Multicenter evaluation on the efficacy and tolerability of repeated Prostavasin (R) treatment in patients with stage III IV PAOD

Background: Clinical studies oil the efficacy and tolerability of prostagla ndin E-1 (PGE(1)) in the treatment of stage III/IV PAOD have so far reporte d only the effect of a single course of treatment lasting an average of 3-4 weeks. In view of the progressive nature of PAOD, however, worsening of th e symptoms may again occur during the further course of the disease. The ai m of the present retrospective study was, therefore, to investigate the que stion whether, under the conditions usually met with in the doctor's office or hospital, patients with stage III/IV PA OD also benefit over the long-t erm, that is, from repeated treatment with PGE(1) (Prostavasin(R)). Patients and Methods: In 13 angiological centers, the data of 277 patients (mean age 67 +/- 11 years) with the typical profile of instable stage III ( n = 93) or stage IV (n = 184) PAOD who underwent more than one course of PG E(1) treatment were analysed. The mean daily dose and duration of the initi al Prostavasin(R) treatment in the 169 hospitalized patients were 2 x 40 mu g PGE(1) i.v. for 21 days, and in the 108 ambulatory patients 1 x 60 mu g PGE(1) i.v. for 20 days. Results: Following the first course of treatment, 46% of the patients were returned from stage III/IV to stage II. On the occasion of the second cours e of treatment, 32% of these patients were still in stage II, while in the remaining patients, after an average treatment-free period of 342 days, the condition had deteriorated. Among this latter group, however, the renewed course of treatment resulted in renewed down-grading to stage II in 67% of the cases. The results seen after a third or fourth course of treatment wer e similarly positive. However, the success of treatment in patients with US Doppler pressures <50 mmHg was less favorable in comparison with higher Do ppler pressures. Here, only 39% as compared with 62% of the cases were down -graded to stage II by the initial treatment. In all 4 courses of treatment , the tolerability of PGE(1) was equally good. Conclusions: In the usual office or hospital setting, intravenous Prostavas in(R) administered to patients with stage III/IV PAOD produces a long-lasti ng clinical improvement. Even in cases subsequently experiencing clinical d eterioration, a renewed course of Prostavasin(R) treatment is successful, a nd the tolerability of the substance remains good.