January 2012
Chaudhur KR, Martinez-Martin P, Cooper J, Rockett CB, Girogi L, Ondo WG
Background: The 24-week, double-blind
Efficacy and Safety Evaluation in PD–Adjunct (EASE-PD Adjunct) study
randomized patients with advanced Parkinson’s disease (PD) suboptimally
controlled with levodopa to once-daily placebo or adjunctive ropinirole
prolonged release (2–24 mg/day). We investigated the effect of
ropinirole prolonged release on nocturnal symptoms in these patients.
Methods: Total and grouped item PD Sleep Scale (PDSS) scores were analyzed post hoc in patients with baseline PDSS total scores ≤ 100 (troublesome nocturnal symptoms) and >100.
Results:
Baseline PDSS total score was ≤ 100 in 93 of 198 (47%) and 89 of 189
(47%) patients receiving ropinirole prolonged release and placebo,
respectively; this subgroup displayed evidence at baseline of greater
daily awake ‘off’ time, reduced night-time sleep and worse quality of
life, than the PDSS >100 subgroup. Significant improvements with
ropinirole prolonged release versus placebo in PDSS score from baseline
to Week 24 last observation carried forward were observed for those with
baseline PDSS ≤ 100 [adjusted mean treatment difference 9.0 (95% CI:
2.76, 15.33; P = 0.0051)], but not >100. The
PDSS ≤ 100 subgroup demonstrated treatment benefits for PDSS groupings
of motor symptoms on waking and global quality of sleep. Changes in
daytime sleepiness were similar between treatment groups. The
PDSS >100 subgroup demonstrated significant treatment benefit for
global quality of sleep. The unadjusted odds ratio for a positive
response with ropinirole prolonged release relative to placebo, for the
PDSS ≤ 100 subgroup, was 2.90 (95% CI: 1.42, 5.95, P = 0.004).
Conclusions:
Once-daily ropinirole prolonged release improves nocturnal symptoms in
patients with advanced PD not optimally controlled with levodopa who
suffer troublesome nocturnal disturbance.
