Drug safety evaluation of ropinirole prolonged release.

INTRODUCTION: The need for multiple administrations and a difficult titration schedule has always represented a limit in the use of dopamine agonists in the treatment of early Parkinson's disease. To avoid these problems, Ropinirole prolonged release (RPR), a non-ergoline dopamine receptor agonist that can be taken once a day, has been formulated. The prolonged release formulation has higher patient compliance due to a simpler and fastest titration schedule; the once-a-day administration makes this molecule especially suitable for young Parkinsonian patients who are still working and having an active lifestyle. AREAS COVERED: In this paper, we will review ropinirole's mechanism of action including pharmacokinetics and pharmacodynamic data and the results of the main clinical studies in early and advanced PD patients. We will also discuss safety data shown during the experimental phase and after RPR commercialization. This article reviews the use of RPR in early and advanced Parkinsonian patients. Medical literature on the use of RPR in Parkinson's disease was identified using MEDLINE and the reference lists of published articles. EXPERT OPINION: RPR is effective in the treatment of patients with early Parkinson's disease; in advanced Parkinsonian patients, the amount of daily off-time significantly decreases, improving the mean on time. RPR has also demonstrated to be effective in ameliorating the quality of sleep without increasing the occurrence of daily sleepiness and nocturnal psychosis. RPR was generally well tolerated in both early and advanced Parkinsonian patients.