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| |  Fospropofol Disodium Effective and Safe for Sedation During Colonoscopy: Presented at ACG By Danny Kucharsky PHILADELPHIA, PA -- October 23, 2007 -- Fospropofol disodium at a dose of 6.5 mg/kg is effective and can successfully be titrated to a targeted level of sedation in patients undergoing colonoscopy, according to a study presented here at the American College of Gastroenterology (ACG) Annual Scientific Meeting. Procedure-related discomfort and slow onset of action are common reasons for patient's dissatisfaction with conventional sedation during colonoscopy, said study presenter Lawrence Cohen, MD, Associate Clinical Professor of Medicine/ Gastroenterologist, Mount Sinai Hospital, New York, New York, United States. About three quarters of all endoscopies in the U.S. are being performed with a combination of midazolam and an opioid, usually fentanyl, Dr. Cohen said during his presentation on October 15. "The problem with those drugs is that they're being used for procedures that take anywhere from 10 minutes for an upper endoscopy to about 20 to 30 minutes for a colonoscopy, while the drugs themselves have a duration of effect anywhere from 30 to 120 minutes." Patients "may not be adequately sedated when you want them to be, but then they're over-sedated when you're finished and you want them up and around. We're looking for drugs that have durations of effect that more closely match the duration of the procedure," Sr. Cohen said. Propofol is "the model drug," he added, but is approved by the U.S. Food and Drug Administration only as an anaesthetic agent, which gastroenterologists are not qualified to use. Fospropofol disodium, the prodrug of propofol, is currently being evaluated for sedation in colonoscopy. In the randomised, double-blind, multicentre, phase 3 trial presented here, patients undergoing colonoscopy were randomly assigned to receive an initial dose of fospropofol disodium 2.0 mg/kg (n=102), fospropofol disodium 6.5 mg/kg (n=158) or midazolam 0.02 mg/kg (n=52). Sedation success, which included completion of the procedure without use of alternative sedative medication and without manual or mechanical ventilation, was significantly higher in the fospropofol disodium 6.5 mg/kg group compared with the fospropofol disodium 2.0 mg/kg group and midazolam 0.02 mg/kg group (87% vs 26% and 69% respectively, P <.001). Patients' rated their overall satisfaction and comfort with the procedure as mean scores of 9.4 and 9.1, respectively, in the fospropofol disodium 6.5 mg/kg group, compared with 9.1 and 8.7, respectively, in the fospropofol disodium 2.0 mg/kg group and 9.1 and 8.9, respectively, in the midazolam 0.02 mg/kg group. The most common adverse events in the fospropofol disodium groups were paresthaesias (68% vs 60%) and pruritus (16% vs 26%). Six patients experienced transient sedation-related adverse events. Dr. Cohen concluded that the fospropofol disodium 6.5 mg/kg dosing regimen was safe and well tolerated. Funding for this study was provided by MGI Pharma.
[Presentation title: Fospropofol Disodium Is Effective and Safe for Sedation During Colonoscopy. Abstract 453]
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