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Intravenous iloprost, titrated from 0.5 up to 2.0 ng/kg/min has been shown in patients with PAOD III/IV to significantly improve healing of trophic lesions, relief of rest pain, and reduce the rate of major amputation or death at 6 months as compared to placebo. The effect is considered related to improvement of the microcirculation. The aim of the present trial was to identify an optimum dose regarding treatment response and tolerability, by studying 4 doses of 25, 50, 75 and 100 micrograms iloprost daily.302 patients with PAOD IV were randomised via a double-blind fashion to one of the 4 doses. The primary endpoint was the responder rate at end of treatment. Responders were defined as patients with very good or good global efficacy, as judged by lesion healing and pain relief. Side effects were documented and a pre-defined benefit/risk index was calculated.No dose-dependency of iloprost regarding primary or secondary endpoints was observed. The rate of responders ranged between 48.7-53.5%. Side effects, mainly related to vasodilation, increased dose-dependently (p0.001, chi 2-test), with a significant decrease of the benefit/risk index from 2.19 +/- 1.19 to 1.64 +/- 0.97 (p = 0.012, ANOVA). Responders had a better outcome at 6 months than non-responders (2.6 fold higher rate of major amputation or death; life table analysis).It is concluded that iloprost should be titrated to the optimum rather than maximum tolerated dose, since a higher incidence of side effects not associated with an increased treatment response was observed at higher doses.

Increasingly and justifiably, clinical studies are now being expected to investigate the influence of therapeutic measures also on the quality of life of the patient.Since no data on the variability of changes in the quality of life of the patient following PGE1 treatment are so far available, the initial investigation was designed as an uncontrolled pilot study. 104 patients (median age 64.5 years) with a maximum of walking distance on the treadmill (3 km/12%) of 50-250 m were included and given a daily intravenous infusion of 60 micrograms PGE1 (Prostavasin) over a period of 4 weeks excluding weekends. This was followed by a treatment-free follow-up period of 3 months. Changes in the quality of life were recorded with both the newly developed disease-specific questionnaire PAVK-86, and the generic questionnaire SF 36; in addition, the pain-free and maximum walking distances on the treadmill were also established prior to and immediately following treatment, as also at the end of the follow-up period.The quality of life was significantly improved in all dimensions (functional status, complaints, pain, mood, anxiety, social life, treatment expectations) in addition to a marked increase in the median pain-free walking distance from 77 to 108 m (p0.001) and the maximum walking distance from 118 to 171 m (p0.001). At the end of the 3-month observation period, the improvement was essentially still demonstrable.The study has shown for the first time that treatment with intravenous PGE1 brings about not only the already known increase in the walking distance, but also a clinically relevant and significant improvement in the patient's quality of life.

In patients with peripheral arterial occlusive disease (PAOD) of stage III/IV and three-level occlusion, the outcome of vascular surgery is still unsatisfactory. Therefore, the aim of our study was to determine both the short-term results and the long-term outcome, in terms of limb salvage and patient survival, of adjuvant intravenous prostaglandin E1 (PGE1) treatment in patients undergoing profundaplasty.A prospective randomized placebo-controlled study was conducted in 83 patients with PAOD of the lower extremities (stage III or IV according to Fontaine). Profundaplasty was carried out in all patients. Starting on the day of surgery and continuing for three weeks, patients of the PGE1 group (n = 42) received twice daily a 2-hour intravenous infusion of 60 micrograms PGE1 in 250 ml of physiological saline. Patients of the control group (n = 41) were given only saline by the same regimen. Following discharge from hospital, patients were re-examined after 6 weeks and subsequently every 6 months for a period of up to 5 years.Short-term results: In the PGE1 group, rest pain disappeared and necrotic lesions healed in a significantly larger proportion of patients as compared with the control group (62% vs 37%; p = 0.05). Moreover, the number of minor amputations, such as toe and forefoot amputations, was significantly smaller in patients treated with PGE1 (7 vs. 19; p0.001). Long-term results: By the end of the 5-year follow-up period, a significantly larger percentage of patients was still alive in the PGE1 group as compared with control (55% vs. 34%; p = 0.046). Moreover, significantly less major amputations became necessary during follow-up in the PGE1 group (8 vs. 16; p = 0.0088).In patients undergoing profundaplasty because of severe limb ischemia due to three-level occlusion, adjuvant intravenous 3-week treatment with PGE1 substantially improves not only the short-term results, but also the long-term outcome after five years in terms of patient survival and limb salvage.