Drug updated on 10/29/2024
Dosage Form | Tablet (oral; 20 mg, 40 mg) |
Drug Class | Adenosine receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- ndicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Istradefylline demonstrated significant improvement in motor symptoms in Parkinson's Disease (PD) patients, evidenced by a reduction in OFF time (-0.58 [-1.01 to -0.16]; p = 0.007) and improvement in ON state with dyskinesia (0.69 [0.02 to 1.37]; p = 0.043), as well as a mean difference of -0.70 in OFF time duration (95% CI [-1.11, -0.30]; P < 0.001) and a mean difference of -1.56 in the Unified Parkinson's Disease Rating Scale (UPDRS) II (95% CI [-2.71, -0.40]; P < .008) in various studies.
- In pooled analyses of eight randomized controlled trials, istradefylline reduced OFF hours/day at doses of 20 mg/day (LSMD = -0.38 h [-0.61, -0.15]) and 40 mg/day (-0.45 h [-0.68, -0.22], p < 0.0001), while increasing ON time without troublesome dyskinesia.
- When compared to other drugs, istradefylline was found to be less effective than safinamide, which showed significant improvements in UPDRS part III scores at both 50 mg (p = 0.0138) and 100 mg (p = 0.0006) doses, although it was superior to opicapone in improving UPDRS III scores (MD = -1.56 vs. opicapone MD = -0.63; P < 0.008).
- Istradefylline exhibited no significant difference in adverse effects compared to placebo, with treatment-emergent adverse events (TEAEs) reported at a relative risk (RR) of 1.11. Dyskinesia incidence was higher with istradefylline (RR = 1.77) compared to opicapone (RR = 3.47), which showed greater prevalence of this adverse event.
- Dyskinesia was the most frequent adverse event associated with istradefylline, occurring in 9.6% of patients on placebo, 16.1% at a dose of 20 mg/day, and 17.7% at a dose of 40 mg/day. The average study completion rate for istradefylline among treated patients was 89.2%.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nourianz (istradefylline) Prescribing Information. | 2023 | Kyowa Kirin Inc., Bedminster, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of istradefylline for Parkinson's disease: A systematic review and meta-analysis | 2022 | Neuroscience Letters |
Systematic Review on Parkinson's Disease Medications, Emphasizing on Three Recently Approved Drugs to Control Parkinson's Symptoms | 2021 | International Journal of Environmental Research and Public Health |
Istradefylline Versus Opicapone for "Off" Episodes in Parkinson's Disease: A Systematic Review and Meta-Analysis | 2021 | Annals of Neurosciences |
Efficacy of Istradefylline, an Adenosine A2A Receptor Antagonist, as Adjunctive Therapy to Levodopa in Parkinson's Disease: A Pooled Analysis of 8 Phase 2b/3 Trials | 2021 | Journal of Parkinson’s Disease |