Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials.

ABSTRACT:

Background

Continuous 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.

Methods

Safety 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).

Results

At 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 event

SUBMITTER: Lang AE 

PROVIDER: S-EPMC5064722 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature