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| Efficacy |
| Significant Symptom Improvement After Night 2 With the Starting Dose |
| The Clinical Global Impression (CGI) scale is a tool widely used to assess the impact of certain disorders and to monitor the success of treatment. The CGI scale comprises 3 subscales, and the subscale CGI-Improvement (CGI-I) was used in the RLS clinical trials for Requip. Physicians using this scale make their assessment by relying on a patient’s own description of their symptoms. In a phase III trial of patients with moderate-to-severe primary RLS, the CGI-I scale was utilized to assess the treatment efficacy in patients following 2 nights of therapy with Requip. [6] |
- Significant improvement at each timepoint measured—from night 2 through
week 12 [6]
- After night 2 in TREAT RLS US, significant improvement in symptom severity was demonstrated with Requip on the IRLS Scale vs. placebo (improvement of 6.8 vs 4.6 points; P=0.003) — results continued through week 12 (P<0.001) [6]
- Comparable results were seen in a similar analysis from pooled studies (TREAT RLS 1 and TREAT RLS 2) after night 2 and through week 12 on both the CGI-I (P<0.001) and IRLS scales (P<0.001) [18]†‡
*TREAT RLS US=Therapy with Ropinirole, Efficacy And Tolerability in RLS in the United States (n=380): a 12-week, randomized, double-blind, placebo-controlled trial to assess efficacy/safety of Requip vs placebo in the treatment of moderate-to-severe primary RLS.
† TREAT RLS 1 (n=284).
‡TREAT RLS 2 (n=266).
CGI-I=Clinical Global Impression-Improvement Scale.
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Requip Helps Relieve the Urge to Move at 9 Months [9]
§A multicenter, double-blind, randomized, placebo-controlled study to evaluate maintained efficacy and tolerability of Requip at a fixed dose vs placebo in the long-term treatment of moderate-to-severe primary RLS (n=92). Maintenance of response was defined as those who did not relapse, where relapse was defined as a deterioration of at least 6 points on the IRLS Rating Scale to a total score of at least 15 points or withdrawal due to lack of efficacy. Clinicians reported patient improvement on the Clinical Global Impression-Improvement (CGI-I) Scale.
- During the 24-week, single-blind phase, 202 patients were treated with Requip [9]
- Responders from the single-blind phase (n=88) were placed into the second phase and were randomized to placebo or continuation of Requip for an additional 12 weeks (total of 36 weeks) [9]
- Significantly fewer patients relapsed at 9 months on ropinirole vs. plecebo (33% vs. 58%; P-0.0156) [9]
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Requip is indicated for patients with moderate-to-severe primary RLS.
Requip has been associated with sedating effects, including somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope or symptomatic hypotension may occur, particularly during initial treatment or dose titration. Impulse control symptoms, including pathological gambling and hypersexuality, have been reported in patients treated with dopaminergic agents, including ropinirole.
For More Safety Information about Requip, click here.
Complete Prescribing Information for Requip® (ropinirole HCl) Tablets
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Efficacy
