Effects of tyramine administration in Parkinson's disease patients treated with selective MAO-B inhibitor rasagiline.
Rasagiline is a novel, potent, and selective MAO-B inhibitor shown to be effective for Parkinson's disease. Traditional nonselective MAO inhibitors have been associated with dietary tyramine interactions that can induce hypertensive reactions. To test safety, tyramine challenges (50-75 mg) were performed in 72 rasagiline-treated and 38 placebo-treated Parkinson's disease (PD) patients at the end of two double-blind placebo-controlled trials of rasagiline. An abnormal pressor response was prespecified as three consecutive measurements of systolic blood pressure (BP) increases of >or= 30 mm Hg and/or bradycardia of < 40 beats/min. In the first study involving 55 patients with early PD on rasagiline monotherapy, no patients randomized to rasagiline (1 mg/2 mg; n = 38) or placebo (n = 17) developed systolic BP (SBP) or heart rate changes indicative of a tyramine reaction. In the second trial involving 55 levodopa-treated patients, 3 of 22 subjects on rasagiline 0.5 mg/day and 1 of 21 subjects on placebo developed asymptomatic, self-limiting SBP elevations >or= 30 mm Hg on three measurements. No subject on 1 mg/day rasagiline (0/12) experienced significant BP or heart rate changes following tyramine ingestion. These data demonstrate that rasagiline 0.5 to 2 mg daily is not associated with clinically significant tyramine reactions and can be used as monotherapy or adjunct to levodopa in PD patients without specific dietary tyramine restriction.
deMarcaida
J Antonelle
JA
Department of Neurology, University of Connecticut, Farmington, Connecticut, USA.
Schwid
Steven R
SR
White
William B
WB
Blindauer
Karen
K
Fahn
Stanley
S
Kieburtz
Karl
K
Stern
Matthew
M
Shoulson
Ira
I
D000284:Administration, Oral; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001794:Blood Pressure / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D018565:Food-Drug Interactions; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000009:adverse effects*; D007980:Levodopa / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D010300:Parkinson Disease / Q000188:drug therapy*; D012307:Risk Factors; D014439:Tyramine / Q000008:administration & dosage
D000978:Antiparkinson Agents; D007189:Indans; D008996:Monoamine Oxidase Inhibitors; C031967:rasagiline; D007980:Levodopa; D014439:Tyramine