A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome.

OBJECTIVE: To assess the long-term safety and efficacy of ropinirole in the treatment of patients with restless legs syndrome (RLS) over 52 weeks. METHODS: A 52-week, multicentre, open-label continuation study involving 310 patients, conducted in 11 countries. Eligible patients from four parent studies were invited to participate. At parent study entry, all patients had a score of > or =15 on the International Restless Legs Scale (IRLS). In this continuation study, all participants received ropinirole, 0.25-4.0 mg once daily, for 52 weeks. The primary study objective was to evaluate the safety of ropinirole. Efficacy was assessed by change in IRLS score, as well as by global improvements (clinical global impression [CGI] scale) and improvements in measures of sleep, work productivity, and quality of life. RESULTS: Overall, 251 (81.0%) patients completed the study. The mean ropinirole dose at study end was 1.90 mg/day. A total of 282 patients (91.3%) reported > or = 1 adverse event. For the majority of patients, the reported adverse events were mild or moderate in intensity. The most common adverse event was nausea. Adverse events led to discontinuation in 8.7% of patients. At week 52, IRLS scores improved by an average of 12.0 points from baseline, and 82.8% of patients were 'much improved' or 'very much improved' on the CGI-improvement scale. Ropinirole treatment was also associated with improvements in measures of sleep and quality of life. CONCLUSIONS: Ropinirole was well tolerated and therapeutic efficacy was maintained over 52 weeks in patients with RLS.

Diagnostic indicators of restless legs syndrome in primary care consultations: the DESYR study.

The objective of this study is to determine whether spontaneous complaints about sleep or the legs could be used as potential indicators of restless legs syndrome (RLS) in primary care. A total of 351 general practitioners participated in the study. In a first historical patient identification phase, all patients with spontaneous complaints of sleep or leg symptoms over the previous year were identified. A control group without such complaints was identified. In a second prospective data collection phase, those who consulted a participating physician were interviewed to assess consensus diagnostic criteria of RLS. Severity was assessed with the International Restless Legs Syndrome Study Group severity rating scale. Of 1,405,823 patients consulting during the historical phase, a leg complaint was reported in 61,685 and a sleep complaint in 40,568. A total of 1,432 consulted during the prospective phase. A diagnosis of RLS was assigned to 42.6% of patients with leg complaints, 35.5% of those with sleep complaints, 54.9% of those with both complaints, and 12.9% of those with no complaints. Median RLS severity scores were 18.8 to 20.4. A total of 63.7% of patients were prescribed a venotonic, 43.7% a hypnotic, and 41.5% an anxiolytic. Complaints of sleep or leg symptoms are frequently associated with a diagnosis of RLS, and their presence should alert the physician to the possibility of a differential diagnosis of RLS.

Comparative effects of duloxetine and desipramine on sleep EEG in healthy subjects.

RATIONALE: Antidepressants are known to modify human sleep patterns. OBJECTIVES: Duloxetine is a new antidepressant with a mechanism of action involving reuptake inhibition of both serotonin (5-HT) and norepinephrine (NE). In this study, the effects of two dosing regimens of duloxetine on sleep electroencephalography (EEG) were investigated at steady-state plasma concentrations in young, healthy, male subjects. METHODS: Placebo (n=12), desipramine (50 mg BID; n=12) and two regimens of duloxetine (80 mg QD, n=6; or 60 mg BID, n=6) were compared in a randomized, double-blind, three-period crossover study, each treatment being administered from day 1 to day 7. Sleep polygraphic recordings took place at baseline (day -1) and day 6 of each period. The Leeds sleep evaluation questionnaire (LSEQ) was also administered on the morning of day 7. RESULTS: Both regimens of duloxetine produced a significant increase in the onset latency of REM sleep as well as a significant mean decrease in total REM sleep duration. Desipramine exhibited comparable effects. When compared to placebo, sleep continuity was significantly reduced with desipramine and duloxetine 60 mg BID whereas a significant improvement was observed with duloxetine 80 mg QD. On the LSEQ, duloxetine 80 mg QD produced a significant improvement in the "getting to sleep" subscale compared to placebo, whereas desipramine demonstrated a significant reduction (worsening) in the "quality of sleep" score versus placebo. CONCLUSIONS: The two dose regimens of duloxetine (80 mg QD and 60 mg BID) produced a REM sleep pattern comparable to that of most antidepressant medications. Duloxetine 80 mg QD appeared to exhibit less impact upon sleep quality than duloxetine 60 mg BID in healthy subjects.