Long-term safety and efficacy of cabergoline for the treatment of idiopathic restless legs syndrome: Results from an open-label 6-month clinical trial
Long-term safety and efficacy of cabergoline for the treatment of idiopathic restless legs syndrome: Results from an open-label 6-month clinical trial
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DOI：
10.1093/sleep/27.4.674
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发表时间：
2004-06-15
期刊：
影响因子：
5.6
通讯作者：
Kohnen, R
中科院分区：
文献类型：
--
作者：
Benes, H;Heinrich, CR;Kohnen, R
研究目的：评估卡麦角林治疗特发性不宁腿综合征（RLS）患者的安全性和有效性。设计：开放标签干预研究，为期26周;无对照组。设置：302例患者（73%为女性，年龄61 +/- 11岁），来自37个德国神经科门诊部和私人诊所。卡麦角林在4周内向上滴定至个体优化剂量。中位治疗持续时间为181天。卡麦角林的中位日剂量为1.5 mg.Measurements：药物的安全性进行了评估的不良事件，疗效进行了评估与RLS-6和国际RLS Rating Scales.Results：在48%的研究参与者，研究人员报告的不良事件怀疑是药物相关。大多数不良事件为轻度和一过性，与胃肠道系统（恶心：16.6%）或中枢神经系统（头晕：7.0%，头痛：4.6%）相关。54例患者（17.9%）提前退出研究，17例患者（3.0%）因药物相关不良事件退出研究。治疗期间，夜间、睡前和白天RLS症状的严重程度以及国际RLS评定量表总分均有所改善。睡眠满意度增加（所有P值<0.001）。在所有患者中，有5%的患者RLS症状恶化，另有6.3%的患者对治疗反应较差。在9例患者（3.0%）之间的1和3个标准的增强noted.Conclusions：长期治疗卡麦角林是一个安全和耐受性良好的治疗选择，绝大多数患者的特发性RLS。该治疗对该适应症的夜间和日间症状均有效，并且可能具有较低的增强风险。
Study Objectives: To assess the safety and efficacy of cabergoline in the treatment of idiopathic restless legs syndrome (RLS) patients.Design: Open-label intervention study for 26 weeks; no control group.Setting: 302 patients (73% women, aged 61 +/- 11 years) from 37 German neurologic outpatient departments and private practices.Intervention: Cabergoline was upwardly titrated over 4 weeks to individually optimized dosages. Median treatment duration was 181 days. The median daily dose of cabergoline was 1.5 mg.Measurements: Drug safety was assessed by adverse events; efficacy was evaluated with the RLS-6 and the International RLS Rating Scales.Results: In 48% of the study participants, investigators reported adverse events suspected to be drug related. Most adverse events were mild and transient and related to the gastrointestinal system (nausea: 16.6%) or the central nervous system (dizziness: 7.0%, headache: 4.6%). Premature dropout from the study occurred in 54 patients (17.9%), in 17 patients (3.0%) due to a drug-related adverse event. The severity of RLS symptoms at night, at bedtime, and during the day, as well as the International RLS Rating Scale total score improved during therapy. Satisfaction with sleep was increased (all P values < .001). In 5% of all patients, RLS symptoms worsened, and in a further 6.3%, response to therapy was poor. In 9 patients (3.0%) between 1 and 3 criteria for augmentation were noted.Conclusions: Long-term therapy with cabergoline is a safe and well-tolerated treatment option for the great majority of patients with idiopathic RLS. The treatment was efficacious both for nighttime and daytime symptoms in this indication and may carry a low risk of augmentation.