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Short- and Long-Term Safety of PEG-J Used for Continuous Infusion of Levodopa-Carbidopa Intestinal Gel


Draganov, Peter, MD, FACG1; Epstein, Michael S., MD, FACG2; Hawes, Robert, MD, FACG3; Johnson, David A., MD, MACG4; Vanagunas, Arvydas, MD, FACG5; Robieson, Weining Z., PhD6; Chatamra, Krai, PhD6; Benesh, Janet A., BSMT6; Eaton, Susan, PharmD6

American Journal of Gastroenterology: October 2015 - Volume 110 - Issue - p S652–S653
Abstracts: ENDOSCOPY

1. University of Florida College of Medicine, Gainesville, FL;

2. Digestive Disorders Associates, Annapolis, MD;

3. University of Central Florida College of Medicine, Orlando, FL;

4. Eastern Virginia Medical School, Norfolk, VA;

5. Northwestern University Feinberg School of Medicine, Chicago, IL;

6. AbbVie Inc., North Chicago, IL.

Introduction: Irregular drug plasma levels due to impaired gastric emptying may contribute to motor complications observed in patients with Parkinson's disease (PD) treated with oral medication. One treatment for PD uses percutaneous endoscopic gastrostomy with jejunal extension tube (PEGJ) to continuously deliver levodopa-carbidopa intestinal gel (LCIG, known in the US as carbidopa-levodopa enteral suspension [CLES]) directly to the jejunum for 16 hours, thereby bypassing the stomach and avoiding fluctuating drug plasma levels. We assessed short- and long-term safety of the PEG-J procedure and device used to deliver LCIG in mobile patients with PD from our most recent clinical trial data cut.

Methods: All patients received a 15 French Freka PEG tube and a 9 French Freka jejunal extension tube, placed during the same endoscopy. The ideal jejunal tube tip position was distal to the ligament of Treitz. PEG-J procedure- and device-related treatment-emergent adverse events (AEs) reported during 4 phase 3 LCIG studies (including an ongoing open-label extension study into which all others filtered) were integrated and evaluated. AEs and serious AEs (SAEs) in patients treated with LCIG were included in this analysis at the March 2014 data cut-off date.

Results: A total of 395 patients were included in this analysis. The median (range) exposure to PEG-J was 986 (1-1972) days; 165 patients were exposed for ≥1095 days, 130 patients were exposed for ≥1260 days, and 70 patients were exposed for ≥1460 days. The incidence of SAEs was highest in the first week and declined rapidly thereafter (Figure 1). Over the long-term, procedure/device-associated AEs occurred in 387 (94%) patients and SAEs occurred in 68 (17%) patients (Table 1), although single events may have been coded to >1 preferred term. Procedure/device-associated AEs led to discontinuation in 19 (4.8%) patients; those that led to discontinuation in >1 patient included complication of device insertion (10 patients; 2.5%), abdominal pain (4 patients, 1.0%), abdominal discomfort (2 patients, 0.5%), and peritonitis (2 patients, 0.5%).

Figure 1

Figure 1

Table 1

Table 1

Conclusion: The overall safety profile of LCIG via PEG-J is comparable to published data in immobile patients (Itkin M et al, Gastroenterology, 2011;141:742-65). Incidence of SAEs declined after the first week post-procedure. The low discontinuation rate of LCIG treatment via PEG-J demonstrates that this treatment can be maintained for long-term use in this mobile patient population with advanced PD.

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