ParkinsonFranceV1, PascalFrancis, Curation, bibRecord, 000772

Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France

Identifieur interne : 000772 ( PascalFrancis/Curation ); précédent : 000771; suivant : 000773

Adverse 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.

RBID : Pascal:05-0350454

Descripteurs français

Pascal (Inist)
- Toxicité, Toxicomanie, Prospective, Pharmacovigilance, France, Midodrine, Heptaminol, Homme, Antihypertenseur, Vasodilatateur coronarien, Antiangoreux, Cardiotonique.
Wicri :
- geographic : France.
- topic : Toxicomanie, Prospective, Homme.

English descriptors

KwdEn :
- Antianginal agent, Antihypertensive agent, Cardiotonic agent, Coronary vasodilator agent, Drug addiction, France, Heptaminol, Human, Midodrine, Pharmacovigilance, Prospective, Toxicity.

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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A14	`02`			`@1 Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, 37 allées Jules Guesde @2 31073 Toulouse @3 FRA @Z 1 aut. @Z 4 aut.`
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C01	`01`		`ENG`	@0 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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Le document en format XML

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<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>
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<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>
</record>

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	La maladie de Parkinson en France (serveur d'exploration)
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La maladie de Parkinson en France (serveur d'exploration)

Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France

Adverse drug reactions related to drugs used in orthostatic hypotension : a prospective and systematic pharmacovigilance study in France

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