Abstract
ABSTRACTBackgroundContinuous administration of levodopa‐carbidopa intestinal gel (carbidopa‐levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.MethodsSafety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device–associated (n = 395) from non‐procedure/device adverse events (n = 412).ResultsAt the data cutoff, median exposure to levodopa‐carbidopa intestinal gel was 911 days (range, 1‐1980 days) with 963 total patient‐years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non‐procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non‐procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment‐emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered “possibly related” to the treatment system.ConclusionIn the largest collection of levodopa‐carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non‐procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients. © 2015 International Parkinson and Movement Disorder Society
Highlights
Hospital, McLaughlin Pavilion, 7th Floor, Room 7-403, 399 Bathurst St., kinson’s disease nurse specialist in the form of an unrestricted grant to
Non-procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non-procedure/ device serious adverse events, with most frequently reported being pneumonia (5%) and Parkinson disease (PD) symptoms (2%)
Most non-procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients
Summary
Safety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device–associated (n 5 395) from non-procedure/device adverse events (n 5 412). AbbVie Inc. participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. N.S. has received compensation from AbbVie Inc. for serving as a consultant, scientific adviser and lecturer. There were 4 prospective, multicenter phase 3 LCIG (designated in the United States as carbidopa-levodopa enteral suspension [CLES]) studies (NCT00357994/ NCT00660387, NCT00335153, NCT00660673, NCT00360568), 3 of which have been previously reported 9-11 and a fourth that is ongoing. The study protocols were approved by the institutional review board/ethics committee at all 90 centers in 16 countries, and all patients provided written informed consent. Ninety-six percent of the 412 patients received concomitant anti-PD medication for any period of time during LCIG treatment, and the most frequent were oral levodopa (83%) and amantadine (28%)
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