Long-term cardiovascular safety of salmeterol powder pharmacotherapy in adolescent and adult patients with chronic persistent asthma: a randomized clinical trial

Chest. 1999 Mar;115(3):642-8. doi: 10.1378/chest.115.3.642.

Abstract

Study objectives: This study investigates the long-term cardiovascular safety of salmeterol powder vs placebo in adolescent and adult patients with mild persistent asthma.

Design: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Setting: Eighteen US clinical centers.

Patients: Three hundred fifty-two patients (> or = 12 years) with mild persistent asthma (duration > or = 6 months) requiring pharmacotherapy; with FEV1 of 70 to 90% of predicted and without abnormal ECG/continuous ambulatory ECG (Holter).

Interventions: Randomized to twice-daily salmeterol powder (50 microg) or placebo via breath-actuated device for 52 weeks. Backup albuterol was available to control asthma symptoms.

Measurements and results: Cardiovascular safety was regularly assessed by 12-lead ECG with a 15-s lead II rhythm strip, 24-h continuous ambulatory ECG (Holter) monitoring, serial vital sign measurements, and review of adverse cardiovascular events. No deaths occurred during the study. No clinically significant between-group differences were observed in pulse rate, ECG QTc interval, median number of ventricular or supraventricular ectopic events, incidence of ventricular ectopic couplets and runs, or incidence of > 100 ventricular or supraventricular ectopic events in 24 h. No clinically significant between-group differences were observed in arterial BP or incidence of adverse cardiovascular events. Salmeterol was well tolerated throughout the 52-week study period, with a cardiovascular safety profile similar to that of placebo.

Conclusions: Long-term, twice-daily pharmacotherapy with salmeterol powder is safe and is not associated with unfavorable clinically significant changes in cardiac function or increases in cardiovascular adverse effects.

Publication types

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

MeSH terms

  • Adolescent
  • Adrenergic beta-Agonists / pharmacology*
  • Adrenergic beta-Agonists / therapeutic use
  • Adult
  • Aged
  • Albuterol / analogs & derivatives*
  • Albuterol / pharmacology
  • Albuterol / therapeutic use
  • Asthma / drug therapy*
  • Cardiovascular System / drug effects*
  • Child
  • Chronic Disease
  • Double-Blind Method
  • Electrocardiography
  • Female
  • Heart / drug effects
  • Humans
  • Male
  • Middle Aged
  • Salmeterol Xinafoate
  • Time Factors
  • Treatment Outcome

Substances

  • Adrenergic beta-Agonists
  • Salmeterol Xinafoate
  • Albuterol