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Efficacy and tolerability of rasagiline in daily clinical use – a post‐marketing observational study in patients with Parkinson’s disease

Identifieur interne : 000944 ( Main/Corpus ); précédent : 000943; suivant : 000945

Efficacy and tolerability of rasagiline in daily clinical use – a post‐marketing observational study in patients with Parkinson’s disease

Auteurs : H. Reichmann ; W. H. Jost

Source :

RBID : ISTEX:5E8B3A4574D46E0EF8E935E2460D8529BBA7027B

English descriptors

Abstract

Background:  The MAO‐B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson’s disease (PD), and its use is supported by evidence from large‐scale, controlled clinical studies. The post‐marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. Methods:  The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire‐39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician’s global judgement of tolerability and efficacy were also examined. Results:  Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non‐classical motor/non‐motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. Conclusions:  In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

Url:
DOI: 10.1111/j.1468-1331.2010.02986.x

Links to Exploration step

ISTEX:5E8B3A4574D46E0EF8E935E2460D8529BBA7027B

Le document en format XML

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<b>Methods: </b>
The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire‐39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician’s global judgement of tolerability and efficacy were also examined.</p>
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<b>Results: </b>
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<b>Conclusions: </b>
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<edition>Received 3 September 2009 Accepted 20 January 2010</edition>
<copyrightDate encoding="w3cdtf">2010</copyrightDate>
</originInfo>
<language>
<languageTerm type="code" authority="rfc3066">en</languageTerm>
<languageTerm type="code" authority="iso639-2b">eng</languageTerm>
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<extent unit="figures">3</extent>
<extent unit="tables">3</extent>
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<abstract lang="en">Background:  The MAO‐B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson’s disease (PD), and its use is supported by evidence from large‐scale, controlled clinical studies. The post‐marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. Methods:  The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire‐39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician’s global judgement of tolerability and efficacy were also examined. Results:  Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non‐classical motor/non‐motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. Conclusions:  In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).</abstract>
<subject lang="en">
<genre>Keywords</genre>
<topic>combination therapy</topic>
<topic>monotherapy</topic>
<topic>Parkinson’s disease</topic>
<topic>quality of life</topic>
<topic>rasagiline</topic>
<topic>switch</topic>
</subject>
<relatedItem type="host">
<titleInfo>
<title>European Journal of Neurology</title>
</titleInfo>
<genre type="Journal">journal</genre>
<identifier type="ISSN">1351-5101</identifier>
<identifier type="eISSN">1468-1331</identifier>
<identifier type="DOI">10.1111/(ISSN)1468-1331</identifier>
<identifier type="PublisherID">ENE</identifier>
<part>
<date>2010</date>
<detail type="volume">
<caption>vol.</caption>
<number>17</number>
</detail>
<detail type="issue">
<caption>no.</caption>
<number>9</number>
</detail>
<extent unit="pages">
<start>1164</start>
<end>1171</end>
<total>8</total>
</extent>
</part>
</relatedItem>
<identifier type="istex">5E8B3A4574D46E0EF8E935E2460D8529BBA7027B</identifier>
<identifier type="DOI">10.1111/j.1468-1331.2010.02986.x</identifier>
<identifier type="ArticleID">ENE2986</identifier>
<accessCondition type="use and reproduction" contentType="copyright">© 2010 The Author(s). European Journal of Neurology © 2010 EFNS</accessCondition>
<recordInfo>
<recordContentSource>WILEY</recordContentSource>
<recordOrigin>Blackwell Publishing Ltd</recordOrigin>
</recordInfo>
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</metadata>
<serie></serie>
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