27623
document
Cardiac safety of formoterol 12 microg twice daily in patients with chronic obstructive pulmonary disease . BACKGROUND Some evidence suggests an increased risk of myocardial infarction and dysrhythmia events associated with beta ( 2 ) -agonist use in patients with chronic obstructive pulmonary disease ( COPD ) . This prospective , multicenter , randomized , double-blind , placebo-controlled study compared the cardiac safety of formoterol and placebo in patients with COPD . METHODS After a 3-14-day run-in , 204 patients were randomized to receive formoterol 12 microg dry powder inhalation or matching placebo twice daily for 8 weeks . Twenty four-hour continuous electrocardiography ( Holter monitoring ) was performed at screening and after 2 and 8 weeks of treatment . RESULTS Only a small number of patients met the predefined criteria for a proarrhythmic event ( 4 formoterol and 2 placebo patients ) . No patients had sustained postbaseline ventricular tachycardia events , postbaseline run of ventricular ectopic beats associated with relevant symptoms ( e.g . hypotension , syncope ) , or an episode of ventricular flutter or fibrillation . Holter monitoring data were variable but showed no clinically meaningful differences between the formoterol and placebo groups , respectively , for variables such as ( mean+/-SD at end of treatment ) : heart rate ( 80+/-8.6 vs. 80+/-10.6 bpm ) , number and rate of ventricular premature beats ( total 732+/-2685.4 vs. 650+/-2090.6 ; rate 35+/-131.0 vs. 30+/-101.3 per h ) , ventricular tachycardia events ( total 0.4+/-1.70 vs. 1.0+/-9.23 ; rate 0.02+/-0.082 vs. 0.05+/-0.479 per h ) , and supraventricular premature beats ( total 504+/-1844.1 vs. 823+/-2961.8 ; rate 22+/-80.6 vs. 37+/-129.6 per h ) . Vital signs and electrocardiogram data , including corrected QT intervals ( Bazett and Fridericia ) , were similar across treatment groups . The overall adverse event experience was similar in the formoterol ( n=26 [ 27 % ] ) and placebo ( n=33 [ 31 % ] ) groups . The most common adverse events , infections and respiratory events , were expected for this patient population . The incidence of cardiac adverse events was low ( 1 formoterol and 4 placebo patients ) . CONCLUSIONS The results of this study confirm the good cardiovascular safety profile of formoterol in patients with COPD .
27624
Intervention_Pharmacological
formoterol
27625
Intervention_Pharmacological
formoterol
27626
Intervention_Control
placebo
27627
Intervention_Pharmacological
formoterol 12 microg dry powder inhalation
27628
Intervention_Control
placebo
27629
Intervention_Physical
Twenty four-hour continuous electrocardiography ( Holter monitoring )
27630
Intervention_Pharmacological
formoterol
27631
Intervention_Control
placebo
27632
Outcome_Physical
Cardiac
27633
Outcome_Physical
myocardial infarction
27634
Outcome_Physical
dysrhythmia events
27635
Outcome_Physical
proarrhythmic event
27636
Outcome_Physical
postbaseline ventricular tachycardia events , postbaseline run of ventricular ectopic beats
27637
Outcome_Physical
hypotension , syncope
27638
Outcome_Physical
episode of ventricular flutter or fibrillation
27639
Outcome_Physical
heart rate
27640
Outcome_Physical
number and rate of ventricular premature beats
27641
Outcome_Physical
ventricular tachycardia events
27642
Outcome_Physical
supraventricular premature beats
27643
Outcome_Physical
Vital signs
27644
Outcome_Other
electrocardiogram data , including corrected QT intervals
27645
Outcome_Adverse-effects
overall adverse event experience
27646
Outcome_Adverse-effects
adverse events , infections and respiratory events
27647
Outcome_Adverse-effects
cardiac adverse events
27648
Outcome_Other
good cardiovascular safety
27649
Participant_Condition
chronic obstructive pulmonary disease
27650
Participant_Condition
chronic obstructive pulmonary disease ( COPD )
27651
Participant_Condition
COPD
27652
Participant_Sample-size
204
27653
Participant_Condition
COPD