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VANCOUVER — Patients with early-stage Parkinson’s disease who are treated with medication alone are 17-times more likely to require treatment with multiple medications after 5 years compared with patients who are treated with subthalamic nucleus deep brain stimulation (STN-DBS) and optimal drug therapy.
Results of the 5-year analysis were presented at the 2017 International Congress of Parkinson’s Disease and Movement Disorders.
The study, led by Mallory Hacker, PhD, of Vanderbilt University in Nashville, Tennessee, was a 3-year continuation of the Deep Brain Stimulation for Early Stage Parkinson’s Disease pilot trial (ClinicalTrials.gov: NCT00282152), which explored the safety and tolerability of STN-DBS in patients with early-stage Parkinson’s disease (N=29; age 50 to 75 years; Hoehn & Yahr, 2.0 [off]; medication duration 6 months to 4 years). Assessment at 2 years suggested that a significantly greater portion of patients assigned to optimal drug therapy (ODT) alone (n=14) required polypharmacy compared with those receiving ODT and STN-DBS (DBS+ODT) (n=15), prompting an additional 3-year follow-up.
At 5-year follow-up, medication duration was 7.1 and 7.2 years for the ODT and DBS+ODT groups, respectively. From baseline to year 5, there was a significant increase in the proportion of ODT patients who required polypharmacy (43% to 93%) compared with those in the DBS+ODT group (33% to 40%) (odds ratio [OR] 17.33; 95% CI: 1.75-17.00; P =.013).
Additionally, mean Unified Parkinson’s Disease Rating Scale III motor scores (on) showed a sustained motor benefit for patients in the DBS+ODT group compared with the ODT group, all while patients in the DBS+ODT group received modest stimulation (mean amplitude at 24 months, 1.9±0.3). From baseline to year 5, patients in the ODT group experienced a 667±323-mg increase in their levodopa equivalent daily dose compared with a 323±638-mg increase in the DBS+ODT group.
Overall, the results show a >94% reduction in risk of polypharmacy after 5 years for patients in the DBS+ODT group compared with the ODT-alone group (OR 0.058; 95% CI: 0.006-0.571; P =.013).
While the study is limited by its open-label design and small size, the results suggest “that patients who receive STN-DBS in early stage PD may be more likely to maintain a simple medication regimen while experiencing better motor control over standard medical therapy,” the investigators wrote.
They are now beginning a prospective, randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial to further evaluate DBS in early-stage Parkinson’s disease.
Disclosures: The authors report multiple relationships with industry. Please see the poster for a full list of disclosures.
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Hacker M, Turchan M, Currie A, et al. Subthalamic nucleus deep brain stimulation in early stage Parkinson’s disease reduces the risk of polypharmacy: five-year analysis. Presented at: 2017 International Congress of Parkinson’s Disease and Movement Disorders. June 4-8, 2017; Vancouver, BC, Canada. Abstract 1341.