29969
document
Dose-response effect of flecainide in patients with symptomatic paroxysmal atrial fibrillation and/or flutter monitored with trans-telephonic electrocardiography : a multicenter , placebo-controlled , double-blind trial . BACKGROUND A double-blind , randomized , parallel-group , placebo-controlled trial was conducted in patients with paroxysmal atrial fibrillation or flutter ( PAF/PAFL ) experiencing 2 or more episodes of symptomatic PAF/PAFL during a 28-day observation period to determine the dose-response effect and safety of flecainide . METHODS AND RESULTS A total of 143 patients at 30 centers were randomized to receive 25 , 50 , or 100 mg of flecainide or placebo twice daily ( BID ) . In 123 patients ( per protocol set ) , those remaining free from PAF/PAFL after the treatment were 3.1 % on placebo , 7.7 % on 25 mg/BID , 9.4 % on 50 mg/BID , and 39.4 % on 100 mg/BID of flecainide . As a whole group , a significant linear dose-response ( p < 0.001 ) was observed and a significant difference between placebo and 100 mg/BID was observed ( p < 0.001 ) . A similar dose-response between the present study and Caucasian study was demonstrated . Although there were 5 patients who needed cardioversion or ablation because of frequent episodes of PAF/PAFL ( 2 in 25 mg/BID , 1 in 50 mg/BID , and 2 in 100 mg/BID of flecainide ) , neither death nor ventricular proarrhythmic event was reported . CONCLUSIONS This study indicated that flecainide exerted a significant dose-dependent effect on the prevention of symptomatic PAF/PAFL recurrence and showed that there was no inter-ethnic difference in the clinical effect of flecainide in patients with PAF/PAFL .
29970
Intervention_Pharmacological
flecainide
29971
Intervention_Control
placebo-controlled
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Intervention_Pharmacological
flecainide
29973
Intervention_Pharmacological
flecainide
29974
Intervention_Control
placebo
29975
Intervention_Control
placebo
29976
Intervention_Pharmacological
flecainide
29977
Intervention_Pharmacological
flecainide
29978
Intervention_Pharmacological
flecainide
29979
Intervention_Pharmacological
flecainide
29980
Outcome_Other
Dose-response effect
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Outcome_Other
effect and safety
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Outcome_Physical
PAF/PAFL
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Outcome_Other
significant linear dose-response
29984
Outcome_Other
dose-response
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Outcome_Physical
cardioversion
29986
Outcome_Physical
ablation
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Outcome_Mortality
death
29988
Outcome_Mortality
ventricular proarrhythmic event
29989
Participant_Condition
symptomatic paroxysmal atrial fibrillation and/or flutter
29990
Participant_Condition
paroxysmal atrial fibrillation or flutter ( PAF/PAFL )
29991
Participant_Condition
symptomatic PAF/PAFL
29992
Participant_Sample-size
143
29993
Participant_Sample-size
123
29994
Participant_Condition
PAF/PAFL