title: Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease.
abstract: Long-term safety of once-daily ropinirole extended/prolonged release (ropinirole XL/PR) was evaluated in subjects with early and advanced Parkinson's disease (PD) in this study, 101468/248. Subjects (n = 419) who completed one of three prior studies evaluating ropinirole XL/PR for the treatment of PD were enrolled in this open-label, multicenter, extension study, and were to be followed for up to 73 months. Ropinirole XL/PR was titrated/continued, and adjusted as appropriate during the maintenance phase (maximum 24 mg/d). Levodopa (L-dopa) and other nondopamine agonist PD medications were permitted. Safety outcomes that were investigated included frequency of adverse events (AEs). Subjects' preference regarding once daily versus three times daily study medication regimens was also investigated in a subset of the study population. The median duration of ropinirole XL/PR exposure was 1275 d. Most subjects (87%) reported at least one AE, with the most common (≥ 10%) AEs being, back pain (14%), hallucinations (13%), somnolence (11%) and peripheral edema (11%). Twenty-five percent of subjects discontinued the study prematurely due to an AE during the treatment period. Long-term treatment with ropinirole XL/PR was not associated with any new or unexpected safety concerns in patients with early and advanced PD, and a majority of subjects preferred the once-daily dosing regimen.
authors.affiliation: a US Medical Affairs -Medical Services , GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors.forename: Clare W
authors.initials: CW
authors.lastname: Makumi
authors.affiliation: b Clinical Statistics , GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors.forename: Afsaneh
authors.initials: A
authors.lastname: Asgharian
authors.affiliation: c R&D Projects, Clinical Platforms, & Sciences , GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Ellis
authors.affiliation: d Classic and Established Medicines , GlaxoSmithKline, Brentford, UK.
authors.forename: Soraya
authors.initials: S
authors.lastname: Shaikh
authors.affiliation: b Clinical Statistics , GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors.forename: Teri
authors.initials: T
authors.lastname: Jimenez
authors.affiliation: e Neuroscience Therapy Area Unit , GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: VanMeter
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001416:Back Pain / Q000139:chemically induced* / Q000453:epidemiology; D003692:Delayed-Action Preparations; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004487:Edema / Q000139:chemically induced* / Q000453:epidemiology; D005221:Fatigue / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006212:Hallucinations / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*; D057240:Patient Preference; D015995:Prevalence
chemical_list: D000978:Antiparkinson Agents; D003692:Delayed-Action Preparations; D018491:Dopamine Agonists; D007211:Indoles; C046649:ropinirole
keywords: 101468/248; Clinicaltrials.gov trial number: NCT00632736; long-term treatment; ropinirole PR; ropinirole XL/PR; safety