The clinical utility of TY-0032 (sustained-release capsule containing 3mg of dihydroergotoxine mesylate) was compared with that of dihydroergotoxine mesylate tablet in 330 patients with cerebrovascular disorders by means of multi-center (57 hospitals) double-blind clinical trial. No significant difference in patient's characteris tics was noted between TY-0032 group (TY group) and dihydroergotoxine mesylate tablet group (DE group), except for significant existence of previous history and tendency of more frequent ischemic heart disease noted in TY group.
As for final global improvement rating (GIR), TY group was significantly superior to DE group (P<0.05).Overall safety rating of TY group was the same as that of DE group, As for stratification analyses of the final GIR and final global utility rating by patient's background characteristics, TY group was significantly superior to DE group in many items, and no reverse findings were noted.
The incidence of side-effects was5% in both groups, and these side-effects were mild in most cases.
No significant abnormal laboratory findings were noted in both groups.
It was concluded that a single medication of TY-0032 a day would be more recommendable than 3-times medication of 1 mg dihydroergotoxine mesylate tablet a day for the treatment of cerebrovascular disorders.