[Administration of the generic prostaglandin E1 VAP 20® in patients with lower limb critical ischaemia: a prospective study].

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

Material 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.