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International Angiology 2002 March;21(1):36-43


lingua: Inglese

Outpatient treatment of severe peripheral ischemia with intravenous intermittent low-dose iloprost. An open pilot study

Banyai S., Jenelten R., Wagner S., Allmann J., Banyai M., Koppensteiner R.

From the Division of Angiology, Department of Medicine, University Hospital Zurich, Zurich, Switzerland


Back­ground. Ilo­prost given in a stan­dard dose reg­i­men (0.5-2 ng/kg/min for 6 hours daily over 21-28 days) has prov­en to be effec­tive and safe in hos­pi­tal­ized ­patients with crit­i­cal limb ische­mia. Major draw­backs of the stan­dard reg­i­men are the high fre­quen­cy of side ­effects, the long dura­tion of the daily infu­sion, and a hos­pi­tal stay of 3 to 4 weeks. Recent­ly, the effi­ca­cy of low doses of ilo­prost (25 μg/day) was dem­on­strat­ed. This open pilot study was under­tak­en to iden­ti­fy a more prac­ti­cal and cost-effec­tive reg­i­men with less side ­effects. The fea­sibil­ity, effi­ca­cy and safe­ty of an indi­vid­u­al­ly adapt­ed, inter­mit­tent­ly ­applied low-dose ilo­prost reg­i­men in an out­pa­tient set­ting were eval­u­at­ed.
Meth­ods. Twen­ty-seven ­patients with ­severe periph­er­al ische­mia in the limbs or part of the limb due to var­i­ous eti­ol­o­gies, who were eli­gible for out­pa­tient treat­ment, were ­enrolled into the study. The infu­sion of ilo­prost (50 µg in 250 ml 0.9% ­saline) was start­ed at 0.5 ng/kg BW/min and titrat­ed to the indi­vid­u­al opti­mum dose, which was ­defined as the max­i­mum dose at which the ­patient felt entire­ly com­fort­able. The fre­quen­cy of the ilo­prost infu­sions and the dura­tion of the treat­ment were indi­vid­u­al­ly deter­mined in each ­patient accord­ing to the sever­ity of the clin­i­cal con­di­tion. Out­come endpoints were the ­response rates ­achieved by day 28, ­defined as sub­stan­tial ­relief from rest pain and evi­dence of ulcer heal­ing. The ­patients were fol­lowed up for a min­i­mum of 6 ­months.
­Results. A total of 27 ­patients (15 male, 12 ­female, mean age 65 years) were treat­ed. Twen­ty-four ­patients ­received daily infu­sions with a break at week­ends (5 times/week); 3 ­patients were treat­ed every sec­ond day (3 times a week). The mean daily ilo­prost dose actu­al­ly given was 20±5 µg, the mean dura­tion of treat­ment was 3.6±0.8 weeks, i.e. a mean of 17±4 infu­sions were admin­is­tered. Six ­patients with one-ves­sel run-off under­went per­cut­ane­ous trans­lu­mi­nal angio­plas­ty (PTA) of their sin­gle calf ves­sel. Twen­ty-six ­patients ­showed clin­i­cal improve­ment by day 28; exclud­ing those who had had PTA, the ­response rate to ilo­prost was 74% (20/27). No ­patient ­required admis­sion to hos­pi­tal while receiv­ing out­pa­tient treat­ment; no side ­effects ­occurred after adjust­ment to the opti­mum dose. At long-term fol­low-up (11±3 ­months), 76% of ­patients were alive and had a ­viable limb.
Con­clu­sions. In a lim­it­ed num­ber of ­patients with ­severe periph­er­al ische­mia of var­i­ous eti­ol­o­gies, long-term out­pa­tient treat­ment with an indi­vid­u­al­ly adapt­ed low-dose ilo­prost reg­i­men was fea­sible and safe. Our data sug­gest that flex­ible treat­ment modal­ities might be as effec­tive as rigid stan­dard treat­ment reg­i­mens, the for­mer being more advan­ta­geous in terms of great­er prac­ti­cabil­ity and cost-effec­tive­ness due to out­pa­tient man­age­ment. Fur­ther stud­ies are need­ed to con­firm the effi­ca­cy of this indi­vid­u­al­ly adapt­ed, low-dose out­pa­tient ilo­prost treat­ment reg­i­men in a larg­er num­ber of ­patients.

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