LONDON, Monday 5 May 2014, 2.00pm – Norgine announced today that new data presented at Digestive Diseases Week (DDW) 2014 in Chicago, US show that the choice of bowel preparation regimen is key in achieving successful colon cleansing prior to colonoscopy.1 Other factors shown to influence the outcome included the patient’s age, gender, body weight and prior use of laxatives.
The cleansing regimen used was the most powerful predictor of response. Regardless of correction for other differences, treatment with 2L polyethylene glycol + ascorbate was significantly more effective than either sodium phosphate or sodium picosulphate with magnesium citrate. Male patients showed a significantly lower odds of achieving a satisfactory cleansing score than females (OR=0.68; 95%CI=0.52-0.89; p<0.01). Age and prior laxative use were not individually statistically significant.
The meta regression analysis is based on individual patient data from five comparative clinical studies which compared the use of 2L PEG/Asc with 4L PEG, sodium phosphate (NaP) and sodium picosulphate/magnesium citrate (NaPic/Mg Cit). There was no significant difference between the bowel preparation success rates for 2L PEG/Asc versus 4L PEG. The trials were carried out in Germany, France and the UK and, of the 1,558 patients randomised, 1,511 received treatment and provided outcome data for the analysis.
The study used the bowel cleansing score, as assessed by the Harefield Cleansing Scale, as the main measurement of acceptable bowel cleansing. Variables with the potential to impact on that score were explored in a single combined data set.
“By demonstrating that selecting the optimum bowel preparation regimen contributes to a successful colonoscopy, patients are likely to benefit from better clinical diagnosis. These data highlight the value of Norgine’s medicines for those undergoing this intrusive procedure, and its long-standing expertise in gastroenterology,” commented Norgine’s Chief Development Officer, Donna McVey.
The study was sponsored by Norgine.
Ends
Notes to Editors
About the meta-analysis
Efficacy results for the five studies included in the analysis (per protocol analysis)1:
|
Study |
Investigator rating A*/B* |
Investigator rating A* |
Expert rating A*/B* |
|||
|
PEG/Asc |
Comparator |
PEG/Asc |
Comparator |
PEG/Asc |
Comparator |
|
|
Bitoun et al |
68.5% |
70.6% |
28.6% |
27.6% |
72.7% |
63.7% |
|
Ell et al |
88.7% |
90.3% |
56.5% |
52.6% |
88.1% |
93.8% |
|
Worthington et al |
90.6% |
72.7% |
50.0% |
15.2% |
90.0% |
72.7% |
|
Ponchon et al |
86.6% |
86.9% |
42.6% |
45.5% |
91.0% |
87.6% |
|
Unpublished study |
95.0% |
45.6% |
71.5% |
14.0% |
93.6% |
24.5% |
* Results of the Harefield Cleansing Scale were mapped to one of two categories: A= Excellent, B=Good
About MOVIPREP®
MOVIPREP® is a flavoured laxative which is indicated for bowel cleansing prior to any clinical procedures requiring a clean bowel, e.g. bowel endoscopy or radiology.[2] MOVIPREP® is a registered trademark of the Norgine group of companies.
About Norgine
Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s total revenue was €274 million and the company employs over 1,000 people.
Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.
For more information, please visit www.norgine.com
NORGINE and the sail logo are trademarks of the Norgine group of companies.
Media Contacts:
Rachelle Michaels: +44 (0)7714 061485
Isabelle Jouin: +44 (0)7714 061327
References
[1] Fishbach W et al ‘Factors determining efficacy in randomised controlled trials of bowel cleansing regimens prior to colonoscopy. A meta-regression analysis based on individual patient data from five clinical trials.’ Poster presentation on Monday 5th May 2014 at Digestive Diseases Week, Chicago, U.S.[2] MOVIPREP® Summary of Product Characteristics, June 2012, accessed online at http://www.medicines.org.uk/emc/medicine/19285/SPC/MOVIPREP%2c+powder+for+oral+solution/
Contact us
