Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects

Azzaro, Albert J.; VanDenBerg, Chad M.; Blob, Lawrence F.; Kemper, Eva M.; Sharoky, Melvin; Oren, Dan A.; Campbell, Bryan J.

doi:10.1177/0091270006289852

Cited by 42 publications

(46 citation statements)

References 37 publications

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“…MAO-B predominates in the brain and selectively deaminates non-polar aromatic amines (as phenylethylamine and dopamine). Tyramine is a substrate for either form of MAO, MAO-A is responsible for intestinal metabolism of tyramine, thereby preventing its systemic absorption (Azzaro et al 2006;Broadley, 2010). Tyramine and phenylethylamine are also subjected to N-methylation by N-methyltransferases, generating the sympathetic neurotransmitter, noradrenaline.…”

Section: Synthesis and Metabolism In Humansmentioning

confidence: 99%

“…Indeed, it has been reported that increasing mainly lipid but also protein content of the meal significantly reduce the tyramine blood pressor response (Audebert et al, 1992). Bioavailability of tyramine when administered with food or as a dietary constituent seems to drastically be reduced and systematic concentrations are reduced by approximately 2-to 3-fold (Patat et al, 1995;Van den Berg et al, 2003;Azzaro et al, 2006).…”

Section: Dose-response Relationshipmentioning

confidence: 99%

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Scientific Opinion on risk based control of biogenic amine formation in fermented foods

Publication¹

2011

EFSA Journal

647

276

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A qualitative risk assessment of biogenic amines (BA) in fermented foods was conducted, using data from the scientific literature, as well as from European Union‐related surveys, reports and consumption data. Histamine and tyramine are considered as the most toxic and food safety relevant, and fermented foods are of particular BA concern due to associated intensive microbial activity and potential for BA formation. Based on mean content in foods and consumer exposure data, fermented food categories were ranked in respect to histamine and tyramine, but presently available information was insufficient to conduct quantitative risk assessment of BA, individually and in combination(s). Regarding BA risk mitigation options, particularly relevant are hygienic measures to minimize the occurrence of BA‐producing microorganisms in raw material, additional microbial controls and use of BA‐nonproducing starter cultures. Based on limited published information, no adverse health effects were observed after exposure to following BA levels in food (per person per meal): a) 50 mg histamine for healthy individuals, but below detectable limits for those with histamine intolerance; b) 600 mg tyramine for healthy individuals not taking monoamino oxidase inhibitor (MAOI) drugs, but 50 mg for those taking third generation MAOI drugs or 6 mg for those taking classical MAOI drugs; and c) for putrescine and cadaverine, the information was insufficient in that respect. Presently, only high‐performance liquid chromatography (HPLC)‐based methods enable simultaneous and high sensitivity quantification of all BA in foods, hence are best suited for monitoring and control purposes. Monitoring of BA concentrations in fermented foods during the production process and along the food chain would be beneficial for controls and further knowledge. Further research on BA in fermented foods is needed; particularly on toxicity and associated concentrations, production process‐based control measures, further process hygiene and/or food safety criteria development, and validation of analysis methods.

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Section: Synthesis and Metabolism In Humansmentioning

confidence: 99%

Section: Dose-response Relationshipmentioning

confidence: 99%

Scientific Opinion on risk based control of biogenic amine formation in fermented foods

Publication¹

2011

EFSA Journal

647

276

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“…Transdermal delivery of selegiline, via STS, bypasses first pass metabolism. STS 6 mg/24 h is sparing of gastrointestinal MAO-A enzyme, the principal enzymatic barrier to ingested tyramine, and STS showed greater systemic delivery of selegiline (Mawhinney et al, 2003;Wecker et al, 2003) and a higher tyramine safety margin compared with oral MAOIs (Azzaro et al, 2006).…”

Section: Introductionmentioning

confidence: 98%

Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)

Jang

Jung

Pae³

et al. 2013

Journal of Affective Disorders

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“…14 With a newer transdermal preparation of selegiline, 6 mg/24 h, larger doses of tyramine (Ͼ250 to 275 mg) may be necessary to induce a hypertensive response than with the oral form of the drug. 15 To put these findings from tyramine sensitivity studies in perspective, the average dose of free tyramine in large quantities of aged cheese is typically 5 to 20 mg. 6 Nonselective MAO inhibitors typically only require 5 to 10 mg of tyramine ingestion to induce substantial elevations in systolic BP, 7 but it is likely that much larger doses of tyramine would be required to have the same sort of pressor response when patients take selective MAO-B inhibitors. Thus, whereas the classical tyramine sensitivity tests assess the potential for an MAO inhibitor to increase BP in response to very large oral doses of tyramine, they may not be comparable to the amounts that are ingested in foodstuffs in everyday meals.…”

Section: Effect Of Tyramine Administration In Patients Taking Selectimentioning

confidence: 99%

“…The selective MAO-B inhibitors have been reported to have a much lesser interaction with tyramine compared with the older nonselective MAO inhibitors. [13][14][15]18,19 These findings are particularly relevant because wider use of the MAO-B inhibitors is seen in patients with Parkinson disease, a group that is typically older and has a high incidence of hypertension. Use of rasagiline, a unique MAO-B inhibitor, may be effective as a monotherapy or in combination with levodopa in patients with Parkinson disease without inducing a BP increase after meals unrestricted in tyramine-rich foods.…”

Section: Perspectivesmentioning

confidence: 99%

Transtelephonic Home Blood Pressure to Assess the Monoamine Oxidase-B Inhibitor Rasagiline in Parkinson Disease

White

Salzman²,

Schwid³

2008

Hypertension

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Abstract-Monoamine oxidase inhibitors are associated with dietary tyramine interactions that can induce hypertensive crises. Rasagiline mesylate is a novel irreversible selective monoamine oxidase type B inhibitor for Parkinson disease that may have a low risk of interaction with dietary tyramine because of its selectivity. To study interactions of rasagiline with diets unrestricted in tyramine-containing foods, we incorporated transtelephonic, self-monitoring of the blood pressure (BP) into a randomized, placebo-controlled trial of rasagiline 0.5 and 1.0 mg daily in 414 levodopa-treated Parkinson patients with motor fluctuations. The proportion of patients with a systolic BP increase of Ͼ30 mm Hg was the primary BP end point. In 13 968 self-measured readings at baseline, the proportion of systolic BP values that increased by Ͼ30 mm Hg after a meal ranged from 9.5% to 12.9% in the 3 treatment groups. In 25 733 BPs obtained postrandomization, the proportion of values with a Ͼ30-mm Hg systolic postprandial increase was 15% in the placebo group, 15% in the rasagiline 0.5-mg group, and 11% in the rasagiline 1-mg group after 3 weeks of double-blind therapy and 13%, 14%, and 12%, respectively, after 26 weeks of treatment (P value was not significant for all of the comparisons among treatment groups). A postprandial increase in systolic BP to Ͼ180 mm Hg at any time after randomization was seen in 3.3%, 2.6%, and 2.9% of the placebo, 0.5-mg, and 1.0-mg rasagiline groups, respectively. These data demonstrate that rasagiline did not induce postprandial hypertension in patients with Parkinson disease who were on an unrestricted diet. is commonly complicated by motor fluctuations and dyskinesias, which cause substantial morbidity for patients with this disorder. 1 Inhibitors of monoamine oxidase (MAO) type B (MAO-B), the main enzyme that metabolizes dopamine in the brain, may potentiate the beneficial motor effects of the dopaminergic agents and reduce the severity of motor complications. 2,3 Rasagiline (N-propargyl-1-(R)-aminodan) mesylate is a new irreversible MAO-B inhibitor with high selectivity for the B isoform of the enzyme shown to improve function in patients with Parkinson disease. 4,5 Tyramine is an amino acid present in high concentrations in certain food types (aged cheeses, fermented meats, and sauerkraut) that can generate pressor responses unless it is metabolized by MAO in the gastrointestinal tract. 6 The usefulness of nonselective MAO inhibitors for depression has been limited by the need to restrict dietary tyramine intake to avoid potentially severe hypertensive reactions. Selective MAO-B inhibitors, such as rasagiline, are relatively free of this limitation, because 90% of MAO activity in the intestine involves the MAO type A isoform. 7 However, it is not clear whether the selectivity is adequate at higher doses or in tyramine-sensitive individuals.To evaluate the safety of rasagiline in patients with an unrestricted diet, we performed a large novel study of selfmonitored transtelephonic blood pressure...

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Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects

Cited by 42 publications

References 37 publications

Scientific Opinion on risk based control of biogenic amine formation in fermented foods

Scientific Opinion on risk based control of biogenic amine formation in fermented foods

Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)

Transtelephonic Home Blood Pressure to Assess the Monoamine Oxidase-B Inhibitor Rasagiline in Parkinson Disease

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