Journal «Angiology and Vascular Surgery» • 

2019 • VOLUME 25 • №3

Clinical study of efficacy and safety of Aducil in patients with chronic lower limb ischaemia

Suchkov I.A.1, Kalinin R.E.1, Gadzhimuradov R.U.2, Larkov R.N.3, Uchkin I.G.4, Chupin A.V.5, Parshin P.Yu.5, Kamaev A.A.1, Porsheneva E.V.1

1) Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan,
2) Moscow State University of Medicine and Dentistry named after A.I. Evdokimov,
3) Moscow Regional Research and Clinical Institute named after M.F. Vladimirsky,
4) N.A. Semashko Central Clinical Hospital №2 of the Open Joint Stock Company "Russian Railways",
5) Federal Research and Clinical Center of Federal Medical Biological Agency, Moscow, Russia

Objective. The study was aimed at assessing efficacy and safety of treatment with Aducil® (cilostazol) compared with Trental® 400 in patients with moderate-to-severe intermittent claudication due to peripheral atherosclerosis.

Patients and methods. The study included a total of one hundred and forty-five 36-to-75-year-old patients. The participants were distributed into 2 groups according to the inclusion/exclusion criteria in a 2 to 1 proportion: patients in group 1 received Aducil® 100 mg BID, in group 2 – Trental® 400 TID for 12 weeks. 142 subjects completed the protocol.

Results. Analysis of the effectiveness of treatment according to the primary criterion showed a better effectiveness of Aducil® as compared with Trental® 400. Subjects who received Aducil® had a higher increase in the absolute maximum walking distance after 12 weeks of treatment as compared with those taking Trental® 400: 126±110 m versus 45±39 m, respectively (р<0.001).

Subjects who received Aducil® had a statistically significant improvement in quality of life parameters such as physical and mental health components according to the SF-36 questionnaire after 12 weeks of treatment (р≤0.01). Subjects in Aducil® group had better quality of life with an increase from 34 to 40 points according to the physical component score, while patients in Trental® 400 group demonstrated minor positive changes (from 35 to 37 points); mean mental component score increased from 45 to 48 points in Aducil® group as compared with an increase from 45 to 47 points in Trental® 400 group. While self-reported physical health status was similar between the groups at baseline, subjects in Aducil® group reported better physical functioning after treatment (р=0.016). Two adverse events were registered in two subjects in Aducil® group.

Conclusion. Analysis of the study endpoints demonstrated that Aducil® had better treatment effectiveness in patients with chronic lower limb ischemia stage IIB according to the classification of A.V. Pokrovsky-Fontaine as compared with Trental® 400, while the safety profile and drug tolerance were similar between the two.

KEY WORDS: chronic lower limb ischemia, intermittent claudication, clinical study, Aducil®, Trental® 400.

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