<p>Profile Of Patients With Advanced Parkinson’s disease Suitable For Device-Aided Therapies: Restrospective Data Of A Large Cohort Of Romanian Patients</p>

Abstract

Background: There is insufficient data in the literature regarding the real-life, daily clinical practice evaluation of patients with advanced Parkinson's disease (APD). We are not sure what is the upper limit of dopaminergic medication, especially the levodopa (LD) dosage, and how it is influenced by access and suitability to the various add-on and device-aided therapies (DAT). Objective: This retrospective study explored the profile of APD patients that were considered and systematically evaluated regarding the suitability for DAT. Methods: We analyzed the data from 311 consecutive patients with APD hospitalized between 2011 and 2017 that 1) described at least 2 hrs/day off periods divided into at least two instances/day (except early morning akinesia), 2) were in stage 3 or above on the Hoehn and Yahr scale, 3) were with or without dyskinesia, and 4) received at least four levodopa doses/day combined with adjuvant therapy. Results: Of the 311 patients enrolled initially, 286 patients showed up for the second visit, of which in 125 cases we assessed that DAT would be necessary. Finally, 107 patients were tested in our clinic to confirm the efficacy of LCIG. Patients selected for DAT had significantly longer off periods, more frequent dyskinesia, early morning akinesia, and freezing despite having significantly higher LD doses than those with an improved conservative therapy. Conclusion: Patients with APD can have a variety of symptoms, and because symptoms and therapeutical efficacy can be manifested in many different combinations, it is not possible to decide using a single, rigid set of criteria which APD patient is eligible for DAT. Nevertheless, treating physicians should refer APD patients to a specialized movement disorder center when patients with an average daily dose of LD of at least 750-1000 mg and maximal complementary therapies present daily motor complications that significantly reduce the quality of life.

<p>Levodopa-Carbidopa Intestinal Gel Infusion Therapy Discontinuation: A Ten-Year Retrospective Analysis of 204 Treated Patients</p>

“…In a recent study, we evaluated the characteristics of real-life therapeutic strategies versus therapeutic availability in PD patients and we mentioned the lack of add-on options and limited access to DAT in our region, which significantly influences the decision-making process. 12 Based on those results and the findings of this study, despite all its limitations, we consider that a more severe stage of the disease and the presence of cognitive impairment can be considered as predictive factors for dropout. The association of polyneuropathy may have similar importance.…”

“…In our previously presented study (311 APD patients), the patients that we considered not to have exhausted the limits of conservative treatment had on average 2.8±0.8 hours off periods, whereas those considered suitable for DAT had 4.7±1.1 hours off. 12 Compared to these values, in this present study, patients who discontinued the LCIG treatment had a mean off period duration of 5.47 hours ( Table 2). The fact that these patients were in a more advanced stage of the Discontinuation rates published in literature are difficult to compare, given the different methods of data collection and the duration of the evaluated periods (both in pivotal and in open studies).…”

“…In recent publications, we evaluated the limits and specificity of the dopaminergic treatment before initiating LCIG therapy and we analyzed the spectrum of motor complications and profiles of patients with APD suitable for deviceaided therapies (DAT), all under the specific conditions in Romania. [12][13][14][15][16] In this retrospective study, after 10 years of experience with LCIG as a therapeutic option in APD, we analyzed the causes that led to the discontinuation of the therapy. We analyzed the data of all dropout cases among the 204 patients with APD that initiated LCIG therapy before the end of 2018, in two Romanian centers with high patient turnover: Timisoara (TM, 90 patients) and Târgu Mureș (MS, 114 patients).…”

“…The rigorous selection criteria and the preparation of the patients/relatives were already described in previous publications. 12,13 All of the patients underwent a nasojejunal test to evaluate their response to continuous administration of LCIG and consequently were considered to be good responders. The data collection was approved by the local ethics committee of each center.…”

“…In this context, the results of the COSMOS study are expected with great interest (a multi-country, retrospective, cross-sectional, post-marketing observational study; the first study fully dedicated to collecting real-world data assessing add-on PD medication used before and during LCIG long-term therapy in a large patient cohort). 30 In a previous publication, 12 we discussed the permanent dilemma between the natural tendency (both from the APD patient's and the attending physician's perspective) to delay the moment of the initiation of an invasive therapy and the observation which is more and more outlined in the literature in the last years that the clinical benefits obtained with DAT are superior in patients with shorter disease duration. 31 In other words, there is the possibility that in the case of "delayed" initiation, some of the benefits of an "on time" initiation may be lost.…”