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Randomized trial comparing primidone initiation schedules for treating essential tremor
Author(s) -
O'Suilleabhain Padraig,
Dewey Richard B.
Publication year - 2002
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.10083
Subject(s) - tolerability , primidone , medicine , essential tremor , anesthesia , confidence interval , randomized controlled trial , side effect (computer science) , adverse effect , surgery , epilepsy , anticonvulsant , physical medicine and rehabilitation , psychiatry , computer science , programming language
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. © 2002 Movement Disorder Society.