Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France
Identifieur interne : 000B55 ( PascalFrancis/Checkpoint ); précédent : 000B54; suivant : 000B56Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France
Auteurs : Atul Pathak [France] ; Valérie Raoul [France] ; Jean-Louis Montastruc [France] ; Jean-Michel Senard [France]Source :
- European journal of clinical pharmacology [ 0031-6970 ] ; 2005.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : France.
- topic : Toxicomanie, Prospective, Homme.
English descriptors
- KwdEn :
Abstract
Objective: The aim of the present study was to investigate and characterise adverse drug reactions (ADRs) to drugs used in France for orthostatic hypotension (OH). Methods: In this prospective and systematic study, 121 consecutive out-patients suffering from primary (Parkinson's disease, pure autonomic failure, multiple system atrophy, Lewy bodies disease) or secondary (diabetic and non-diabetic peripheral neuropathies) autonomic failure with symptomatic OH requiring pharmacological treatment with at least one drug marketed in France for OH were included together with six patients with refractory neurocardiogenic syncope. Results: Of the patients, 85 received a monotherapy-mainly with midodrine (49.4%)-and 42 received various combinations, the association of midodrine and fludrocortisone being the most frequent (66.6%). Of all the 127 patients, 88 suffered from a total of 141 ADRs (1.60 per patient) with no statistical difference in ADR frequency between monotherapy and drug combinations (P>0.05). Among ADRs, 24 (17.0%) were considered as "serious" and 16 (11.3%) were considered as "unexpected", most of them observed with heptaminol. Conclusions: This study shows a high frequency of ADRs (especially serious and unexpected ADRs) with antihypotensive drugs. It strongly suggests the need for a better evaluation of the safety profile of antihypotensive drugs and improvement in summary of product characteristics.
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type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Raoul, Valerie" sort="Raoul, Valerie" uniqKey="Raoul V" first="Valérie" last="Raoul">Valérie Raoul</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Hôpitaux de Toulouse, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Montastruc, Jean Louis" sort="Montastruc, Jean Louis" uniqKey="Montastruc J" first="Jean-Louis" last="Montastruc">Jean-Louis Montastruc</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Hôpitaux de Toulouse, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Club d'Etude du Système Nerveux Autonome, Faculté de Médecine, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Senard, Jean Michel" sort="Senard, Jean Michel" uniqKey="Senard J" first="Jean-Michel" last="Senard">Jean-Michel Senard</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Hôpitaux de Toulouse, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Club d'Etude du Système Nerveux Autonome, Faculté de Médecine, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">European journal of clinical pharmacology</title><title level="j" type="abbreviated">Eur. j. clin. pharmacol.</title><idno type="ISSN">0031-6970</idno><imprint><date when="2005">2005</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">European journal of clinical pharmacology</title><title level="j" type="abbreviated">Eur. j. clin. pharmacol.</title><idno type="ISSN">0031-6970</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antianginal agent</term><term>Antihypertensive agent</term><term>Cardiotonic agent</term><term>Coronary vasodilator agent</term><term>Drug addiction</term><term>France</term><term>Heptaminol</term><term>Human</term><term>Midodrine</term><term>Pharmacovigilance</term><term>Prospective</term><term>Toxicity</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Toxicité</term><term>Toxicomanie</term><term>Prospective</term><term>Pharmacovigilance</term><term>France</term><term>Midodrine</term><term>Heptaminol</term><term>Homme</term><term>Antihypertenseur</term><term>Vasodilatateur coronarien</term><term>Antiangoreux</term><term>Cardiotonique</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Toxicomanie</term><term>Prospective</term><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: The aim of the present study was to investigate and characterise adverse drug reactions (ADRs) to drugs used in France for orthostatic hypotension (OH). Methods: In this prospective and systematic study, 121 consecutive out-patients suffering from primary (Parkinson's disease, pure autonomic failure, multiple system atrophy, Lewy bodies disease) or secondary (diabetic and non-diabetic peripheral neuropathies) autonomic failure with symptomatic OH requiring pharmacological treatment with at least one drug marketed in France for OH were included together with six patients with refractory neurocardiogenic syncope. Results: Of the patients, 85 received a monotherapy-mainly with midodrine (49.4%)-and 42 received various combinations, the association of midodrine and fludrocortisone being the most frequent (66.6%). Of all the 127 patients, 88 suffered from a total of 141 ADRs (1.60 per patient) with no statistical difference in ADR frequency between monotherapy and drug combinations (P>0.05). Among ADRs, 24 (17.0%) were considered as "serious" and 16 (11.3%) were considered as "unexpected", most of them observed with heptaminol. Conclusions: This study shows a high frequency of ADRs (especially serious and unexpected ADRs) with antihypotensive drugs. It strongly suggests the need for a better evaluation of the safety profile of antihypotensive drugs and improvement in summary of product characteristics.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0031-6970</s0></fA01><fA02 i1="01"><s0>EJCPAS</s0></fA02><fA03 i2="1"><s0>Eur. j. clin. pharmacol.</s0></fA03><fA05><s2>61</s2></fA05><fA06><s2>5-6</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France</s1></fA08><fA11 i1="01" i2="1"><s1>PATHAK (Atul)</s1></fA11><fA11 i1="02" i2="1"><s1>RAOUL (Valérie)</s1></fA11><fA11 i1="03" i2="1"><s1>MONTASTRUC (Jean-Louis)</s1></fA11><fA11 i1="04" i2="1"><s1>SENARD (Jean-Michel)</s1></fA11><fA14 i1="01"><s1>Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Hôpitaux de Toulouse, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></fA14><fA14 i1="02"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ></fA14><fA14 i1="03"><s1>Club d'Etude du Système Nerveux Autonome, Faculté de Médecine, 37 allées Jules Guesde</s1><s2>31073 Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></fA14><fA20><s1>471-474</s1></fA20><fA21><s1>2005</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>13739</s2><s5>354000138621650230</s5></fA43><fA44><s0>0000</s0><s1>© 2005 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>18 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>05-0350454</s0></fA47><fA60><s1>P</s1><s3>CC</s3></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>European journal of clinical pharmacology</s0></fA64><fA66 i1="01"><s0>DEU</s0></fA66><fC01 i1="01" l="ENG"><s0>Objective: The aim of the present study was to investigate and characterise adverse drug reactions (ADRs) to drugs used in France for orthostatic hypotension (OH). Methods: In this prospective and systematic study, 121 consecutive out-patients suffering from primary (Parkinson's disease, pure autonomic failure, multiple system atrophy, Lewy bodies disease) or secondary (diabetic and non-diabetic peripheral neuropathies) autonomic failure with symptomatic OH requiring pharmacological treatment with at least one drug marketed in France for OH were included together with six patients with refractory neurocardiogenic syncope. Results: Of the patients, 85 received a monotherapy-mainly with midodrine (49.4%)-and 42 received various combinations, the association of midodrine and fludrocortisone being the most frequent (66.6%). Of all the 127 patients, 88 suffered from a total of 141 ADRs (1.60 per patient) with no statistical difference in ADR frequency between monotherapy and drug combinations (P>0.05). Among ADRs, 24 (17.0%) were considered as "serious" and 16 (11.3%) were considered as "unexpected", most of them observed with heptaminol. Conclusions: This study shows a high frequency of ADRs (especially serious and unexpected ADRs) with antihypotensive drugs. It strongly suggests the need for a better evaluation of the safety profile of antihypotensive drugs and improvement in summary of product characteristics.</s0></fC01><fC02 i1="01" i2="X"><s0>002B02</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Toxicité</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Toxicity</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Toxicidad</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Toxicomanie</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Drug addiction</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Toxicomanía</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Prospective</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Prospective</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Prospectiva</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Pharmacovigilance</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Pharmacovigilance</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Farmacovigilancia</s0><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>France</s0><s2>NG</s2><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>France</s0><s2>NG</s2><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Francia</s0><s2>NG</s2><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Midodrine</s0><s2>NK</s2><s2>FR</s2><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Midodrine</s0><s2>NK</s2><s2>FR</s2><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Midodrina</s0><s2>NK</s2><s2>FR</s2><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Heptaminol</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Heptaminol</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Heptaminol</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Homme</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Human</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Hombre</s0><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Antihypertenseur</s0><s5>23</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Antihypertensive agent</s0><s5>23</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Antihipertensivo</s0><s5>23</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Vasodilatateur coronarien</s0><s5>24</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Coronary vasodilator agent</s0><s5>24</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Vasodilatator coronario</s0><s5>24</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Antiangoreux</s0><s5>25</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Antianginal agent</s0><s5>25</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Antianginoso</s0><s5>25</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Cardiotonique</s0><s5>26</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Cardiotonic agent</s0><s5>26</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Cardiotónico</s0><s5>26</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Europe</s0><s2>NG</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Europe</s0><s2>NG</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Europa</s0><s2>NG</s2></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Agoniste</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Agonist</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Agonista</s0><s5>37</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Sympathomimétique</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Sympathomimetic</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Simpaticomimético</s0><s5>38</s5></fC07><fN21><s1>248</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>France</li></country><region><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li></region><settlement><li>Toulouse</li></settlement></list><tree><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Pathak, Atul" sort="Pathak, Atul" uniqKey="Pathak A" first="Atul" last="Pathak">Atul Pathak</name></region><name sortKey="Montastruc, Jean Louis" sort="Montastruc, Jean Louis" uniqKey="Montastruc J" first="Jean-Louis" last="Montastruc">Jean-Louis Montastruc</name><name sortKey="Montastruc, Jean Louis" sort="Montastruc, Jean Louis" uniqKey="Montastruc J" first="Jean-Louis" last="Montastruc">Jean-Louis Montastruc</name><name sortKey="Pathak, Atul" sort="Pathak, Atul" uniqKey="Pathak A" first="Atul" last="Pathak">Atul Pathak</name><name sortKey="Pathak, Atul" sort="Pathak, Atul" uniqKey="Pathak A" first="Atul" last="Pathak">Atul Pathak</name><name sortKey="Raoul, Valerie" sort="Raoul, Valerie" uniqKey="Raoul V" first="Valérie" last="Raoul">Valérie Raoul</name><name sortKey="Senard, Jean Michel" sort="Senard, Jean Michel" uniqKey="Senard J" first="Jean-Michel" last="Senard">Jean-Michel Senard</name><name sortKey="Senard, Jean Michel" sort="Senard, Jean Michel" uniqKey="Senard J" first="Jean-Michel" last="Senard">Jean-Michel Senard</name><name sortKey="Senard, Jean Michel" sort="Senard, Jean Michel" uniqKey="Senard J" first="Jean-Michel" last="Senard">Jean-Michel Senard</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France
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