:A Double Blind Trial in Comparison with Propramolol

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Anti-anginal effect of nicorandil was evaluated by a double blind trial incomparison with propranolol in 80 patients with angina pectoris. Nicorandil was given in a daily dose of 15-45 mg to 36 patients and propranolol in a daily dose of 30-90mg to 44 patients, both divided into three doses, for a period of 3 weeks. Inactive placebo was given in the 1st and 2nd weeks, either 15 mg nicorandil or 30mg propranolol was given in the 3rd week, either 30mg nicorandil or 60mg propranolol was given in the 4th week, and variable doses (the same dose as that used in the 4th week or 50% increase ordecrease of the dose used in the 4th week) were given in the 5th week, and the following results were obtained: 1. There was no significant difference in background between nicorandil and propranolol groups. 2. Decrease in number of anginal attacks/week in the 4th and 5th weeks in nicorandil group was significantly larger than that in propranolol group.Reduction of nitroglycerin consumption in the former group, however, was not significantly larger than that in the latter group. 3. The rate of grobal improvement was 94. 4% with nicorandil and 77. 3%with propranolol. The difference in rate of improvement was statistically significant (z=2. 4785, U-test). 4. Improvement in ischemic ST change was observed in 45. 8% in nicorandil group and in 56.0% in propranolol group.However, the difference in rate of improvement was not significant. 5. Adverse side-effects such as headache and gastrointestinal disturbance were observed in 13.5% of nicorandil group, and those such as general malaise and gastrointestinal disturbance in 16.7% of propranolol group.The difference in rate of side-effects between two groups, however, was not significant. Laboratory examinations revealed no abnormal findings indicative of clinical significance in both groups. 6. The rate of usefullness assessed from grobal improvement and adverse side-effects was 91.7% with nicorandil and 77.3% with propranolol. The difference in usefulness between these two groups was statistically significant (z= 2. 1777, U-test). The results indicate that anti-anginal effect of nicorandil is superior to propranolol.
一般社団法人日本臨床薬理学会の論文

:A Double Blind Trial in Comparison with Propramolol

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