title: Fospropofol.
abstract: Fospropofol (fospropofol disodium), a sedative/hypnotic agent, is a water-soluble prodrug of propofol, metabolized in vivo to produce liberated propofol (producing the sedative effect), phosphate and formaldehyde. Intravenous fospropofol 6.5 mg/kg was significantly more effective than fospropofol 2.0 mg/kg (a placebo surrogate) as sedation in patients undergoing colonoscopy or flexible bronchoscopy, with regard to the primary endpoint of sedation success rate in randomized, double-blind, phase III trials. In patients undergoing colonoscopy, the sedation success rate was >3-fold higher among fospropofol 6.5 mg/kg (n = 158) than fospropofol 2.0 mg/kg recipients (n = 102). Similar results were observed in patients undergoing flexible bronchoscopy; the sedation success rate was >3-fold greater among fospropofol 6.5 mg/kg (n = 150) than among fospropofol 2.0 mg/kg recipients (n = 102). Fospropofol was generally well tolerated in clinical trials. Adverse events were mostly of mild to moderate severity, and were transient and self-limiting. Patients undergoing flexible bronchoscopy appeared to have a higher rate of sedation-related adverse events requiring airway assistance than did those undergoing colonoscopy or minor procedures.
authors.affiliation: Adis, Auckland, New Zealand. demail@adis.co.nz
authors.forename: Karly P
authors.initials: KP
authors.lastname: Garnock-Jones
authors.forename: Lesley J
authors.initials: LJ
authors.lastname: Scott
mesh_terms: D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D001999:Bronchoscopy; D003113:Colonoscopy; D006801:Humans; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D018686:Anesthetics, Intravenous; C472965:fospropofol; D015742:Propofol