狭心症に対する塩酸ニカルジピン徐放製剤 (YC-93LA) 長期使用時の臨床的有効性と安全性について

抄録

Long-acting nicardipine hydrochloride was given at 100 to 150 mg/day for more than 6 months to 30 patients with angina pectoris, to evaluate the clinical response and safety of the drug during long term therapy. The results were as follows.
1) Twenty-seven of the 30 patients received the drug for more than 6 months, while the treatment was discontinued in the remaining 3 before 6 months (24 weeks) had elapsed. The reasons for withdrawal were a request by one patient to change the therapy, change of address for one, and a surgical operation for the other. No patient was withdrawn from the study because of adverse reactions.
2) Overall improvement was calculated by moderate improvement or better. It was 66. 7% in patients receiving long-acting nicardipine hydrochloride alone, and 84.2% in those receiving long-acting nicardipine hydrochloride together with other drugs. Response was good, whether the drug was used alone or together with other treatments.
3) Adverse reactions developed in 3 of the 30 patients (10. 0%). Headache was reported from one, dizziness and dysarthria from one, and degree I A-V block from one. In the patient with A-V block, the treatment was considered to be slightly unsafe. No severe adverse reactions were detected during the long-term use of the drug. Clinical laboratory tests revealed no abnormalities related to the long-term use of the drug.
4) The drug was judged to be useful or better in 62. 5% of the patients receiving the drug alone, and 89. 5% in those receiving the drug together with other treatments.
In conclusion, long-acting nicardipine hydrochloride produced good response and high safety during long term therapy. It was shown to be a very valuable anti-anginal drug in practice.