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

Autor:	Suchkov IA; Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan, Russia., Kalinin RE; Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan, Russia., Gadzhimuradov RU; Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia., Lar'kov RN; Moscow Regional Research and Clinical Institute named after M.F. Vladimirsky, Moscow, Russia., Uchkin IG; N.A. Semashko Central Clinical Hospital #2 of the Open Joint Stock Company 'Russian Railways', Moscow, Russia., Chupin AV; Federal Research and Clinical Center of Federal Medical Biological Agency, Moscow, Russia., Parshin PI; Federal Research and Clinical Center of Federal Medical Biological Agency, Moscow, Russia., Kamaev AA; Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan, Russia., Porsheneva EV; Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan, Russia.
Jazyk:	ruština
Zdroj:	Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery [Angiol Sosud Khir] 2019; Vol. 25 (3), pp. 29-37.
DOI:	10.33529/ANGIO2019305
Abstrakt:	Aim: 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.
Databáze:	MEDLINE
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