By Maria Bishop
BOSTON, MA -- May 3, 2007 -- A 24-hour, prolonged-release formulation of ropinirole once-daily significantly reduced "off" time and improved mood in patients with Parkinson's disease who are suboptimally controlled with levodopa (L-dopa), researchers reported here at the American Academy of Neurology (AAN) 59th Annual Meeting.
A total of 393 patients aged 30 years or older with idiopathic Parkinson's disease that was suboptimally controlled with L-dopa were enrolled in the Efficacy And Safety Evaluation in PD (EASE-PD) adjunct study.
Lead author Robert A. Hauser, MD, professor of neurology, pharmacology, and experimental therapeutics, and director, Parkinson's Disease and Movement Disorders Center, University of South Florida College of Medicine, Tampa, Florida presented the study here on May 3rd.
In the treatment cohort (n = 201) ropinirole was titrated upwards from 2 mg/day to a maximum dose of 24 mg/day over the course of 24 weeks. At 8 mg/day, and with each subsequent dose increase, L-dopa dose reduction was required. Patients who did not experience improvements in symptoms after 2 up-titrations of ropinirole could have their L-dopa dose increased back up to baseline levels.
Mean patient age was approximately 66 years in both treatment and placebo groups.
At week 24, the reduction in mean awake "off" time was significantly greater in the ropinirole group compared with those in the placebo group. The adjusted mean change from baseline was -2.1 hours and -0.3 hours in the treated and placebo groups, respectively, leaving an adjusted mean treatment difference of -1.7 hours (P <.0001).
Immediate reduction in L-dopa patients was seen at week 2 and then at all subsequent visits through week 24.
Ropinirole treatment also led to significant improvements in mood as measured by the Beck Depression Inventory II (BDI-II) total score at week 24: Adjusted mean change from baseline was -2.1 in the treatment group and -0.5 in the placebo group, leaving an adjusted mean treatment difference of -1.6 (P =.0130). Mean score on the BDI-II had been approximately 16 points in each group at baseline.
Once-daily ropinirole 24-hour prolonged release was generally well tolerated, and the proportion of patients who withdrew from the study was low and was similar between groups, Dr. Hauser said.
"Off" time refers to the time when the control of Parkinson's disease treatment begins to wear off and the symptoms of the disease return. The duration of L-dopa's effect diminishes over time as the disease progresses, and "off" time therefore grows increasingly longer.
In this study, "off" time was measured by patient diaries, and was recorded at a mean of approximately 7 hours at baseline.
Depression has been reported to occur in the PD population at twice the rate of that found in the general population.
This study was supported by GlaxoSmithKline and Skye Pharma.
[Presentation title: Ropinirole 24-Hour Prolonged Release Improves Mood and Reduces "Off Time as Adjunctive Therapy in Parkinsons Disease. Abstract P06.021]
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