Background: A group of patients with severe peripheral vascular disease has been treated with PGE1 alpha-ciclodestrina (as reported in the previous 9 articles) including 595 patients (mean age 64.52 +/- 12; 307 with intermittent claudication and 237 with critical limb ischemia, rest pain and gangrene). Also 51 diabetics were studied and treated (25% with claudication and the remaining group with critical ischemia and/or neuropathy). The mean dosage administered in most patients (83% were treated with the short-term protocol) had been 20 + 40 micrograms on the first day and 60 + 40 micrograms on the second day.
Methods: Subjects had been treated on average 2.6 times (cycles of short term treatment); 37% of patients had received at least 3 cycles of short term treatment. Clinically relevant side effects have been observed in 30 patients (5% of the 595 treated patients). Temporary suspension of treatment has reduced/abolished side effects in 18 out of 30 patients and only in 5 patients (0.8%) therapy had to be suspended. Clinical improvement was evaluated according to subjective improvement, objective improvement (as defined by the treating physician/surgeon) and one or more physiological parameters (flux, flow, treadmill test). Among patients with intermittent claudication (only considered endpoint was walking distance) 78% was significantly improved. In patients with critical ischemia (endpoints were pain control, decrease of ischemic areas and perfusion improvement, objectively measured) 66% of patients improved. In diabetics (including both claudicants and subjects with critical ischemia) 58% improved.
Conclusions: Global analysis of the previous 9 studies indicates that PGE1 alpha-ciclodestrina treatment is effective, there are few and controllable (in most patients) side effects and the treatment (particularly the short term protocol) is very cost effective.