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Background: In this study we evaluated a group of 76 patients (mean age 66 +/- 12) treated with the short-term PGE1 alpha-ciclodestrina protocol (60 micrograms/die for 2 days). Responders to PGE1 alpha-ciclodestrina treatment were considered patients with an increase in flow/perfusion and an associated improvement in signs/symptoms. Moderate responders were considered patients with only flow/perfusion increase or only sign/symptoms improvement. Non-responders were characterised by no increase in flow/perfusion and no clinical improvement., Methods: Signs/symptoms variations were measured on an analogue scale line. Perfusion measurements (laser Doppler, transcutaneous PO2, arterial inflow with straingauge plethysmography) were recorded after the two days of the short term treatment., Results: In the group of 38 patient with claudication (200-600 m) 54% were considered responders, 12% non responders and 34% moderate responders. In the more severe claudication group (distance < 200 m) including 18 patients, 66% were responders, 8% non responders and 26% were considered moderate responders. In the rest pain group (13 patients) there were 63% responders, 9% non-responders and 28% moderate responders. In the gangrene group (10 patients) 60% were considered responders, 10% non-responders and 3% moderate responders. The overall percentages were 61.25% of responders, 10% of non-responders and 28.75% moderate responders., Conclusions: The evaluation of the response to PGE1 alpha-ciclodestrina treatment may indicate which group of patients will benefit from the treatment and which group will have no benefits or only limited benefits. This may induce changes in treatment (i.e. increasing doses, more prolonged treatment) or other solutions (revascularisation if possible, arterial infusion or amputation).

Background: Morbidity and mortality were evaluated in three groups of vascular patients: one group was treated with PGE1 alpha-ciclodestrina according to the short term protocol; the second group was treated with PGE1 alpha-ciclodestrina and subcutaneous calcium heparin (SCH; 0.5 ml once daily, in the evening) while a third group was a historical reference group., Methods: All included patients had a follow up of at least 12 months. The historical reference group had been managed without PGE1 alpha-ciclodestrina or SCH while in the two PGE1 alpha-ciclodestrina groups included patients who had been treated with at least four PGE1 alpha-ciclodestrina short-term treatment cycles per year. The 3 groups were comparable for sex and age distribution. In the PGE1 alpha-ciclodestrina group 142 patients (64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia). The historical reference group included 157 patients (65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia). The group treated with PGE1 alpha-ciclodestrina and SCH included 74 patients (27 with claudication and 47 with critical ischemia)., Results: In claudicants yearly cardiovascular morbidity was reduced from 15.5% in the reference group to 10.2% in patients treated with PGE1 alpha-ciclodestrina and to 7.9% in those treated with PGE1 alpha-ciclodestrina and SCH. Mortality decreased from 11.3% in the reference group to 6% in the PGE1 alpha-ciclodestrina group and to 5.1% in the PGE1 alpha-ciclodestrina + SCH group. In patients with critical limb ischemia morbidity decreased from 28.6% in the reference group to 23.2% in PGE1 alpha-ciclodestrina-group and to 19.4% in the PGE1 alpha-ciclodestrina + SCH group. Mortality also decreased from 16% (reference group) to 13% in the PGE1 alpha-ciclodestrinagroup, to 10.3% in the PGE1 alpha-ciclodestrina + SCH group., Conclusion: Cyclic treatment with PGE1 alpha-ciclodestrina produces an important decrease in cardiovascular morbidity and mortality which could be further reduced by the chronic use of subcutaneous calcium heparin.

Background: In this study patients with peripheral vascular disease were treated with PGE1 alpha-ciclodestrina. In the intermittent claudication group (walking distance at inclusion between 200-600 m) we included 55 patients treated with PGE1 alpha-ciclodestrina (15 diabetics) and 22 controls (not treated with PGE1 alpha-ciclodestrina). In the critical ischemia group 46 patients were treated and 47 patients followed up as controls (rest pain or necrotic lesions had been present for more than 2 weeks)., Methods: Patients with intermittent claudication were evaluated by a treadmill test (walking distance was the endpoint) and in those with critical ischemia the number of minor and major amputations in 12 months were considered as endpoints. A dose of PGE1 alpha-ciclodestrina (60-80 micrograms/day for 2 days) was repeated either every 6 or, in alternative, every 10 weeks. In the control group only antiplatelet agents, support treatment (control of risk factors) and exercise were used., Results: All subgroups of patients treated with PGE1 alpha-ciclodestrina with intermittent claudication increased their walking distance (including the subgroup of diabetics). In critical ischemia there were no major amputations (only 2 minor amputations) in the PGE1 alpha-ciclodestrina group vs 10.6% (of major amputations) in the control group. Also an evaluation of laser Doppler flow, volume flow and transcutaneous PO2 indicated in subgroups of patients an improvement of microcirculation and limb perfusion with PGE1 alpha-ciclodestrina., Conclusions: The cost analysis and the quality of life evaluation indicated a benefit of preserving limbs from amputation.