TY - JOUR
T1 - Ophthalmologic baseline characteristics and 2-year ophthalmologic safety profile of pramipexole IR compared with ropinirole IR in patients with early Parkinson's disease
AU - Seiple, William
AU - Jennings, Danna
AU - Rosen, Richard B.
AU - Borchert, Leona
AU - Canale, Lee
AU - Fagan, Nora
AU - Gordon, Mark Forrest
N1 - Publisher Copyright:
© 2016 William Seiple et al.
PY - 2016
Y1 - 2016
N2 - Background. Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n=121) or ropinirole (n=125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure,computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71-1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year,-4.1±8.9, and 2 years,-0.7±10.1, and ropinirole: 1 year,-3.7±8.2, and 2 years,-1.7±10.5) and Hoehn-Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.
AB - Background. Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n=121) or ropinirole (n=125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure,computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71-1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year,-4.1±8.9, and 2 years,-0.7±10.1, and ropinirole: 1 year,-3.7±8.2, and 2 years,-1.7±10.5) and Hoehn-Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.
UR - http://www.scopus.com/inward/record.url?scp=85008707973&partnerID=8YFLogxK
U2 - 10.1155/2016/8298503
DO - 10.1155/2016/8298503
M3 - Article
AN - SCOPUS:85008707973
SN - 2090-8083
VL - 2016
JO - Parkinson's Disease
JF - Parkinson's Disease
M1 - 8298503
ER -