Levodopa/carbidopa intestinal gel infusion and weight loss in Parkinson's disease

Fabbri, Margherita; Zibetti, Maurizio; Beccaria, Laura; Merola, Aristide; Romagnolo, Alberto; Montanaro, Elisa; Ferreira, JJ; Palermo, Sara; Lopiano, Leonardo

doi:10.1111/ene.13844

Cited by 26 publications

(20 citation statements)

References 22 publications

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“…Among PD patients, weight loss is usually related to multiple factors, such as dysphagia, difficulties in self‐feeding, intestinal hypomotility, depression, and cognitive impairment. However, in LCIG‐treated patients, it can be strictly related to dyskinesia, in particular with the percentage of the waking day spent with dyskinesia 21 . Even though a lower BW does not keep significance at the logistic regression analysis for troublesome dyskinesia.…”

Section: Discussionmentioning

confidence: 96%

“…However, in LCIGtreated patients, it can be strictly related to dyskinesia, in particular with the percentage of the waking day spent with dyskinesia. 21 Even though a lower BW does not keep significance at the logistic regression analysis for troublesome dyskinesia. At the same time, we know that young age at disease onset, female gender, low BW, AK phenotype, greater motor disability, and higher LEDD are recognized risk factors for LID among PD patients on oral treatment.…”

Section: Discussionmentioning

confidence: 99%

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Levodopa/Carbidopa Intestinal Gel Long‐Term Outcome in Parkinson's Disease: Focus on Dyskinesia

Fabbri

Zibetti

Calandra‐Buonaura

et al. 2020

Movement Disord Clin Pract

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Background Background: Levodopa-carbidopa intestinal gel (LCIG) treatment has shown variable effect on dyskinesia in Parkinson's disease (PD). Objective Objective: To identify PD patients who are likely to have troublesome dyskinesia under LCIG treatment and describe the pharmacokinetic-dynamic profile and dyskinesia phenomenology of those patients. Methods Methods: PD patients were assessed for clinical and therapeutic variables, before LCIG treatment (T0) and at last outpatient visit (T1). Subgroups of patients with and without "troublesome dyskinesia" (UPDRS IV, item 33 ≥2), matched for disease and LCIG treatment duration, underwent a pharmacokinetic-dynamic assessment. Results Results: We included 53 PD patients. After a mean of 51.7 AE 34.1 months of LCIG treatment, "off-time" was significantly reduced, whereas, dyskinesia duration/disability did not change. The multivariate regression model, adjusted for LCIG treatment duration, showed that being female increases the risk of presenting troublesome dyskinesia at T1 (odds ratio [OR] = 9.2; 95% confidence interval [CI] = 2.4-37.4) that was also significantly associated to longer off periods at T1 (OR= 4.4; 95% CI = 1.1-14.3). Female patients showed a higher risk for a higher dyskinesia score at T1 (sum of the items 32 and 33: P = 0.001). Patients with troublesome dyskinesia showed a tendency for a lower motor benefit and the appearance of more severe dyskinesia despite similar levodopa plasma concentration. Conclusion Conclusion: Dyskinesia should be carefully monitored in patients undergoing LCIG, with particular caution for female patients. Whether combined clinical and pharmacodynamic assessments could be helpful to manage patients with troublesome dyskinesia under LCIG treatment needs further evaluation in a larger group of patients.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Levodopa/Carbidopa Intestinal Gel Long‐Term Outcome in Parkinson's Disease: Focus on Dyskinesia

Fabbri

Zibetti

Calandra‐Buonaura

et al. 2020

Movement Disord Clin Pract

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“…Weight loss should be routinely evaluated, as weight loss is a complication of treatment with LCIG as well as a marker of PD progression [41,42]. Findings from a recent study showed that in 44 patients treated with LCIG for 51.6 ± 28.5 (range 10-120) months, 12 experienced a >10-kg weight loss, and 30 patients experienced a loss of at least 2 kg (average weight loss, 7.6 ± 7.1 kg), with the extent of weight loss associated with the length of waking day with dyskinesia [43]. Patients can be referred to a nutritionist/ dietitian to help manage any weight loss.…”

Section: Monitoring and Follow-up Carementioning

confidence: 99%

24-Hour Levodopa-Carbidopa Intestinal Gel: Clinical Experience and Practical Recommendations

et al. 2021

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Infusion of levodopa-carbidopa intestinal gel (LCIG; also designated carbidopa-levodopa enteral suspension) for 16 hours is a standard treatment for patients with advanced Parkinson's disease, and clinical observations suggest that 24-hour LCIG infusion may further reduce symptoms. This review provides practical advice on the management of patients transitioning to 24-hour LCIG infusion. We review available clinical data for 24-hour infusion and discuss adjustments to dosing, recommendations for monitoring, and management of patient concerns, based on our clinical experience. Data from multiple studies suggest that LCIG may improve non-motor symptoms. Although few studies have examined 24-hour LCIG infusion, available data indicate that certain patients may benefit from around-the-clock treatment. Studies of 24-hour LCIG infusion are limited by small sample sizes and open-label study designs, which may hamper translation to clinical practice. In our experience, we have found that patients may benefit from 24-hour infusion when reductions in nocturnal symptoms and improvements to quality of sleep are needed. Levodopa-unresponsive freezing of gait or poorly controlled troublesome dyskinesias may also indicate a patient may benefit from 24-hour infusion. Dose adjustments, especially of the nocturnal rate, are typically necessary and, as with 16-hour infusion, patients should be monitored for autonomic dysfunction; overnight wearing off symptoms; weight changes; fluctuations in plasma levels of vitamins B 6 /B 12 , folate, and homocysteine; changes in sleep patterns; or worsening of hallucinations, delusions, and/or nightmares. Available data and our clinical experience suggest that 24-hour LCIG may be warranted among selected patients who have poorly controlled nocturnal fluctuations or early morning "off" symptoms.

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“…Parkinson's Disease found a correlation between nutritional status (as measured by the Mini Nutritional Assessment) and levodopa equivalent daily dose [24]. Weight loss in PD is likely a multifaceted phenomenon that occurs subsequent to many contributing factors, including underlying pathological changes (e.g., metabolic and gastrointestinal dysfunction), ageing, and administration of levodopa.…”

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confidence: 99%

Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

Zadikoff

Poewe

Boyd

et al. 2020

Parkinson's Disease

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Background. Levodopa-carbidopa intestinal gel (LCIG) provides continuous levodopa administration and clinical benefits to patients with advanced Parkinson’s disease (PD). This report evaluates long-term safety and efficacy of high-dose LCIG in PD patients. Methods. Data were collected from several prospective, phase III clinical studies and an observational registry. The phase III program (N = 412) included four multicenter studies: a 12-week, randomized, double-blind study and three open-label studies extending ≥12 months. GLORIA (N = 375) was a 24-month, multicountry, observational registry. LCIG safety (adverse effects (AEs)/adverse drug reactions (ADRs)) and efficacy (modified Unified Parkinson’s Disease Rating Scale (UPDRS) part IV item 32 and 39 scores for “On” time with dyskinesia and “Off” time) were assessed in patients who received ≥2000 mg/day vs <2000 mg/day LCIG. Results. A total of 72 of 412 (17.5%) patients required dosages ≥2000 mg/day LCIG in the phase III program and 47 of 375 (12.5%) patients in GLORIA. Baseline demographics and disease severity were similar between dosage groups with more men in the high-dosage group. Compared with the <2000 mg/day dosage group, patients requiring ≥2000 mg/day LCIG had higher rates of AEs/ADRs including polyneuropathy; improvements in “Off” time and discontinuations due to AEs were similar between dosage groups and lower for discontinuations due to ADRs reported in GLORIA. Conclusions. Patients who require ≥2000 mg/day LCIG exhibited a safety profile comparable to the established safety/tolerability of LCIG with similar clinical improvements. Higher AEs were noted but within what is accepted for LCIG. Continuous administration of LCIG is beneficial to advanced PD patients who require very high doses of levodopa.

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Levodopa/carbidopa intestinal gel infusion and weight loss in Parkinson's disease

Cited by 26 publications

References 22 publications

Levodopa/Carbidopa Intestinal Gel Long‐Term Outcome in Parkinson's Disease: Focus on Dyskinesia

Levodopa/Carbidopa Intestinal Gel Long‐Term Outcome in Parkinson's Disease: Focus on Dyskinesia

24-Hour Levodopa-Carbidopa Intestinal Gel: Clinical Experience and Practical Recommendations

Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

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