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New Evidence Shows incidence of Colo-rectal Cancer may be Reduced in Patients with Ulcerative Colitis

GERMANY, MUNICH
28 November 2003

Healthcare providers have key role to ensure patients realise benefits of mesalazine acid treatment

Over one million Europeans suffer from IBD, or inflammatory bowel disease of the colon and rectum.  Patients who don't take their medication, thereby receiving 'no therapy' are at higher risk of developing cancer of the large colon and rectum (colo-rectal cancer) and by simply ensuring that they take their prescribed medication as recommended by their doctors this risk may be reduced. (1)

The link between developing colo-rectal cancer in patients with IBD, such as ulcerative colitis and Crohn's disease has long been recognised, with estimates putting the risk as six to ten times greater than that of the general population. (2)

According to the world's leading gastroenterologists, presenting at the Ferring sponsored "6th IBD and Salicylates" meeting in Munich, Germany (28/29th November 2003), colo-rectal cancer is the most common form of cancer that develops in this group of patients.  As many as 30 percent of IBD patients with inflammation affecting the whole of the colon (pancolitis) go on to develop colorectal cancer after an average of 35 years, and at a much earlier age than seen in the general population. (3) Yet so far, monitoring strategies aimed to reduce this risk have proved unsatisfactory.

But, all this could be set to change.  Recent research presented at the meeting indicated that the increased risk of colo-rectal cancer seen in patients with IBD can be reduced to that of the general population (around three percent) by improving patient medication-taking (compliance) and treating them with a medication called 5-aminosalicylate (5-ASA) also known as mesalazine. * (4)

"This latest evidence reinforces earlier observations", explained Dr Stephen Hanauer, director of the Gastroenterology and Nutrition section of the University of Chicago's Pritzker School of Medicine.  "It looks like treatments containing mesalazine could become the most cost-effective and successful way of preventing the development of, and deaths from, colo-rectal cancer in this group of patients".

"However, our research also shows that it is essential for patients to be fully educated about the importance of fully complying with their maintenance treatment if they are to receive the full range of long-term benefits from 5-ASA-based therapies. To be most effective, the patient needs to be told that they must take their medication regularly and as prescribed, even when they are feeling well and their IBD is in remission."

Inflammatory disease of the colon and rectum characterised by diarrhoea, pain and loss of weight is often difficult to diagnose in its early stages.  It cycles through periods of activity (ranging from mild to severe), when the inflammation flares up, and remission, tempting patients to stop taking their medication during the periods when they feel better. 

"Non-compliance with prescribed medication is high amongst these patients", said Dr Jayne Eaden, consultant gastroenterologist at the Walsgrave Hospital in Coventry, England.  "As many as six out of ten patients discontinue treatment, despite the fact that the 5-ASA class of medication is very well-tolerated and has low levels of side-effects."

The risk of a patient with IBD developing colo-rectal cancer is dependent upon a number of factors.  These include the age of the patient when the disease first started, how long they have had the disease, how much of the intestine is affected by the disease and whether they have a family history of colo-rectal cancer.

Dr Eaden added, "Although such patients already undergo regular screening and biopsies, such procedures are not 100 percent reliable and it is felt that the use of mesalazine would be a better way to prevent the development of colo-rectal cancer". 

"The greatest degree of protection comes to patients who take their medication properly in addition to seeing their doctors regularly for check-ups and reviews.  All steps under direct control of the patient."

There is a range of evidence to suggest that the changes linked to colo-rectal cancer occur slowly over a long time period according to Professor Christophe Gasche associate professor of medicine at the University of Vienna, in Austria.  "This time window allows physicians to counteract cancer development by chemo-prevention."

"Mesalazine helps control IBD by dampening down the inflammation that occurs in the intestines.  It is not clear why it should reduce the risk of colo-rectal cancer, but it is thought that it may prevent tumours developing by inhibiting the growth of cancerous cells and encouraging their death.  It may also stabilise the cell's DNA template reducing the chance of mutations." he added.

In addition, the outstanding research work of two European doctors was also acknowledged at the meeting. Dr Fellermann from Germany and Dr Esteve of Spain, shared the "Ferring Fellowship" for their scientific contribution to the field of IBD.  The Fellowship which they are to share took the form of a € 15,000 financial award to be used for further scientific activities.


Notes for editors:
The anti-cancer benefits of mesalazine were first proposed in the mid 1990s, when it was seen that the numbers of cases of colo-rectal cancer in Danish ulcerative colitis patients, where mesalazine had been the mainstay of treatment for many years, was considerably lower than the numbers in other parts of Europe. (5)

The 6th IBD and Salicylate Symposium, attended by over 700 of the world's leading scientists and doctors in the field of gastroenterology, is part of Ferring's commitment to create world-wide research alliances and encourage the dissemination of ground-breaking work in the field of inflammatory colo-rectal disease.

Ferring Pharmaceuticals markets PENTASA, a prolonged release 5-ASA in more than 50 markets world-wide.


Ferring is a research driven, speciality biopharmaceutical group active in global markets.  The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynecology, infertility and urology.

In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.

To learn more about Ferring or our products please visit us at
www.Ferring.com


References
1. Kane S, Huo D, Aikens J, Hanauer S. Medication non adherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003 Jan;114(1):39-43
2. Eaden JA, Abrams KR, Mayberry JF. The risk of colorectal cancer in ulcerative colitis: a meta-analysis. Gut. 2001 Apr;48(4):526-35.
3. Ekbom A et al. The New England Journal of Medicine 1990, Nov 1,323 (18), 1228-33
4. Eaden J, Abrams K, Ekbom A, Jackson E, Mayberry J.  Colorectal cancer prevention in ulcerative colitis: a case-control study. Aliment Pharmacol Ther. 2000 Feb;14(2):145-53.
5. Munkholm P et al. Aliment Pharmacol Ther 2003; 18 (Suppl. 2): 1-5.


For more information, please contact:
Sharmi Albrechtsen
Ferring International Center
Telephone: + 45 28 78 72 09
Email: sharmi.albrechtsen@ferring.com 

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