Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease
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 immedia...
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| Format: | Article |
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Wiley
2016-01-01
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| Series: | Parkinson's Disease |
| Online Access: | http://dx.doi.org/10.1155/2016/8298503 |
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| author | William Seiple Danna Jennings Richard B. Rosen Leona Borchert Lee Canale Nora Fagan Mark Forrest Gordon |
| author_facet | William Seiple Danna Jennings Richard B. Rosen Leona Borchert Lee Canale Nora Fagan Mark Forrest Gordon |
| author_sort | William Seiple |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-1d1ea57cc29c4dc0a61b2b0bbbf1113c |
| institution | OA Journals |
| issn | 2090-8083 2042-0080 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Parkinson's Disease |
| spelling | doaj-art-1d1ea57cc29c4dc0a61b2b0bbbf1113c2025-08-20T02:01:43ZengWileyParkinson's Disease2090-80832042-00802016-01-01201610.1155/2016/82985038298503Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s DiseaseWilliam Seiple0Danna Jennings1Richard B. Rosen2Leona Borchert3Lee Canale4Nora Fagan5Mark Forrest Gordon6Lighthouse Guild, Arlene R. Gordon Research Institute, New York, NY, USAInstitute for Neurodegenerative Disorders, Suite 8B, 60 Temple Street, New Haven, CT 06510, USANew York Eye & Ear Infirmary and Icahn School of Medicine of Mount Sinai, 310 East 14th Street, New York, NY 10003, USABoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USABoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USABoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USABoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USABackground. 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.http://dx.doi.org/10.1155/2016/8298503 |
| spellingShingle | William Seiple Danna Jennings Richard B. Rosen Leona Borchert Lee Canale Nora Fagan Mark Forrest Gordon Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease Parkinson's Disease |
| title | Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease |
| title_full | Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease |
| title_fullStr | Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease |
| title_full_unstemmed | Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease |
| title_short | Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease |
| title_sort | ophthalmologic baseline characteristics and 2 year ophthalmologic safety profile of pramipexole ir compared with ropinirole ir in patients with early parkinson s disease |
| url | http://dx.doi.org/10.1155/2016/8298503 |
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