[Reduction of cardiovascular morbidity/mortality in arteriopathies treated ith PGE1 alpha-cyclodextrin].

BACKGROUND

Cardiovascular morbidity and mortality were evaluated in two groups of vascular patients (one treated with PGE1 alpha-ciclodestrina according to the short term protocol and one reference group) with a follow up of at least 24 month.

METHODS

The former group included patients who had been treated with at least four PGE1 alpha-ciclodestrina, short-term treatment cycles per year while the latter was a historical reference group managed without prostaglandins. The two groups were comparable for sex and age distribution.

RESULTS

In the PGE1 alpha-ciclodestrina group 142 patients (mean age 64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia: 43 for rest pain, and 52 for localised gangrene). The historical reference group included 157 patients (mean age 65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia (49 rest pain, 55 gangrene). In claudicants yearly cardiovascular morbidity was reduced from the 15% observed in the reference group to 10% in patients treated with PGE1 alpha-ciclodestrina. Yearly mortality decreased from 11% in the reference group to 6% in the treated group. In rest pain patients morbidity decreased from 24% in the reference group to 19% in the treated group. Mortality also decreased (from 16% to 11%). In patients with gangrene the difference in morbidity between the reference group (35%) and the PGE1 alpha-ciclodestrina group (27%) was even more evident (P < 0.025). In this group the mortality per year was reduced from 26% in the reference group to 17% in the PGE1 alpha-ciclodestrina treated group.

CONCLUSION

It appears that cyclic treatment with PGE1 alpha-ciclodestrina produces not only an improvement in signs and symptoms related to vascular disease but also an important decrease in cardiovascular morbidity and mortality which has not been previously reported.