Adverse drug reactions to selegiline : A review of the French Pharmacovigilance Database
Identifieur interne : 003C14 ( Main/Exploration ); précédent : 003C13; suivant : 003C15Adverse drug reactions to selegiline : A review of the French Pharmacovigilance Database
Auteurs : Jean-Louis Montastruc [France] ; Cathy Chaumerliac [France] ; Karine Desboeuf [France] ; Mimosa Manika [France] ; Haleh Bagheri [France] ; Olivier Rascol [France] ; Maryse Lapeyre-Mestre [France]Source :
- Clinical neuropharmacology [ 0362-5664 ] ; 2000.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Base de données, Homme, Mortalité.
English descriptors
- KwdEn :
Abstract
The present pharmacoepidemiologic study was performed to characterize the profile of adverse drug reactions (ADRs) reported with selegiline, a monoamine oxidase B (MAO-B) inhibitor used in the treatment of Parkinson's disease and previously reported to induce an excess of mortality. The analysis was performed with use of the French Pharmacovigilance Database between 1989 and 1997.This database includes all ADRs reported by French practitioners (and especially "serious" and "unexpected" ADRs). Three different analyses were performed: identification of ADRs reported with selegiline, comparison with the ADR profile observed with other antiparkinsonian drugs, and a case/non-case study investigating the occurrence of cardiovascular ADRs with selegiline in comparison with other drugs in general and other antiparkinsonian drugs (e.g., levodopa [L-Dopa], dopamine agonists) in particular. The most often reported ADRs with selegiline were psychiatric (delirium, hallucinations, agitations), cardiovascular (orthostatic hypotension, arterial hypertension, etc.) and neurologic (sedation, abnormal movements, etc.). Psychiatric and cardiovascular ADRs were more frequently reported with selegiline than with L-Dopa or dopamine agonists. The case/ non-case study found an increased risk of cardiovascular ADRs (OR = 1.72; 95% CI = 1.16-2.55) when selegiline was associated with L-Dopa. These data show that the profile of selegiline-induced ADRs differs from that of other antiparkinsonian drugs (L-Dopa, dopamine agonists) with more psychiatric and cardiovascular ADRs. We suggest that the higher frequency of cardiovascular ADRs could explain, at least partially, the previously reported increase in mortality rate.
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Desboeuf</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Pharmacology, Centre Midi-Pyrénées de Pharmacovigilance, de PharmacoÉpidemiologie et d'Informations sur le Médicament, Faculté de Medecine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Manika, Mimosa" sort="Manika, Mimosa" uniqKey="Manika M" first="Mimosa" last="Manika">Mimosa Manika</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Pharmacology, Centre Midi-Pyrénées de Pharmacovigilance, de PharmacoÉpidemiologie et d'Informations sur le Médicament, Faculté de Medecine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>1 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type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Pharmacology, Centre Midi-Pyrénées de Pharmacovigilance, de PharmacoÉpidemiologie et d'Informations sur le Médicament, Faculté de Medecine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Lapeyre Mestre, Maryse" sort="Lapeyre Mestre, Maryse" uniqKey="Lapeyre Mestre M" first="Maryse" last="Lapeyre-Mestre">Maryse Lapeyre-Mestre</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Pharmacology, Centre Midi-Pyrénées de Pharmacovigilance, de PharmacoÉpidemiologie et d'Informations sur le Médicament, Faculté de Medecine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Clinical neuropharmacology</title><title level="j" type="abbreviated">Clin. neuropharmacol.</title><idno type="ISSN">0362-5664</idno><imprint><date when="2000">2000</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Clinical neuropharmacology</title><title level="j" type="abbreviated">Clin. neuropharmacol.</title><idno type="ISSN">0362-5664</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson agent</term><term>Cardiovascular disease</term><term>Central nervous system disease</term><term>Chemotherapy</term><term>Database</term><term>Epidemiology</term><term>Heart disease</term><term>Human</term><term>MAO B inhibitor</term><term>Mortality</term><term>Nervous system diseases</term><term>Organic mental disorder</term><term>Parkinson disease</term><term>Pharmacovigilance</term><term>Selegiline</term><term>Toxicity</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Sélégiline</term><term>Antiparkinsonien</term><term>IMAO B</term><term>Parkinson maladie</term><term>Appareil circulatoire pathologie</term><term>Cardiopathie</term><term>Base donnée</term><term>Pharmacovigilance</term><term>Epidémiologie</term><term>Homme</term><term>Traitement</term><term>Chimiothérapie</term><term>Toxicité</term><term>Mortalité</term><term>Système nerveux pathologie</term><term>Système nerveux central pathologie</term><term>Trouble mental organique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Base de données</term><term>Homme</term><term>Mortalité</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The present pharmacoepidemiologic study was performed to characterize the profile of adverse drug reactions (ADRs) reported with selegiline, a monoamine oxidase B (MAO-B) inhibitor used in the treatment of Parkinson's disease and previously reported to induce an excess of mortality. The analysis was performed with use of the French Pharmacovigilance Database between 1989 and 1997.This database includes all ADRs reported by French practitioners (and especially "serious" and "unexpected" ADRs). Three different analyses were performed: identification of ADRs reported with selegiline, comparison with the ADR profile observed with other antiparkinsonian drugs, and a case/non-case study investigating the occurrence of cardiovascular ADRs with selegiline in comparison with other drugs in general and other antiparkinsonian drugs (e.g., levodopa [L-Dopa], dopamine agonists) in particular. The most often reported ADRs with selegiline were psychiatric (delirium, hallucinations, agitations), cardiovascular (orthostatic hypotension, arterial hypertension, etc.) and neurologic (sedation, abnormal movements, etc.). Psychiatric and cardiovascular ADRs were more frequently reported with selegiline than with L-Dopa or dopamine agonists. The case/ non-case study found an increased risk of cardiovascular ADRs (OR = 1.72; 95% CI = 1.16-2.55) when selegiline was associated with L-Dopa. These data show that the profile of selegiline-induced ADRs differs from that of other antiparkinsonian drugs (L-Dopa, dopamine agonists) with more psychiatric and cardiovascular ADRs. We suggest that the higher frequency of cardiovascular ADRs could explain, at least partially, the previously reported increase in mortality rate.</div></front></TEI><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="Montastruc, Jean Louis" sort="Montastruc, Jean Louis" uniqKey="Montastruc J" first="Jean-Louis" last="Montastruc">Jean-Louis Montastruc</name></region><name sortKey="Bagheri, Haleh" sort="Bagheri, Haleh" uniqKey="Bagheri H" first="Haleh" last="Bagheri">Haleh Bagheri</name><name sortKey="Chaumerliac, Cathy" sort="Chaumerliac, Cathy" uniqKey="Chaumerliac C" first="Cathy" last="Chaumerliac">Cathy Chaumerliac</name><name sortKey="Desboeuf, Karine" sort="Desboeuf, Karine" uniqKey="Desboeuf K" first="Karine" last="Desboeuf">Karine Desboeuf</name><name sortKey="Lapeyre Mestre, Maryse" sort="Lapeyre Mestre, Maryse" uniqKey="Lapeyre Mestre M" first="Maryse" last="Lapeyre-Mestre">Maryse Lapeyre-Mestre</name><name sortKey="Manika, Mimosa" sort="Manika, Mimosa" uniqKey="Manika M" first="Mimosa" last="Manika">Mimosa Manika</name><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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