[Cardiovascular morbidity/mortality modified by the use of FGE1 alpha-cyclodextran and calcium heparin in patients with severe vascular diseases].
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alpha-ciclodestrina and subcutaneous calcium heparin (SCH; 0.5 ml once daily, in the evening) while a third group was a historical reference group.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 The historical reference group had been managed without PGE1 alpha-ciclodestrina or SCH while in the two PGE1 alpha-ciclodestrina groups included patients who had been treated with at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 The historical reference group included 157 patients (65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia).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.


CONCLUSIONS
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.
Belcaro
G
G
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Cesarone
M R
MR
Bucci
M
M
Iacobitti
P
P
Dugall
M
M
D000368:Aged; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000401:mortality*; D003505:Cyclodextrins / Q000494:pharmacology / Q000627:therapeutic use*; D015232:Dinoprostone / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy*; D007511:Ischemia / Q000188:drug therapy; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index
D003505:Cyclodextrins; D015232:Dinoprostone