Objective: To compare the proportion of subjects on polypharmacy after five years in the deep brain stimulation (DBS) in early stage Parkinson’s disease (PD) pilot trial.

Background: Subthalamic nucleus (STN) DBS improves motor symptoms and quality of life while reducing medication requirements in mid- and advanced stage PD. A safety and tolerability trial of STN-DBS in early stage PD (NCT00282152) demonstrated that a significantly higher proportion of optimal drug therapy (ODT) subjects required polypharmacy after two years compared to DBS+ODT subjects [1]. Subjects were followed for three additional years.

Methods: Medications were managed by the subjects’ treating neurologist and grouped into the following classes: levodopa; levodopa+COMT inhibitor; dopamine agonists; MAO-B inhibitors; amantadine. Polypharmacy was defined as subjects being prescribed more than one class of medication at the study visit. A likelihood ratio test was used to compare five year polypharmacy status between the groups.

Results: At the five year visit, PD medication duration was 7.1±1.1 years and 7.2±1.4 years for the ODT and DBS+ODT groups, respectively. The proportion of ODT subjects on polypharmacy increased from 43% (6/14) at baseline to 93% (13/14) by five years. By contrast, the proportion of DBS+ODT subjects receiving polypharmacy was 36% (5/14) at baseline and 43% (6/14) at five years. This represents a significant reduction in the risk of requiring polypharmacy after 5 years for subjects receiving DBS+ODT compared to ODT (p=0.013; OR=0.058; 95%CI:0.006-0.571).

Conclusions: These results suggest that people with early stage PD treated with medications alone are 17 times more likely to require polypharmacy after five years compared to those treated with STN-DBS. More investigation is needed to understand medication use after DBS therapy, and the FDA has approved the conduct of a prospective, randomized, double-blind, placebo-controlled, multicenter, phase III, pivotal clinical trial testing DBS in early stage PD (IDE#G050016).

Previously submitted to the American Academy of Neurology for presentation April 2017.

References: [1] J Parkinsons Dis. 2016 Feb 26;6(1):125-31.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/subthalamic-nucleus-deep-brain-stimulation-in-early-stage-parkinsons-disease-reduces-the-risk-of-polypharmacy-five-year-analysis/