MovDisordV3, PascalFrancis, Curation, bibRecord, 000537

Randomized trial comparing primidone initiation schedules for treating essential tremor

Identifieur interne : 000537 ( PascalFrancis/Curation ); précédent : 000536; suivant : 000538

Randomized trial comparing primidone initiation schedules for treating essential tremor

Auteurs : Padraig O'Suilleabhain [États-Unis] ; Richard B. Jr Dewey [États-Unis]

Source :

Movement disorders [ 0885-3185 ] ; 2002.

RBID : Pascal:02-0311360

Descripteurs français

Pascal (Inist)
- Tremblement, Essentiel, Primidone, Anticonvulsivant, Dose faible, Chimiothérapie, Traitement, Initiation, Homme, Effet secondaire, Pyrimidine dérivé.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Anticonvulsant, Chemotherapy, Essential, Human, Initiation, Low dose, Primidone, Pyrimidine derivatives, Secondary effect, Treatment, Tremor.

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.

A01	`01`	`1`		`@0 0885-3185`
A03		`1`		`@0 Mov. disord.`
A05				`@2 17`
A06				`@2 2`
A08	`01`	`1`	`ENG`	`@1 Randomized trial comparing primidone initiation schedules for treating essential tremor`
A11	`01`	`1`		`@1 O'SUILLEABHAIN (Padraig)`
A11	`02`	`1`		`@1 DEWEY (Richard B. JR)`
A14	`01`			`@1 Department of Neurology, University of Texas Southwestern Medical Center @2 Dallas, Texas @3 USA @Z 1 aut. @Z 2 aut.`
A20				`@1 382-386`
A21				`@1 2002`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 20953 @5 354000100907450230`
A44				`@0 0000 @1 © 2002 INIST-CNRS. All rights reserved.`
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A60				`@1 P @3 CC`
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C01	`01`		`ENG`	@0 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.
C02	`01`	`X`		`@0 002B02B06`
C02	`02`	`X`		`@0 002B17A01`
C03	`01`	`X`	`FRE`	`@0 Tremblement @5 01`
C03	`01`	`X`	`ENG`	`@0 Tremor @5 01`
C03	`01`	`X`	`SPA`	`@0 Temblor @5 01`
C03	`02`	`X`	`FRE`	`@0 Essentiel @5 02`
C03	`02`	`X`	`ENG`	`@0 Essential @5 02`
C03	`02`	`X`	`SPA`	`@0 Esencial @5 02`
C03	`03`	`X`	`FRE`	`@0 Primidone @2 NK @2 FR @5 04`
C03	`03`	`X`	`ENG`	`@0 Primidone @2 NK @2 FR @5 04`
C03	`03`	`X`	`SPA`	`@0 Primidona @2 NK @2 FR @5 04`
C03	`04`	`X`	`FRE`	`@0 Anticonvulsivant @5 05`
C03	`04`	`X`	`ENG`	`@0 Anticonvulsant @5 05`
C03	`04`	`X`	`SPA`	`@0 Anticonvulsivante @5 05`
C03	`05`	`X`	`FRE`	`@0 Dose faible @5 07`
C03	`05`	`X`	`ENG`	`@0 Low dose @5 07`
C03	`05`	`X`	`SPA`	`@0 Dosis débil @5 07`
C03	`06`	`X`	`FRE`	`@0 Chimiothérapie @5 16`
C03	`06`	`X`	`ENG`	`@0 Chemotherapy @5 16`
C03	`06`	`X`	`SPA`	`@0 Quimioterapia @5 16`
C03	`07`	`X`	`FRE`	`@0 Traitement @5 17`
C03	`07`	`X`	`ENG`	`@0 Treatment @5 17`
C03	`07`	`X`	`SPA`	`@0 Tratamiento @5 17`
C03	`08`	`X`	`FRE`	`@0 Initiation @5 18`
C03	`08`	`X`	`ENG`	`@0 Initiation @5 18`
C03	`08`	`X`	`SPA`	`@0 Iniciación @5 18`
C03	`09`	`X`	`FRE`	`@0 Homme @5 20`
C03	`09`	`X`	`ENG`	`@0 Human @5 20`
C03	`09`	`X`	`SPA`	`@0 Hombre @5 20`
C03	`10`	`X`	`FRE`	`@0 Effet secondaire @5 23`
C03	`10`	`X`	`ENG`	`@0 Secondary effect @5 23`
C03	`10`	`X`	`SPA`	`@0 Efecto secundario @5 23`
C03	`11`	`X`	`FRE`	`@0 Pyrimidine dérivé @5 27`
C03	`11`	`X`	`ENG`	`@0 Pyrimidine derivatives @5 27`
C03	`11`	`X`	`SPA`	`@0 Pirimidina derivado @5 27`
C07	`01`	`X`	`FRE`	`@0 Système nerveux pathologie @5 37`
C07	`01`	`X`	`ENG`	`@0 Nervous system diseases @5 37`
C07	`01`	`X`	`SPA`	`@0 Sistema nervioso patología @5 37`
C07	`02`	`X`	`FRE`	`@0 Trouble neurologique @5 38`
C07	`02`	`X`	`ENG`	`@0 Neurological disorder @5 38`
C07	`02`	`X`	`SPA`	`@0 Trastorno neurológico @5 38`
C07	`03`	`X`	`FRE`	`@0 Mouvement involontaire @5 39`
C07	`03`	`X`	`ENG`	`@0 Involuntary movement @5 39`
C07	`03`	`X`	`SPA`	`@0 Movimiento involuntario @5 39`
C07	`04`	`X`	`FRE`	`@0 Posologie @5 53`
C07	`04`	`X`	`ENG`	`@0 Posology @5 53`
C07	`04`	`X`	`SPA`	`@0 Posología @5 53`
N21				`@1 175`
N82				`@1 PSI`

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Pascal:02-0311360

Le document en format XML

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<s2>Dallas, Texas</s2>
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<author><name sortKey="Dewey, Richard B Jr" sort="Dewey, Richard B Jr" uniqKey="Dewey R" first="Richard B. Jr" last="Dewey">Richard B. Jr Dewey</name>
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<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>
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<fC01 i1="01" l="ENG"><s0>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.</s0>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Randomized trial comparing primidone initiation schedules for treating essential tremor

Randomized trial comparing primidone initiation schedules for treating essential tremor

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