Parkinson's disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement, and postural instability. Within 5 years of starting levodopa/carbidopa treatment, half of people living with PD begin to experience 'off' time, including problems with movement.3 Adjunctive therapies may be used to treat these episodes but are often hampered by safety and tolerability issues that limit their clinical utility.1
'With the growing landscape of adjunctive therapies for Parkinson's disease, it is important for physicians to have data that demonstrates the relative risk profiles of these treatment options,' said lead author
About the Study
Researchers updated a previously published SLR with an additional 20 randomized controlled trials from
NOURIANZ is an adenosine receptor antagonist indicated as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing 'off' episodes. It is not known if istradefylline is safe and effective in children.4
Important Safety Information
Warnings and Precautions
Dyskinesia: NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In clinical trials, 1% of patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia, compared to 0% for placebo.
Hallucinations / Psychotic Behavior: Because of the potential risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with NOURIANZ. Consider dosage reduction or discontinuation if a patient develops hallucinations or psychotic behaviors while taking NOURIANZ.
Impulse Control / Compulsive Behaviors: Patients treated with NOURIANZ and one or more medication(s) for the treatment of Parkinson's disease (including levodopa) may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges. In clinical trials, 1 patient treated with NOURIANZ 40 mg was reported to have impulse control disorder, compared to no patient on NOURIANZ 20 mg or placebo.
DRUG INTERACTIONS
The maximum recommended dosage in patients taking strong CYP3A4 inhibitors is 20 mg once daily. Avoid use of NOURIANZ with strong CYP3A4 inducers.
SPECIAL POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm.
ADVERSE REACTIONS
The most common adverse reactions with an incidence =5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively.
You are encouraged to report suspected adverse reactions to
Please click to see full Prescribing Information for Nourianz.
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