Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease.
Identifieur interne : 000453 ( Main/Exploration ); précédent : 000452; suivant : 000454Randomized, 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 IsaacsonSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.
Descripteurs français
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- 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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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><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Silver, Dee" sort="Silver, Dee" uniqKey="Silver D" first="Dee" last="Silver">Dee Silver</name></author><author><name sortKey="Choudhry, Azhar" sort="Choudhry, Azhar" uniqKey="Choudhry A" first="Azhar" last="Choudhry">Azhar Choudhry</name></author><author><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name></author><author><name sortKey="Isaacson, Stuart" sort="Isaacson, Stuart" uniqKey="Isaacson S" first="Stuart" last="Isaacson">Stuart Isaacson</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24919813</idno><idno type="pmid">24919813</idno><idno type="doi">10.1002/mds.25877</idno><idno type="wicri:Area/PubMed/Corpus">000476</idno><idno type="wicri:Area/PubMed/Curation">000476</idno><idno type="wicri:Area/PubMed/Checkpoint">000455</idno><idno type="wicri:Area/Ncbi/Merge">004023</idno><idno type="wicri:Area/Ncbi/Curation">004023</idno><idno type="wicri:Area/Ncbi/Checkpoint">004023</idno><idno type="wicri:Area/Main/Merge">000453</idno><idno type="wicri:Area/Main/Curation">000453</idno><idno type="wicri:Area/Main/Exploration">000453</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease.</title><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><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Silver, Dee" sort="Silver, Dee" uniqKey="Silver D" first="Dee" last="Silver">Dee Silver</name></author><author><name sortKey="Choudhry, Azhar" sort="Choudhry, Azhar" uniqKey="Choudhry A" first="Azhar" last="Choudhry">Azhar Choudhry</name></author><author><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name></author><author><name sortKey="Isaacson, Stuart" sort="Isaacson, Stuart" uniqKey="Isaacson S" first="Stuart" last="Isaacson">Stuart Isaacson</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Dopamine Agonists (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Indans (therapeutic use)</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dopamine Agonists</term><term>Indans</term><term>Neuroprotective Agents</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Outcome Assessment (Health Care)</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term></keywords></textClass></profileDesc></teiHeader><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></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><noCountry><name sortKey="Choudhry, Azhar" sort="Choudhry, Azhar" uniqKey="Choudhry A" first="Azhar" last="Choudhry">Azhar Choudhry</name><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name><name sortKey="Isaacson, Stuart" sort="Isaacson, Stuart" uniqKey="Isaacson S" first="Stuart" last="Isaacson">Stuart Isaacson</name><name sortKey="Silver, Dee" sort="Silver, Dee" uniqKey="Silver D" first="Dee" last="Silver">Dee Silver</name></noCountry><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. 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