Pharmacokinetic and pharmacodynamic effects of midodrine on blood pressure, the autonomic nervous system, and plasma natriuretic peptides: a prospective, randomized, single-blind, two-period, crossover, placebo-controlled study
Background: Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure...
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| Published in | Clinical therapeutics Vol. 30; no. 9; pp. 1629 - 1638 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Belle Mead, NJ
EM Inc USA
01.09.2008
Excerpta Medica Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Background: Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP).
Objective: The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers.
Methods: This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration.
Results: Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At C
max, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (
P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (
P = 0.022). A significant correlation was found between DGM concentration and HR ( ϕ -0.61;
P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed.
Conclusion: This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return. |
|---|---|
| AbstractList | Background: Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP).
Objective: The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers.
Methods: This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration.
Results: Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At C
max, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (
P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (
P = 0.022). A significant correlation was found between DGM concentration and HR ( ϕ -0.61;
P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed.
Conclusion: This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return. Midodrine is an alpha-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP). The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers. This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration. Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At Cmax, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (P = 0.022). A significant correlation was found between DGM concentration and HR ( varphi -0.61; P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed. This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return. Abstract Background: Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP). Objective: The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers. Methods: This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration. Results: Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At Cmax , midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL ( P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm ( P = 0.022). A significant correlation was found between DGM concentration and HR ( ϕ -0.61; P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed. Conclusion: This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return. Background_ Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP). Objective_ The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers. Methods_ This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration. Results_ Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At Cmax, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (P = 0.022). A significant correlation was found between DGM concentration and HR ( [varphi] -0.61; P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed. Conclusion_ This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return. Midodrine is an alpha-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP).BACKGROUNDMidodrine is an alpha-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its effects may be mediated not only by its hypertensive properties but also by its neurohumoral influences independent of blood pressure (BP).The present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers.OBJECTIVEThe present study aimed to simultaneously characterize the effects of midodrine on BP, plasma catecholamines, plasma atrial natriuretic peptide (ANP), and power spectral analysis of heart rate (HR) in healthy volunteers.This was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration.METHODSThis was a prospective, randomized, single-blind, 2-period, crossover study in which a single, oral, 5-mg dose of midodrine was compared with placebo. The washout period between midodrine and placebo was 1 week. The study parameters included plasma DGM (as measured by high-performance liquid chromatography [HPLC]); systolic and diastolic BP (as measured with an oscillometric monitor); HR; plasma catecholamines (measured by HPLC); plasma ANP, also known as venous return (measured by a radio-immunoassay); and low- and high-frequency HR variation (calculated from computerized 5-minute electrocardiographic recordings). All study parameters were measured simultaneously 12 times just before and over a period of 8 hours after drug administration.Fifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At Cmax, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (P = 0.022). A significant correlation was found between DGM concentration and HR ( varphi -0.61; P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed.RESULTSFifteen healthy nonsmoking male subjects (14 white, 1 black; mean [SD] age, 28.6 [4.7] years; weight, 74.5 [16.4] kg; seated BP, 109.9 [9.0]/73.6 [9.5] mm Hg; seated HR, 63.8 [8.4] bpm) were randomized. No significant effects of midodrine on BP were observed. At Cmax, midodrine decreased norepinephrine from 188.4 (30.6) to 162.5 (29.8) pg/mL (P = 0.011) and HR from 57.2 (7.3) to 54.9 (6.6) bpm (P = 0.022). A significant correlation was found between DGM concentration and HR ( varphi -0.61; P = 0.014). A DGM-related increase in plasma ANP (+29.6 [90.0] fmoL/mL) was observed.This study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return.CONCLUSIONThis study in healthy male volunteers found that midodrine has sympatholytic influences that are independent of BP but related to augmented venous return. |
| Author | Larochelle, Pierre Souich, Patrick du Lamarre-Cliche, Maxime Champlain, Jacques de |
| Author_xml | – sequence: 1 givenname: Maxime surname: Lamarre-Cliche fullname: Lamarre-Cliche, Maxime email: maxime.lamarre-cliche@ircm.qc.ca organization: Institut de Recherches Cliniques de Montréal, Montréal, Québec, Canada – sequence: 2 givenname: Patrick du surname: Souich fullname: Souich, Patrick du organization: Department of Pharmacology, Faculty of Medicine, Université de Montréal, Montréal, Canada – sequence: 3 givenname: Jacques de surname: Champlain fullname: Champlain, Jacques de organization: Institut de Recherches Cliniques de Montréal, Montréal, Québec, Canada – sequence: 4 givenname: Pierre surname: Larochelle fullname: Larochelle, Pierre organization: Institut de Recherches Cliniques de Montréal, Montréal, Québec, Canada |
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| Keywords | orthostatic hypotension drug therapy neurocardiogenic syncope midodrine Biological fluid Pharmacokinetic pharmacodynamic relationship Agonist Vasodilator agent Pharmacotherapy Cardiovascular disease Atrial natriuretic peptide Blood plasma Prospective Postural hypotension Randomization Natriuretic hormone Syncope Autonomic nervous system Arterial pressure Blood pressure Neurological disorder Nervous system diseases Consciousness impairment Sympathomimetic Midodrine Crossover study Treatment Arterial hypotension Diseases of the autonomic nervous system Placebo Antihypertensive agent Hemodynamics |
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| Snippet | Background: Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic... Abstract Background: Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with... Midodrine is an alpha-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic syncope. Its... Background_ Midodrine is an α-agonist prodrug of desglymidodrine (DGM) that has been reported to be of clinical benefit in patients with neurocardiogenic... |
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| SubjectTerms | Adult Autonomic Nervous System - drug effects Biological and medical sciences Blood Pressure - drug effects Catecholamines Chromatography, High Pressure Liquid Cross-Over Studies Disorders of higher nervous function. Focal brain diseases. Central vestibular syndrome and deafness. Brain stem syndromes Dopamine Drug dosages drug therapy Fainting Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Heart attacks Heart rate Heart Rate - drug effects Humans Hypertension Hypotension, Orthostatic - drug therapy Internal Medicine Male Medical Education Medical sciences Menstruation midodrine Midodrine - administration & dosage Midodrine - pharmacokinetics Midodrine - pharmacology Midodrine - therapeutic use Natriuretic Peptides - blood Natriuretic Peptides - pharmacology Natriuretic Peptides - therapeutic use Nervous system Nervous system (semeiology, syndromes) neurocardiogenic syncope Neurology Norepinephrine - blood Orthostatic hypotension Peptides Pharmacokinetics Pharmacology. Drug treatments Plasma Prospective Studies Single-Blind Method Sympathomimetics - administration & dosage Sympathomimetics - pharmacokinetics Sympathomimetics - pharmacology Sympathomimetics - therapeutic use Syncope, Vasovagal - drug therapy |
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| Title | Pharmacokinetic and pharmacodynamic effects of midodrine on blood pressure, the autonomic nervous system, and plasma natriuretic peptides: a prospective, randomized, single-blind, two-period, crossover, placebo-controlled study |
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