Journal «Angiology and Vascular Surgery» • 

2013 • VOLUME 19 • №2

Administration of the generic prostaglandin e1 vap 20® in patients with lower limb critical ischaemia: a prospective study

Pokrovsky A.V.1, Chupin A.V.3, Parshin P.Yu.3, Mikhailov I.P.2, Lavrenov V.N.2, Kharazov A.F.1, Kutyrev O.E.2

1) Department of Vascular Surgery, A.V. Vishnevsky Institute of Surgery under the RF Ministry of Public Health and Social Development,
2) Department of Vascular Surgery, Scientific Research Institute of Emergency Ambulance Care named after N.V. Sklifosovsky,
3) Department of Vascular Surgery, “Federal Scientific Clinical Centre for Special Types of Medical Care and Medical Technologies” under the Federal Biomedical Agency of Russia, Moscow, Russia

Objective: The study was aimed at assessing efficacy and safety of administering the generic alprostadil VAP in patients presenting with lower limb critical ischaemia.

Materials and methods: We carried out a prospective study including a total of 30 patients with lower limb critical ischaemia. The patients’ mean age was 67.7±7.8 years, with men predominating – 60%. Trophic ulcers were observed in 40% of patients. The proximal level of the lesion was localized in the arteries below the inguinal ligament in 19 (63.3%) patients, in the aortofemoral segment – in 9 (30%) patients, and in the popliteal-crural-plantar segment – in 2 (6.6%) subjects. The average ankle-brachial index amounted to 0.49±0.4. The studied agent was used at a dose of 40 mcg once a day in patients with stage III ischaemia and a dose of 40 mcg twice daily in patients with stage IV ischaemia. The drug was administered for 14 days followed by a 14-day follow-up period.

Results: The pain syndrome score over the 14 days of treatment decreased twofold from 6.1±2.5 to 3.5±2.6 and within the subsequent 14 days it did not increase – 2.4±3.1 (p<0.05). The number of patients in whom the pain syndrome decreased by 50% amounted to 19 (63.3%). The consumption of analgesic agents decreased from 60% (at the beginning of treatment) to 12 (40%) (14 days after treatment) and to 8 (26.6%) (at the end of the follow-up period). In patients with trophic ulcers, the average size of the ulcers during treatment decreased from 3.3±3.7 cm to 2.8±3.8 after 14 days, and at the end of the follow-up period the size of the ulcers amounted to 2.1±2.8 cm (p>0.05). The number of patients responding to treatment amounted to 22 (77.3%). The ABI during treatment did not change, being 0.49±0.4 at the beginning of treatment, 0.53±0.4 after 14 days of treatment, and 0.47±0.3 at the end of the follow-up period. There were no amputations either during treatment or within the follow-up period. Only one lethal outcome occurred which was related to acute coronary insufficiency. The "response to treatment" was significantly influenced only by the level of the proximal lesion and age (p<0.05).

Conclusion: VAP 20® demonstrated good efficacy and tolerability comparable to those of the original preparations.

KEY WORDS: prostanoids, critical ischaemia.

P. 24

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