Journal «Angiology and Vascular Surgery» • 

2021 • VOLUME 27 • №1

Randomized study of tolerability, safety and efficacy of Pletax in intermittent claudication

Kazantsev A.N.1, Goryunov S.V.2, Ershova O.B.3, Erofeeva S.B.4, Gurgenyan E.V.5

1) Department of Surgery №3, Alexandrovskaya Hospital, Saint Petersburg,
2) Department of Surgery №17, Municipal Clinical Hospital №15 named after O.M. Filatov under the Moscow Healthcare Department, Moscow,
3) Clinical Hospital of Emergency Medical Care named after N.V. Solovyev, Yaroslavl,
4) Clinic "Bessalar", Centre of Clinical Trials, Moscow,
5) Therapeutic Department №11, Municipal Clinical Hospital №23, Moscow, Russia

Objective. This study was aimed at assessing tolerability, safety and therapeutic efficacy of Pletax® (cilostazol) compared with Trental® (pentoxifylline) in patients with moderate-to-severe intermittent claudication.

Patients and methods. The study included a total of one hundred 40-to-65-year-old patients presenting with confirmed diagnosis of moderate-to-severe intermittent claudication. Depending on the therapeutic regimen, the patients were divided into two groups.

Group 1: 50 patients orally took Pletax® (cilostazol) at a dose of 100 mg twice daily 30 minutes before meals or 2 hours after meals together with conventional therapy.

Group 2: 50 patients took oral Trental® (pentoxifylline) in a dose of 400 mg 3 times daily 30 minutes before meals or 2 hours after meals along with conventional therapy.

The duration of the follow up period amounted to 24 weeks for both groups.

The treadmill test was carried out at room temperature, with the running track tilt angle of 0º at a speed of 3 km/h.

The primary parameters of efficacy were as follows: the dynamics of the minimal walking distance (a distance walked by the patient until the appearance of pain in the extremity) and dynamics of the maximal walking distance (a distance walked by the patients until full stop due to pain in the extremity).

Results. Analysing efficacy demonstrated higher results of Pletax® compared with Trental®. The obtained findings suggested that Pletax® showed a significant clinical effect as soon as at 2 weeks, followed by advantage during the whole period of follow up. Analysing the parameters of the minimal and maximal walking distances in the group of patients taking Pletax® demonstrated clear superiority over the Trental® group as soon as by week 2 of administration, which preserved during the whole follow-up period.

The minimal pain-free walking distance in the Pletax group at baseline amounted to 92.9±83.4 m (Trental group – 92.3±78.4; p=0.3), followed by an increase at week 8 to 126±115 m (Trental group – 116±96.3; p=0.51), at week 16 to 136±116 m (Trental group – 118±95.5; p=0.04), at week 24 to 149±126 b (Trental group – 127±98.9; p=0.01). At the same time, the effect of Pletax® and Trental® on the secondary parameter of efficacy, i.e., the ankle-brachial index was comparable: at baseline – 0.472 and 0.482 (p=0.28), at 2 weeks – 0.48 and 0.483 (p=031), at 8 weeks – 0.49 and 0.485 (p=0.74), at 16 weeks – 0.494 and 0.492 (p=0.2), at 24 weeks – 0.501 and 0.496 (p=0.45).

Conclusion. The obtained findings demonstrated advantages of Pletax® over Trental®, manifesting themselves in the achievement of the highest parameters by such criteria as the minimal and maximal walking distance. High safety and efficacy of Pletax® were confirmed by low frequency of unfavourable events during therapy.

KEY WORDS: Pletax®, cilostazol, Trental®, pentoxifillin, intermittent claudication, chronic lower limb ischaemia, ankle-brachial index, minimal walking distance, maximum walking distance.

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