Abstract

The objective: of the study was to assess the efficacy and safety of the treatment with Mildronate (1 g/day) in combination with a standard therapy for the exercise tolerance of patients with stable angina pectoris.

Design and methods: The study was a prospective, randomized, double-blind, placebo controlled phase III trial with two treatment groups. The study was carried out in 37medical centres in 4 countries (Latvia, Lithuania, Russian Federation and Ukraine). The study group comprised 317 patients with chronic coronary heart disease (CHD, II–III according to the classification of the Canadian Cardiovascular Society (CCS)) who had ischemia as the limiting factor in the exercise test. The treatment period lasted for 12 months.

Results: The mean value of the change in the total exercise time in the mildronate group at month 12 was 55.05 ± 88.01 seconds (sec), while the placebo patients had the mean value 0.79 ± 68.21 sec. The difference

between the treatment groups was highly significant (p < 0.001). The mean value of the change at the maksimum achieved load in the mildronate group was 7.78±13.90W, while the placebo patients had the mean value 0.10±

12.40W. The difference between the treatment groups was highly significant (p < 0.001). Atmonth 12 the time to deviation of ST-segment to 1 mm at least in the mildronate group increased from 425.63±160.97 sec to 483.83±193.99 sec, whereas a decrease with respect to the visit 6 was observed in the placebo group: from 436.76±177.66 to 425.98 ± 159.12 sec. The difference between the treatment groups at month 12 was significant (p = 0.01).

At month 12 the time to the onset of angina in the mildronate group increased from 460.50 ± 155.51 sec to 490.50 ± 207.27 sec, whereas a slight decrease was observed in the placebo group. The difference between the treatment groups at month 12 was significant (p = 0.044).

Conclusions: This study has revealed the superiority of the treatment with Mildronate (1 g/day) in combination with a standard therapy for the exercise tolerance of patients with stable angina pectoris over the treatment with placebo in combination with a standard therapy.