RYTHMOL clinical studies: Difference between revisions

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Created page with "__NOTOC__ {{Propafenone}} {{CMG}}; {{AE}} {{SS}} ==Clinical Studies== In 2 randomized, crossover, placebo-controlled, double-blind trials of 60 to 90 days’ duration in sub..."
 
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__NOTOC__
#REDIRECT [[Procainamide#Clinical Studies]]
{{Propafenone}}
{{CMG}}; {{AE}} {{SS}}
 
==Clinical Studies==
 
In 2 randomized, crossover, placebo-controlled, double-blind trials of 60 to 90 days’ duration in subjects with paroxysmal [[supraventricular arrhythmias ]](paroxysmal atrial fibrillation/flutter [PAF], or paroxysmal [[supraventricular tachycardia]] [PSVT]), propafenone reduced the rate of both [[arrhythmias]], as shown in Table 3.
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The patient population in the above trials was 50% male with a mean age of 57.3 years. Fifty percent of the subjects had a diagnosis of PAF and 50% had PSVT. Eighty percent of the subjects received 600 mg/day propafenone. No subject died in the above 2 trials.
 
In US long-term safety trials, 474 subjects (mean age: 57.4 + 14.5 years) with [[supraventricular arrhythmias]] [195 with PAF, 274 with PSVT and 5 with both PAF and PSVT] were treated up to 5 years (mean: 14.4 months) with propafenone. Fourteen of the subjects died. When this mortality rate was compared with the rate in a similar patient population (n = 194 subjects; mean age: 43.0 + 16.8 years) studied in an [[arrhythmia]] clinic, there was no age-adjusted difference in mortality. This comparison was not, however, a randomized trial and the 95% confidence interval around the comparison was large, such that neither a significant adverse or favorable effect could be ruled out.
 
==References==
{{Reflist}}
 
[[Category:Antiarrhythmic agents]]
[[Category:Ketones]]
[[Category:Phenol ethers]]
[[Category:Alcohols]]
[[Category:Amines]]
[[Category:Sodium channel blockers]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 03:32, 22 July 2014