MovDisordV3, PubMed, Checkpoint, bibRecord, 000455

Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease.

Identifieur interne : 000455 ( PubMed/Checkpoint ); précédent : 000454; suivant : 000456

Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease.

Auteurs : Robert A. Hauser [États-Unis] ; Dee Silver ; Azhar Choudhry ; Eli Eyal ; Stuart Isaacson

Source :

Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.

RBID : pubmed:24919813

Descripteurs français

Wicri :
- geographic : États-Unis.

English descriptors

KwdEn :
- Aged, Dopamine Agonists (therapeutic use), Double-Blind Method, Female, Humans, Indans (therapeutic use), Male, Middle Aged, Neuroprotective Agents (therapeutic use), Outcome Assessment (Health Care), Parkinson Disease (drug therapy), Severity of Illness Index, Time Factors, United States.
MESH :
- chemical , therapeutic use : Dopamine Agonists, Indans, Neuroprotective Agents.
- geographic : United States.
- drug therapy : Parkinson Disease.
- Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Outcome Assessment (Health Care), Severity of Illness Index, Time Factors.

Abstract

Dopamine agonists (DA) are often used as first-line monotherapy for the symptomatic control of Parkinson's disease (PD). However, DA monotherapy typically becomes inadequate within a few years, at which time the DA dosage must be increased or other antiparkinsonian medications added. Adding a monoamine oxidase-B (MAO-B) inhibitor to DA monotherapy might improve symptomatic control while maintaining good safety and tolerability. We conducted an 18-week, randomized, double-blind, placebo-controlled trial of rasagiline 1 mg/d as an add-on to DA therapy (ropinirole ≥ 6 mg/d or pramipexole ≥ 1.0 mg/d) in early PD patients whose conditions were not adequately controlled on their current treatment regimen. The primary efficacy variable was the change in total Unified Parkinson Disease Rating Scale (UPDRS) score (sum of parts I, II, and III) from baseline to week 18, comparing rasagiline and placebo groups. The modified intent-to-treat (ITT) population included 321 subjects whose mean ± SD age was 62.6 ± 9.7, and duration of PD was 2.1 ± 2.1 years. Results demonstrated a significantly greater improvement in total UPDRS scores from baseline to week 18 in the rasagiline group compared with the placebo group (least squares [LS] mean difference ± SE, -2.4 ± 0.95; 95% confidence interval [CI], -4.3, -0.5; P = 0.012). Mean improvement (LS mean ± SE) was -3.6 ± 0.68 in the rasagiline group and -1.2 ± 0.68 in the placebo group. Rasagiline was well tolerated, and the most common adverse events (AEs; rasagiline vs. placebo) were dizziness (7.4% vs. 6.1%), somnolence (6.8% vs. 6.7%), and headache (6.2% vs. 4.3%). Rasagiline 1 mg/d provided statistically significant improvement when added to dopamine agonist therapy and was well tolerated.

DOI: 10.1002/mds.25877
PubMed: 24919813

Affiliations:

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Le document en format XML

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<author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name>
<affiliation wicri:level="4"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida</wicri:regionArea>
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<author><name sortKey="Silver, Dee" sort="Silver, Dee" uniqKey="Silver D" first="Dee" last="Silver">Dee Silver</name>
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<author><name sortKey="Choudhry, Azhar" sort="Choudhry, Azhar" uniqKey="Choudhry A" first="Azhar" last="Choudhry">Azhar Choudhry</name>
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<author><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name>
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<author><name sortKey="Silver, Dee" sort="Silver, Dee" uniqKey="Silver D" first="Dee" last="Silver">Dee Silver</name>
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<term>Male</term>
<term>Middle Aged</term>
<term>Neuroprotective Agents (therapeutic use)</term>
<term>Outcome Assessment (Health Care)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>United States</term>
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<term>Outcome Assessment (Health Care)</term>
<term>Severity of Illness Index</term>
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<front><div type="abstract" xml:lang="en">Dopamine agonists (DA) are often used as first-line monotherapy for the symptomatic control of Parkinson's disease (PD). However, DA monotherapy typically becomes inadequate within a few years, at which time the DA dosage must be increased or other antiparkinsonian medications added. Adding a monoamine oxidase-B (MAO-B) inhibitor to DA monotherapy might improve symptomatic control while maintaining good safety and tolerability. We conducted an 18-week, randomized, double-blind, placebo-controlled trial of rasagiline 1 mg/d as an add-on to DA therapy (ropinirole ≥ 6 mg/d or pramipexole ≥ 1.0 mg/d) in early PD patients whose conditions were not adequately controlled on their current treatment regimen. The primary efficacy variable was the change in total Unified Parkinson Disease Rating Scale (UPDRS) score (sum of parts I, II, and III) from baseline to week 18, comparing rasagiline and placebo groups. The modified intent-to-treat (ITT) population included 321 subjects whose mean ± SD age was 62.6 ± 9.7, and duration of PD was 2.1 ± 2.1 years. Results demonstrated a significantly greater improvement in total UPDRS scores from baseline to week 18 in the rasagiline group compared with the placebo group (least squares [LS] mean difference ± SE, -2.4 ± 0.95; 95% confidence interval [CI], -4.3, -0.5; P = 0.012). Mean improvement (LS mean ± SE) was -3.6 ± 0.68 in the rasagiline group and -1.2 ± 0.68 in the placebo group. Rasagiline was well tolerated, and the most common adverse events (AEs; rasagiline vs. placebo) were dizziness (7.4% vs. 6.1%), somnolence (6.8% vs. 6.7%), and headache (6.2% vs. 4.3%). Rasagiline 1 mg/d provided statistically significant improvement when added to dopamine agonist therapy and was well tolerated.</div>
</front>
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<CopyrightInformation>© 2014 International Parkinson and Movement Disorder Society.</CopyrightInformation>
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<country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name>
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Movement Disorders (revue)

Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease.

Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease.

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki