Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Identifieur interne : 000755 ( PubMed/Curation ); précédent : 000754; suivant : 000756Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Auteurs : François Viallet [France] ; 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
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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><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23176073</PMID><DateCreated><Year>2012</Year><Month>12</Month><Day>19</Day></DateCreated><DateCompleted><Year>2013</Year><Month>05</Month><Day>23</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1473-4877</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>1</Issue><PubDate><Year>2013</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Current medical research and opinion</Title><ISOAbbreviation>Curr Med Res Opin</ISOAbbreviation></Journal><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></Pagination><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><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Viallet</LastName><ForeName>François</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Centre Hospitalier du Pays d’Aix, Aix-en-Provence, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pitel</LastName><ForeName>Séverine</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Lancrenon</LastName><ForeName>Sylvie</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Blin</LastName><ForeName>Olivier</ForeName><Initials>O</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017429">Clinical Trial, Phase IV</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>12</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Curr Med Res Opin</MedlineTA><NlmUniqueID>0351014</NlmUniqueID><ISSNLinking>0300-7995</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D052160">Benzothiazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007189">Indans</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008996">Monoamine Oxidase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>003N66TS6T</RegistryNumber><NameOfSubstance UI="C031967">rasagiline</NameOfSubstance></Chemical><Chemical><RegistryNumber>83619PEU5T</RegistryNumber><NameOfSubstance UI="C061333">pramipexole</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000978" MajorTopicYN="N">Antiparkinson Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D052160" MajorTopicYN="N">Benzothiazoles</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005767" MajorTopicYN="N">Gastrointestinal Diseases</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007189" MajorTopicYN="N">Indans</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008996" MajorTopicYN="N">Monoamine Oxidase Inhibitors</DescriptorName><QualifierName 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