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3720-3726-Domiciliary Treatment with Intravenous Iloprost

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3720-3726-Domiciliary Treatment with Intravenous Iloprost European Review for Medical and Pharmacological Sciences 2016; 20: 3720-3726 Efficacy, safety and feasibility of intravenous iloprost in the domiciliary treatment of patients with ischemic disease of the lower limbs R. POLIGNANO1, C. BAGGIORE1, F. FALCIANI2, U. RESTELLI3, N. TROISI4, S. MICHELAGNOLI4, G. PANIGADA5, S. TATINI1, A. FARINA6, G. LANDINI1 1Medical Department, USL Centro Toscana, Florence, Italy 2Skin Lesions Observatory, USL Centro Toscana, Florence, Italy 3School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Centre for Research on Health Economics, Social and Health Care Management, Carlo Cattaneo University – LIUC, Castellanza (Varese), Italy 4Department of Surgery, Vascular and Endovascular Surgery Unit, San Giovanni di Dio Hospital, Florence, Italy 5Internal Medicine Unit, Santi Cosma e Damiano Hospital, Pescia, Italy 6Medical Affairs Department, Italfarmaco S.p.A., Cinisello Balsamo, Milan, Italy Abstract. – OBJECTIVE: Intravenous iloprost Introduction is an important option in the treatment of isch- emic disease of the lower limbs; however, the administration of therapy is frequently compro- The term ischemic disease of the lower limbs mised because of the need for long cycles of in- defines a wide number of pathological conditions fusion in a hospital setting. The aim of the study of both large and small peripheral arteries and is to evaluate the efficacy, safety, feasibility, and veins, including peripheral artery disease (PAD), the economic impact of infusion therapy in the diabetic microangiopathy, thromboangiitis oblite- outpatient setting. PATIENTS AND METHODS: rans or Buerger’s disease, and other inflammatory Twenty-four con- 1 secutive patients were treated with iloprost at vasculitis . Although these conditions are cha- their homes where they were administered a slow racterized by different pathogenetic mechanisms, rate of infusion for 24 hours a day, during 9.9 ± 2.3 similar clinical manifestations may occur due to days, with a portable syringe pump (Infonde®). the common mismatch between the supply of RESULTS: The clinical condition of patients oxygen and nutrients and the metabolic demand evaluated with the modified SVS/ISCVS scale sig- nificantly improved after treatment (+1.29 ± 1.04 of tissues, with microcirculatory defects including points vs. baseline, p<0.001). The drug was well endothelial dysfunction, altered hemorheology, tolerated; neither significant adverse events as- white blood cell activation and inflammation, and sociated with medication nor problems related maldistribution of the cutaneous microcirculation1. to venous access were recorded at home. Nine- Symptoms may be more or less severe, depending ty-six percent of patients successfully complet- on the seriousness and location of the disease, and ed the entire treatment cycle, and the evaluation questionnaire showed a high acceptance of the may range from intermittent claudication during therapy. From the perspective of the hospital au- exercise to the most serious manifestation of cri- thority, lower direct medical costs were estimat- tical limb ischemia (CLI). CLI represents a major ed for the domiciliary infusion process compared healthcare issue, since it is characterized by a poor with the inpatient infusion setting. long-term prognosis, a high occurrence of major CONCLUSIONS: Treatment with iloprost in the outpatient setting is effective, safe, feasible, cardiovascular events and a high degree of disabi- and more acceptable to patients than infusion at lity because of frequent and severe rest pain, ulcers the hospital. In addition, it has a favorable eco- and amputations of the lower limbs1,2. nomic and organizational impact on the medi- The primary goals of the treatment are to im- cal ward. prove patient function and quality of life, relieve Key Words: ischemic pain, heal ischemic ulcers, prevent limb Critical limb ischemia, Iloprost, Home treatment, loss, and, possibly, prolong survival2. Revascu- Quality of life. larization could optimally achieve some of these 3720 Corresponding Author: Alberto Farina, Pharm.D; e-mail: [email protected] Domiciliary treatment with intravenous iloprost goals, but the severity of comorbidities, along wi- other vasculitis) for which the treatment with intra- th the durability of the reconstruction in patients venous iloprost was deemed clinically appropriate, with CLI, demands a risk-benefit analysis to de- at the Hospital of Florence, Italy. The study was termine the optimal therapy. Some patients who conducted in accordance with current ethical stan- turn to vascular surgeons for surgical or endova- dards and with the Declaration of Helsinki. Inclu- scular procedures are poor candidates for such sion criteria involved ability (though reduced) to interventions because of medical comorbidities, walk, adequate ability to understand instructions, non-ambulatory status, or poor outflow vessels in cooperative family, adequate tolerability to the the limb3. Thus, medical treatment, including ag- first infusion of iloprost received in a hospital gressive modification of cardiovascular risk fac- setting, normal standard blood tests and ECG, tors, control of pain and infection in the ischemic informed consent. Patients with severe medical leg, prevention of progression of systemic athero- conditions requiring hospitalization were excluded sclerosis, and restoration of microcirculation, is a from the study. Patients that matched the inclusion crucial option in the management of CLI4-6. and exclusion criteria were offered the opportunity To date, the only pharmacotherapy for CLI to continue the treatment at home. Figure 1 descri- recommended by current guidelines in patients bes the complete operative procedure. unsuitable for revascularization is represented by Iloprost was administered with a low infusion prostanoids, particularly intravenous iloprost1,5,6. rate, equal to 0.5 ng/kg/min for 6 hours in a ho- Several randomized studies have shown that ilo- spital setting on the first day of treatment and at prost administration has a favorable impact on the fixed rate of 2 μg/hour for 24 hours/day the patient function, pain, ulcer healing, amputation following days, at the patient’s home. A low rate rates, and mortality7-9. Moreover, a pharmacologi- of infusion was used to promote the tolerability of cal approach to improve the microcirculation may the treatment and to administer the whole conten- enhance the results of revascularization1,10. ts of a vial of medication avoiding any waste of an One of the main issues related to iloprost treat- active ingredient. The length of treatment ranged ment is the need for prolonged cycles of admini- from 6 to 16 days depending on the clinical con- stration, consisting of many hours per day up to 4 ditions of the patients. consecutive weeks, in a hospital setting, as indica- Clinical evaluations included the clinical con- ted by the manufacturer recommendations. This dition of the patient measured by the modified approach is no longer consistent with the current SVS/ISCVS (Society for Vascular Surgery/In- needs of the National Health System (NHS), which ternational Society for Cardiovascular Surgery) increasingly requires the optimization of resources scale11, the occurrence of adverse events, the by reducing the number of hospitalizations, health percentage of completion of treatment, and the care staff, and budgets. Moreover, many patients satisfaction of patients at the end of the treatment show a poor compliance to such treatments, be- period, which lasted 9.9 ± 2.3 days. Patient sa- cause of the need to stay in the hospital for a long tisfaction was evaluated by a questionnaire that period. Altogether, these factors may limit the ac- included three statements to which patients were cess to important treatments for a large number of asked to assign a score ranging from 1 (comple- patients, and, when administered, such treatments tely disagree) to 10 (completely agree), and one are often inadequate from the economic and orga- question. The statements were: “I am in favor of nizational point of view. home therapy”; “I consider home therapy safe”; In this paper, we report the clinical and eco- “I can perform my daily tasks easily”; and the nomic results obtained with the home admini- question was “If I could choose between treat- stration of intravenous iloprost in a group of ment at home or in the hospital, which one would outpatients with peripheral vascular diseases of I choose?”. In case of loss to follow-up (1 patient), the lower limbs at the Hospital of Florence, Italy. the scores were considered as “totally disagree” and “not willing to repeat the treatment at home”. Patients and Methods Statistical Analysis Data were expressed as means ± standard de- This was a prospective observational study that viations (SD). The SVS/ISCVS score at follow-up included 24 consecutive patients with periphe- was compared with baseline using a paired sam- ral vascular diseases (peripheral arterial disease, ples t-test. Statistical significance was considered diabetic microangiopathy, Buerger’s disease, and at p-values <0.05. 3721 R. Polignano, C. Baggiore, F. Falciani, U. Restelli, N. Troisi, S. Michelagnoli et al. Figure 1. Operative procedure for the domiciliary treatment with intravenous iloprost. Economic Analysis Among the devices on the market, Infonde® is To evaluate the economic impact of the ma- the one that best fits the home administration of nagement of domiciliary iloprost from the
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