MediLexicon News - Asacol 800mg MR Tablets Dosed At 4.8g/Day Herald Fast Symptom Relief And Improved Quality Of Life For Moderately Active UC Patients

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Asacol 800mg MR Tablets Dosed At 4.8g/Day Herald Fast Symptom Relief And Improved Quality Of Life For Moderately Active UC Patients

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Crohn's
Article Date: 08 Feb 2008

Procter & Gamble Pharmaceuticals (NYSE: P&G) announced that Asacol(R) (mesalazine) 800mg Modified Release (MR) tablets are now available in the UK for the treatment of mild to moderate acute exacerbations of ulcerative colitis (UC), and the maintenance of remission in UC and Crohn's ileo-colitis patients.1 The ASCEND I and II clinical trials have shown that Asacol 800mg MR tablets at 4.8 g/day provide symptom relief* 10 days faster (median time) than a mesalazine 400mg at 2.4 g/day for moderate UC patients.2 The new dose also provides a significant improvement in quality of life at three weeks3 (as a mean change from baseline).

"It is difficult to underestimate the emotional distress and disruption caused by the symptoms of acute ulcerative colitis. To have an effective treatment that reduces the time to symptom relief with no significant increase in side effects compared to the current standard dose is a significant clinical advance", said Simon Travis, DPhil, FRCP, Consultant Physician and Gastroenterologist at the John Radcliffe Hospital in Oxford.

The ASCEND I and II clinical trials evaluated overall treatment success as the primary endpoint. In addition, pooled results from these trials demonstrated that for moderately active UC patients receiving Asacol 800mg MR tablets dosed at 4.8 g/day, median time to resolution of both rectal bleeding and stool frequency (symptom relief) was 10 days faster, 19 days compared to 29 days, than for those receiving a mesalazine 400mg at 2.4 g/day (p=0.02).2 Asacol 800mg MR tablets dosed at 4.8 g/day also provided significant improvement in quality of life at three weeks as indicated by the mean change from baseline in total quality of life (IBDQ**) scores at three and six weeks (34 vs. 45 respectively, p<0.0001).3 Furthermore, results from the pooled ASCEND I and II trials have found no significant differences in the overall adverse event profile of Asacol 800mg MR tablets at 4.8 g/day at six weeks compared to Asacol 400mg dosed at 2.4 g/day.5

The marketing authorisation for Asacol 800mg MR tablets was granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2007. They are indicated for the treatment of mild (2.4 g/day) and moderate (4.8 g/day) acute exacerbations of ulcerative colitis, to be administered in divided doses.1 Divided dosing offers the convenience of twice daily dosing which is associated with better patient compliance6 versus three times daily dosing.7 Asacol 800mg MR tablets, administered up to 2.4 g/day, are also indicated for the maintenance of remission of ulcerative colitis and Crohn's ileo-colitis.1

Interchangeability between Asacol 400mg MR tablets and the new Asacol 800mg MR tablets has not been established. Different mesalazines are not interchangeable and should be prescribed according to their mode and site of action with the brand name specified.8 It is also important to state the strength of mesalazine tablets in order to ensure the intended medicine is correctly dispensed.

*Symptom relief is defined as both absence of blood in the stool and normalization of stool frequency.
** The Inflammatory Bowel Disease Questionnaire (IBDQ) score is obtained from a 32 item questionnaire which ascertains a heath status measurement directly from IBD patients.4

Notes

About Asacol 800mg MR Tablets

Data analysis is from the combined results of two double-blind, randomised, multi-site, 6-week, controlled clinical trials designed to assess the safety and efficacy of 4.8 g/day modified-release mesalazine with a new 800mg tablet compared to 2.4 g/day modified-release mesalazine with a 400mg tablet for the treatment of moderately active ulcerative colitis (UC).

The two ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) studies demonstrated that for patients with moderately active UC, beginning treatment with twice the standard dose of mesalazine, 4.8 g/day with a new 800mg tablet rather than 2.4 g/day using a 400mg mesalazine tablet for six weeks, resulted in faster symptom relief for moderately active UC patients2 with no change in adverse event profile.5 Treatment success was defined as overall improvement from baseline at week six with either complete response (remission) or partial response (improvement) to treatment. 72% vs. 58% of moderate UC patients of the pooled moderate population experienced treatment success with 4.8 g/day (Asacol 800mg tablets) and a mesalazine at 2.4 g/day (400mg tablets), respectively; p=0.0034.9

There was no difference between adverse event profiles of Asacol 800mg MR tablets at 4.8 g/day compared to Asacol 400mg tablets dosed at 2.4 g/day.5 Reported adverse events were generally mild and transient, and seldom resulted in discontinuation of treatment. The most common adverse events were headache, abdominal pain and diarrhoea. Please refer to the Asacol 800mg MR tablet Summary of Product Characteristics for a complete list of adverse events.1

Asacol 800mg MR tablets are indicated for the treatment of mild acute exacerbations of UC, and for the treatment of moderate acute UC to be administered in divided doses up to 2.4 g/day and 4.8 g/day, respectively. Asacol 800mg MR tablets, administered at 2.4 g/day, are also indicated for the maintenance of remission of UC and Crohn's ileo-colitis in divided doses.1

Interchangeability between Asacol 800mg MR tablets and Asacol 400mg MR tablets has not been established.

About Ulcerative Colitis (UC)

UC is an inflammatory bowel disease (IBD) which causes inflammation and tiny ulcers to develop on the inside of the rectum and/or the colon.10 It is a debilitating condition requiring life long treatment.11 For the sufferer, active disease symptoms may include pain, urgent and bloody diarrhoea and continual tiredness.10 UC is characterised by episodes of remission (where patients experience few or no symptoms) and relapses - also known as 'flares', when symptoms become progressively worse.6 UC affects up to 120,000 people in the UK, which is about 1 in 500. Between 6,000 and 12,000 new cases are diagnosed each year.10

About Procter & Gamble Pharmaceuticals

Procter & Gamble has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late 1960s. Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel®, Asacol®, Crest®, Fibresure®, Intrinsa®, Metamucil®, Oral-B®, Pepto-bismol®, Thermacare®, Vicks®, Pampers®, Ariel®, Always®, Pantene®, Herbal Essences®, Mach3®, Fairy®, Ace®, Lenor®, M. Propre®, Tampax®, Tempo®, Dash®, Pringles®, Iams®, Eukanuba®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit http://www.pgpharma.com

References

1. Asacol 800mg tablets Summary of Product Characteristics

2. Marion JF et al. Gut April 2006; Suppl 2, Vol 55: Abstract 140

3. Data on file, Procter & Gamble Pharmaceuticals

4. Guyatt G, et al. Gastroenterology 1989; 96:804-810

5. Hanauer SB et al. Gut April 2006; Suppl 2, Vol 55: Abstract 308

6. Carter et al. Gut 2004; 53 (Suppl V): v1-v16

7. Greenberg RN. Clin Ther 1984; 6(5):590-599

8. MIMS - Monthly Index of Medical Specialities (MIMS) UK, January 2008; p203

9. Hanauer SB et al. Gut October 2005; Suppl 7, Vol 54: A56

10. National Association for Colitis and Crohn's (NACC) website information on Ulcerative Colitis, http://www.nacc.org.uk Accessed 4 January 2008

11. Kane S V et al. Ailment Pharmacol Ther 2006; 23:577-585

Procter & Gamble Pharmaceuticals

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Asacol 800mg MR Tablets Dosed At 4.8g/Day Herald Fast Symptom Relief And Improved Quality Of Life For Moderately Active UC Patients

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