Optimal dose of propafenone hydrochloride in patients with ventricular premature contractions. Double-blind study at three dose levels.:Double-Blind Study at Three Dose Levels

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A double-blind controlled study was conducted in 140 patients with ventricular premature contractions to find the optimal regimen for propafenone hydrochloride in Japanese patients. Three dose levels, 300 mg/day, 450 mg/day, and 600 mg/day, were compared.<BR>Response was assessed by the reduction in number and severity of premature contractions. The rate of the response was 24 % at 300 mg/day, 56% at 450 mg/day, and 63% at 600 mg/day. The two higher dose levels were significantly better than the lowest dose of 300 mg/day.<BR>Side effects were reported from 8 patients (17%) who received 300 mg/day, 2 (4%) at 450 mg/day, and 14 (30%) at 600 mg/day. The incidence was low at all doses, but it was significantly lower at 450 mg/day than at the two other dose levels. Conduction disturbance was related to 600 mg/day in some patients.<BR>The clinical value of the drug was assessed, considering both the response of ventricular premature contractions and the incidence of adverse reactions. The drug was valuable or better in 24% of the patients who received 300 mg/day, 52% at 450 mg/day, and 56 % at 600 mg/day. The two higher dose levels were significantly better than the lowest dose of 300 mg/day. In conclusion, propafenone hydrochloride was shown to be effective in Japanese patients with ventricular premature contractions. Data on response and safety suggest an optimal dose of 450 mg/day.
一般社団法人日本臨床薬理学会の論文