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| |  Investigative Fospropofol Appears Safe, Effective, and Potentially Opioid-Sparing in Colonoscopy Sedation: Presented at DDW By Bruce Sylvester WASHINGTON, DC -- May 24, 2007 -- The investigative agent fospropofol (Aquavan®) is safe and effective for providing minimal to moderate sedation to patients undergoing colonoscopy, and it could become an alternative to current colonoscopy sedation that often relies on adjunctive use of opioid drugs, according to researchers who conducted a phase 3 clinical trial. The findings were presented here on May 23rd at Digestive Disease Week (DDW). "This study demonstrates that fospropofol is an effective method for sedating patients undergoing colonoscopy," said presenter and coinvestigator Lawrence Cohen, MD, associate clinical professor of medicine, Mount Sinai Hospital and School of Medicine, New York, New York. "We were able to achieve sedation success in 87% of patients," he added. "It compared favorably to the comparator drug midazolam. The safety profile is excellent. It appears that this is an effective, safe sedative for procedural sedation." The investigators randomised 312 adults scheduled for colonoscopies to a 2:3:1 allocation ratio to receive an initial dose of fospropofol 2.0 mg/kg, fospropofol 6.5 mg/kg, or midazolam 0.02 mg/kg after pretreatment with fentanyl citrate (50 mcg). The researchers allowed subjects to receive supplemental doses of sedative per protocol. The primary endpoint was sedation success, which was defined as 3 consecutive scores of 4 or less on the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) after administration of sedation, and completion of the procedure without use of an alternative sedative medication and without manual or mechanical ventilation. Additional endpoints included measures of clinical benefit, recovery, sedation adequacy, and safety. The investigators reported that 87% of patients who received an initial intravenous bolus of fospropofol 6.5 mg/kg achieved sedation success compared with 26% of patients in the fospropofol 2.0-mg/kg arm and 69% of the midazolam 0.02-mg/kg arm. However, the researchers noted, "The study was not powered to show differences between [fospropofol disodium] and [midazolam]." The most common adverse events were in the fospropofol groups and were mild, including burning sensation (22.3%), paresthesia (16.5%), anal discomfort (11.9%), and pruritis (11.9%). There were no drug-related serious adverse events or deaths during the study and no subjects required manual or mechanical ventilation. "This study also is a first step in allowing us to begin to compare fospropofol to regimens that we currently use for sedation in colonoscopy, so it is encouraging in that direction," said copresenter and investigator, Douglas Rex, MD, professor of medicine, Indiana University Medical Center, Indianapolis, Indiana, United States. "Now, in clinical practice, opioid drugs are widely used in combination with midazolam for sedation in this procedure. This could become an effective and opioid-sparing alternative," Dr. Rex said. The study was supported by MGI Pharma, Inc.
[Presentation title: Fospropofol Disodium Is Effective and Safe for Minimal to Moderate Sedation in Patients Undergoing Colonoscopy: Results of a Phase 3, Randomized, Double-Blind, Trial. Abstract W1451]
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