Treatment of ulcerative colitis active: demonstrated similar referral results between the standard dose of mesalazine (Pentasa ®) 2 g twice a day and the 4 g dose once a day.

According to a study presented in the United European Gastroenterology Week (UEGW), held in Stockholm

– it is estimated that some 70,000 people in Spain and 900,000 in Europe suffering from colitis ulcerative.

-diarrhea, abdominal pain and weight loss, with significant deterioration in the quality of life of the patient, as well as emotional distress and social isolation, these are some of the symptoms.

-patients fail often standard treatment, two daily doses of 2 g, with the risk of significant increase in symptoms, so a single daily dose can positively affect compliance.

Madrid, October 2011.- The results of a new estudio1 tabled yesterday in the United European Gastroenterology Week (UEGW), held in Stockholm show that a single daily dose of 4 g mesalazine (extended release granular ® Pentasa) is not less than the standard dose of 2 g administered twice per day, in the induction of remission in patients with active Ulcerative colitis.

The objective of the study was to show non-inferiority of a daily dose of mesalazine (extended release granular ® Pentasa) compared to the standard dosage – two times a day – for the remission of active Ulcerative colitis. Patients with active Ulcerative colitis mild to moderate were randomized to receive 4 g mesalazine once a day or 2 g mesalazine twice a day. During 4 weeks all received also rectal suspension mesalazine (1 g / day). Main criterion of assessment: clinical and endoscopic remission at week 8 (UC-DAI ≤ 1 score). Secondary evaluation criteria: clinical remission in weeks 4, 8, 12 (frequency of normal bowel movements, without blood in stool, not disease activity active according to comprehensive assessment of the health care provider), healing of the mucosa in week 8 (UC-DAI of the endoscopic appearance of the mucosa ≤ 1 score). The primary objective was reached. The study showed similar clinical and endoscopic remission rates for 4 g dose once a day and 2 g 2 times a day (52.1% and 41.8% respectively, p = 0,1402). Secondary objectives, the rates of clinical remission at weeks 4, 8 and 12 were similar between the dose of 4 g once a day and 2 g twice a day being 39.8% vs 27.6 &Amp; (p = 0.07 >), 45.1% vs 40.8% (p = 0.53), 92.4 per cent vs. 79.4% (p = 0.13); healing of the mucosa to 8 week by scoring UC-DAI < 1: 87.5 per cent versus 71.1 per cent (p = 0, 007).

Ulcerative colitis is a type of disease inflammatory bowel (IBD), which causes inflammation and ulcers throughout the interior of the colon. This swelling can interfere with the normal functioning of the colon, affecting the quality of life of patients, often causing cramps, swelling, diarrhea, bleeding, fatigue or weight loss. It is estimated that some 70,000 people in Spain and 900,000 in Europe suffer from ulcerative colitis.

The mesalazine is the usual treatment of ulcerative colitis mild to moderate. Patients with active Ulcerative colitis often receive multiple daily doses. However, the lack of adherence to treatment, significantly increases the risk of recurrence and persistence of the symptoms.

Know a long time that a single daily dose is effective to maintain remission in patients suffering from ulcerative colitis, mild to moderate. “This new study suggests that the benefits of the Administration once a day can also be extended to patients with active Ulcerative colitis,” said Dr. Bernard Flourie, Hospital de Lyon Sud, France.

About Pentasa ® (mesalazine)

Pentasa ® belongs to a class of anti-inflammatory drugs called aminosalicilatos, used to treat and control the symptoms of ulcerative colitis (CU).

Inflammatory bowel disease (IBD)

By inflammatory bowel disease (IBD) we understand a number of chronic diseases of the digestive system, including ulcerative colitis and Crohn’s disease. It is characterized by intermittent outbreaks with debilitating symptoms such as diarrhea, abdominal pain and weight loss, which can lead to a significant worsening of the quality of life of the patient, causing emotional distress and social isolation. In addition, patients may also experience a series of serious complications in their disease that may require treatment of by life and often surgery.

EC and UC are chronic diseases, and although the symptoms may disappear with treatment, tend to recur over time. Thus, patients at risk of future outbreaks unless they continue treatment to maintain remission.

During the acute phase stronger treatments may be prescribed to control inflammation, despite its potential harmful effects, looking for the improvement of the patient. The side effects of treatment of maintenance are considerably lower. Since it is very likely that patients must undergo treatment for life, they must be effective and safe. Mesalazine complies with these requirements, in addition to being comfortable Administration to the patient.

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