Emerging issues on selection criteria of levodopa carbidopa infusion therapy: considerations on outcome of 28 consecutive patients

Abstract

Many studies confirmed the efficacy and safety of continuous infusion of intrajejunal levodopa/carbidopa gel (CIILG) for advanced Parkinson's disease (PD). Although this treatment is widely used, definite inclusion/exclusion criteria do not exist. In this prospective open-label study, we evaluated the long-term outcome in 28 consecutive patients and sought to detect any predictive factor to identify the best candidates for CIILG therapy. The assessment was carried out routinely at baseline, after 6 months and every year with UPDRS III-IV, FOG Questionnaire, non-motor symptoms scale, PD questionnaire (PDQ-8), cognitive and psychiatric status evaluation (MMSE, FAB, NPI) and caregiver's quality of life. 17/28 patients reached the 24-month follow-up. A statistically significant beneficial effect was shown on motor complications in short- and long-term follow-up, also on axial symptoms like gait disturbances. A concomitant improvement in PDQ8 score was observed, with a parallel mild amelioration, but not significant, on Caregivers QoL. When classified according to their outcome on QoL, the only predictive positive factor was less severe at Neuropsychiatric Inventory (NPI) score at baseline. Considering the improvement in motor scores (duration of "off" period), the more advanced age was associated with a poorer outcome. Our results confirmed a sustained efficacy and safety in long-term follow-up and suggest that younger age at operation and absence or mild presence of psychiatric/behavioural symptoms could be considered valid predicting factors in selecting the best candidates for this efficacious therapy.

Long-term response to continuous duodenal infusion of levodopa/carbidopa gel in patients with advanced Parkinson disease: The Barcelona registry

“…In fact the majority of our patients reported a significant reduction of prevalence and duration of all type of off-phenomena. Regarding on periods, contrary to other groups [20], we did not report improvement of axial symptoms in on state. Moreover we reported a global increase of waking time with dyskinesias related to LCIG specifically in those patients having less dyskinesias before the treatment (less of 50% of waking day).…”

Levodopa/Carbidopa Intestinal Gel Infusion Therapy: Focus on Gait and Balance

“…The present study reported positive outcomes on balance and gait disorders of LCIG treatment. Moreover, the results on QoL, motor scores, and non‐motor symptoms are in line with previous research . There was no effect on cognition (Table ).…”

“…We conducted an observational open‐label study enrolling patients who were screened as candidates for LCIG therapy according to the criteria described elsewhere . Only those who reported the feeling of feet glued to the floor, or unsteadiness while walking or standing, or any other gait and/or balance complaints were included in this sample.…”

“…Although numerous treatments have been trialed, they are still difficult to treat with conventional therapies. Some benefits from levodopa‐carbidopa intestinal gel (LGIC) infusion have been reported, however there has yet to be a prospective study that takes into consideration LCIG treatment specifically for these axial symptoms.…”

Levodopa-carbidopa enteral suspension in advanced Parkinson’s disease: clinical evidence and experience

“…These are summarized in Table 5. Factors that may predict the effectiveness of LCIG include the patient's age and the absence of psychiatric/behavioral symptoms [Sensi et al 2014]. In addition, a correlation analysis from two clinical trials showed that patients with the greatest motor disabilities, assessed by the UPDRS, gained the greatest benefits from LCIG infusion [Westin et al 2006].…”