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.

KEYWORDS:

• 101468/248
• ropinirole XL/PR
• safety
• long-term treatment
• ropinirole PR
• Clinicaltrials.gov trial number: NCT00632736

Acknowledgements

This study was funded by GlaxoSmithKline (study number 101468/248). The authors acknowledge the investigators who participated in this study (listed in Appendix 1), Dr. Brian Hunter for his contribution to the design and ongoing scientific oversight of the study, Dr. Michael Winnem for his contributions to the design and medical oversight of the study, Dr. Luigi Giorgi and Dr. Ken Shulman for the contributions towards medical oversight during the ongoing management of the study (all former GlaxoSmithKline employees), Katie Rolfe (GlaxoSmithKline, Stockley Park, United Kingdom) for statistical support during the conduct of the study and Dr. Jasna Knezevic (GlaxoSmithKline, Stockley Park, United Kingdom) for safety and pharmacovigilance guidance. We wish to acknowledge QUINTILES Limited for the study management and PAREXEL International for the data management of this study.

Declaration of Interests

The authors (Dr Makumi, Ms. Asgharian, Ms. Jimenez, Dr VanMeter, Dr Shaikh, and Mr. Ellis) are all employees and shareholders in GlaxoSmithKline and have no other conflicts of interest to declare. The authors alone are responsible for the content and writing of the article.

This work was funded by GlaxoSmithKline (GSK) Research & Development (study number 101468/248).