Objectives Xiapex is a novel drug under observation from the Italian Medicine Agency (AIFA), an innovative and expensive drug. The drug is allowed by law to be given for three times on the same palmar fascia for 4 weeks.Aim Xiapex utilization monitoring during a 10 month period of marketing.Methods or Study Design From the AIFA database were obtained the eligibility criteria for the Xiapex treatment such as: - the joint involved in the treatment (metacarpophalangeal, MP, or proximal interphalageal, PIP) - degree of contracture (between 20 and 50 for MP; between 15 and 40 for PIP) - prior surgical intervention (only aponeurotomy or fasciotomy) Clinical data of 24 patients (P) were available from the doctor as well as data on tolerability and efficacy of the drug after 4 weeks of treatment.Results PRESCRIBING PATTERN Age range of P was from 40 to 90 years. Of that 4 were women and 20 men. CONCOMITANT CONDITIONS 19 P not present other disease 2 P diabetes 2 P hypercholesterolemia 1 P tabagism MAIN ISSUE 22 P had a metacarpophalangeal contracture. In particular: - 11 P with a contracture score of 30 - 2 P with a score of 35 - 7 P with a score of 40 - 2 P with a score of 50. 2 P had a proximal interphalangeal contracture. In particular: - 1 P with a score of 35 - 1 P with a score of 40. Only 2 P had previous surgical intervevention (fasciotomy).Discussion All the 24 P treated once was sufficient to resolve the Dupuytren’s contracture (specifically the remaining residual delta of muscolar contraction was trascurable). Only minor, modest and short side effects were observed such as skin rush at the armpit, light skin abrasions and ecchymosis.Conclusions These preliminary results show that clinically different patients but within the AIFA criterias, benefit of the treatment with very low side effects in all patients.

CP-156 Prescribing pattern, tolerability and efficacy study (4 weeks) of the novel drug ‘xiapex’

C. Polidori;
2016

Abstract

Objectives Xiapex is a novel drug under observation from the Italian Medicine Agency (AIFA), an innovative and expensive drug. The drug is allowed by law to be given for three times on the same palmar fascia for 4 weeks.Aim Xiapex utilization monitoring during a 10 month period of marketing.Methods or Study Design From the AIFA database were obtained the eligibility criteria for the Xiapex treatment such as: - the joint involved in the treatment (metacarpophalangeal, MP, or proximal interphalageal, PIP) - degree of contracture (between 20 and 50 for MP; between 15 and 40 for PIP) - prior surgical intervention (only aponeurotomy or fasciotomy) Clinical data of 24 patients (P) were available from the doctor as well as data on tolerability and efficacy of the drug after 4 weeks of treatment.Results PRESCRIBING PATTERN Age range of P was from 40 to 90 years. Of that 4 were women and 20 men. CONCOMITANT CONDITIONS 19 P not present other disease 2 P diabetes 2 P hypercholesterolemia 1 P tabagism MAIN ISSUE 22 P had a metacarpophalangeal contracture. In particular: - 11 P with a contracture score of 30 - 2 P with a score of 35 - 7 P with a score of 40 - 2 P with a score of 50. 2 P had a proximal interphalangeal contracture. In particular: - 1 P with a score of 35 - 1 P with a score of 40. Only 2 P had previous surgical intervevention (fasciotomy).Discussion All the 24 P treated once was sufficient to resolve the Dupuytren’s contracture (specifically the remaining residual delta of muscolar contraction was trascurable). Only minor, modest and short side effects were observed such as skin rush at the armpit, light skin abrasions and ecchymosis.Conclusions These preliminary results show that clinically different patients but within the AIFA criterias, benefit of the treatment with very low side effects in all patients.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11581/405900
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