[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been treated with at least four PGE1 alpha-ciclodestrina, short-term treatment cycles per year while the latter was a historical reference group managed without prostaglandins.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 The historical reference group included 157 patients (mean age 65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia (49 rest pain, 55 gangrene).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.


CONCLUSIONS
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.
Belcaro
G
G
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Bucci
M
M
Cesarone
M R
MR
Incandela
L
L
De Sanctis
M T
MT
D017677:Age Distribution; D000368:Aged; D000527:Alprostadil / Q000494:pharmacology / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality; D003505:Cyclodextrins / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005734:Gangrene / Q000188:drug therapy; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy; D007511:Ischemia / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012744:Sex Ratio
D003505:Cyclodextrins; D000527:Alprostadil