dosing in terms of percentage of sachets used. Patient questionnaires yielded higher compliance scores for once daily than twice daily and patient acceptability of treatment was significantly better for once daily.
Compliance expert, Dr Andrew Robinson, Consultant Physician and Gastroenterologist, Hope Hospital, Salford, commented, "This is the first large study to demonstrate greater efficacy and compliance with once daily mesalazine compared to multiple dosing. Although it was designed as a non-inferiority trial the results unexpectedly favour single daily dosing which may be due to better compliance, altered pharmacodynamics or both. The true test of compliance and effectiveness is in a real life, non-trial environment and this trial not only reassures us that outcomes will not be compromised by single daily dosing but also asks us to think about factors such as having a whole dose in a single sachet".
Speculating on why this trial shows superiority, Professor Dignass added, "In addition to helping compliance by dosing once per day with a single sachet, there may be other influencing factors where questions still remain, such as differences in sustained bioavailability of active drug substance between the pH independent, sustained release profile of Pentasa® compared to more pH dependent formulations."
UC is an ongoing disease and, although symptoms may disappear with treatment, they tend to come back over time. Thus, patients are at risk of future episodes unless they continue to take their medication to keep them in remission. Furthermore, consistently complying with mesalazine therapy is associated with reduced risk of colorectal cancer, which is elevated in patients with UC.
"Whatever can be done to assist people with ulcerative colitis and to help them in regularly taking their treatments is another positive step towards improving the quality of life and quality of care of patients with this chronic illness, especially if they are able in time to take their medication only once a day" said Rod Mitchell, Chairman of the European Federation of Crohn's and Ulcerative Colitis Associations (EFCCA).
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NOTES FOR EDITORS
The PODIUM study is also known as Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission (PODIUM) trial.
Inflammatory Bowel Disease (IBD)
IBD describes a range of chronic diseases of the gastrointestinal system, encompassing Ulcerative Colitis (UC) and Crohn's Disease (CD). IBD is characterised by intermittent flares with debilitating symptoms (such as diarrhoea, abdominal pain and weight loss) that can result both in a significant worsening of the patient's quality of life as well as causing emotional distress and social isolation. In addition, patients can also suffer from a number of serious complications of the disease and may require life-long treatment and often surgery.
Both CD and UC are ongoing diseases and, although symptoms may disappear with treatment, they tend to come back over time. Thus, patients are at risk of future attacks unless they continue to take their medication to keep them in remission.
During the acute, active phase of IBD doctors may prescribe stronger therapies to control the inflammation, despite their potential harmful effects, if they will help the patient get better. However, side effects from a treatment being used for maintenance therapy are far less acceptable. Since patients will most probably have to take these medications over their entire lifetime, they must be both effective and safe. Mesalazine fulfils these requirements, as well as being convenient for the patient.
Incidence of IBD
IBD is mainly a condition of the industrialised world. It affects men and women equally and all races, although it is more common in some races than others.
In Northern Europe and the USA, the number of people affected by UC is approximately 120-270 per 100,000 - that is 1 in every 370-830 people(1,2,3) - with between 3-25 new cases per 100,000 people diagnosed each year.
For CD, the number of people affected is approximately the same, with 145 per 100,000 affected, and between 6-8 new cases per 100,000 people diagnosed each year.(1,2,3) However, unlike UC, the number of new cases of CD each year is increasing, particularly in young people, although the reasons for this are unclear.(4)
1. Rubin GP et al. Aliment Pharmacol Ther 2000; 14(12): 1553-1559
2. Farrokhayr F et al. Scand J Gastroenterol. 2001; 36(1): 2-15
3. Satsangi J and Sutherland L (2003) In: Inflammatory Bowel Disease, Churchill Livingstone
4. Loftus EV et al. Gastroenterology 1998; 114: 1161-1168
About Pentasa® (mesalazine)
Pentasa® belongs to a class of anti-inflammatory drugs called the aminosalicylates, which are used to treat and control the symptoms of inflammatory bowel disease (IBD) - both ulcerative colitis (UC) and Crohn's disease (CD).
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