[Randomized study of tolerability, safety and efficacy of Pletax in intermittent claudication]. / Randomizirovannoe issledovanie perenosimosti, bezopasnosti i éffektivnosti preparata Pletaks pri peremezhaiushcheisia khromote.

AIM: 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 0° 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.

[Effectiveness of pentoxifylline and of bio-electromagnetic therapy in lower limb obliterative arterial disease]. / A pentoxifillin és a bioelektromágnes-regulációs kezelés hatása alsó végtagi obliteratív veroérbetegségben.

INTRODUCTION: There are limited therapeutic options to improve microcirculation. AIM: The question of the study was to investigate any potential beneficial effect of bio-electro-magnetic-regulation therapy on microcirculation in patients suffering from obliterative peripheral arterial disease including the circulation of lower extremities, as well as intermittent claudication. METHOD: Thirty patients suffering from obliterative peripheral arterial disease (Fontaine IIa and IIb) were recruited. The first step of the study was to determine the pain free and maximal walking distance with a treadmill unit. After the placebo period patients received 8 and 20 minutes bio-electro-magnetic-regulation treatment 16 times. After the treatment the pain free and maximal walking distance were measured again. In the second stage of the study the patients were treated by pentoxifylline infusions. RESULTS: Bio-electro-magnetic-regulation treatment increased the pain free period by 57.4% (p = 0.005) and the maximal walking distance by 36.6% (p = 0.042). The two forms of therapy together increased the pain free and maximal walking distance by 81.9% and by 84.0%, respectively. The combined therapy was very effective in contrast to placebo and bio-electro-magnetic-regulation treatment (p = 0.000373 and p = 0.00741, respectively). CONCLUSIONS: The bio-electro-magnetic-regulation therapy mainly affected the microvessels and pentoxifylline therapy rather had beneficial effects on hemorheology. The clinical effectiveness of combined therapy was good or excellent in 70% of patients.