Efficacy and safety of Actovegin in the treatment of intermittent claudication: results of an international, multicenter, placebo-controlled, randomized, phase IIIb clinical trial (APOLLO)

Suchkov I.A. Mzhavanadze N.D. Bogachev V.Y. Bokuchava M. Kuznetsov M.R. Lukyanov Y.V. Kelimbetov R. Pang H. Araslanov S.A.
October 2022 Edizioni Minerva Medica

International Angiology
2022 #41 Issue 5 405 - 412 pp.

Background: This study aimed to assess the efficacy and safety of Actovegin for the treatment of patients with Fontaine stage IIB peripheral arterial disease (PAD). Methods: The study included 366 patients with Fontaine stage IIB PAD from 19 centers (Russia, Georgia, Kazakhstan). Placebo or Actovegin (1200 mg daily [QD]) were administered intravenously for two weeks, followed by a 10-week course of oral administration (placebo or Actovegin 1200 mg QD). The primary efficacy outcome was percentage change in the initial claudication distance (ICD) by week 12. Secondary outcomes included percent and absolute changes in ICD, absolute claudication distance (ACD) and changes in Quality of Life (QoL) assessed by the SF-36 Mental Health Score. Results: The increase in ICD after 12 weeks of Actovegin treatment was 29.19% (LS mean [Actovegin vs. placebo]; 95% CI: 9.35-49.02; P=0.0041). The percentage increase in ICD at 24 weeks was 35.51% (LS mean; 95% CI: 10.96-60.05; P=0.0047), which correspond to an increase in absolute ICD of 41.22 m (LS mean; 95% CI: 16.77-65.66; P=0.0010). The percentage increase in ACD after 24 weeks was 36.47% compared with the baseline (LS mean; 95% CI: 10.07-62.88; P=0.0069), which corresponded to an absolute increase in ACD of 50.92 m (LS mean; 95% CI: 18.35-83.49; P=0.0023). A statistically significant improvement in QoL with Actovegin compared with placebo was demonstrated within 24 weeks (LS mean 2.28; 95% CI: 0.88-3.68; P=0.0015). Actovegin demonstrated an acceptable safety and tolerability profile with minor differences from placebo. Conclusions: The results of this 12-week course of Actovegin demonstrated its superiority over placebo in the increase in ICD and ACD at weeks 2, 12 and 24 from the start of treatment. Actovegin has an acceptable safety and tolerability profile.

Actovegin , Clinical trial , Intermittent claudication , Peripheral arterial disease

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Department of Cardiovascular and Endovascular Surgery and Diagnostic Radiology, Ryazan State Medical University, Ryazan, Russian Federation
Pirogov Russian National Research Medical University, Moscow, Russian Federation
N. Bokhua Memorial Cardiovascular Center, Tbilisi State Medical University, Tbilisi, Georgia
Institute of Cluster Oncology named after L.L. Levshin of Sechenov University, Moscow, Russian Federation
Research Center for Cardiovascular Surgery and Angiology, Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
Turkestan Regional Clinical Hospital, Shymkent, Kazakhstan
Statistics and Quantitative Sciences, Takeda Pharmaceuticals International Co., Cambridge, MA, United States
Department of Medicine, Takeda Russia, Moscow, Russian Federation

Department of Cardiovascular and Endovascular Surgery and Diagnostic Radiology
Pirogov Russian National Research Medical University
N. Bokhua Memorial Cardiovascular Center
Institute of Cluster Oncology named after L.L. Levshin of Sechenov University
Research Center for Cardiovascular Surgery and Angiology
Turkestan Regional Clinical Hospital
Statistics and Quantitative Sciences
Department of Medicine

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