| Abstract | OBJECTIVE: Restless legs syndrome (RLS) seems to improve immediately after a single dose of dopamine-agonists (DA). The aim of the present study was to investigate the acute effects of a low standard dose of pramipexole in RLS drug-naïve patients. METHODS: A single-blind placebo-controlled study in 32 consecutive idiopathic RLS de-novo patients was carried out. Patients who met the standard criteria for RLS, with a PLMS index greater than 10 as well as an RLS rating scale score greater than 20 underwent clinical and neurophysiological evaluation, hematological screening and two consecutive full-night polysomnographies. On the second night, all patients received 0.25mg of pramipexole or placebo at 9:00 p.m. Acute symptom response was assessed by a visual analogical scale (VAS). RESULTS: Eighteen patients received pramipexole and 14 patients received placebo. Compared to placebo, the single low dose (0.25mg) of pramipexole significantly improved RLS symptoms (VAS: from 7.4+/-1.68 to 1.3+/-1.62, p<0.00001) and strongly reduced PLMS index (from 45.8+/-33.56 to 9.4+/-11.40, p<0.0002). A significant increase in the percentage of stage 2 non-rapid eye movement (NREM) sleep was also observed in the pramipexole group (from 38.7+/-10.50 to 50.6+/-12.13, p<0.02). CONCLUSIONS: A low dose of pramipexole was effective in treatment-naïve patients with RLS from the first night of administration. These results support a direct involvement of the dopaminergic system in RLS pathogenesis and might have important implications for a possible future pramipexole administration on-demand, as well as for a pharmacological test to confirm diagnosis in clinically complex cases. |
| Authors | Mauro Manconi, Raffaele Ferri, Marco Zucconi, Alessandro Oldani, Maria Livia Fantini, Vincenza Castronovo, Luigi Ferini-Strambi
(Affiliation: Sleep Disorders Center, Department of Neurology, Scientific Institute and University Ospedale San Raffaele, Vita-Salute University, Milan, Italy. manconi.mauro at hsr.it)
|
| Journal | Sleep medicine
(Sleep Med)
Vol. 8
Issue 5
Pg. 491-7
(Aug 2007)
ISSN: 1389-9457 Netherlands |
| PMID | 17512780
(Publication Type: Journal Article, Randomized Controlled Trial)
|
| Chemical References |
- Benzothiazoles
- Dopamine Agonists
- pramipexol
|
| Topics |
- Adult
- Aged
- Benzothiazoles
(administration & dosage)
- Dopamine Agonists
(administration & dosage)
- Dose-Response Relationship, Drug
- Female
- Humans
- Male
- Middle Aged
- Polysomnography
(methods)
- Questionnaires
- Restless Legs Syndrome
(drug therapy)
- Severity of Illness Index
- Single-Blind Method
- Sleep Stages
(drug effects)
- Treatment Outcome
|
