NOW for your patients with early or late-stage Parkinson’s disease
With NEW REQUIP XL 24-hour—the first once-a-day dopaminergic therapy—patients can take their dose and get on with their day. • The only once-a-day oral DA • Simple titration • Significant reduction in “off” time within 2 weeks • Proven safety and tolerability
A simple approach... for moments that last
Deliver Early Results That Last By week 2 and throughout treatment, REQUIP XL 24-hour significantly reduced awake time spent “off” Awake time spent “off” (mean change) from baseline through week 24 REQUIP XL 24-hour Placebo
1.0 0.5
Mean Change From Baseline (+/- 2 SE)
0.0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 -3.5
1 2 3 4
6
8
10
12
16
20
24
Week 24 LOCF
Time (weeks)
*Statistical significance was achieved at each assessment point, except at week 1.
Mean reduction from baseline in daily “off” time at week 24
REQUIP XL 24-hour 0
Hours
-1
-2
-3
-2.1
HOURS REDUCTION
Placebo
-0.3
HOUR REDUCTION
P<0.0001
It Starts With a Simple Dose… Conversion Instantly convert patients from REQUIP IR to REQUIP XL CONVERSION SCHEDULE (TOTAL DAILY DOSE) REQUIP XL 24-hour
IR Ropinirole
2 mg 4 mg 6 mg 8 mg 12 mg 16 mg 20 mg
0.75 to 2.25 mg 3.0 to 4.5 mg 6 mg 7.5 to 9.0 mg 12 mg 15 to 18 mg 21 mg
Switch patients to the dose of REQUIP XL 24-hour that most closely matches the total daily dose of IR ropinirole. • In clinical trial patients switched to REQUIP XL 24-hour overnight, the mean dose of ropinirole remained unchanged after switching
Titration The 4-week Starter Kit provides a convenient, simple way to get patients started on REQUIP XL 24-hour
WEEK 1
WEEK 2
WEEK 3
WEEK 4
2 mg qd
4 mg qd
6 mg qd
8 mg qd
REQUIP XL 24-hour 8 mg # 30 tabs Sig 1 qd
• After week 4, doses may be increased by 4 mg/day every WEEK 2 1 to 2 weeks (if necessary) to a maximum daily dose of 24 mg • Doses greater than 24 mg/day have not been studied clinically
WEEK 3
WEEK 3
As PD progresses, the efficacy of lower doses of L-dopa wears off1 Changes in total scores on the Unified Parkinson’s Disease Rating Scale (UPDRS) in patients receiving L-dopa or placebo1*
Change in Total Score (units)
12
Placebo (n=90) L-dopa 150 mg (n=92)
L-dopa L-dopa
Simplified Dosing for Lasting Results REQUIP XL 24-hour reduced the need for treatment with L-dopa Reduction in daily L-dopa dose vs placebo at week 24*
P<0.0001
300 mg (n=88) 600 mg (n=91)
8
REQUIP XL 24-hour
4 0
34%
-4 -8
2
6
10
14
18
22
26
30
34
38
42
164 mg Reduction
46
Week
278 mg Reduction Withdrawal of Study Drug
* From the Parkinson’s Disease Study Group. Changes in subjects treated with L-dopa at different doses or with placebo were determined on the basis of total scores on the UPDRS. Scores were obtained by blinded treating investigators who performed the evaluation before the daily morning dose of the study drug. Points on the curves indicate mean changes from baseline in total scores at each visit. Improvement in parkinsonism is represented by lower scores and worsening is depicted by higher scores. Negative scores on the curves indicate improvement from baseline. The bars indicate standard error.
Lower doses of L-dopa only maintain control for a brief period of time2 • Many patients who initially achieved symptom relief with L-dopa returned to baseline starting at week 222 • Higher doses of L-dopa (600 mg/day) were necessary for patients to achieve the best results2
High Doses of L-dopa May Increase the Risk of Dyskinesia of early PD patients treated with L-dopa over 40 weeks experienced dyskinesia at 600 mg/day (n=91; P<0.001).2† • Placebo: 3% (n=90) • 150 mg/day: 3% (n=92) • 300 mg/day: 2% (n=88)
Data from a multicenter, placebo-controlled, randomized, dose-ranging, double-blind clinical trial. Study assessed the effect of L-dopa on disease progression in patients with early PD (Hoehn & Yahr stage I-III).
†
21%
REDUCTION
REDUCTION
Baseline
17%
Placebo (+ L-dopa)
93%
maintained reduction in daily L-dopa dose
• L-dopa dose reduction was maintained in 93% of patients taking REQUIP XL vs 72% of those treated with placebo (P<0.0010) • Only 7% of patients taking REQUIP XL required L-dopa dose reinstatement vs 28% of patients treated with placebo