Dolasetron. A review of its pharmacology and therapeutic potential in the management of nausea and vomiting induced by chemotherapy, radiotherapy or surgery

Drugs

Volumn 54, Issue 2, 1997, Pages 273-298

  Balfour, Julia A ^a   Goa, Karen L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIEMETIC AGENT; ANTINEOPLASTIC AGENT; CISPLATIN; DOLASETRON MESILATE; GRANISETRON; METOCLOPRAMIDE; ONDANSETRON;

CANCER CHEMOTHERAPY; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; ELECTROCARDIOGRAM; HEADACHE; HIGH RISK PATIENT; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; META ANALYSIS; NAUSEA; ORAL DRUG ADMINISTRATION; POSTOPERATIVE COMPLICATION; RADIOTHERAPY; REVIEW; VERTIGO; VOMITING;

EMESIS;

EID: 0030739796     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-199754020-00008     Document Type: Review

References (86)

1. Graves T. Emesis as a complication of cancer chemotherapy: pathophysiology, importance and treatment. Pharmacotherapy 1992; 12: 337-45
2. Veyrat-Follet C. Farinotti R, Palmer JL. Physiology of chemotherapy-induced emesis and antiemetic therapy. Predictive models for evaluation of new compounds. Drugs 1997; 53 (2): 206-34
3. Andrews PLR, Hawthorn J, Sanger GJ. The effect of abdominal visceral nerve lesions and a novel 5HT-M receptor antagonist on cylotoxic and radiation induced emesis in the ferret. J Physiol (Lond) 1986; 382: 47P
4. Watcha MF, White PF. Postoperative nausea and vomiting. Anesthesiology 1992; 77: 162-84
5. Rabey PG, Smith G. Anaesthetic factors contributing to postoperative nausea and vomiting. Br J Anaesth 1992; 69: 40S-5S
6. 3 receptors: focus on alcohols and anaesthetic agents. Trends in Pharmaceutical Science 1996; 17: 95-9
7. 3 receptors in human brain. J Neurol Sci 1996; 144: 119-27
8. 3 receptors. Drug Dev Res 1993 Jan; 28: 87-93
9. 3 receptor antagonist. Drug Dev Res 1995 Mar; 34: 289-96
10. Boeijinga PH, Galvan M, Baron BM, et al. Characterization of the novel 5-HT3 antagonists MDL 73147EF (dolasetron mesilate) and MDL 74156 in NG108-15 neuroblastoma x glioma cells. Eur J Pharmacol 1992 Aug 14; 219: 9-13
11. Choo YS, Galvan M, Dimmitt DC, et al. Potential contribution of dolasetron and its active metabolites to clinical antiemetic activity of dolasetron mesylate [abstract]. Pharm Res 1995 Sep; 12 Suppl.: 412
12. 3 receptors: pharmacologic and therapeutic aspects. J Clin Pharmacol 1995 Sep; 35: 845-55
13. 3 receptor ligands. Neurosci Biobehav Rev 1992; 16 (1): 107-13
14. 3 receptor in mammalian brain: a new target for the development of psychotropic drugs? Neuropsychophurmacology 1993; 8 (2): 117-30
15. 3 mediated control of dopaminergic function. Psychopharmacology 1993; 112 Suppl.: S60-7
16. 3 antagonists in neuropsychiatric disorders. CNS Drugs 1995; 3 (5): 363-92
17. Wilde MI, Markham A. Ondansetron: a review of its pharmacology and preliminary clinical findings in novel applications. Drugs 1996; 52 (5): 773-94
18. Moran PM, Moser PC. MDL-73,147EF, a 5-HT3 antagonist, facilitates latent inhibition in the rat. Pharmacol Biochem Behav 1992 Jul; 42: 519-22
19. 3 receptor antagonist, on A9 and A10 dopamine neurons. Eur J Pharmacol 1989 Apr 12; 163: 115-8
20. Dumaine R, Hartmann HA, Leishman DJ, et al. Actions of dolasetron and its major metabolite on guinea-pig papillary muscle fibres and the α-subunit of human heart sodium channels expressed in Xenopus oocytes, Drug Dev Res 1996 Apr; 37: 223-30
21. Gillespie TA, Eckstein JA, Nardella P, et al. Determination of dolasetron and its reduced metabolite in human plasma by GC-MS and LC. J Pharm Biomed Anal 1993 Oct; 11: 955-62
22. McElvain JS, Vandiver VJ, Eichmeier LS. Validation of a reversed-phase HPLC method for directly quantifying the enantiomers of MDL 74 156, the primary metabolite of dolasetron mesylate, in human plasma. J Pharm Biomed Anal 1997; 15: 513-21
23. Huebert ND, Schwartz J-J. Zeidler L, et al. Simultaneous measurement of dolasetron and its major metabolite, MDL 74,156. in human plasma and urine. J Chromatogr B Biomed Appl 1996 (685): 291-7
24. Sanwald P, Huebert ND, Haegele KD. Simultaneous measurement of the major metabolites of dolasetron mesilate in human urine using solid-phase extraction and high-performance liquid Chromatography. J Chromatogr B Biomed Appl 1994 Nov 4; 661: 101-7
25. Boxenhaum H, Gillespie T, Heck K, et al. Human dolasetron pharmacokinetics; I. Disposition following single-dose intravenous administration to normal male subjects. Biopharm Drug Dispos 1992 Dec; 13: 693-701
26. Shah A, Lanman R, Bhargava V, et al. Pharmacokinetics of dolasetron following single- and multiple-dose intravenous administration to normal male subjects. Biopharm Drug Dispos 1995 Apr; 16: 177-89
27. Choo YS, Dimmitt DC, McElvain JS, et al. Pharmacokinetics and dose-proportionality of dolasetron mesylate following intravenous administration to healthy volunteers [abstract]. Pharm Res 1995 Sep; 12 Suppl.: S388
28. Boxenbaum H, Gillespie T, Heck K, et al. Human dolasetron pharmacokinetics: II. Absorption and disposition following single-dose oral administration to normal male subjects. Biopharm Drug Dispos 1993 Mar; 14: 131-41
29. Hunt TL, Cramer M, Christy-Bittel J, et al. Multiple-dose, placebo-controlled, phase I study of oral dolasetron. Pharmacotherapy 1996 Mar-Apr; 16: 253-60
30. Keung AC-F, Gossard D, Spenard J, et al. Pharmacokinetics (PK) of single IV and oral doses of dolasetron mesylate in women [abstract]. Pharm Res 1995 Sep; 12 Suppl.: S387
31. Lerman J, Sims C, Sikich N, et al. Pharmacokinetics of the active metabolite (MDL 74,156) of dolasetron mesylale after oral or intravenous administration to anaesthetized children. Clin Pharmacol Ther 1996; 60 (5): 485-92
32. Dempsey E, Bourque S, Spénard J, et al. Pharmacokinetics of single intravenous and oral doses of dolasetron mesylate in healthy elderly volunteers. J Clin Pharmacol 1996; 36: 903-10
33. Landriault H, Spenard J, Dempsey E, et al. Pharmacokinetics of dolasetron mesylate in elderly volunteers [abstract]. J Clin Pharmacol 1994 Oct; 34: 1018
34. Huebert ND, Schwartz J-J, Hinze C, et al. Bioavailabilty and the effect of food on the pharmacokinetics of dolasetron mesylate and its active metabolite, MDL 74156, in man [abstract], Br J Clin Pharmacol 1994 Jan; 37: 120P-1P
35. Reith MK, Sproles GD, Cheng LK. Human metabolism of dolasetron mesylate, a 5-HT3 receptor antagonist. Drug Metab Dispos 1995 Aug; 23: 806-12
36. Sanwald P, David M, Dow J. Characterization of the cytochrome P450 enzymes involved in the in vitro metabolism of dolasetron. Drug Metab Dispos 1996 May; 24: 602-9
37. Shah A, Arumugham T, Halstenson C, et al. Pharmacokinetics of dolasetron and metabolites in subjects with renal impairment [abstract]. Pharm Res 1995 Sep; 12 Suppl.: S395
38. Shah AK, Bhargava VO, Hahne WF, et al. Population pharmacokinetics and pharmacodynamics of metabolite after intravenous administration of dolasetron mesylate in patients receiving cisplatin chemotherapy [abstract]. Pharm Res 1995 Sep; 12 Suppl.: S360
39. Lofters WS, Zee B. Dolasetron (DOL) versus ondansetron (OND) with and without dexamethasone (DEX) in the prevention of nausea (N) and vomiting (V) in patients receiving moderately emetogenic chemotherapy (MEC). Eur J Cancer 1995; 31A Suppl. 5: S252
40. Chevallier B, Cappelaere P, Splinter T, et al. A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy. Support Care Cancer 1997; 5: 22-30
41. Fauser AA, Bleiberg H, Chevallier B. et al. A double-blind, randomized, parallel study of IV dolasetron mesilate versus IV metoclopramide in patients receiving moderately emetogenic chemotherapy. Cancer J 1996; 9: 196-202
42. Fauser AA, Duclos B, Chemaissani A, et al. Therapeutic equivalence of single oral doses of dolasetron mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy. Eur J Cancer 1996; 32A: 1523-9
43. 3 antagonists ondansetron and dolasetron in the control of delayed onset nausea and vomiting in patients receiving moderately emetogenic chemotherapy. Ann Oncol 1997; 8: 181-5
44. 3 antagonist, in cancer patients treated with cisplatin. Am J Clin Oncol Cancer Clin Trials 1994 Apr; 17: 97-102
45. Kris MG, Grunberg SM, Gralla RJ, et al. Dose-ranging evaluation of the serotonin antagonist dolasetron mesylate in patients receiving high-dose cisplatin. J Clin Oncol 1994 May; 12: 1045-9
46. Thant M, Pendergrass K, Harman G, et al. Double-blind, randomized study of the dose-response relationship across five single doses of IV dolasetron mesylate (DM) for prevention of acute nausea and vomiting (ANC) after cisplatin chemotherapy (CCT) [abstract no. 1727]. Proc Am Soc Clin Oncol 1996; 15: 533
47. Yeilding A, Bertoli L, Eisenberg P, et al. Antiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy. Am J Clin Oncol 1996; 19 (6): 619-23
48. Hesketh PJ, Gandara DR, Hesketh AM, et al. Dose-ranging evaluation of the antiemetic efficacy of intravenous dolasetron in patients receiving chemotherapy with doxorubicin or cyclophosphamide. Support Care Cancer 1996 Mar; 4: 141-6
49. Grote T, Pineda L, Figlin RA, et al. Oral dolasetron mesylate in patients receiving moderately emetogenic platinum-containing chemotherapy. Cancer J Sci Am 1997; 3: 45-51
50. Rubenstein EB, Gralla RJ, Hainsworth JD, et al. Randomized, double blind, dose-response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy. Cancer 1997; 79 (6): 1216-24
51. Pendergrass K, Audhuy B, Hesketh P, et al. Analysis of optimal dose from eight pooled clinical trials assessing the acute antiemetic efficacy of IV dolasetron mesylate (DM) after emetogenic chemotherapy (ECT) [abstract no. 1782]. Proc Am Soc Clin Oncol 1996; 15: 547
52. Audhuy B, Whitmore J, Cramer M, et al. Optimal IV dolasetron dose for prevention of nausea and vomiting (NV) after cisplatin (CDDP) chemotherapy: analysis of mg doses from 14 pooled trials [abstract no. 102]. Support Care Cancer 1996; 4 (3): 249
53. Harman GS, Omura GA, Ryan K, et al. A randomized, double-blind comparison of single-dose and divided multiple-dose dolasetron for cisplutin-induced emesis. Cancer Chemother Pharmacol 1996 Aug; 38: 323-8
54. Harman G, Plezia P, Whitmore J, et al. Efficacy of IV dolasetron (D) for prevention of nausea & vomiting (N/V) during retreatment (RTX) chemotherapy (CT) [abstract no. 103]. Support Care Cancer 1996; 4 (3): 250
55. Rubenstein E, Hesketh P, Whitmore J, et al. Pooled dose response analysis across three trials studying oral doses of dolasetron (D) for prevention of acute nausea/vomiting (ANV) after moderately emetogenic chemotherapy (MEC) [abstract no. 101]. Support Care Cancer 1996; 4 (3): 249
56. Audhuy B, Cappelaere P, Martin M, et al. A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of dolasetron mesilate and granisetron in patients receiving high dose cisplatin chemotherapy. Eur J Cancer A 1996 May; 32A: 807-13
57. Hesketh P, Navari R, Grote T, et al. Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. J Clin Oncol 1996 Aug; 14: 2242-9
58. Kris MG, Pendergrass KB, Navari RM, et al. Prevention of acute emesis in cancer patients following high-dose cisplatin with the combination of oral dolasetron and dexamethasone. J Clin Oncol 1996; 15 (5): 2135-8
59. Aapro M, Whitmore J, Cramer M, et al. Effect of previous chemotherapy (CT) with and without emesis on antiemetic response in dolasetron mesylate (DM) clinical trials [abstract no. 104]. Support Care Cancer 1996; 4: 250
60. Leclerc JM, Greenberg M, Lau R, et al. Open label iv dolasetron mesylate in pediatric patients receiving moderately to highly emetogenic chemotherapy: pharmacokinetics, efficacy and safety [abstract no. 37]. Support Care Cancer 1995; 5 (3): 343
61. Young RW. Mechanisms and treatment of radiation-induced nausea and vomiting. Colloque Inserm 1992; 223: 157-65
62. Danjoux CE, Rider WD, Fitzpatrick PJ. The acute radiation syndrome: a memorial to William Michael Court-Brown. Clin Radiol 1979; 30: 581-4
63. Wilkinson PM, Bey P, Bosset JF, et al. Antiemetic efficacy and safety of IV dolasetron in cancer patients after high-dose radiotherapy [abstract no. 41]- Support Care Cancer 1995; 3 (5): 344
64. Bey P, Wilkinson PM, Resbeut M, et al. A double-blind, placebo-controlled trial of i.v. dolasetron mesilate in the prevention of radiotherapy-induced nauseu and vomiting in cancer patients. Support Care Cancer 1996; 4: 378-83
65. Fauser AA. Pilot study of the antiemetic efficacy of dolasetron in leukaemia patients receiving total body irradiation (TBI) and chemotherapy before bone-marrow transplantation [abstract no. 51]. Support Care Cancer 1995; 3 (5): 347
66. Diemunsch P, Leeser J, Feiss P, et al. Intravenous dolasetron mesilate ameliorates postoperative nausea and vomiting. Can J Anaesthesiol 1997; 44 (2): 173-81
67. Warriner B, Knox D, Belo S, et al. Prophylactic oral dolusetron mesylate reduces postoperative nausea and vomiting following abdominal hysterectomy [abstract]. Anesthesiology 1995; 83 (3A): A312
68. Graczyk SG, McKenzie R, Kallar S, et al. Intravenous dolasetron for the prevention of postoperative nausea and vomiting after outpatient laparoscopic gynecologic surgery. Anesth Analg 1997; 84: 325-30
69. Diemunsch P, Navé S, Meyerson LJ. Evaluation of the antiemetic properties of dolasetron mesilate in gynecological surgery [abstract no. A.159], Br J Anaesth 1994 Feb; 72 Suppl. 1: 82
70. Diemunsch P, Leeser J, Helmers JH, et al. Oral dolasetron mesylate for prevention of postoperative nausea and vomiting (PONV) [abstract A3]. Anesthesiology 1996; 85 (3A)
71. Kovac A, Chelly J, McKenzie R, et al. Multicenter intravenous dose response trial to assess the efficacy and safety of dolasetron mesylate in preventing postoperative nausea and vomiting [abstract no. A1]. Anesthesiology 1996; 85 (3A)
72. Korttila K, Clergue F, Leeser J, et al. Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study. Acta Anaesthesiol Scand. In press
73. Kovac A, Melson T, Graczyk S, et al. Treatment of postoperative nausea and vomiting with single doses of iv dolasetron: a multicenter trial [abstract]. Anesthesiology 1995; 83 (3A): A6
74. Philip B, McLeskey C, Chelly J, et al. Evaluation of dolasetron mesylate dose needed to prevent post operative nausea and vomiting [abstract]. Anesthesiology 1996; 85 (3A): A37
75. Watkins WD, Kovac A, Hickock C, et al. Evaluation of optimally effective IV dose of dolasetron mesylate (DM) for treating established post operative nausea and vomiting (PONV)[abstract]. Anesthesiology 1996; 85 (3A): A17
76. McDermott S, Songer S, Benedict C, et al. Safety profile of dolasetron. Eur Hosp Pharm 1996; 2 Suppl. 1: S25-31
77. Hunt TL, Cramer M, Shah A, et al. A double-blind, placebo-controlled, dose-ranging safety evaluation of single-dose intravenous dolasetron in healthy male volunteers. J Clin Pharmacol 1995 Jul; 35: 705-12
78. Dixon RM, Cramer M, Shah AK, et al. Single-dose, placebo-controlled, phase 1 study of oral dolasetron. Pharmacotherapy 1996 Mar-Apr; 16: 245-52
79. Baltzer L, Kris MG, Hinkley L, et al. Reversible electrocardiographic interval prolongations following the specific serotonin antagonists ondansetron (OND) and dolasetron mesylate (DM): a possible drug class effect without sequelae? [abstract]. Proc Am Soc: Clin Oncol 1994 Mar; 13: 433
80. Benedict CR, Arbogast R, Martin L, et al. Single-blind study of the effects of intravenous dolasetron mesylate versus ondansetron on electrocardiographic parameters in normal volunteers. J Cardiovasc Pharmacol 1996 Jul; 28: 53-9
81. Hoechst Marion Roussel. Summary of Product Characteristics for Anzemet IV
82. Hoechst Marion Roussel. Summary of Product Characteristics for Anzemet 200 (Tablets)
83. Sung Y-F. Risks and benefits of drugs used in the management of postoperative nausea and vomiting. Drug Saf 1996 Mar; 14: 181-97
84. Milne RJ, Heel RC. Ondansetron. Therapeutic use as an antiemetic. Drugs 1991 Apr; 41: 574-95
85. Yarker YE, McTavish D. Granisetron: an update of its therapeutic use in nausea and vomiting induced by antineoplastic therapy. Drugs 1994 Nov; 48: 761-93
86. Lee CR, Plosker GL, McTavish D. Tropisetron. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential as an antiemetic. Drugs 1993 Nov; 46: 925-43