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Randomized trial comparing primidone initiation schedules for treating essential tremor.

Padraig O'Suilleabhain1, Richard B Dewey

  • 1Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Texas, USA. padraig.osuilleabhain@UTSouthwestern.edu

Movement Disorders : Official Journal of the Movement Disorder Society
|March 29, 2002
PubMed
Summary

Starting primidone for essential tremor with a suspension formulation did not reduce early side effects or improve tolerability compared to tablets. Compliance may even be worse with the suspension, though more research is needed.

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Area of Science:

  • Neurology
  • Pharmacology

Background:

  • Essential tremor is a neurological condition often treated with primidone.
  • Early side effects limit primidone tolerability in up to one-third of patients.
  • A suspension formulation allows for lower initial doses, potentially improving tolerability.

Purpose of the Study:

  • To compare the tolerability and compliance of primidone initiation using suspension versus tablet formulations.
  • To determine if a lower initial dose in suspension reduces early side effects in essential tremor patients.

Main Methods:

  • A double-blind, double-dummy randomized trial involving 40 essential tremor patients.
  • Patients were randomized to initiate primidone at 2.5 mg (suspension) or 25 mg (tablet).
  • Doses were gradually increased over 3 weeks to 150 mg/day, with medication cessation due to side effects as the primary endpoint.

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Main Results:

  • No significant difference in medication cessation due to early side effects between suspension and tablet groups (Relative Risk 1.9).
  • Early side effects were equally common in both groups within the first 48 hours.
  • Treatment benefits were comparable, but compliance tended to be worse in the suspension group.

Conclusions:

  • Initiating primidone with a very low initial dose in suspension formulation did not improve tolerability for essential tremor.
  • The suspension formulation did not appear to offer advantages over the tablet form regarding early side effect incidence.
  • The study was underpowered to definitively conclude on equivalence, suggesting further investigation into compliance differences.