Effects of @entity2779 on XXXX : double-blind, parallel, randomized, placebo-controlled dose-ranging study.

@entity1 @entity1165 @entity713 @entity1757 @entity1540 @entity299 @entity943 @entity2779
@entity2779 is a new class Ic antiarrhythmic compound with a broad pharmacologic profile. In this study, its dose-response relationship was examined in a double-blind, randomized, placebo-controlled five treatment parallel design protocol. @entity1 enrolled had @entity299 with Lown grade 2 @entity1540 ( @entity1540 ) (greater than or equal to 30/hr) documented on 24-hour Holter recordings. @entity2779 was compared in four doses (337.5, 450, 675, and 900 mg/day) to placebo. The double-blind phase lasted 2 weeks. Two hundred twenty-six @entity1 were enrolled, of whom 171 were @entity1 and 55 were @entity1 ; their mean age was 59.8 years and 85% were Caucasian and 4% were black. The @entity943 were symptomatic in 173. Twenty (8.8%) withdrew from the study before completion: 15 had adverse reactions, two had intercurrent illnesses, and three withdrew for administrative reasons. In one @entity1 , the density of @entity943 appeared to increase with @entity2779 . Side effects were of central nervous system or gastrointestinal origin; less than 5% of @entity1 developed first-degree @entity713 or @entity1757 . There were no deaths in the study. The occurrence of side effects was not related to dose. @entity2779 had no effect on heart rate. It increased the PR interval at all doses (9% to 22% compared to placebo at baseline; p less than 0.01) at 450 to 900 mg/day after 2 weeks of therapy. The drug increased the QRS duration at all doses, highly significantly at 675 mg/day (8.5 msec; p less than 0.01) and at 900 mg/day (15.7 msec; p less than 0.01) after 2 weeks of therapy. Only at the highest dose was the QTc slightly but significantly (14.3 msec; p less than 0.01) increased. @entity2779 exerted a dose-dependent effect on @entity1540 recorded on serial 24-hour Holter recordings: compared to placebo, at 2 weeks 337.5 mg/day reduced @entity1540 by 70.8% (p less than 0.05), 450 mg/day reduced @entity1540 by 82.0% (p less than 0.01), 675 mg/day reduced @entity1540 by 90.2% (p less than 0.01) and 900 mg/day reduced @entity1540 by 95.3% (p less than 0.01). The effects of the two highest doses of @entity2779 were significantly greater than those of 337.5 mg/day. In 68% of the @entity1 receiving 900 mg/day, 80% or greater reduction in total @entity1540 was found. In addition, there was a greater than 90% decrease in ventricular couplets, and 96% decrease in @entity1165 ( @entity1165 ) beats. @entity2779 eliminated @entity1540 in 8% of all @entity1 , ventricular couplets in 58%, and @entity1165 beats in 91%.(ABSTRACT TRUNCATED AT 400 WORDS)
