The extrapulmonary effects of increasing doses of formoterol in patients with asthma

Eur J Clin Pharmacol. 1998 Apr;54(2):141-7. doi: 10.1007/s002280050435.

Abstract

Objective: To assess the cardiovascular and metabolic responses to increasing doses of formoterol administered from a dry powder inhaler.

Methods: Twenty patients with mild to moderate asthma were given 12, 24, 48 and 96 microg of formoterol or a matched placebo on separate days. The doses were administered using a randomised, cross-over, double-blind design. The effects on heart rate, blood pressure, electromechanical systole (QS2I), the electrocardiographic QTc interval, plasma potassium (K); blood glucose and FEV1 were assessed prior to, and for 9 h following each dose.

Results: There was no difference between the maximum effects of formoterol 12 microg and placebo; the 24 microg dose significantly decreased plasma K (-0.2 mmol x l(-1)) and increased blood glucose (1.8 mmol x l(-1)) compared to placebo. The two highest doses affected most of the variables with the 96 microg dose being significantly different from placebo for all indices, heart rate (9 beats x min(-1)), systol BP (4 mmHg), diastolic BP (-3 mmHg), QS2I (-11 ms), QTc (17 ms), plasma K (-0.5 mmol x l(-1)) and blood glucose (2.6 mmol x l(-1)). All doses of formoterol increased FEV1.

Conclusion: Although there were dose-dependent effects on the extrapulmonary measurements, only the effects at the highest dose may be of clinical significance.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-Agonists / administration & dosage*
  • Adrenergic beta-Agonists / adverse effects*
  • Adult
  • Asthma / blood
  • Asthma / drug therapy
  • Asthma / physiopathology*
  • Blood Glucose / drug effects
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / adverse effects
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Ethanolamines / administration & dosage*
  • Ethanolamines / adverse effects*
  • Female
  • Formoterol Fumarate
  • Hemodynamics / drug effects*
  • Humans
  • Male
  • Middle Aged
  • Potassium / blood
  • Time Factors

Substances

  • Adrenergic beta-Agonists
  • Blood Glucose
  • Bronchodilator Agents
  • Ethanolamines
  • Potassium
  • Formoterol Fumarate