普拉克索治疗不宁腿综合征的Meta分析

目的 系统评价普拉克索治疗不宁腿综合征(restless legs syndrome,RLS)的疗效与安全性.方法 检索中国期刊全文数据库( CNKI)、美国国立医学生物信息中心PubMed数据库( PubMed)、荷兰医学文摘数据库(Embase)、Cochrane Library数据库关于普拉克索治疗RLS的随机、双盲、安慰剂对照研究.对符合条件的研究结果用RevMan 5.0软件进行Meta分析.以普拉克索组和安慰剂组在国际不宁腿研究组评分量表( International RLS Study Group rating scale,IRLS)评分变化方面的加权均数差(weighted mean difference,WMD)和普拉克索组相对于安慰剂组在临床疗效总评(clinical global impression-improvement,CGI-I)方面疗效显著率的相对危险度(relative risk,RR)为指标进行疗效评价,以其在不良事件方面的相对危险度为指标进行安全性评价.结果 共纳入5项研究,1776例患者被随机分配,其中普拉克索组945例,安慰剂组831例.Meta分析结果显示,普拉克索组相对于安慰剂组在IRLS评分变化方面的WMD=-6.34 (Z=12.76,P＜0.01),在CGI-I显著性评估方面的RR=1.65 (Z=10.39,P＜0.01);两组在不良事件方面的RR=1.14 (Z=1.87,P=0.06).结论 普拉克索是治疗RLS的有效且安全的药物.     

不安腿综合征的主观睡眠质量评估及多导睡眠图研究

目的了解不安腿综合征(RLS)患者的主、客观睡眠质量,以及RLS严重程度量表评分与睡眠质量的相关性。方法选取30例RLS患者(RLS组)和30名年龄、性别匹配的健康正常人(对照组),通过BECK抑郁量表、BECK焦虑量表、Chalder疲惫量表、匹兹堡睡眠质量指数量表、Epworth嗜睡量表、RLS生活质量量表评估RLS患者主观睡眠质量及生活质量。运用多导睡眠图分析患者客观睡眠质量情况。对RLS严重程度与睡眠质量进行相关性分析。结果与对照组比较,RLS组抑郁量表评分、Chalder疲惫量表评分、匹兹堡睡眠质量指数量表评分均增高。RLS严重程度量表评分(IRLS)与Chalder疲惫量表评分、匹兹堡睡眠质量指数量表评分及RLS生活质量量表评分具有显著相关性。多导睡眠图检测:RLS组总睡眠时间减少,睡眠效率下降;N1期睡眠比例、入睡后清醒时间及微觉醒指数增高;RLS组睡眠期周期性肢体运动(PLMS)指数显著增高(P0.001)。IRLS评分与PLMS指数具有相关性(r=0.371,P=0.044),而与其他客观睡眠参数无相关性。结论 RLS显著影响患者睡眠质量及生活质量,且主观睡眠质量、生活质量及PLMS指数与IRLS具有相关性。     

普拉克索治疗原发性不安腿综合征疗效观察

目的观察普拉克索治疗原发性不安腿综合征（RLS）的临床疗效及安全性。方法将66例原发性RLS患者随机分为普拉克索组与美多巴组,应用国际不安腿综合征评估量表（IRLS）和汉密尔顿抑郁量表（HAMD）分别于治疗前及治疗后6周进行病情评估,观察比较2组治疗前后各量表评分情况,并记录2组患者出现的药物不良反应。结果2组患者治疗后IRLS与HAMD评分较治疗前均明显下降（P〈0．05）,相比美多巴组,普拉克索组治疗后IRLS评分差异无统计学意义（P〉0．05）,但HAMD评分下降更为明显（P〈0．01）,2组药物不良反应发生率差异无统计学意义（P〉0．05）。结论普拉克索能有效缓解原发性RLS症状,且药物不良反应较小,相比美多巴其抗抑郁的优势更为明显。     

小剂量氯氮平治疗帕金森病合并睡眠障碍的疗效观察

目的观察小剂量氯氮平治疗帕金森病患者睡眠障碍的临床疗效和安全性。方法将60例患者按随机、双盲法分为治疗组和对照组各30例,治疗组给予小剂量氯氮平12.5~50mg/d,睡前服用;对照组给予艾司唑仑1~2mg/d,睡前服用。疗程均为1个月。通过Epworth嗜睡量表(ESS)、帕金森病睡眠量表(PDSS)比较2组治疗前后的疗效及观察不良反应。结果2组治疗后ESS、PDSS评分均较治疗前明显改善(P0.05),但治疗组较对照组改善明显(P0.05)。治疗过程中未见明显不良反应。结论小剂量氯氮平能有效改善PD患者的睡眠障碍,安全性好。     

普拉克索治疗帕金森病运动并发症的临床研究

目的 探讨普拉克索对经复方左旋多巴治疗并且已经出现运动并发症的中晚期帕金森病(PD)患者的疗效和安全性.方法 42例PD患者在原有复方左旋多巴治疗的基础上加用普拉克索1.5～3.0mg/d,为期12周.疗效指标为治疗前后统一PD评定量表(Unified Parkinson's Disease Rating Scale,UPDRS)及汉密尔顿抑郁量表(Hamilton Depression Scale,HAMD)评分,其中UPDBS Ⅰ及HAMD用于评价精神、行为、情绪等非运动症状;UPDRS Ⅱ评价日常生活活动能力;UPDRS Ⅲ、Ⅳ及"开"期和"关"期时间的变化用于评价运动功能,并对患者的临床疗效进行整体评价.安全性指标为不良反应、血压、脉搏、实验室检查、心电图及对认知功能的影响.结果 治疗12周后,UPDRS各项评分均减少,差异具有统计学意义(UPDRS总分:52.05±7.69与39.26±7.64,t=25.378,P＜0.05).UPDRS运动评分改善22.61%,"开"期持续时间增加约1.64 h;复方左旋多巴用最平均减少129.46 mg/d;治疗并发症评分变化均值下降1.45分;HAMD评分均值下降6.14分.不良反应主要有头晕、嗜睡、恶心、便秘、厌食等.结论 普拉克索对运动症状和非运动症状均有较好的疗效,不良反应发生率低,中晚期PD患者加用普拉克索是安全而有效的.     

多巴胺受体激动剂普拉克索治疗帕金森病非运动症状的疗效观察

目的 研究多巴胺受体激动剂普拉克索治疗帕金森病(PD)非运动症状的临床疗效.方法 给予29例PD患者普拉克索0.5 mg每天3次(经过3周加量期)治疗,持续12个月;在治疗前和治疗12个月后进行汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)和简易精神状态检查(MMSE)量表评分,观察治疗前后感觉异常、便秘、排尿障碍、性功能障碍和肢体水肿的变化,以及不良反应.结果 PD患者治疗后HAMA、HAMD评分比治疗前显著降低(均P<0.01),而MMSE量表评分与治疗前的差异无统计学意义.治疗后感觉异常的患者(6例,20.7%)比治疗前(11例,37.9%)显著减少(P<0.05),治疗前后排尿障碍、便秘、性功能障碍及肢体水肿患者比例的差异无统计学意义.患者未出现明显不良反应.结论 普拉克索能够减轻PD患者的焦虑、抑郁状态,改善其感觉异常的症状.     

日间嗜睡与急性缺血性卒中短期预后的关系

目的 通过分析急性缺血性卒中患者日间嗜睡及急性期神经功能转归情况,探索日间嗜睡与急性缺 血性卒中短期预后之间的关系。 方法 连续收集2015年6月-2015年9月北京市海淀医院神经内科收治的发病48 h内的住院急性缺血 性卒中患者临床资料,包括：人口学特征、既往病史、入院时及发病14 d美国国立卫生研究院卒中量 表（National Institutes of Health Stroke Scale,NIHSS）评分及入院时日间嗜睡量表[爱波沃斯嗜睡量表 （Epworth Sleepiness Scale,ESS）]评分等,回顾性评估患者发病前一个月的ESS评分,分析其与患者基线 特点、入院NIHSS评分、入院ESS评分、发病14 d NIHSS评分、发病14 d与发病时NIHSS评分差值（△NIHSS） 之间的相关性。根据发病前ESS评分将患者分为嗜睡组和无嗜睡组,比较两组入院时NIHSS、发病 14 d NIHSS、△NIHSS及入院时ESS评分的差异。 结果 共纳入106例急性缺血性卒中患者。结果显示：①发病前ESS评分与入院时NIHSS评分、发病 14 d NIHSS评分及入院时ESS评分呈正相关,Pearson相关系数分别为0.199、0.276及0.407,P值分别为 0.041、0.004及＜0.001;发病前ESS评分与△NIHSS评分呈负相关,Pearson相关系数为-0.189,P =0.042; ②嗜睡组28例,非嗜睡组78例,嗜睡组入院时NIHSS、发病14 d NIHSS及入院时ESS评分明显高于非嗜 睡组,P值分别为0.033、0.043和＜0.001。嗜睡组△NIHSS评分明显低于非嗜睡组,P =0.046。 结论 发病前存在日间嗜睡的患者在发生急性缺血性卒中后,入院时及发病14 d病情更加严重,短期 预后更差,并且卒中后日间嗜睡程度会加重。     

普拉克索添加治疗帕金森病的疗效观察

目的 观察添加普拉克索治疗帕金森病(PD)的疗效和安全性.方法 78例Hoehn-Yahr分级为Ⅱ～Ⅲ级的PD患者在接受左旋多巴达到剂量稳定≥30 d的基础上随机分为3组.A组添加普拉克索0.125 ng,每日2次,4周滴定至0.75 mg/d,维持8周.B组添加普拉克索0.125 mg,每日2次,6周滴定至1.5 mg/d,维持6周.C组不添加普拉克索.治疗前后应用统一PD评定量表(UPDRS)评分并评估疗效,观察不良反应.结果 与治疗前相比,治疗12周A组、B组的UPDRSⅡ、Ⅲ评分明显下降(均P＜0.05);B组显效率(21例,80.8%)显著高于A组(12例,46.2%)(P＜0.01).3组均未发生严重不良反应.B组2例出现轻度头晕、恶心,未影响治疗.结论 应用左旋多巴治疗的PD患者添加普拉克索可以有效缓解症状,改善生活质量;添加普拉克索1.5 mg/d的疗效优于0.75 mg/d.     

共患不宁腿综合征对偏头痛患者情绪和睡眠的影响

目的探讨偏头痛患者的不宁腿综合征(RLS)的发病率及其对情绪和睡眠的影响。方法对200例偏头痛患者(偏头痛组)和100名正常成人(对照组)进行RLS发病率、严重程度、睡眠质量和焦虑及抑郁程度评分,比较偏头痛人群与对照组之间的差异。并对共患有RLS的偏头痛患者的情绪和睡眠情况进行分析。结果成人慢性偏头痛组的RLS发病率(16.25%)较对照组(5%)高,差异有统计学意义(P0.05);发作性偏头痛组的RLS发病率(12.5%)与对照组(5%)比较,差异无统计学意义(P0.05)。共患RLS的偏头痛患者较单纯偏头痛者的睡眠质量差、焦虑及抑郁评分高,差异有统计学意义(均P0.05)。头痛频率及RLS为抑郁、焦虑及睡眠障碍的影响因素(均P0.05)。偏头痛患者的汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分及匹茨堡睡眠质量量表(PSQI)评分与国际RLS评估量表(IRLS)的相关系数分别为rHAMD=0.397、rHAMA=0.434和rPSQI=0.500;RLS严重程度与抑郁、焦虑及睡眠障碍的严重程度呈正相关关系(均P0.05)。结论慢性偏头痛患者的RLS发病率更高,且RLS症状更严重。RLS的严重程度与抑郁、焦虑和睡眠障碍程度呈正相关关系。     

依达拉奉治疗急性高血压脑出血30例疗效观察

目的 观察依达拉奉治疗高血压脑出血的疗效.方法 高血压脑出血患者60例,随机分为2组,依达拉奉治疗组(30例),在常规治疗基础上加用依达拉奉30 mg加入生理盐水100 ml静滴,2次/d,连用14 d;对照组(30例)常规治疗加生理盐水100 ml静滴,2次/d,连用14 d,2组均在治疗前及治疗后2周、4周进行神经功能缺损评分(ESS)和日常生活活动量表评分(ADL).结果 治疗组ESS及ADL评分均显著高于对照组(P<0.01).结论 依达拉奉治疗脑出血安全、有效.     

Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study)

BACKGROUND AND OBJECTIVE: To demonstrate the long-term efficacy and safety of pramipexole for Restless Legs Syndrome (RLS) using physician and patient RLS ratings, along with subjective assays of sleep parameters, in a 26-week, open-label trial. PATIENTS AND METHODS: Among 107 Finnish adults with moderate to severe RLS, pramipexole initiated at 0.125 mg/day was titrated to a maximum 0.75 mg/day. Efficacy evaluations included the International RLS Study Group Rating Scale (IRLS), Patient Global Impression (PGI) scale, Clinical Global Impressions-Improvement (CGI-I) scale, Epworth Sleepiness Scale (ESS), and Short Form-36 (SF-36) Health Survey. Subjective Sleep Quality was assessed by patient ratings of sleep and morning tiredness. Safety was documented by Adverse Events reported in >5% of patients. RESULTS: The mean reduction in IRLS score was 73.5% (P<0.05). The IRLS responder rate, defined by score reduction of >or= 50%, was 81.3%. On the PGI scale, 89.7% of patients rated themselves as "very much" or "much" better. By CGI-I assessment, 94.8% of patients were considered either "very much" or "much" improved. Mean ESS score showed a modest but statistically significant reduction (P<0.05) within the normal range, indicating that long-term pramipexole did not increase daytime sleepiness. On the SF-36 all 8 domains showed improvement, 5 of them statistically significant (P<0.05) and 4 of these 5 (role-physical, bodily pain, vitality, and role-emotional) by >10 points on a 100-point scale. Subjective Sleep Quality also improved. The most frequent Adverse Events were influenza (17.8%), headache (15.0%), and fatigue (10.3%). CONCLUSION: Pramipexole is well tolerated and effective for long-term treatment of RLS.     

Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).

We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (+/-SE) in IRLS score were 5.7 (+/-0.9) for placebo (median dose 0.47 mg/day) and 12.3 (+/-0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.     

Efficacy and safety of pramipexole in restless legs syndrome

OBJECTIVE: To evaluate the efficacy and safety of pramipexole in patients with moderate to severe restless legs syndrome (RLS) METHODS: The authors conducted a 12-week, double-blind, randomized, placebo-controlled trial of fixed doses of pramipexole (0.25, 0.50, and 0.75 mg/day). Patients (N = 344) were up-titrated to their randomized dose over 3 weeks. The primary efficacy endpoints were patient ratings of symptom severity on the International RLS Study Group Rating Scale (IRLS) and clinician ratings of improvement on the Clinical Global Impressions-Improvement (CGI-I) scale. Secondary efficacy endpoints included visual analogue ratings of sleep and quality of life (QOL) RESULTS: By both primary measures, pramipexole was superior to placebo. For IRLS, the adjusted mean (SE) change from baseline to week 12 was -9.3 (1.0) for placebo, -12.8 (1.0) for 0.25 mg/day, -13.8 (1.0) for 0.50 mg/day, and -14.0 (1.0) for 0.75 mg/day (all p < 0.01). Similarly, pramipexole increased the percentage of patients with a CGI-I rating of "very much improved" or "much improved" at the end of the trial (51.2% for placebo and 74.7%, 67.9%, and 72.9% for pramipexole; all p < 0.05). Pramipexole significantly improved ratings of symptom severity, day and night, and also ratings of sleep satisfaction and QOL. Pramipexole was well tolerated: The most frequent adverse events with higher occurrence in the pramipexole group were nausea (19.0% vs 4.7%) and somnolence (10.1% vs 4.7%) CONCLUSION: As rated by patients and by clinicians, pramipexole was efficacious and safe in reducing the symptoms of restless legs syndrome.     

Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study

BACKGROUND AND PURPOSE: To evaluate the effects of pramipexole (0.125-0.75 mg/d) on polysomnographic (PSG) measures and patient and clinician ratings of restless legs syndrome (RLS). PATIENTS AND METHODS: Patients (n=109) with moderate to severe RLS were randomized to placebo or fixed doses of pramipexole during a 3-week, double-blind, placebo-controlled, dose-finding study. RESULTS: In each pramipexole dose group, the periodic limb movements during time in bed index (PLMI) decreased significantly, compared with placebo (adjusted mean difference in log-transformed data: 0.125 mg, -1.54; 0.25 mg, -1.93; 0.50 mg, -1.89; and 0.75 mg, -1.52; P<0.0001). At all doses, International RLS Study Group Rating Scale (IRLS) scores were also significantly reduced, with the greatest adjusted mean reduction in the 0.50mg group (-17.01). At all but the lowest pramipexole dose, the percentage of responders (> or =50% reduction of IRLS score) was substantially higher than for placebo (61.9-77.3, vs 33.3%). In the pramipexole groups, 50.0-77.3% of patients rated their condition as 'much better' or 'very much better', compared with 38.1% of patients in the placebo group (P=0.0139 for the 0.50 mg dose). Clinical global impressions (CGI) scale ratings of 'much improved' or 'very much improved' were given to 61.9-86.4% of patients in the pramipexole groups, compared with 42.9% in the placebo group (P<0.05 for the 0.25, 0.50, and 0.75 mg groups). Pramipexole was well tolerated and did not produce somnolence at any dose. CONCLUSION: Pramipexole is effective and safe in the treatment of both objective and subjective facets of RLS.     

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.

Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.     

A method to switch from oral dopamine agonists to rotigotine in patients with restless legs syndrome and mild augmentation

BackgroundWe examined the short- and long-term efficacy and tolerability of a cross-titration algorithm from oral dopamine agonists to the rotigotine transdermal patch in patients dissatisfied with their restless legs syndrome (RLS) treatment, predominantly with mild augmentation.MethodsPatients with RLS (n = 20) were recruited at a single site. The cross-titration consisted of decreasing oral dopaminergic agents (ropinirole by 1 mg or pramipexole by 0.25 mg) and increasing rotigotine by 1 mg every two days. Efficacy and adverse events (AEs) were assessed at one, three, six and 12 months after the switch.ResultsPatients had moderate–severe RLS symptoms at the baseline (mean international restless legs syndrome (IRLS) score 19.4 ± 5.5); 85% had augmentation and 45% reported afternoon RLS symptoms. The baseline mean pramipexole equivalent dose was 0.6 ± 0.3 mg. At Week 5, 85% (17/20) had successfully switched from their oral dopamine agonist to rotigotine (mean dose 2.5 ± 0.6 mg; change in IRLS score: −6.7 ± 8.4, p = 0.002); 14 patients were CGI-I responders (much or very much improved). Three patients withdrew due to lack of efficacy. Twelve months after cross-titration, 10 patients continued on rotigotine, of whom four required either higher doses of rotigotine or supplemental RLS medication compared with their optimal Week 5 dose; five patients withdrew due to AEs and two due to lack of efficacy.ConclusionA cross-titration to rotigotine was efficacious after five weeks in 70% of patients dissatisfied with RLS treatment, most of whom had mild augmentation. At one year following the medication switch, 50% had discontinued rotigotine due to lack of continued efficacy or side effects.     

Pramipexole for Chinese people with primary restless legs syndrome: a 12-week multicenter,randomized, double-blind study

BackgroundRestless legs syndrome (RLS) often responds to agents that enhance dopamine neurotransmission. The present 12-week study aimed to evaluate the efficacy and adverse events of pramipexole (PPX) for the treatment of adult, Chinese people with primary RLS.MethodsA total of 204 Chinese people with RLS were randomly assigned to receive either the placebo or PPX (flexibly titrated from 0.25 mg to 0.75 mg), 2 h to 3 h before bedtime for 12 weeks. The primary measuring outcomes were the International RLS Study Group Rating Scale (IRLS) and the Clinical Global Impressions-Improvement (CGI-I) scale. The secondary outcome was adverse events.ResultsOne hundred and ninety participants completed the study. At 12 weeks, the adjusted mean (SE) change from baseline was greater for PPX (vs placebo) for the IRLS score (−13.2 ± 0.7 vs −9.4 ± 0.6; p <0.01), and (−12.1 ± 0.6 vs −8.3 ± 0.6; p <0.01) at the end of one month follow-up after treatment. The CGI-I rating of “very much improved” or “much improved” in the percentage of participants (61.8% vs 34.3%; p <0.01), and (51.0% vs 26.5%; p <0.01) after week 12, and one month follow-up of treatment, respectively. The proportion of adverse events was 60.8% in the PPX group and 45.1% in the placebo group. No deaths related to PPX treatment were recorded.ConclusionsIn summary, the present study showed that PPX is efficacious and well tolerated in Chinese people with primary RLS.     

Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome

OBJECTIVE: In the absence of comparative trials a meta-analysis was performed to compare the efficacy and tolerability of the non-ergot derived dopamine agonists, pramipexole and ropinirole, in restless legs syndrome (RLS). METHODS: Frequentist fixed and random-effects models were pre-specified for the direct comparisons and a Bayesian approach for the indirect comparison. Efficacy outcomes included the mean change from baseline in the International RLS Study Group Rating Scale (IRLS) score and the percentage of responders on the clinical global impressions - improvement scale (CGI-I). Safety outcomes included the incidence of withdrawal and adverse events. RESULTS: The direct meta-analysis confirmed superior efficacy for both treatments versus placebo for the IRLS (pramipexole: -5.45; 95% CI: -7.70; -3.20; ropinirole: -3.16; 95% CI: -4.26; -2.05) and the CGI-I (pramipexole: OR=2.98; 95% CI: 2.08; 4.26; ropinirole: OR=1.99; 95% CI: 1.52; 2.60). Placebo comparisons showed a significantly higher incidence of nausea for pramipexole (p<0.01), whereas nausea, vomiting, dizziness, and somnolence were significantly higher for ropinirole (all p<0.01). The indirect comparison showed with a probability of > or = 95%, a superior reduction in the mean IRLS score (-2.33; 95% credibility interval [CrI]: -4.23; -0.41), higher CGI-I response rate (OR=1.50; 95% CrI: 0.97; 2.32) and significantly lower incidence of nausea, vomiting, and dizziness for pramipexole compared to ropinirole. CONCLUSION: Differences in efficacy and tolerability favouring pramipexole over ropinirole can be observed. These findings should be further confirmed in head-to-head clinical trials.     

Low-dose pramipexole in the management of restless legs syndrome. An open label trial

Dopaminergic agents are considered the treatment of choice for restless legs syndrome (RLS); levodopa is the only substance licensed for this disorder in some European countries. However, in a substantial proportion of patients symptoms are not adequately controlled for a whole night due to the short half-life of levodopa or because symptom augmentation may develop. To further investigate the impact of pramipexole on the management of RLS we performed a short-term open label trial with pramipexole in 17 patients who were being insufficiently treated with levodopa or for whom pramipexole was primarily being considered because of the severity of the RLS symptoms. A single dose of 0.125-0.75 mg pramipexole (mean 0.3 +/- 0.2 mg) in the evening resulted in a significant improvement of subjective RLS symptoms as rated by the International RLS Study Group Severity Scale (IRLS scores: 29.8 +/- 4.7 baseline vs. 7.3 +/- 5.9 endpoint; p = 0.0001). Polysomnographic recordings showed a significant improvement of the periodic leg movements (PLM) index, PLM sleep arousal index, sleep-onset latency, total sleep time and sleep efficiency. All patients who had developed a worsening of RLS symptoms under levodopa recovered from daytime symptoms after their medication was switched to pramipexole. Since pramipexole was well tolerated, an ideal dosage to control RLS symptoms could be reached rapidly. Pramipexole has proven a suitable alternative in patients with moderate to severe RLS, particularly when their therapy has to be switched to a dopamine agonist.