Abstract
The efficacy and overall safety of levocarnitine chloride (LC-80) in treatment of patientswith ischemic heart disease (effort angina, effort and rest angina, and silent myocardialischemia), were investigated, using serial multistage treadmill exercise test, and were comparedwith that of dilazep hydrochloride used as the control treatment, by the method ofmulticenter double-blind, group comparison study. The results obtained were as follows.
1. The study comprised 166 patients, with 134 of them compared for efficacy, 166 for safety, and 112 for overall usefulness.
2. Global improvement: “better than ‘moderately improved’ ” was the finding in 45.6%of the levocarnitine chloride-treated group (LC group) and in 33.3% of the dilazephydrochloride-treated group (D group). There was no significant difference in globalimprovement between these two groups.
3. Overall safety: no problem was observed in 95.0% of the LC group, and 95.3% of the D group.No patient in the LC group had to discontinue the test, but two patients inthe D group did so.
4. Overall usefulness: “better than ‘useful’ ” was the finding in 43.7% of the LC group andin 31.0% of the D group.In the X2 test, no significant difference in overall usefulnessbetween these two groups was observed, but in the U test, significant difference wasnoted.
5. Overall evaluation of the findings of exercise electrocardiogram: “better than ‘moderatelyimproved’” was the finding in 46.3% of the LC group, and in 30. 3% of the Dgroup.There was no significant difference in overall evaluation of the findings ofexercise electrocardiogram between these two groups.
6. The maximal exercise duration was prolonged in the LC group compared to pre-treatmentlevels, but in the D group such prolongation was not observed. However, therewas no significant difference in the maximal exercise duration between these two groups.
7. The time to onset of the 1mm ST segment depression was significantly prolonged inthe LC group after the treatment. This prolongation was not observed in the D group.However, there was no significant difference in the time to onset of the 1mm ST segmentdepression between these two groups.
8. The extent of ST depression after the treatment was significantly improved in the LCgroup, when compared at the same period of exercise, but there was no significantimprovement in the D group.There was no significant difference in the extent of STdepression after the treatment between these two groups.
9. Side effects: four patients (5.0%) complained of side effects in the LC group, and fivepatients (5.8%) complained in the D group.But no severe case was reported.
10. Abnormal laboratory findings: GOT and LDH levels increased in one case in the LCgroup ; on the other hand, CPK level increased in one case in the D group.Neitherwas clinically significant.
The results suggested that the treatment with levocarnitine chloride (LC-80), administeredat a level of 1, 800 mg/day (in 3 doses), improved significantly the exercise tolerancecapability in patients with ischemic heart disease (effort angina, effort and rest angina, andsilent myocardial ischemia), and is as useful as, or more useful than dilazep hydrochloride.We concluded that levocarnitine chloride is a clinically useful drug for the treatment ofischemic heart disease.
