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Partial inhibition of fatty acid oxydation increases the exercise tolerance of patients with peripheral arterial disease: the Mildronate Study
  • Vilnis Dzerve, Dace Matisone, Indulis Kukulis, Iveta Mintale, Edvins Lietuvietis, Dainis Krievins, Aigars Lacis, Gunars Mednis, Juris Rits, Marcis Gedins, Kaspars Kisis, Valerijs Aleksandrovics, Sergejs Kovalovs
  • Seminars in Cardiovascular Medicine, 2011; 17:3
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Abstract

The objective: of the study was to assess the efficacy and safety of the treatment with mildronate (1 g/day) in combination with standard therapy for the exercise tolerance of patients with peripheral arterial disease (PAD).

Design and Methods: The study was a prospective, randomized, double-blind, placebo controlled phase II study with two treatment groups. The study totally included 62 male and female patients with PAD and intermittent claudication as a limiting factor for physical load (the treadmill test). The follow-up time comprised 33 weeks: a 5-week run-in period plus 24 weeks of randomized therapy followed by a 4-week follow-up period.

Results: The mean value of the change in the absolute claudication distance (ACD) during the treadmill test in the mildronate group after 24 weeks of treatment was 231.22±179.02 meters, while the placebo group patients

had the mean value of 126.67 ± 120.72 meters. The difference between the treatment groups was significant (p-value = 0.026). The mean value of the change in the initial claudication distance (ICD) before and after 24 weeks of doubleblind therapy during the treadmill test in the mildronate group was 123.93 ±114.73 meters, while the placebo group patients had the mean value of 50.30 ±62.56 meters. The difference between the treatment groups was significant (p-value = 0.033). The mean value of the change in the ACD from visit T24 (24 weeks of treatment) till one month after the discontinuation of the treatment (visit PT) during the treadmill test in the mildronate group was 19.68±85.58 meters, while the placebo group patients had the mean value – 31.43 ±79.17 meters. The diference between the treatment groups was significant (p-value = 0.032).

Conclusions: The study confirms the superiority of treatment with mildronate (1 g/day) versus placebo in combination with standard therapy for the improvement of exercise tolerance in patients with PAD. The 4 weeks interruption of the mildronate course without loosing the effect could be acceptable in cases of the long-term use of mildronate.