Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients

Anesthesiology

Volumn 113, Issue 1, 2010, Pages 74-82

  Singla, Neil K ^a   Singla, Sonia K ^a   Chung, Frances ^b   Kutsogiannis, Demetrios J ^c   Blackburn, Linda ^d   Lane, Stephen R ^d   Levin, Jeremey ^d   Johnson, Brendan ^d   Pergolizzi, Joseph V ^e,f  

^a HUNTINGTON MEMORIAL HOSPITAL   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF ALBERTA   (Canada)

^d GLAXOSMITHKLINE   (United States)

^e JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CASOPITANT; NEUROKININ 1 RECEPTOR; ONDANSETRON; PLACEBO; ANTIEMETIC AGENT; PIPERAZINE DERIVATIVE; PIPERIDINE DERIVATIVE;

ADULT; ARTICLE; CHOLECYSTECTOMY; CLIMACTERIUM; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GENERAL ANESTHESIA; HEADACHE; HIGH RISK PATIENT; HOSPITAL DISCHARGE; HUMAN; LAPAROSCOPY; LAPAROTOMY; MAJOR CLINICAL STUDY; MONOTHERAPY; MOTION SICKNESS; MULTICENTER STUDY; OPTIMAL DRUG DOSE; PHASE 1 CLINICAL TRIAL; POSTOPERATIVE NAUSEA AND VOMITING; POSTOPERATIVE PERIOD; PREMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETCHING; TREATMENT RESPONSE; ADOLESCENT; CHEMICALLY INDUCED DISORDER; DRUG ANTAGONISM; DRUG COMBINATION; GYNECOLOGIC SURGERY; METHODOLOGY; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; RISK FACTOR; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANESTHESIA, GENERAL; ANTIEMETICS; CHOLECYSTECTOMY, LAPAROSCOPIC; CONSTIPATION; DIZZINESS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GYNECOLOGIC SURGICAL PROCEDURES; HEADACHE; HUMANS; MIDDLE AGED; ONDANSETRON; PIPERAZINES; PIPERIDINES; POSTOPERATIVE NAUSEA AND VOMITING; RECEPTORS, NEUROKININ-1; RISK FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77954177812     PISSN: 00033022     EISSN: 15281175     Source Type: Journal    
DOI: 10.1097/ALN.0b013e3181d7b13a     Document Type: Article

References (25)

1. Gupta A, Wu CL, Elkassabany N, Krug CE, Parker SD, Fleisher LA: Does the routine prophylactic use of antiemetics affect the incidence of postdischarge nausea and vomiting following ambulatory surgery? ANESTHESIOLOGY 2003; 99:488-495
2. Habib AS, Gan TJ: Pharmacotherapy of post-operative nausea and vomiting. Expert Opin Pharmacother 2003; 4:457-473
3. Eberhart LHJ, Morin AM, Wulf H, Geldner G: Patient preferences for immediate post-operative recovery. Br J Anaesthesia 2002; 89:760-761
4. Watcha MF, White PF: Post-operative nausea and vomiting. Its etiology, treatment, and prevention. ANESTHESIOLOGY 1992; 77:162-184
5. Kovac AL: Prevention and treatment of post-operative nausea and vomiting. Drugs 2000; 59:213-243
6. Marcus JR, Tyrone JW, Few JW, Fine NA, Mustoe TA: Optimization of conscious sedation in plastic surgery. Plast Reconstr Surg 1999; 104:1338-1345
7. Bradshaw WA, Gregory BC, Finley C, Ross A, Wilds T, Still M, Smith CD: Frequency of post-operative nausea and vomiting in patients undergoing laparoscopic foregut surgery. Surg Endosc 2002; 16:777-780
8. Naguib M, el Bakry AK, Khoshim MH, Channa AB, el Gammal M, el Gammal K, Elhattab YS, Attia M, Jaroudi R, Saddique A: Prophylactic antiemetic therapy with ondan-setron, tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: A randomized, double-blind comparison with placebo. Can J Anaesth 1996; 43:226-231
9. Wang JJ, Ho ST, Uen YH, Lin MT, Chen KT, Huang JC, Tzeng JI: Small-dose dexamethasone reduces nausea and vomiting after laparoscopic cholecystectomy: A comparison of tropisetron with saline. Anesth Analg 2002; 95:229-232
10. Koivuranta M, L̈aär̈a E, Snare L, Alahuhta S: A survey of postoperative nausea and vomiting. Anaesthesia 1997; 52:443-449
11. Apfel CC, L̈aärä E, Koivuranta M, Koivuranta M, Greim CA, Roewer N: A simplified risk score for predicting post-operative nausea and vomiting. ANESTHESIOLOGY 1999; 91:693-700
12. Sinclair DR, Chung F, Mezei G: Can post-operative nausea and vomiting be predicted? ANESTHESIOLOGY 1999; 91:109-118
13. Gan TJ, Meyer T, Apfel CC, Chung F, Davis P, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr MR, Watcha M; Department of ANESTHESIOLOGY, Duke University Medical Center: Consensus guidelines for managing post-operative nausea and vomiting. Anesth Analg 2003; 97:62-71
14. Kranke P, Schuster F, Eberhart LH: Recent advances trends, and economic considerations in the risk assessment, prevention and treatment of postoperative nausea and vomiting. Exp Opin Pharmacother 2007; 8:3217-3235
15. Gesztesi Z, Scuderi PE, White PF, Wright W, Wender RH, D'Angelo R, Black LS, Dalby PL, MacLean D: Substance P (neurokinin-1) antagonist prevents post-operative vomiting after abdominal hysterectomy procedures. ANESTHESI-OLOGY 2000; 93:931-937
16. Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF: Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established post-operative nausea and vomiting after major gynaecological surgery. Br J Anaesthesia 1999; 82:274-276
17. Minthorn E, Mencken T, King AG, Shu A, Rominger D, Gontarek RR, Han C, Bambal R, Davis CB: Pharmacokinet-ics and brain penetration of casopitant, a potent and selective neurokinin-1 receptor antagonist, in the ferret. Drug Metab Dispos 2008; 36:1846-1852
18. Johnson BM, Hoke JF, Bandekar R, Blackburn LM, Levin J, Russo MW: Casopitant for the prevention of post-operative nausea and vomiting (PONV): Population pharmacokinet-ics and pharmacodynamics (PK/PD). Clin Pharm Ther 2007; 81(suppl 1):S94
19. Tukey JW, Ciminera JL, Heyse JF: Testing the statistical certainty of a response to increasing doses of a drug. Biometrics 1985; 41:295-301
20. Ahmed AB, Hobbs GJ, Curran JP: Randomized, placebo-controlled trial of combination antiemetic prophylaxis for day-case gynaecological laparoscopic surgery. Br J Anaesthesia 2000; 85:678-682
21. Habib AS, Gan TJ: Combination therapy for postoperative nausea and vomiting\a more effective prophylaxsis? Am-bul Surg 2001; 9:59-71
22. Gan TJ: Post-operative nausea and vomiting\can it be eliminated? JAMA 2002; 287:1233-1236
23. Bergström M, Hargreaves RJ, Burns HD, Goldberg MR, Sciberras D, Reines SA, Petty KJ, Ogren M, Antoni G, Långström B, Eskola O, Scheinin M, Solin O, Majumdar AK, Constanzer ML, Battisti WP, Bradstreet TE, Gargano C, Hietala J: Human positron emission tomography studies of brain neurokinin 1 receptor occupancy by aprepitant. Biol Psychiatry 2004; 55:1007-1012
24. de Wit R, Herrstedt J, Rapoport B, Carides AD, Carides G, Elmer M, Schmidt C, Evans JK, Horgan KJ: Addition of the oral NK1 antagonist aprepitant to standard antiemetics provides protection against nausea and vomiting during multiple cycles of cisplatin-based chemotherapy. J Clin Oncol 2003; 21:4105-4111
25. Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, Chawla SP, Carides AD, Ianus J, Elmer ME, Evans JK, Beck K, Reines S, Horgan KJ; Aprepitant Protocol 052 Study Group: The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: A multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin\the Aprepitant Protocol 052 Study Group. J Clin Oncol 2003; 21:4112-4119