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Rivista di Angiologia

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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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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