RYTHMOL clinical studies: Difference between revisions
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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. | 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. | 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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = RYTHMOL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8dd938c8-d37c-4a82-b36d-dd0a2d31c8fa | publisher = | date = | accessdate = 12 March 2014 }}</ref> | ||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 01:19, 13 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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.[1]
References
- ↑ "RYTHMOL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]". Retrieved 12 March 2014.