A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients.
Identifieur interne : 000F06 ( Main/Exploration ); précédent : 000F05; suivant : 000F07A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients.
Auteurs : Fabrizio Stocchi [Italie] ; Rupam Borgohain ; Marco Onofrj ; Anthony H V. Schapira ; Mohit Bhatt ; Valentina Lucini ; Rodolfo Giuliani ; Ravi AnandSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2012.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Alanine (analogs & derivatives), Alanine (pharmacokinetics), Alanine (therapeutic use), Analysis of Variance, Antiparkinson Agents (pharmacokinetics), Antiparkinson Agents (therapeutic use), Benzylamines (pharmacokinetics), Benzylamines (therapeutic use), Dopamine Agonists (pharmacology), Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, International Cooperation, Male, Middle Aged, Parkinson Disease (drug therapy), Retrospective Studies, Severity of Illness Index.
- MESH :
- chemical , analogs & derivatives : Alanine.
- chemical , pharmacokinetics : Alanine, Antiparkinson Agents, Benzylamines.
- chemical , pharmacology : Dopamine Agonists.
- chemical , therapeutic use : Alanine, Antiparkinson Agents, Benzylamines.
- drug therapy : Parkinson Disease.
- Adult, Aged, Aged, 80 and over, Analysis of Variance, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, International Cooperation, Male, Middle Aged, Retrospective Studies, Severity of Illness Index.
Abstract
Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.
DOI: 10.1002/mds.23954
PubMed: 21913224
Affiliations:
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Le document en format XML
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Schapira</name></author><author><name sortKey="Bhatt, Mohit" sort="Bhatt, Mohit" uniqKey="Bhatt M" first="Mohit" last="Bhatt">Mohit Bhatt</name></author><author><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name></author><author><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name></author><author><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2012">2012</date><idno type="doi">10.1002/mds.23954</idno><idno type="RBID">pubmed:21913224</idno><idno type="pmid">21913224</idno><idno type="wicri:Area/PubMed/Corpus">001056</idno><idno type="wicri:Area/PubMed/Curation">001056</idno><idno type="wicri:Area/PubMed/Checkpoint">000F66</idno><idno type="wicri:Area/Ncbi/Merge">003374</idno><idno type="wicri:Area/Ncbi/Curation">003374</idno><idno type="wicri:Area/Ncbi/Checkpoint">003374</idno><idno type="wicri:Area/Main/Merge">000F56</idno><idno type="wicri:Area/Main/Curation">000F06</idno><idno type="wicri:Area/Main/Exploration">000F06</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients.</title><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neuroscience, IRCCS San Raffaele, Rome, Italy. fabstocc@tin.it</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neuroscience, IRCCS San Raffaele, Rome</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name></author><author><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H V" last="Schapira">Anthony H V. Schapira</name></author><author><name sortKey="Bhatt, Mohit" sort="Bhatt, Mohit" uniqKey="Bhatt M" first="Mohit" last="Bhatt">Mohit Bhatt</name></author><author><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name></author><author><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name></author><author><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</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="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Alanine (analogs & derivatives)</term><term>Alanine (pharmacokinetics)</term><term>Alanine (therapeutic use)</term><term>Analysis of Variance</term><term>Antiparkinson Agents (pharmacokinetics)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Benzylamines (pharmacokinetics)</term><term>Benzylamines (therapeutic use)</term><term>Dopamine Agonists (pharmacology)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>International Cooperation</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Retrospective Studies</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Alanine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Alanine</term><term>Antiparkinson Agents</term><term>Benzylamines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Dopamine Agonists</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Alanine</term><term>Antiparkinson Agents</term><term>Benzylamines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>International Cooperation</term><term>Male</term><term>Middle Aged</term><term>Retrospective Studies</term><term>Severity of Illness Index</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.</div></front></TEI><affiliations><list><country><li>Italie</li></country><region><li>Latium</li></region><settlement><li>Rome</li></settlement></list><tree><noCountry><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name><name sortKey="Bhatt, Mohit" sort="Bhatt, Mohit" uniqKey="Bhatt M" first="Mohit" last="Bhatt">Mohit Bhatt</name><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H V" last="Schapira">Anthony H V. Schapira</name></noCountry><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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