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The importance of studying history: lessons learnt from a trial of tacrolimus in myasthenia gravis
  1. Michael Benatar1,
  2. Donald Sanders2
  1. 1Neuromuscular Division, Department of Neurology, University of Miami, Miami, Florida, USA
  2. 2Duke University Medical School, Durham, North Carolina, USA
  1. Correspondence to Professor D Sanders, Box 3403, Duke University Medical Center, Durham, NC 27710, USA; donald.sanders{at}duke.edu

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In writing about reason and common sense, in his Life of reason, George Santayana observed that “those who cannot remember the past are condemned to repeat it”. Regrettably, this aphorism is true of clinical trials in myasthenia gravis (MG). Yoshikawa and colleagues1 report the results of a randomised, double blind, placebo controlled trial of tacrolimus in patients with MG (see page 970). Ironically, the authors cite as models for their protocol two recent trials that similarly failed to show efficacy of mycophenolate mofetil in MG, and probably for the same reasons.

This was a 28 week study in which patients with MG who were in minimal manifestation status (authors' definition) on prednisone 10–20 mg/day were randomised to receive either placebo or tacrolimus 3 mg/day. Prednisone dose was gradually tapered beginning at week 4; the primary outcome measure was …

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