Psychiatric issues often manageable during Parkinson’s infusion therapy
Study found new events in 22% of patients, often eased by dose changes
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- Patients starting the advanced Parkinson’s disease treatment Vyalev may experience new psychiatric issues, particularly hallucinations or psychosis.
- New-onset psychiatric symptoms were more common in patients with pre-existing cognitive impairment.
- These psychiatric problems were generally manageable through individualized infusion-rate adjustments or low-dose antipsychotic medications.
A real-world study found that psychiatric issues, including hallucinations and delusions, developed in some people with advanced Parkinson’s disease after they started Vyalev (foscarbidopa and foslevodopa), but most were manageable with infusion-rate adjustments or low-dose antipsychotic medications.
The study, “Real-world neuropsychiatric safety profile of foslevodopa/foscarbidopa infusion in advanced Parkinson’s disease,” was published in the Journal of Neurology.
“Our findings indicate that [Vyalev] is generally well-tolerated in routine clinical practice, with most [neuropsychiatric adverse events] being mild, transient, and manageable through individualized dose adjustments and targeted pharmacological interventions,” the researchers wrote.
How Vyalev delivers Parkinson’s treatment
Parkinson’s is a neurological disorder in which brain cells that make dopamine, a chemical messenger involved in movement, become damaged and die. Levodopa is a mainstay Parkinson’s treatment that the brain converts into dopamine. It is usually given with carbidopa, which allows more levodopa to reach the brain.
Levodopa/carbidopa therapies are usually taken by mouth. Vyalev, however, is given continuously under the skin through a specialized pump. Vyalev is approved in the U.S. and many other countries to treat motor fluctuations in adults with advanced Parkinson’s disease.
Vyalev was approved based on data from clinical trials, which found that the therapy was generally well tolerated and outperformed immediate-release oral carbidopa/levodopa at controlling symptoms of Parkinson’s disease. However, clinical trials use strict eligibility criteria, so their results may not fully reflect the wider range of patients treated in routine practice.
Researchers in Italy looked back at clinical data from 77 people with advanced Parkinson’s who started Vyalev at two specialized referral centers. When they started Vyalev, their average age was 66, and they had been living with Parkinson’s for about 14 years.
Before starting Vyalev, about half of the patients met criteria for cognitive impairment. About one in four (26%) had a history of hallucinations or psychosis, and 27% had a history of impulse control disorders. Eight patients (10%) had active neuropsychiatric problems when they started Vyalev. Hallucinations involve seeing or hearing things that aren’t there, while psychosis can include delusions, or fixed beliefs without a basis in reality. These psychiatric issues are common nonmotor symptoms of advanced Parkinson’s and can be influenced by dopamine-related treatments.
All patients who remained on treatment were followed for at least six months after initiation of Vyalev. At follow-up, assessments indicated that motor symptoms had improved, consistent with benefits seen in clinical trials.
New psychiatric events occurred in 22% of patients
More than one in five (22%) patients had new-onset psychiatric complaints — mostly hallucinations or psychosis — after starting Vyalev. These complaints developed a median of about one month after starting treatment, although nearly half occurred within the first two weeks. Patients who developed them had worse baseline cognitive performance and were more likely to have mild cognitive impairment or dementia.
Although psychiatric complaints were relatively common, they were usually manageable. Psychosis was “generally easily manageable and well responsive to a combination of antipsychotic drug introduction and dosing adjustment,” the scientists wrote. The researchers said reducing the nighttime infusion rate was an effective first step. If that wasn’t enough, low-dose antipsychotic medications could be added.
Thirteen patients (17%) discontinued Vyalev during follow-up. Three stopped because of severe neuropsychiatric events, while 10 others discontinued for other adverse events or reasons, including skin reactions, switching to deep brain stimulation, device intolerance, perceived lack of benefit, polyneuropathy, or an unrelated medical issue. But overall, the researchers concluded that Vyalev “demonstrated an overall favorable safety profile and low discontinuation rate within the first [six] months of treatment, with excellent effectiveness in reducing motor fluctuations.”
The researchers said more prospective, multicenter studies of Vyalev treatment are needed to confirm and extend these real-world findings.
Vyalev is marketed by Abbvie. The paper did not report Abbvie as a study funder; some co-authors disclosed previously receiving speaking fees from the company.
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