Comparison of pramipexole with and without domperidone co-administration on alertness, autonomic, and endocrine functions in healthy volunteers

British Journal of Clinical Pharmacology

Volumn 64, Issue 5, 2007, Pages 591-602

  Samuels, Ebony R ^a   Hou, Ruihua H ^a   Langley, Robert W ^a   Szabadi, Elemer ^a   Bradshaw, Christopher M ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

Alertness; Darkness reflex; Domperidone; Light reflex; Pramipexole; Pupil

Indexed keywords

DOMPERIDONE; DOPAMINE 2 RECEPTOR BLOCKING AGENT; DOPAMINE 2 RECEPTOR STIMULATING AGENT; GROWTH HORMONE; PRAMIPEXOLE; PROLACTIN; THYROTROPIN;

ADULT; ALERTNESS; ANALYSIS OF VARIANCE; ARTICLE; AUTONOMIC NERVOUS SYSTEM; BLOOD PRESSURE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICAL FLICKER FUSION; DATA ANALYSIS; DOUBLE BLIND PROCEDURE; ENDOCRINE FUNCTION; GROWTH HORMONE BLOOD LEVEL; HEART RATE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PUPIL REFLEX; PUPILLOGRAPHY; RANDOMIZED CONTROLLED TRIAL; SALIVATION; TEMPERATURE; THYROTROPIN BLOOD LEVEL; VISUAL ANALOG SCALE; VOLUNTEER;

ADOLESCENT; ADULT; AUTONOMIC NERVOUS SYSTEM; BENZOTHIAZOLES; DOMPERIDONE; DOPAMINE ANTAGONISTS; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDOCRINE SYSTEM; HUMANS; MALE; PSYCHOPHYSIOLOGY; PUPIL; REFLEX, PUPILLARY; TREATMENT OUTCOME;

EID: 35248872905     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2007.02938.x     Document Type: Article

References (59)

1. Parkinson Study Group. Safety and efficacy of pramipexole in early Parkinson disease: a randomized dose-ranging study. JAMA 1997 278 : 125 30.
2. Parkinson Study Group. Pramipexole vs. levodopa as initial treatment for Parkinson disease: a randomized controlled trial. JAMA 2000 284 : 1931 8.
3. Piercey MF. Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson's disease. Clin Neuropharmacol 1998 21 : 141 51.
4. Reichmann H, Brecht MH, Köster J, Kraus PH, Lemke MR. Pramipexole in routine clinical practice: a prospective observational trial in Parkinson's disease. CNS Drugs 2003 17 : 965 73.
5. Dooley M, Markham A. Pramipexole. A review of its use in the management of early and advanced Parkinson's disease. Drugs Aging 1998 12 : 495 514.
6. Hauser RA, Gauger L, McDowell Anderson W, Zesiewicz TA. Pramipexole-induced somnolence and episodes of daytime sleep. Mov Disord 2000 15 : 658 63.
7. O'Suilleabhain PE, Dewey RB. Contributions of dopaminergic drugs and disease severity to daytime sleepiness in Parkinson's disease. Arch Neurol 2002 59 : 986 9.
8. Etminan M, Gill S, Samii A. Comparison of the risk of adverse effects with pramipexole and ropinirole in patients with Parkinson's disease: a meta-analysis. Drug Saf 2003 26 : 439 44.
9. Samuels ER, Hou RH, Langley RW, Szabadi E, Bradshaw CM. Comparison of pramipexole and modafinil on arousal, autonomic, and endocrine functions in healthy volunteers. J Psychopharmacol 2006 20 : 756 70.
10. Samuels ER, Hou RH, Langley RW, Szabadi E, Bradshaw CM. Comparison of amisulpride and pramipexole on alertness, autonomic and endocrine functions in healthy volunteers. Psychopharmacology (Berl.) 2006 187 : 498 510.
11. Wermuth L, The Danish Pramipexole Study Group. A double-blind, placebo-controlled, randomized, multi-center study of pramipexole in advanced Parkinson's disease. Eur J Neurol 1998 5 : 235 42.
12. Weiner WJ, Factor SA, Jankovic J, Hauser RA, Tetrud JW, Waters CH, Shulman LM, Glassman PM, Beck B, Paume D, Doyle C. The long-term safety and efficacy of pramipexole in advanced Parkinson's disease. Parkinsonism Relat Disord 2001 7 : 115 20.
13. Pogarell O, Gasser T, van Hilten JJ, Spieker S, Pollentier S, Meier D, Oertel WH. Pramipexole in patients with Parkinson's disease and marked drug resistant tremor: a randomised, double blind, placebo controlled multicentre study. J Neurol Neurosurg Psychiatry 2002 72 : 713 20.
14. Silber MH, Girish M, Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep 2003 26 : 819 21.
15. Obering CD, Chen JJ, Swope DM. Update on apomorphine for the rapid treatment of hypomobility ('off') episodes in Parkinson's disease. Pharmacotherapy 2006 26 : 840 52.
16. Tan EK, Ratnagopal P, Han SY, Wong MC. Piribedil and bromocriptine in Parkinson's disease: a single-blind crossover study. Acta Neurol Scand 2003 107 : 202 6.
17. Kuzel MD. Ropinirole. a dopamine agonist for the treatment of Parkinson's disease. Am J Health-Syst Pharm 1999 56 : 217 24.
18. Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ 1986 135 : 457 61.
19. Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother 1999 33 : 429 40.
20. Dollery C. Therapeutic Drugs, 2nd edn. Edinburgh : Churchill Livingstone, 1999, D196-D199.
21. Kompoliti K, Wang QE, Goetz CG, Leurgans S, Raman R. Effects of central dopaminergic stimulation by apomorphine on speech in Parkinson's disease. Neurology 2000 54 : 458 62.
22. Quinn N, Illas A, Lhermitte F, Agid Y. Bromocriptine and domperidone in the treatment of Parkinson disease. Neurology 1981 31 : 662 7.
23. Capria A, Attanasio A, Quatrana M, Cannata D, Fioravanti M, Stocchi F, Ruggieri S. Cardiovascular effects of lisuride continuous intravenous infusion in fluctuating Parkinson's disease. Clin Neuropharmacol 1989 12 : 331 8.
24. Jansen PA, Herings RM, Samson MM, De Vreede PL, Schuurmans-Daemen LM, Hovestadt A, Verhaar HJ, Van Laar T. Quick titration of pergolide in cotreatment with domperidone is safe and effective. Clin Neuropharmacol 2001 24 : 177 80.
25. Jenner P. Parkinson's disease. pathological mechanisms and actions of piribedil. J Neurol 1992 239 (Suppl 1 S2 S8.
26. Navan P, Findley LJ, Jeffs JAR, Pearce RKB, Bain PG. Double-blind, single-dose, cross-over study of the effects of pramipexole, pergolide, and placebo on rest tremor and UPDRS part III in Parkinson's disease. Mov Disord 2003 18 : 176 80.
27. Wright CE, Lasher Sisson T, Ichhpurani AK, Peters GR. Steady-state pharmacokinetic properties of pramipexole in healthy volunteers. J Clin Pharmacol 1997 37 : 520 5.
28. Huang YC, Colaizzi JL, Bierman RH, Woestenborghs R, Heykants JJ. Pharmacokinetics and dose proportionality of domperidone in healthy volunteers. J Clin Pharmacol 1986 26 : 628 32.
29. Bond AJ, Lader MH. The use of analogue scales in rating subjective feelings. Br J Med Psychol 1974 47 : 211 8.
30. Smith JM, Misiak H. Critical flicker frequency (CFF) and psychotropic drugs in normal human subjects- a review. Psychopharmacology (Berl.) 1976 47 : 175 82.
31. Lüdtke H, Wilhelm B, Adler M, Schaeffel F, Wilhelm H. Mathematical procedures in data recording and processing of pupillary fatigue waves. Vision Res 1998 38 : 2889 96.
32. Samuels ER, Hou RH, Langley RW, Szabadi E, Bradshaw CM. Modulation of the acoustic startle response by the level of arousal: comparison of clonidine and modafinil in healthy volunteers. Neuropsychopharmacol 2007 Epub ahead of print.
33. Rye DB, Jankovic J. Emerging views of dopamine in modulating sleep/wake state from an unlikely source: PD. Neurol 2002 58 : 341 6.
34. Keating GL, Rye DB. Where you least expect it: dopamine in the pons and modulation of sleep and REM-sleep. Sleep 2003 26 : 788 9.
35. 2-recepor agonists evoke behavioural and electrocortical sleep in rats. Br J Pharmacol 1988 95 : 860 6.
36. Ornstein K, Milon H, McRae-Degueurce A, Alvarez C, Berger B, Würzner HP. Biochemical and radioautographic evidence for dopaminergic afferents of the locus coeruleus originating in the ventral tegmental area. J Neural Transm 1987 70 : 183 91.
37. Maeda T, Kitahama K, Geffard M. Dopaminergic innervation of rat locus coeruleus: a light and electron microscope immunohistochemical study. Microsc Res Tech 1994 29 : 211 8.
38. Rye DB. Parkinson's disease and RLS: the dopaminergic bridge. Sleep Med 2004 5 : 317 28.
39. Lesser J, Bateman DN. Domperidone. Br Med J 1985 290 : 241.
40. Loewenfeld IE. The pupil: anatomy, physiology, and clinical applications. Detroit, Michigan : Wayne State University Press, 1993.
41. Swanson LW. The projections of the ventral tegmental area and adjacent regions: a combined fluorescent retrograde tracer and immunofluorescence study in the rat. Brain Res Bull 1982 9 : 321 53.
42. Mansour A, Watson SJ Jr. Dopamine receptor expression in the central nervous system. In : Psychopharmacology: The Fourth Generation of Progress, eds. Bloom FE, Kupfer DJ. New York : Raven Press, 1995, 207 19.
43. Landis SC, Jackson PC, Fredieu JR, Thibault J. Catecholaminergic properties of cholinergic neurons and synapses in adult rat ciliary ganglion. J Neurosci 1987 7 : 3574 87.
44. Dearry A, Falardeau P, Shores C, Caron MG. D2 dopamine receptors in the human retina: cloning of cDNA and localization of mRNA. Cell Mol Neurobiol 1991 11 : 437 53.
45. Luchsinger A, Velasco M, Urbina A, Morillo J, Romero E, Alvarez R, Hernandez Pieretti O. Comparative effects of dopaminergic agonists on cardiovascular, renal, and renin-angiotensin systems in hypertensive patients. J Clin Pharmacol 1992 32 : 55 60.
46. Kujawa K, Leurgans S, Raman R, Blasucci L, Goetz CG. Acute orthostatic hypotension when starting dopamine agonists in Parkinson's disease. Arch Neurol 2000 57 : 1461 3.
47. Franchi F, Lazzeri C, Barletta Gianni L, Mannelli M. Centrally mediated effects of bromocriptine on cardiac sympathovagal balance. Hypertension 2001 38 : 123 9.
48. Korchounov A, Kessler KR, Schipper HI. Differential effects of various treatment combinations on cardiovascular dysfunction in patients with Parkinson's disease. Acta Neurol Scand 2004 109 : 45 51.
49. Jadhav AL, Willett RN, Sapru HN, Lokhandwala MF. Involvement of central dopamine receptors in the hypotensive action of pergolide. Naunyn-Schmiedeberg's Arch Pharmacol 1983 324 : 281 6.
50. Ziegler MG, Kennedy B, Holland OB, Murphy D, Lake CR. The effects of dopamine agonists on human cardiovascular and sympathetic nervous systems. Int J Clin Pharmacol Ther Toxicol 1985 23 : 175 9.
51. Szabo B, Crass D, Starke K. Effect of the dopamine D2 receptor agonist quinpirole on renal sympathetic nerve activity and renal norepinephrine spillover in anesthetized rabbits. J Pharmacol Exp Ther 1992 263 : 806 15.
52. Toscano CF, Lahlou S. Blood pressure effects of intravenous apomorphine in conscious deoxycorticosterone-acetate salt-hypertensive rats. J Cardiovasc Pharmacol 2003 42 : 772 81.
53. Willems JL, Buylaert WA, Lefebvre RA, Bogaert MG. Neuronal dopamine receptors on autonomic ganglia and sympathetic nerves and dopamine receptors in the gastrointestinal system. Pharmacol Rev 1985 37 : 165 216.
54. Cornish JL, van den Buuse M. Pressor responses to electrical and chemical stimulation of the rat brain A10 dopaminergic system. Neurosci Lett 1994 176 : 142 6.
55. Worth DP, Harvey JN, Brown J, Worral A, Lee MR. Domperidone treatment in man inhibits the fall in plasma renin activity induced by intravenous gamma-L-glutamyl-L-dopa. Br J Clin Pharmacol 1986 21 : 497 502.
56. MacDonald TM. Metoclopramide, domperidone and dopamine in man: actions and interactions. Eur J Clin Pharmacol 1991 40 : 225 30.
57. Reichlin S. Neuroendocrinology. In : Williams Textbook of Endocrinology., eds Wilson JD, Foster DW, Kronenberg HM, Larsen PR. Philadelphia : W.B. Saunders Company, 1998, 165 248.
58. Schilling JC, Adamus WS, Palluk R. Neuroendocrine and side effect profile of pramipexole, a new dopamine receptor agonist, in humans. Clin Pharmacol Ther 1992 51 : 541 8.
59. Roesch-Ely D, Scheffel H, Weiland S, Schwaninger M, Hundemer H-P, Kolter T, Weisbrod M. Differential dopaminergic modulation of executive control in healthy subjects. Psychopharmacol (Berl.) 2005 178 : 420 30.