In a real-world clinical setting, Neupro Patches (rotigotine) eased the clinical signs and symptoms of Parkinson’s disease, with more than 70% of patients reporting mild improvement or better, including those 80 years and older, a real-world study shows.
No new or notable safety concerns were reported.
The study, “Real-world safety and effectiveness of rotigotine in patients with Parkinson’s disease: analysis of a post-marketing surveillance study in Japan,” was published in the International Journal of Neuroscience.
The Neupro Patch (rotigotine, developed by UCB) is approved to treat early and advanced-stage Parkinson’s disease. Delivered through the skin into the bloodstream, it stimulates dopamine receptors in the brain by mimicking the action of dopamine, which is found in lower-than-normal levels in the brains of Parkinson’s patients.
Clinical trials have demonstrated that it improves motor functioning and daily living activities, and follow-up studies have shown its effect was maintained over a year.
However, clinical trials commonly dictate dose, disease severity, and participants’ ages, which excluded some patients, including those 80 and older. As such, the results may not reflect the use of Neupro Patches in real-world clinical settings.
“This study was conducted to evaluate the long-term effectiveness and safety of [Neupro Patches] in patients with [Parkinson’s disease] under clinical practice,” researchers wrote.
Scientists at Otsuka Pharmaceuticals, the company that markets Neupro Patches in Japan, in collaboration with investigators at Wakayama Medical University, conducted a real-world, post-marketing surveillance study to evaluate the safety profile and impact of Neupro Patches in Parkinson’s patients over one year.
For the safety assessment, 340 women and 263 men were enrolled, including 112 patients 80 and older. The efficacy analysis included 599 of these patients. Before and during the study, most patients were receiving other Parkinson’s medications.
The initial daily dose was 2.6 mg, the most frequent daily dose was 4.8 mg, and the average maximum daily dose was 5.4 mg.
The overall levodopa equivalent daily dose (LED) — the combined total of Parkinson’s medications — increased from 531 mg/day at the start of the study (baseline) to 692.1 mg/day.
While treatment with levodopa, or l-dopa, a precursor to dopamine, remained almost unchanged, the average dose of other dopamine mimic medications decreased significantly over the one-year study period.
A total of 273 patients discontinued the therapy in which 139 patients stopped due to adverse side effects, 73 due to patient or family request, 34 patients transferred hospitals, and there were no therapeutic effects in 25 patients. No notable trends were observed in the timing of discontinuation.
The frequency of patients who experienced adverse effects was 34.3%, in which the majority were non-serious, including body movements, visual hallucinations, drowsiness, and nausea.
Application site reactions with the patch occurred in 122 patients (20.2%), and all were non-serious, including itching, redness, skin inflammation (dermatitis), and rash.
The frequency of adverse effects in patients 80 and older were similar to those in younger patients.
Motor symptoms were assessed by the Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) total score at baseline and three, six, nine, and 12 months. Higher scores indicated more severe impairment.
A statistically significant reduction in UPDRS-III scores was observed at all time points, decreasing from an average of 33.4 at baseline to 28.2 at the final assessment, “demonstrating improvement in the score throughout the follow-up” the researchers wrote. This trend was the same, regardless of age.
A subgroup analysis comparing the changes in the average UPDRS-III scores from baseline to the final assessment showed significant differences in whether patients were treated with other dopamine mimics, the number of days Neupro Patches were administered, and the history of Parkinson’s treatment.
Items within the UPDRS-III related to daily living activities included facial expression, arising from a chair, gait, posture stability, and body tremors and muscle rigidity. From baseline to the final assessment, all scores showed improvements.
More than 70% of patients achieved mild improvement or higher. Marked improvements occurred in 12 of 230 patients assessed, 63 patients reported moderate improvement, 92 mild improvement, and 40 remained unchanged.
Mild worsening occurred in 18 patients, three reported moderate worsening, and one patient experienced marked worsening.
No association between age and improvement or worsening was observed.
“There were no new or notable safety concerns observed in the frequency and type of [adverse effects], and the effectiveness of [Neupro Patch] was suggested under daily clinical practice,” the researchers concluded.
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