PORTLAND, OR—High doses of transdermal nicotine failed to improve off motor symptoms in patients with Parkinson’s disease, according to trial results presented at the Fourth World Parkinson Congress. Nicotine may have provided benefit on secondary outcome measures, researchers said.
Gabriel Villafane, MD
Gabriel Villafane, MD, a neurologist at Henri Mondor University Hospital in Créteil, France, and colleagues conducted the Nicopark2 Study, a single-blind, controlled, randomized trial to evaluate the effect of high doses of transdermal nicotine (approximately 90 mg per day) on motor symptoms in Parkinson’s disease.
Cigarette smoking is associated with a dose-dependent reduction in risk of Parkinson’s disease. Nicotine’s effect on motor symptoms in Parkinson’s disease is controversial. Seven of eight open-label studies suggested that nicotine improves motor symptoms, but four placebo-controlled studies were negative.
The investigators enrolled 40 patients with Parkinson’s disease in the study. Eligible patients were nonsmokers age 35 to 70 with a Hoehn and Yahr off stage of four or less and a Hoehn and Yahr on stage of three or less. Patients had received levodopa treatment for at least three years. Exclusion criteria included neurosurgery, psychiatric disease, and symptomatic orthostatic hypotension.
The primary outcome was mean difference between groups in change of Unified Parkinson’s Disease Rating Scale off motor score from baseline to week 39 on blinded video rating.
Twenty patients were randomized to receive transdermal nicotine, and 20 patients were randomized to a control group. The change in motor score between groups was not statistically significant. Change in quality of life assessed by the Parkinson’s Disease Questionnaire was not statistically significant. At 39 weeks, a reduction in levodopa doses, a reduction in dyskinesias, and an improvement in activities of daily living were observed in the nicotine group, the researchers said.
Adverse events occurred in more patients the nicotine group than in the control group. They included worsening of parkinsonism (30% vs 5%), cutaneous reactions (35% vs 5%), gastrointestinal complaints (65% vs 15%), hypotension (25% vs 5%), insomnia (25% vs 5%), and nervousness and anxiety (20% vs 0%). Ten patients in the nicotine group had a serious adverse event, compared with three patients in the control group.
—Jake Remaly