LONDON, May 5, 2014 /PRNewswire/ --
- Treatment with MOVIPREP® (2L polyethylene glycol + ascorbate) was significantly more effective than either Fleet Phospho-Soda® (sodium phosphate)or sodium picosulphate plus magnesium citrate in achieving an acceptable colon cleansing result: OR 0.25 (95%CI 0.18-0.34, p<0.0001) and 0.43 (95%CI 0.19-0.95, p<0.05) respectively.[i]
Norgine B.V. 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.[i] 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 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.
Full press release on http://www.norgine.com
i. 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.
Rachelle Michaels: +44(0)7714-061485
Isabelle Jouin: +44(0)7714-061327
SOURCE Norgine B.V.