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document
[ Comparison of the efficacy/tolerability ratio of cibenzoline and propafenone in the treatment of ventricular arrhythmia ] . Cibenzoline ( C ) was compared with propafenone ( P ) in 18 adult patients ( 7 women and 11 men ) aged 50 +/- 7 in double-blind , placebo-controlled crossover trial . After a therapeutic wash-out period corresponding to 5 times the half-life of previous anti-arrhythmic drugs , patients with more than 100 premature ventricular contractions ( PVC ) per hour in two 24 hour Holter records obtained at an interval of 7 days were treated in succession and after randomised by C ( 390 mg/day in 3 divided doses ) and P ( 900 mg/day in 3 divided doses ) for a period of two weeks , each active sequence being followed by a two week wash-out period . Efficacy ( based upon the decrease in PVC/hour in a 24 hour Holter ) and tolerability were evaluated at the end of each sequence , with samples drawn at the same times for assay of the study drugs . Three patients dropped out of the trial , 1 with each active drug ( for epigastric pain ) and 1 with dummy . No significant difference was seen between the two drugs regarding the decrease in the total number of PVC/hour in the 15 patients completing the cross-over protocol . A reduction in PVC/hour of more than 70 per cent was seen in 7 patients with C and in 9 patients with P. C was better tolerated than P on the basis of both clinical and electrocardiographic parameters . One patient developed troublesome adverse reactions with C as compared with 4 patients in the case of P. A more than 20 per cent increase in QRS was seen in 7 patients with C and in 10 patients with P , the figures for PR being 2 and 6 patients respectively . One patient showed a proarrhythmic effect with P. Plasma levels of C were significantly higher in responders ( 328 +/- 149 ng/ml ) than in non-responders ( 137 +/- 41 ng/ml , p less than 0.05 ) . No significant difference was found concerning plasma levels of P ( 578 +/- 477 ng/ml compared with 646 +/- 457 ng/ml , p greater than 0.05 ) . In conclusion , the efficacy/tolerability ratio in this population with a low risk of serious rhythm events appeared to be better with C than with P .
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Intervention_Pharmacological
cibenzoline
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Intervention_Pharmacological
propafenone
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Intervention_Pharmacological
Cibenzoline ( C )
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Intervention_Pharmacological
propafenone ( P )
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
anti-arrhythmic drugs
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Intervention_Pharmacological
C
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Intervention_Pharmacological
P
25205
Intervention_Pharmacological
C
25206
Intervention_Pharmacological
C
25207
Intervention_Pharmacological
C
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Intervention_Pharmacological
P
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Intervention_Pharmacological
C
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Intervention_Pharmacological
P .
25211
Outcome_Pain
epigastric pain )
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Outcome_Other
total number of PVC/hour
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Outcome_Other
reduction in PVC/hour
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Outcome_Other
C was better tolerated
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Outcome_Physical
than P on the basis of both clinical and electrocardiographic parameters .
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Outcome_Adverse-effects
adverse reactions
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Outcome_Physical
20 per cent increase in QRS
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Outcome_Physical
proarrhythmic effect with P. Plasma levels of C were significantly higher in responders ( 328 +/- 149 ng/ml ) than in non-responders ( 137 +/- 41 ng/ml , p less than 0.05 ) .
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Outcome_Physical
concerning plasma levels of P ( 578 +/- 477 ng/ml
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Outcome_Other
efficacy/tolerability ratio