Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Identifieur interne : 000788 ( PubMed/Corpus ); précédent : 000787; suivant : 000789Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Auteurs : François Viallet ; Séverine Pitel ; Sylvie Lancrenon ; Olivier BlinSource :
- Current medical research and opinion [ 1473-4877 ] ; 2013.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Benzothiazoles (administration & dosage), Benzothiazoles (adverse effects), Double-Blind Method, Female, Gastrointestinal Diseases (chemically induced), Humans, Indans (administration & dosage), Indans (adverse effects), Male, Middle Aged, Monoamine Oxidase Inhibitors (administration & dosage), Monoamine Oxidase Inhibitors (adverse effects), Parkinson Disease (drug therapy), Sleep Wake Disorders (chemically induced), Time Factors.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Benzothiazoles, Indans, Monoamine Oxidase Inhibitors.
- chemical , adverse effects : Antiparkinson Agents, Benzothiazoles, Indans, Monoamine Oxidase Inhibitors.
- chemically induced : Gastrointestinal Diseases, Sleep Wake Disorders.
- drug therapy : Parkinson Disease.
- Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Time Factors.
Abstract
Rasagiline is a second-generation, irreversible MAO-B inhibitor (MAOB-I) previously shown to be efficacious and well-tolerated compared to placebo in the treatment of early Parkinson's disease (PD). ACTOR (ACceptabilité TOlérance Rasagiline) was a 15-week, multi-center, randomized, double-blind study aimed to assess the safety and tolerability of rasagiline compared to the dopaminergic agonist pramipexole in the treatment of early PD.
DOI: 10.1185/03007995.2012.752351
PubMed: 23176073
Links to Exploration step
pubmed:23176073Le document en format XML
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<author><name sortKey="Viallet, Francois" sort="Viallet, Francois" uniqKey="Viallet F" first="François" last="Viallet">François Viallet</name>
<affiliation><nlm:affiliation>Centre Hospitalier du Pays d’Aix, Aix-en-Provence, France.</nlm:affiliation>
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</author>
<author><name sortKey="Pitel, Severine" sort="Pitel, Severine" uniqKey="Pitel S" first="Séverine" last="Pitel">Séverine Pitel</name>
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<author><name sortKey="Lancrenon, Sylvie" sort="Lancrenon, Sylvie" uniqKey="Lancrenon S" first="Sylvie" last="Lancrenon">Sylvie Lancrenon</name>
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<author><name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name>
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<author><name sortKey="Pitel, Severine" sort="Pitel, Severine" uniqKey="Pitel S" first="Séverine" last="Pitel">Séverine Pitel</name>
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<term>Benzothiazoles (administration & dosage)</term>
<term>Benzothiazoles (adverse effects)</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Gastrointestinal Diseases (chemically induced)</term>
<term>Humans</term>
<term>Indans (administration & dosage)</term>
<term>Indans (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Monoamine Oxidase Inhibitors (administration & dosage)</term>
<term>Monoamine Oxidase Inhibitors (adverse effects)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Sleep Wake Disorders (chemically induced)</term>
<term>Time Factors</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Benzothiazoles</term>
<term>Indans</term>
<term>Monoamine Oxidase Inhibitors</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Benzothiazoles</term>
<term>Indans</term>
<term>Monoamine Oxidase Inhibitors</term>
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<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Gastrointestinal Diseases</term>
<term>Sleep Wake Disorders</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
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<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Double-Blind Method</term>
<term>Female</term>
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<front><div type="abstract" xml:lang="en">Rasagiline is a second-generation, irreversible MAO-B inhibitor (MAOB-I) previously shown to be efficacious and well-tolerated compared to placebo in the treatment of early Parkinson's disease (PD). ACTOR (ACceptabilité TOlérance Rasagiline) was a 15-week, multi-center, randomized, double-blind study aimed to assess the safety and tolerability of rasagiline compared to the dopaminergic agonist pramipexole in the treatment of early PD.</div>
</front>
</TEI>
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<DateCreated><Year>2012</Year>
<Month>12</Month>
<Day>19</Day>
</DateCreated>
<DateCompleted><Year>2013</Year>
<Month>05</Month>
<Day>23</Day>
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<DateRevised><Year>2015</Year>
<Month>11</Month>
<Day>19</Day>
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<JournalIssue CitedMedium="Internet"><Volume>29</Volume>
<Issue>1</Issue>
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<Month>Jan</Month>
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<Title>Current medical research and opinion</Title>
<ISOAbbreviation>Curr Med Res Opin</ISOAbbreviation>
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<ArticleTitle>Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.</ArticleTitle>
<Pagination><MedlinePgn>23-31</MedlinePgn>
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<ELocationID EIdType="doi" ValidYN="Y">10.1185/03007995.2012.752351</ELocationID>
<Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Rasagiline is a second-generation, irreversible MAO-B inhibitor (MAOB-I) previously shown to be efficacious and well-tolerated compared to placebo in the treatment of early Parkinson's disease (PD). ACTOR (ACceptabilité TOlérance Rasagiline) was a 15-week, multi-center, randomized, double-blind study aimed to assess the safety and tolerability of rasagiline compared to the dopaminergic agonist pramipexole in the treatment of early PD.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients with early, untreated idiopathic PD were randomized to receive 1 mg rasagiline (n = 53) or 1.5 mg pramipexole (n = 56) daily. The primary outcome was the number of patients experiencing a 'clinically important adverse event' (classified as a serious adverse event, an event leading to withdrawal or severe according to the patient). Safety outcomes were evaluated by the investigator and the patient. Analysis of the primary criterion was a comparative analysis using the chi-squared test. The Wilcoxon Mann-Whitney test was conducted to test the severity of patient-reported adverse events. Other tests performed include a covariance analysis and Student's t-tests.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Mean disease duration was 3.4 months, and mean age was 62.6 years. Of patients taking pramipexole, 44.6% reported at least one 'clinically important' adverse event compared to 32.1% of patients taking rasagiline; non-inferiority of rasagiline was reached, with a difference in proportions of -12.6% [confidence interval of -27.8%; 2.6%]. There were no significant differences in clinical effectiveness between the treatments, measured by clinical and patient global impression of improvement (CGI-I, PGI-I) and PDQ-8 scales. A significant decrease in the incidence of gastrointestinal symptoms (p = 0.015) and sleep disorders (p = 0.027) was reported by physicians in the rasagiline group compared to the pramipexole group; the propensity to sleepiness improved significantly in the rasagiline group (p = 0.020), and worsened in the pramipexole group (p = 0.042).</AbstractText>
<AbstractText Label="LIMITATIONS" NlmCategory="CONCLUSIONS">Limitations of this study include the limited sample size due to the lower than anticipated recruitment and the accidental inclusion of a patient who had taken contraindicated medication.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In this study, the safety profile of rasagiline had clinically favorable differences in gastrointestinal and sleep adverse events compared to pramipexole, whilst showing comparable clinician and patient-rated clinical effectiveness as a monotherapy for the treatment of early idiopathic PD.</AbstractText>
</Abstract>
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<ForeName>François</ForeName>
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