Pharmacokinetic and safety assessments of galantamine and risperidone after the two drugs are administered alone and together

Journal of Clinical Pharmacology

Volumn 42, Issue 12, 2002, Pages 1341-1351

  Huang, Fenglei ^a   Lasseter, Kenneth C ^c   Janssens, Luc ^b   Verhaeghe, Tom ^b   Lau, Henry ^a   Zhao, Qinying ^a  

^a LLC   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c Clinical Pharmacology Associates Miami   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLINESTERASE INHIBITOR; GALANTAMINE; NEUROLEPTIC AGENT; PALIPERIDONE; RISPERIDONE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE CALCULATION; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; ELDERLY CARE; EXTRAPYRAMIDAL SYMPTOM; FATIGUE; FEMALE; HEADACHE; HEART ATRIUM FIBRILLATION; HEART PALPITATION; HUMAN; HYPOTENSION; MALE; MAXIMUM ALLOWABLE CONCENTRATION; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEDATION; SIDE EFFECT; STEADY STATE; TACHYCARDIA; TARDIVE DYSKINESIA; VERTIGO;

AGED; AGED, 80 AND OVER; ANTIPSYCHOTIC AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CHOLINESTERASE INHIBITORS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; FEMALE; GALANTAMINE; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; HUMANS; ISOXAZOLES; MALE; MIDDLE AGED; PYRIMIDINES; RISPERIDONE; TIME FACTORS;

EID: 18744367217     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270002042012005     Document Type: Article

References (41)

1. Burgio L: Interventions for the behavioral complications of Alzheimer's disease: Behavioral approaches. Int Psychogeriatr 1996; 8(suppl. 1):45-52.
2. Victoroff J, Mack WJ, Nielson KA: Psychiatric complications of dementia: Impact on caregivers. Dement Geriatr Cogn Disord 1998;9(1):50-55.
3. Grutzendler J, Morris JC: Cholinesterase inhibitors for Alzheimer's disease. Drugs 2001;61(1):41-52.
4. Raskind MA, Peskind ER, Wessel T, Yuan W: Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. The Galantamine USA-1 Study Group. Neurology 2000;54(12):2261-2268.
5. Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C: A 5-month, randomized, placebo-controlled trial of galantamine in AD. The Galantamine USA-10 Study Group. Neurology 2000;54(12):2269-2276.
6. Wilcock GK, Lilienfeld S, Gaens E: Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: Multicentre randomised controlled trial. BMJ 2000;321(7274):1445-1449.
7. Sramek JJ, Frackiewicz EJ, Cutler NR: Review of the acetylcholinesterase inhibitor galantamine. Expert Opin Investig Drugs 2000;9(10):2393-2402.
8. Woodruff-Pak DS, Santos IS: Nicotinic modulation in an animal model of a form of associative learning impaired in Alzheimer's disease. Behav Brain Res 2000;113(1-2):11-19.
9. Coyle J, Kershaw P: Galantamine, a cholinesterase inhibitor that allosterically modulates nicotinic receptors: Effects on the course of Alzheimer's disease. Biol Psychiatry 2001;49(3):289-299.
10. Woodruff-Pak DS, Vogel RW III, Wenk GL: Galantamine: Effect on nicotinic receptor binding, acetylcholinesterase inhibition, and learning. Proc Natl Acad Sci USA 2001;98(4):2089-2094.
11. Maelicke A, Samochocki M, Jostock R, Fehrenbacher A, Ludwig J, Albuquerque EX, et al: Allosteric sensitization of nicotinic receptors by galantamine, a new treatment strategy for Alzheimer's disease. Biol Psychiatry 2001;49(3):279-288.
12. Lilienfeld S, Parys W: Galantamine: Additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord 2000;11(suppl. 1):19-27.
13. Kewitz H: Pharmacokinetics and metabolism of galantamine. Drugs Today 1997;33(4):265-272.
14. Bickel U, Thomsen T, Weber W, Fisher JP, Bachus R, Nitz M, et al: Pharmacokinetics of galantamine in humans and corresponding cholinesterase inhibition. Clin Pharmacol Ther 1991;50:420-428.
15. Westra P, van Thiel MJS, Vermeer GA, Soeterbroek AM, Scaf AHJ, Claessens HA: Pharmacokinetics of galantamine (a long-acting anticholinesterase drug) in anaesthetized patients. Br J Anaesth 1986;58:1303-1307.
16. Mihailova D, Yamboliev I, Zhivkova Z, Tencheva J, Jovovich V: Pharmacokinetics of galantamine hydrobromide after single subcutaneous and oral dosage in humans. Pharmacology 1989;39:50-58.
17. Reminyl (galantamine HBr) tablets and oral solution [product information], in: Physicians' Desk Reference. Montvale, NJ: Medical Economics Data Production Company, 2002.
18. Reisberg B, Ferris SH, de Leon MJ, Crook T: The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry 1982;139(9):1136-1139.
19. Roth M, Tomlinson BE, Blessed G: Correlation between scores for dementia and counts of "senile plaques" in cerebral grey matter of elderly subjects. Nature 1966;209(18):109-110.
20. Naranjo CA, Herrmann N, Mittmann N, Bremner KE: Recent advances in geriatric psychopharmacology. Drugs Aging 1995;7(3):184-202.
21. Janssen PA, Niemegeers CJ, Awouters F, Schellekens KH, Megens AA, Meert TF: Pharmacology of risperidone (R 64 766), a new antipsychotic with serotonin-S2 and dopamine-D2 antagonistic properties. J Pharmacol Exp Ther 1988;244(2):685-693.
22. He H, Richardson JS: A pharmacological, pharmacokinetic and clinical overview of risperidone, a new antipsychotic that blocks serotonin 5-HT2 and dopamine D2 receptors. Int Clin Psychopharmacol 1995;10(1):19-30.
23. Gelders YG, Heylen SL, Vanden Bussche G, Reyntiens AJ, Janssen PA: Pilot clinical investigation of risperidone in the treatment of psychotic patients. Pharmacopsychiatry 1990;23(5):206-211.
24. Mesotten F, Suy E, Pietquin M, Burton P, Heylen S, Gelders Y: Therapeutic effect and safety of increasing doses of risperidone (R 64766) in psychotic patients. Psychopharmacology 1989;99(4):445-449.
25. Zaudig M: A risk-benefit assessment of risperidone for the treatment of behavioural and psychological symptoms in dementia. Drug Safety 2000;23(3):183-195.
26. Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M: Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: A randomized, double-blind trial. Risperidone Study Group. J Clin Psychiatry 1999;60(2):107-115.
27. De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PL, Eriksson S, et al: A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology 1999;53(5):946-955.
28. Bhana N, Spencer CM: Risperidone: A review of its use in the management of the behavioural and psychological symptoms of dementia. Drugs Aging 2000;16(6):451-471.
29. Mannens G, Huang ML, Meuldermans W, Hendrickx J, Woestenborghs R, Heykants J: Absorption, metabolism, and excretion of risperidone in humans. Drug Metab Dispos 1993;21(6):1134-1141.
30. Koymans L, Vermeulen NP, van Acker SA, te Koppele JM, Heykants JJ, Lavrijsen K, et al: A predictive model for substrates of cytochrome P450-debrisoquine (2D6). Chem Res Toxicol 1992;5(2):211-219.
31. Risperdal (risperidone) tablets/oral solution [product information], in: Physicians' Desk Reference, Montvale, NJ: Medical Economics Data Production Company, 2002.
32. van Beijsterveldt LE, Geerts RJ, Leysen JE, Megens AA, Van den Eynde HM, Meuldermans WE, et al: Regional brain distribution of risperidone and its active metabolite 9-hydroxy-risperidone in the rat. Psychopharmacology (Berl) 1994;114(1):53-62.
33. Huang ML, Van Peer A, Woestenborghs R, De Coster R, Heykants J, Jansen AA, et al: Pharmacokinetics of the novel antipsychotic agent risperidone and the prolactin response in healthy subjects. Clin Pharmacol Ther 1993;54(3):257-268.
34. Grant S, Fitton A: Risperidone: A review of its pharmacology and therapeutic potential in the treatment of schizophrenia. Drugs 1994;48(2):253-273.
35. Heykants J, Huang ML, Mannens G, Meuldermans W, Snoeck E, Van Beijsterveldt L, et al: The pharmacokinetics of risperidone in humans: A summary. J Clin Psychiatry 1994;55(suppl.):13-17.
36. U.S. Food and Drug Administration: Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendation for Dosing and Labeling. Washington, DC: U.S. Food and Drug Administration, 1999.
37. Brosen K, Gram LF: Clinical significance of the sparteine/debrisoquine oxidation polymorphism. Eur J Clin Pharmacol 1989;36(6):537-547.
38. Markowitz JS, Brown CS, Moore TR: Atypical antipsychotics: Part I. Pharmacology, pharmacokinetics, and efficacy [see comments]. Ann Pharmacother 1999;33(1):73-85.
39. Brown CS, Markowitz JS, Moore TR, Parker NG: Atypical antipsychotics: Part II. Adverse effects, drug interactions, and costs. Ann Pharmacother 1999;33(2):210-217.
40. Stern Y, Mayeux R, Sano M, Hauser WA, Bush T: Predictors of disease course in patients with probable Alzheimer's disease. Neurology 1987;37(10):1649-1653.
41. McShane R, Keene J, Gedling K, Fairburn C, Jacoby R, Hope T: Do neuroleptic drugs hasten cognitive decline in dementia? Prospective study with necropsy follow up. BMJ 1997;314(7076):266-270.