A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: Polysomnographic evaluation of periodic leg movements and sleep disturbance

Jama, Leni; Hirvonen, Kari; Partinen, Markku; Alakuijala, Anniina; Hublin, Christer; Tamminen, Ilkka; Koester, J.

doi:10.1016/j.sleep.2008.05.014

Cited by 38 publications

(42 citation statements)

References 23 publications

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“…Pramipexole. It is highly likely that pramipexole improves RLS symptoms as measured by the IRLS (3 Class I 16-18 and 6 Class II studies [19][20][21][22][23][24] over varying timeframes). It is likely that pramipexole improves PLMS (3 Class II studies 20,22,25 ) and subjective sleep measures (1 Class I 17 and 3 Class II studies, 19,21,23 with an additional Class II study lacking the precision to exclude an important effect 24 ).…”

mentioning

confidence: 99%

“…It is highly likely that pramipexole improves RLS symptoms as measured by the IRLS (3 Class I 16-18 and 6 Class II studies [19][20][21][22][23][24] over varying timeframes). It is likely that pramipexole improves PLMS (3 Class II studies 20,22,25 ) and subjective sleep measures (1 Class I 17 and 3 Class II studies, 19,21,23 with an additional Class II study lacking the precision to exclude an important effect 24 ). There is insufficient evidence to support or refute an effect of pramipexole on other polysomnographic measures (e.g., sleep latency, sleep efficiency, WASO, or TST) on the basis of results with varied statistical significance and clinical importance across 3 Class II studies 20,22,25 with sometimes limited statistical reporting.…”

mentioning

confidence: 99%

“…It is likely that pramipexole improves PLMS (3 Class II studies 20,22,25 ) and subjective sleep measures (1 Class I 17 and 3 Class II studies, 19,21,23 with an additional Class II study lacking the precision to exclude an important effect 24 ). There is insufficient evidence to support or refute an effect of pramipexole on other polysomnographic measures (e.g., sleep latency, sleep efficiency, WASO, or TST) on the basis of results with varied statistical significance and clinical importance across 3 Class II studies 20,22,25 with sometimes limited statistical reporting. It is likely that pramipexole improves RLS-specific QoL at 12 weeks (1 Class I 16 and 3 Class II studies, 19,23,24 with one of the Class II studies showing limited improvement 24 ).…”

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confidence: 99%

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Practice guideline summary: Treatment of restless legs syndrome in adults

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confidence: 99%

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Practice guideline summary: Treatment of restless legs syndrome in adults

et al. 2016

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“…The same group of researchers repeated a 3 weeks, polysomnographic, double-blind, placebo-controlled study in 107 patients with RLS, obtaining comparable good results on symptoms and PLM. 44 Therefore, the literature agrees in define PRA as a well tolerated drug with a good efficacy in idiopathic RLS form in the control of both sensitive symptoms and PLM, at least at short follow up intervals.…”

Section: 44mentioning

confidence: 82%

“…All of these instruments demonstrated that PRA is significantly more effective than placebo on RLS sensitive symptoms. [40][41][42][43][44] However, a recent meta-analysis showed a notable placebo effect in the subjective evaluation of efficacy for PRA and for the other RLS medications, especially by using the IRLSRS. 73 The placebo effect is smaller for subjective and objective sleep parameters, and almost absent when PLMS were considered as the endpoint.…”

Section: Efficacymentioning

confidence: 99%

Pharmacotherapy of Restless Legs Syndrome with Pramipexole

Manconi

Ferini‐Strambi

2009

Clinical Medicine. Therapeutics

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Abstract:The dopamine agonist pramipexole (PRA) ((S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride; molecular formula C 10 H 17 N 3 S⋅2(HCl), is a D 3 selective compound, approved in 1997 for the treatment of Parkinson disease and in 2006 for that of idiopathic restless legs syndrome (RLS). Because of its tolerability, safety and half-life, PRA is favored over levodopa and on the other ergot derivate dopamine agonists, and it is considered nowadays one of the first choices in the therapy of RLS. PRA is rapidly and completely absorbed after oral administration, its protein binding is around 15%, it is almost unaffected by hepatic metabolism and excreted by urine unchanged. PRA has a linear pharmacokinetics, with a half-life ranging between 8 and 14 hours. Double-blind, placebo-controlled studies demonstrated that PRA, even at low dosages and since the first nights of administration, is significantly effective on the typical sensitive symptoms of RLS, on the periodic leg movements during sleep, and in improving the quality of life of patients with RLS. A subjective improvement of sleep quality is usually also reported by the patients, but the polysomnographic assessment gave less solid results on objective sleep parameters. The most common PRA related side effects include headache, nausea and orthostatic hypotension. Data on the long-term therapy of PRA in RLS, and on the efficacy of PRA in symptomatic forms of RLS are warranted to better delineate the role of PRA in RLS treatment.

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Development and validation of GC/MS method for determination of pramipexole in rat plasma

Panchal

Patel

Menon

2011

Biomedical Chromatography

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A simple, rapid and sensitive method has been developed and validated for the determination of pramipexole in rat plasma by using gas chromatography mass spectrometry. The lower limit of quantification (LLOQ) is superior to the other reported LC-MS/MS methods. After being made alkaline with NaOH, plasma samples (0.1 mL) were subjected to liquid-liquid extraction using methyl-t-butyl ether. Analytes were determined using electron impact ionization in a single quadrupole mass spectrometer. GC/MS was performed in the selected ion monitoring mode using target ions at m/z 211, 212 and 152 for pramipexole and m/z 194 and 165 for caffeine as internal standard. A linear calibration curve was plotted over the range of 20-1000 pg/mL for pramipexole (r(2) > 0.996). The LLOQ was 20.0 pg/mL, respectively, which offered high sensitivity and selectivity enough for bioanalytical investigation. Inter- and intraday precisions ranged from 0.3 to 8.8% and from 0.9 to 11.33%, respectively. The recovery of pramipexole from plasma ranged from 82.4 ± 7.1 to 87.8 ± 5.7%. The method fulfills all standards required for bioanalytical methods and can be successfully applied to a pharmacokinetic study of pramipexole in rats.

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A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: Polysomnographic evaluation of periodic leg movements and sleep disturbance

Cited by 38 publications

References 23 publications

Practice guideline summary: Treatment of restless legs syndrome in adults

Practice guideline summary: Treatment of restless legs syndrome in adults

Pharmacotherapy of Restless Legs Syndrome with Pramipexole

Development and validation of GC/MS method for determination of pramipexole in rat plasma

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