title: Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease.
abstract: 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.
authors.affiliation: Lighthouse Guild, Arlene R. Gordon Research Institute, New York, NY, USA; Department of Ophthalmology, NYU School of Medicine, New York, NY, USA; Institute of Vision, Aging in Vision and Action Lab, CNRS-INSERM, University Pierre & Marie Curie, Paris, France; Jesse Brown VA Medical Center, Chicago, IL, USA.
authors.forename: William
authors.identifier: 0000-0002-5750-650X
authors.initials: W
authors.lastname: Seiple
authors.affiliation: Institute for Neurodegenerative Disorders, Suite 8B, 60 Temple Street, New Haven, CT 06510, USA.
authors.forename: Danna
authors.initials: D
authors.lastname: Jennings
authors.affiliation: New York Eye & Ear Infirmary and Icahn School of Medicine of Mount Sinai, 310 East 14th Street, New York, NY 10003, USA.
authors.forename: Richard B
authors.identifier: 0000-0001-9643-3510
authors.initials: RB
authors.lastname: Rosen
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Leona
authors.initials: L
authors.lastname: Borchert
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Lee
authors.initials: L
authors.lastname: Canale
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Nora
authors.initials: N
authors.lastname: Fagan
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Mark Forrest
authors.identifier: 0000-0002-0271-3050
authors.initials: MF
authors.lastname: Gordon