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Table 3 Improvement in efficacy over a 2-year maintenance treatment with transdermal rotigotine: Mean change from baseline; mean ± SD or number (%)

From: Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

 

Baseline of double-blind study

Change at end of year 1

(as observed)

Change at end of year 1

(LOCF)

Change at end of year 2

(as observed)

Change at end of year 2

(LOCF)

 

N

Score

N

Score

Score

N

Score

Score

IRLS total score

295

27.8 ± 5.9

220

-18.8 ± 8.8

-17.4 ± 9.9

190

-17.2 ± 9.2

-15.4 ± 10.3

RLS-6

        

   Satisfaction with sleep

293

7.2 ± 2.5

216

-4.5 ± 3.4

-4.1 ± 3.5

190

-4.3 ± 3.3

-3.7 ± 3.4

   Severity at bedtime

293

6.0 ± 3.0

215

-4.6 ± 3.2

-4.2 ± 3.3

189

-4.0 ± 3.1

-3.8 ± 3.2

   Severity during the night

294

6.8 ± 2.7

216

-5.2 ± 3.0

-4.9 ± 3.1

190

-4.9 ± 3.0

-4.5 ± 3.2

   Severity during the day when resting

293

4.9 ± 2.6

216

-3.4 ± 2.6

-3.4 ± 2.7

190

-2.9 ± 2.7

-2.9 ± 3.0

   Severity during the day when active

294

1.9 ± 2.0

217

-1.4 ± 1.9

-1.5 ± 2.0

190

-1.2 ± 2.0

-1.2 ± 2.2

   Daytime tiredness or sleepiness

294

4.8 ± 2.6

217

-2.8 ± 2.9

-2.6 ± 3.1

190

-2.4 ± 2.7

-2.2 ± 3.0

CGI-1 (severity of illness)

295

5.1 ± 0.9

217

-2.9 ± 1.2

-2.8 ± 1.3

191

-2.8 ± 1.2

-2.6 ± 1.4

QoL-RLS total score

273

30.2 ± 10.4

200

-19.1 ± 12.2

-17.7 ± 13.2

178

-17.7 ± 12.8a

-15.8 ± 13.8a

ESS total score

289

6.7 ± 5.2

215

-1.5 ± 4.5

n.d.

185

-0.8 ± 4.6

-0.6 ± 4.6

  1. a after 21 months of maintenance