Randomized trial comparing primidone initiation schedules for treating essential tremor.
Identifieur interne : 006131 ( Main/Merge ); précédent : 006130; suivant : 006132Randomized trial comparing primidone initiation schedules for treating essential tremor.
Auteurs : Padraig O'Suilleabhain [États-Unis] ; Richard B. DeweySource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2002.
English descriptors
- KwdEn :
- Administration, Oral, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Essential Tremor (diagnosis), Essential Tremor (drug therapy), Female, Humans, Male, Middle Aged, Primidone (administration & dosage), Primidone (adverse effects).
- MESH :
- chemical , administration & dosage : Primidone.
- chemical , adverse effects : Primidone.
- diagnosis : Essential Tremor.
- drug therapy : Essential Tremor.
- Administration, Oral, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged.
Abstract
Early side effects are common when primidone is used to treat essential tremor, with as many as one-third of patients failing to tolerate the tablets. Lower doses can be prescribed initially using a suspension formulation. We suspected suspension initiation would result in fewer early side effects, allow better acclimatization, and improve compliance. Forty patients with essential tremor were randomized to begin primidone treatment using either 2.5 mg doses in the suspension form or 25 mg doses in the tablet form. Doses gradually increased over 3 weeks to 150 mg/day. This was a double-blind, double-dummy trial. Medication cessation due to side effects was designated the primary end-point. Four patients in the suspension group and two in the tablet group dropped out due to early side effects, resulting in a relative risk of 1.9 (95% confidence interval 0.4 to 9.2). Side effects in the first 48 hours of treatment were equally common, affecting seven subjects in each group. Treatment benefits were the same in both groups. We concluded that use of a very low initial dose and a graduated titration schedule in suspension formulation did not appear to improve primidone tolerability. If anything, compliance tended to be worse when compared with the tablet formulation, though the study was under-powered to reject the null hypothesis of equivalence.
PubMed: 11921128
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pubmed:11921128Le document en format XML
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Dewey</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2002">2002</date><idno type="RBID">pubmed:11921128</idno><idno type="pmid">11921128</idno><idno type="wicri:Area/PubMed/Corpus">003B17</idno><idno type="wicri:Area/PubMed/Curation">003B17</idno><idno type="wicri:Area/PubMed/Checkpoint">003957</idno><idno type="wicri:Area/Ncbi/Merge">000734</idno><idno type="wicri:Area/Ncbi/Curation">000734</idno><idno type="wicri:Area/Ncbi/Checkpoint">000734</idno><idno type="wicri:doubleKey">0885-3185:2002:O Suilleabhain P:randomized:trial:comparing</idno><idno type="wicri:Area/Main/Merge">006131</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Randomized trial comparing primidone initiation schedules for treating essential tremor.</title><author><name sortKey="O Suilleabhain, Padraig" sort="O Suilleabhain, Padraig" uniqKey="O Suilleabhain P" first="Padraig" last="O'Suilleabhain">Padraig O'Suilleabhain</name><affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Texas, USA. padraig.osuilleabhain@UTSouthwestern.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Texas</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Dewey, Richard B" sort="Dewey, Richard B" uniqKey="Dewey R" first="Richard B" last="Dewey">Richard B. Dewey</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2002" type="published">2002</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Essential Tremor (diagnosis)</term><term>Essential Tremor (drug therapy)</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Primidone (administration & dosage)</term><term>Primidone (adverse effects)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Primidone</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Primidone</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Essential Tremor</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Essential Tremor</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Early side effects are common when primidone is used to treat essential tremor, with as many as one-third of patients failing to tolerate the tablets. Lower doses can be prescribed initially using a suspension formulation. We suspected suspension initiation would result in fewer early side effects, allow better acclimatization, and improve compliance. Forty patients with essential tremor were randomized to begin primidone treatment using either 2.5 mg doses in the suspension form or 25 mg doses in the tablet form. Doses gradually increased over 3 weeks to 150 mg/day. This was a double-blind, double-dummy trial. Medication cessation due to side effects was designated the primary end-point. Four patients in the suspension group and two in the tablet group dropped out due to early side effects, resulting in a relative risk of 1.9 (95% confidence interval 0.4 to 9.2). Side effects in the first 48 hours of treatment were equally common, affecting seven subjects in each group. Treatment benefits were the same in both groups. We concluded that use of a very low initial dose and a graduated titration schedule in suspension formulation did not appear to improve primidone tolerability. If anything, compliance tended to be worse when compared with the tablet formulation, though the study was under-powered to reject the null hypothesis of equivalence.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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