Mariachiara Sensi1, Giovanni Cossu2, Francesca Mancini3, Manuela Pilleri4, Maurizio Zibetti5, Nicola Modugno6, Rocco Quatrale7, Filippo Tamma8, Angelo Antonini9. 1. Department of Neurology, Azienda Ospedaliera Universitaria Arcispedale S.Anna, Ferrara, Italy. 2. Department of Neurology, Ospedale Brotzu, Cagliari, Italy. Electronic address: giovannicossu@aob.it. 3. Department of Neurology, Humanitas San Pio X-Milano, Milan, Italy. 4. Department of Neurology, (Neurology Service), Villa Margherita Private Hospital, Arcugnano, Vicenza, Italy. 5. Department of Neuroscience, A.O. Città della Salute e della Scienza di Torino, Turin, Italy. 6. Department of Neurology, Neuromed IRCSS Pozzilli, Pozzilli, Italy. 7. Department of Neurology, Ospedale dell'Angelo, Mestre, Italy. 8. Department of Neurology, Ospedale F.Miulli, Acquaviva delle Fonti (BA), Italy. 9. Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy.
Abstract
OBJECTIVES: To report the results of a national survey aimed at quantifying the current level of diffusion of Levodopa/carbidopa intestinal gel (LCIG) in Italy. METHODS: Sixty Parkinson's Disease (PD) specialists in Italy were invited to complete a survey covering issues on clinical and practical aspects of LCIG therapy. RESULTS: Clinical features of 905 patients were collected retrospectively. The majority of centres reported the use of a multidisciplinary team, biochemistry testing, neurophysiological and neuropsychological tests before and after treatment, in addition to caregivers' training and patient's follow as outpatients. Most centres (60%) used internal guidelines for patient selection. The overall rate of adverse events was 55.1%. Weight loss, chronic polyneuropathy and stoma infection were the most frequently reported. 40% of centres used replacement therapy with Vitamin B12 and Folic acid from the start of LCIG and continued this for the duration of treatment. The rate of discontinuation was of 25.7% overall, with 9.5% of cases occurring in the first year. The main causes of withdrawal were device-related complications, disease progression (comorbidity, severe dementia) and caregiver and/or patient dissatisfaction. CONCLUSIONS: In Italy LCIG infusion is managed in a uniform manner at a clinical, practical and organizational level even though the selection criteria are not standardized through the country. The high percentage of patients remaining on treatment in the short- and long-term follow-up confirms effectiveness of treatment, careful follow-up, and appropriate patient and caregivers training.
OBJECTIVES: To report the results of a national survey aimed at quantifying the current level of diffusion of Levodopa/carbidopa intestinal gel (LCIG) in Italy. METHODS: Sixty Parkinson's Disease (PD) specialists in Italy were invited to complete a survey covering issues on clinical and practical aspects of LCIG therapy. RESULTS: Clinical features of 905 patients were collected retrospectively. The majority of centres reported the use of a multidisciplinary team, biochemistry testing, neurophysiological and neuropsychological tests before and after treatment, in addition to caregivers' training and patient's follow as outpatients. Most centres (60%) used internal guidelines for patient selection. The overall rate of adverse events was 55.1%. Weight loss, chronic polyneuropathy and stoma infection were the most frequently reported. 40% of centres used replacement therapy with Vitamin B12 and Folic acid from the start of LCIG and continued this for the duration of treatment. The rate of discontinuation was of 25.7% overall, with 9.5% of cases occurring in the first year. The main causes of withdrawal were device-related complications, disease progression (comorbidity, severe dementia) and caregiver and/or patient dissatisfaction. CONCLUSIONS: In Italy LCIG infusion is managed in a uniform manner at a clinical, practical and organizational level even though the selection criteria are not standardized through the country. The high percentage of patients remaining on treatment in the short- and long-term follow-up confirms effectiveness of treatment, careful follow-up, and appropriate patient and caregivers training.
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