Fospropofol disodium for sedation

Drugs of Today

Volumn 45, Issue 8, 2009, Pages 567-576

  Campion, Megan E ^a   Gan, Tong J ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FENTANYL; FOSPROPOFOL; LUSEDRA; MIDAZOLAM; PROPOFOL; UNCLASSIFIED DRUG; HYPNOTIC SEDATIVE AGENT; PRODRUG;

AMNESIA; ANALGESIA; APNEA; BOLUS INJECTION; BRADYCARDIA; BURNING SENSATION; CLINICAL TRIAL; CONTINUOUS INFUSION; DOSE RESPONSE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE TITRATION; DRUG ELIMINATION; DRUG EXCRETION; DRUG FATALITY; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; HEART ARRHYTHMIA; HUMAN; HYPERKALEMIA; HYPOTENSION; HYPOXEMIA; INJECTION PAIN; KIDNEY FAILURE; LIVER DYSFUNCTION; MAXIMUM PLASMA CONCENTRATION; METABOLIC ACIDOSIS; MYOCLONUS; PARESTHESIA; PATIENT SATISFACTION; PROPOFOL INFUSION SYNDROME; PRURITUS; REVIEW; RHABDOMYOLYSIS; SEDATION; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; UNITED STATES; ANALOGS AND DERIVATIVES; CONSCIOUS SEDATION; PROCEDURES;

CONSCIOUS SEDATION; HUMANS; HYPNOTICS AND SEDATIVES; PRODRUGS; PROPOFOL;

EID: 76249118469     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2009.45.8.1396674     Document Type: Review

References (37)

1. Rex, D.K. Moderate sedation for endoscopy: Sedation regimens for non-anaesthesiologists. Aliment Pharmacol Ther 2006, 24(2): 163-71.
2. Rex, D.K. The science and politics of propofol. Am J Gastroenterol 2004, 99(11): 2080-3.
3. Gross J.B., Bailey P.L., Connis R.T. et al. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002, 96(4): 1004-17.
4. Waring, J.P., Baron, T.H., Hirota, W.K. et al. Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy. Gastrointest Endosc 2003, 58(3): 317-22.
5. Gan, T.J. Pharmacokinetic and pharmacodynamic characteristics of medications used for moderate sedation. Clin Pharmacokinet 2006, 45(9): 855-69.
6. Aisenberg, J., Brill, J.V., Ladabaum, U., et al. Sedation for gastrointestinal endoscopy: New practices, new economics. Am J Gastroenterol 2005, 100(5): 996-1000.
7. Skues, M.A., Prys-Roberts, C. The pharmacology of propofol. J Clin Anesth 1989, 1(5): 387-400.
8. Silvestri, G.A., Vincent, B.D., Wahidi, M.M. et al. A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy. Chest 2009, 135(1): 41-7.
9. Vargo, J.J., Bramley, T., Meyer, K., et al. Practice efficiency and economics: The case for rapid recovery sedation agents for colonoscopy in a screening population. J Clin Gastroenterol 2007, 41(6): 591-8.
10. Lubarsky, D.A., Candiotti, K., Harris, E. Understanding modes of moderate sedation during gastrointestinal procedures: A current review of the literature. J Clin Anesth 2007, 19(5): 397-404.
11. Cohen, L.B. Clinical trial: A dose-response study of fospropofol disodium for moderate sedation during colonoscopy. Aliment Pharmacol Ther 2008, 27(7): 597-608.
12. Heuss, L.T., Schnieper, P., Drewe, J. et al. Safety of propofol for conscious sedation during endoscopic procedures in high-risk patients-a prospective, controlled study. Am J Gastroenterol 2003, 98(8): 1751-7.
13. Rex, D.K., Cohen, L.B., Kline, J. et al. Fospropofol disodium for sedation during colonoscopy produces clear-headed recovery: Results of a phase 3, randomized, double-blind trial. Gastrointest Endosc 2007, 65(5, Suppl. S): AB367.
14. Cohen, L.B., Rex, D.K., Kline, J. et al. Patient and physician satisfaction with fospropofol disodium: Results of a phase 3, randomized, double-blind trial evaluating fospropofol disodium for sedation in patients undergoing colonoscopy. Gastrointest Endosc 2007, 65(5, Suppl. S): AB367.
15. Cohen, L.B., Wecsler, J.S., Gaetano, J.N. et al. Endoscopic sedation in the United States: Results from a nationwide survey. Am J Gastroenterol 2006, 101(5): 967-74.
16. Shah, A., Fechner, J., Struys, M. et al. Differential PK/PD of propofol after intravenous fospropofol and Diprivan in healthy subjects. American Society of Anesthesiologists Annual Meeting (13 Oct, San Francisco) 2007, Abst 46.
17. Jansson, J.R., Fukada, T., Ozaki, M. et al. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care 2006, 34(3): 362-8.
18. Fechner, J., Ihmsen, H., Hatterscheid, D. et al. Pharmacokinetics and clinical pharmacodynamics of the new propofol prodrug GPI 15715 in volunteers. Anesthesiology 2003, 99(2): 303-13.
19. Trapani, G., Altomare, C., Liso, G. et al. Propofol in anesthesia. Mechanism of action, structure-activity relationships, and drug delivery. Curr Med Chem 2000, 7(2): 249-71.
20. Fechner, J., Ihmsen, H., Hatterscheid, D. et al. Comparative pharmacokinetics and pharmacodynamics of the new propofol prodrug GPI 15715 and propofol emulsion. Anesthesiology 2004, 101(3): 626-39.
21. Cohen, L.B., Hightower, C.D., Wood, D.A. et al. Moderate level sedation during endoscopy: A prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc 2004, 59(7): 795-803.
22. Fechner, J., Schwilden, H., Schuttler, J. Pharmacokinetics and pharmacodynamics of GPI 15715 or fospropofol (Aquavan injection) - a water-soluble propofol prodrug. Handb Exp Pharmacol 2008, 182: 253-66.
23. Fechner, J., Ihmsen, H., Schiessl, C. et al. Sedation with GPI 15715, a water-soluble prodrug of propofol, using target-controlled infusion in volunteers. Anesth Analg 2005, 100(3): 701-6.
24. Shafer, S.L. Advances in propofol pharmacokinetics and pharmacodynamics. J Clin Anesth 1993, 5(6 Suppl. 1): 14S-21S.
25. Comments of the American Society of Anesthesiologists. American Society of Anesthesiologists letter to the FDA Re: Comments to the Anesthetic and Life Support Drugs Advisory Committee for the May 7, 2008 meeting to discuss the new drug application (NDA) 22-244, fospropofol disodium injection (35 mg/mL) (proposed tradename Aquavan), MGI Pharma, Inc., for the proposed indication of sedation in adult patients undergoing diagnostic or therapeutic procedures. 2008.
26. Struys, M.M., Vanluchene, A.L., Gibiansky, E. et al. AQUAVAN Injection, a water-soluble prodrug of propofol, as a bolus injection: a phase I dose-escalation comparison with DIPRIVAN (part 2): pharmacodynamics and safety. Anesthesiology 2005, 103(4): 730-43.
27. Shinozaki, M., Usui, Y., Yamaguchi, S. et al. Recovery of psychomotor function after propofol sedation is prolonged in the elderly. Can J Anaesth 2002, 49(9): 927-31.
28. Clarke, J.P. Sedation for endoscopy: The safe use of propofol by general practitioners. Med J Aust 2002, 177(3): 163-4; author reply 165.
29. Cohen, L.B. Endoscopic sedation in the United States in 2004: Results from a postal survey of 5000 gastroenterologists. Gastrointest Endosc 2005, 61(5): AB111.
30. Riker, R.R. and Fraser, G.L. Altering intensive care sedation paradigms to improve patient outcomes. Crit Care Clin 2009, 25(3): 527-38, viii-ix.
31. Gibiansky, E., Struys, M.M., Gibiansky, L. et al. AQUAVAN injection, a water-soluble prodrug of propofol, as a bolus injection: A phase I dose-escalation comparison with DIPRIVAN (part 1): pharmacokinetics. Anesthesiology 2005, 103(4): 718-29.
32. Pruitt, R.E. A randomized, open-label, multicenter, dose-ranging study of sedation with Aquavan injection (GPI 15715) during colonoscopy. Gastrointest Endosc 2005, 61(5): AB111.
33. ClinicalTrials.gov. Clinical trials of fospropofol. 2009 [cited 5 January 2009]; Available from http://clinicaltrials.gov/ct2/results?term= fospropofol.
34. Gan, T.J., Hardi, R., Ekman, E. et al. Safety of fospropofol for sedation during minor surgical procedures. J Clin Anesth 2009, in press.
35. Yavas, S., Lizdas, D., Gravenstein, N. et al. Interactive web simulation for propofol and fospropofol, a new propofol prodrug. Anesth Analg 2008, 106(3): 880-3.
36. Rex, D.K., Cohen, L.B., Kline, J. et al. Fospropofol disodium is effective and safe for sedation in patients undergoing colonoscopy: Results of a phase 3, randomized, double-blind trial. Gastrointest Endosc 2007, 65(5, Suppl. S): AB369.
37. Shah, A., Mistry, B., Gibiansky, E. et al. Fospropofol assay issues and impact on pharmacokinetic and pharmacodynamic evaluation. Anesthesiology 2008, 109(5): 937.