Salix says Osmoprep effective colonoscopy aid

By Elaine Rigoli

Tampa, Fla., May 23 - Salix Pharmaceuticals, Ltd. said the results of two company-sponsored trials of Osmoprep showed efficacy for colonoscopy preparation.

The first study, Osmoprep versus Visicol: Irrigation Requirements During Colonoscopy, was a multicenter, investigator-blinded study of 704 patients that compared the irrigation requirements during colonoscopy for two different sodium phosphate tablet bowel cleansing agents.

Patients were randomized to receive either 40 tablets of Osmoprep, 32 tablets of Osmoprep or 40 tablets of Visicol. Patients took 20 tablets the evening prior, and the remainder the next morning three to five hours before colonoscopy.

Overall colon cleansing was evaluated in terms of colonic content and need for suctioning, according to a news release.

Colon cleansing was comparable between the three groups with greater than or equal to 95% having Excellent/Good scores. Significantly fewer patients receiving 40 (21%) and 32 tablets (25%) of Osmoprep required irrigation during colonoscopy compared with patients receiving Visicol (44%), the release said.

The second study, Osmoprep versus Visicol: Comparison of Overall and Ascending Colon Cleansing Rate, 262 patients received 40 Osmoprep tablets, 269 received 32 Osmoprep tablets and 264 received 40 Visicol tablets.

Overall colon cleansing (OCC) and ascending colon cleansing (ACC) were assessed based upon colonic contents. The percentage of OCC responders reported was 97% for Osmoprep 40 tablet patients, 96% for Osmoprep 32 tablet patients and 94% Visicol 40 tablet patients.

The percentage of ACC responders was significantly higher for Osmoprep compared to Visicol, with 96% of Osmoprep 40 tablet and 94% of Osmoprep 32 tablet patients responding compared with 88% Visicol 40 tablet patients, the release said.

Salix Pharmaceuticals, based in Raleigh, N.C., develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.

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