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Device Complaints and Longevity of PEG-J Used for Continuous Infusion of Levodopa-Carbidopa Intestinal Gel in Ambulatory Patients With Parkinson's Disease


Johnson, David A., MD, MACG1; Epstein, Michael S., MD, FACG2; Hawes, Robert, MD, FACG3; Draganov, Peter, MD, FACG4; Schmulewitz, Nathan, MD5; Vanagunas, Arvydas, MD, FACG6; Hall, Coleen M., MS7; Robieson, Weining Z., PhD7; Chatamra, Krai, PhD7; Benesh, Janet A., BSMT7; Eaton, Susan, PharmD7

American Journal of Gastroenterology: October 2015 - Volume 110 - Issue - p S651–S652
Abstracts: ENDOSCOPY

1. Eastern Virginia Medical School, Norfolk, VA;

2. Digestive Disorders Associates, Annapolis, MD;

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

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

5. University of Cincinnati College of Medicine, Cincinnati, OH;

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

7. AbbVie Inc., North Chicago, IL.

Introduction: Motor complications observed in patients with Parkinson's disease (PD) treated with oral medication may be caused by impaired gastric emptying and the short half-life of PD treatment, levodopa-carbidopa. Delivery of levodopa-carbidopa intestinal gel (LCIG, known in the US as carbidopa-levodopa enteral suspension [CLES]) using a percutaneous endoscopic gastrostomy (PEG tube) with jejunal extension tube (J tube) to continuously administer LCIG directly to the jejunum prevents motor complications caused by fluctuating drug plasma levels. We assessed the durability and longevity of the devices used in the LCIG system among ambulatory PD patients enrolled in clinical trials.

Methods: A 15 French Freka PEG tube and a 9 French J extension were endoscopically placed in study participants by proceduralists experienced in placing gastrostomy-jejunostomy tubes. A battery-operated pump connected to a medication cassette attached to the J tube administered LCIG continuously for 16 hours per day. The durability and longevity of the PEG and J tubes and the incidence of device complaints were assessed using data collected during 3 phase 3 LCIG studies and an ongoing long-term extension study through March 2014.

Results: A total of 395 patients were included in this analysis. The median exposure to the PEG and J tubes was 986 days (range, 1-1972 days); 165 patients had ≥1095 exposure days, 130 of whom had ≥1260 exposure days. The PEG tube did not require replacement in 292 (74%) patients and the J tube did not require replacement in 172 (44%) patients. The PEG tube was replaced 1 time in 78 (20%) patients and ≥ 2 times in 24 (6%) patients. The J tube was replaced 1 time in 93 (24%) patients and ≥ 2 times in 129 (33%) patients. The median time to first PEG tube replacement was 1711 days (95% confidence interval [CI], 1346-NA), and the median time to first J tube replacement was 695 days (95% CI, 522-862) (Figure 1). Overall, 371 (94%) patients reported device complaints (Table 1); however, 66% of patients had a device complaint that required no action. The most common action taken was pump replacement (59% of patients).

Figure 1

Figure 1

Table 1

Table 1

Conclusion: The PEG and J tubes demonstrated longevity in this ambulatory patient population, with a majority of patients not requiring replacement of PEG tubing. Over a total of 972 patient years, device complaints were common, with issues of pump alarm reported by the most patients.

© The American College of Gastroenterology 2015. All Rights Reserved.