Salbutamol increases survival motor neuron (SMN) transcript levels in leucocytes of spinal muscular atrophy (SMA) patients: relevance for clinical trial design

J Med Genet. 2010 Dec;47(12):856-8. doi: 10.1136/jmg.2010.080366. Epub 2010 Sep 12.

Abstract

Background: Spinal muscular atrophy (SMA) is a neuromuscular disorder caused by mutations of the SMN1 gene. Based on severity, three forms of SMA are recognised (types I-III). All patients usually have 2-4 copies of a highly homologous gene (SMN2) which produces insufficient levels of functional survival motor neuron (SMN) protein. Recently, evidence has been provided that SMN2 expression can be enhanced in vitro by salbutamol, a β2-adrenergic agonist. This compound has also been shown to improve motor function of SMA patients in two different pilot trials.

Aim: To evaluate the in vivo molecular efficacy of salbutamol in SMA patients.

Methods: Twelve type II-III patients took salbutamol orally for 6 months. SMN2 full length transcript levels were determined in peripheral blood leucocytes by absolute real-time PCR, at baseline and after 3 and 6 months of treatment.

Results: A significant and constant increase in SMN2 full length transcript levels was detected; the response was directly proportional to SMN2 gene copy number.

Conclusions: The data strongly support salbutamol as a candidate for treating SMA, and suggest that SMN2 copy number may predict the molecular response to treatment and may be a useful randomisation parameter in a double blind placebo controlled clinical trial design.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Adrenergic beta-2 Receptor Agonists / pharmacology
  • Adult
  • Albuterol / administration & dosage
  • Albuterol / pharmacology*
  • Child
  • Child, Preschool
  • Female
  • Gene Expression Regulation / drug effects*
  • Humans
  • Leukocytes / drug effects*
  • Leukocytes / metabolism*
  • Male
  • Middle Aged
  • Muscular Atrophy, Spinal / genetics*
  • Muscular Atrophy, Spinal / pathology*
  • RNA, Messenger / genetics
  • RNA, Messenger / metabolism
  • Survival of Motor Neuron 2 Protein / genetics*
  • Survival of Motor Neuron 2 Protein / metabolism

Substances

  • Adrenergic beta-2 Receptor Agonists
  • RNA, Messenger
  • Survival of Motor Neuron 2 Protein
  • Albuterol