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

Szczegóły
Abstrakt

Tytuł:: [Randomized study of tolerability, safety and efficacy of Pletax in intermittent claudication].
Autorzy:: Kazantsev AN; Department of Surgery #3, Alexandrovskaya Hospital, Saint Petersburg, Russia.
Goriunov SV; Department of Surgery #17, Municipal Clinical Hospital #15 named after O.M. Filatov under the Moscow Healthcare Department, Moscow, Russia.
Ershova OB; Clinical Hospital of Emergency Medical Care named after N.V. Solovyev, Yaroslavl, Russia.
Erofeeva SB; Clinic 'Bessalar', Centre of Clinical Trials, Moscow, Russia.
Gurgenian EV; Therapeutic Department #11, Municipal Clinical Hospital #23, Moscow, Russia.
Transliterated Title:: Randomizirovannoe issledovanie perenosimosti, bezopasnosti i éffektivnosti preparata Pletaks pri peremezhaiushcheĭsia khromote.
Źródło:: Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery [Angiol Sosud Khir] 2021; Vol. 27 (1), pp. 7-16.
Typ publikacji:: Journal Article; Randomized Controlled Trial
Język:: Russian
Imprint Name(s):: Original Publication: [Moskva] : Izd-vo Info-Media, c1995-
MeSH Terms:: Intermittent Claudication*/diagnosis
Intermittent Claudication*/drug therapy
Pentoxifylline*
Adult ; Aged ; Cilostazol ; Exercise Test ; Humans ; Middle Aged ; Walking
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Contributed Indexing:: Keywords: Pletax®; Trental®; ankle-brachial index; chronic lower limb ischaemia; cilostazol; intermittent claudication; maximum walking distance; minimal walking distance; pentoxifillin
Local Abstract: [Publisher, Russian] Цель исследования – оценка переносимости, безопасности и терапевтической эффективности Плетакса® (цилостазол) в сравнении с Тренталом® (пентоксифиллин) у пациентов с умеренно выраженной и тяжелой перемежающейся хромотой. Материалы и методы. В исследование включено 100 пациентов в возрасте от 40 до 65 лет с наличием подтвержденного диагноза умеренно выраженной и тяжелой перемежающейся хромоты. В зависимости от схемы лечения все пациенты распределялись на две группы. Группа 1: 50 пациентов получали препарат Плетакс® (цилостазол) по 100 мг 2 раза в сутки внутрь за 30 минут до еды либо через 2 часа после приема пищи совместно со стандартной терапией. Группа 2: 50 пациентов получали препарат Трентал® (пентоксифиллин) по 400 мг 3 раза в сутки внутрь за 30 минут до еды либо через 2 часа после приема пищи совместно со стандартной терапией. Период наблюдения составил 24 недели для обеих групп. Тредмил-тест проводился при комнатной температуре, угол наклона дорожки – 0°, скорость движения – 3 км/ч. Первичные параметры эффективности: динамика минимальной дистанции ходьбы (расстояние, проходимое пациентом до возникновения боли в конечности) и динамика максимальной дистанции ходьбы (расстояние, проходимое пациентом до окончательной остановки из-за болей в конечности). Результаты. Анализ эффективности показал более высокие результаты препарата Плетакс® в сравнении с Тренталом®. Полученные данные свидетельствуют, что Плетакс® продемонстрировал значимый клинический эффект уже через 2 недели приема с дальнейшим преимуществом на всем протяжении наблюдения. При анализе показателей минимальной и максимальной дистанции ходьбы в группе пациентов, принимающих Плетакс®, отмечались явные превосходства над группой Трентала® уже ко 2-й неделе приема, что сохранялось на всем протяжении наблюдения. Минимальная дистанция безболевой ходьбы в группе Плетакса® исходно составляла 92,9±83,4 м (группа Трентала® – 92,3±78,4; р=0,3) с последующим увеличением на 8-й неделе до 126±115 м (группа Трентала® – 116±96,3; р=0,51), на 16-й неделе – до 136±116 м (группа Трентала® 118±95,5; р=0,04), на 24-й неделе – до 149±126 м (группа Трентала® – 127±98,9; р=0,01). В то же время влияние Плетакса® и Трентала® на вторичный показатель эффективности лодыжечно-плечевого индекса было сопоставимым: исходно – 0,472 и 0,482 (р=0,28), через 2 недели – 0,48 и 0,483 (р=0,31), через 8 недель – 0,49 и 0,485 (р=0,74), через 16 недель – 0,494 и 0,492 (р=0,2), через 24 недели – 0,501 и 0,496 (р=0,45). Заключение. Результаты проведенного анализа продемонстрировали преимущества Плетакса® над препаратом Трентал®, выражающиеся в достижении наибольших показателей по таким критериям, как минимальная и максимальная дистанция ходьбы. Высокая безопасность и эффективность препарата Плетакс® подтверждена низкой частотой нежелательных явлений в ходе приема терапии.
Substance Nomenclature:: N7Z035406B (Cilostazol)
SD6QCT3TSU (Pentoxifylline)
Entry Date(s):: Date Created: 20210407 Date Completed: 20210409 Latest Revision: 20210409
Update Code:: 20240104
DOI:: 10.33529/ANGIO2020405
PMID:: 33825723
: Czasopismo naukowe

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.

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