JankovicV1, Ncbi, Checkpoint, bibRecord, 000216

Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects

Identifieur interne : 000216 ( Ncbi/Checkpoint ); précédent : 000215; suivant : 000217

Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects

Auteurs : Joëlle Micallef [France] ; Marc Rey [France] ; Alexandre Eusebio [France] ; Christine Audebert [France] ; Frank Rouby [France] ; Elisabeth Jouve [France] ; Sophie Tardieu [France] ; Oliver Blin [France]

Source :

British Journal of Clinical Pharmacology [ 0306-5251 ] ; 2009.

RBID : PMC:2675044

Abstract

AIMS

To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.

METHODS

Placebo, bromocriptine (2.5 mg), L-dopa (100 mg) and pramipexole (0.5 mg) were administered in a single oral dose on four separate days, with at least a 2-week wash-out period in a randomized cross-over design. Induced somnolence was assessed using Multiple Sleep Latency Test (MSLT) and subjective scaling of vigilance. Twelve male subjects (26.3 ± 5.5 years old) without anxiety, mood, sleep or sedation disorders were enrolled.

RESULTS

Pramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [−6.1 min (−9.8, −2.4), P = 0.002] and 5 h 30 min [−5.6 min (−7.7, −3.5), P = 0.003] after administration. In addition, the total duration of sleep during the tests was higher with pramipexole than with placebo [+6.0 min (2.3, 9.7), P < 0.001]. These differences were not observed with L-dopa and bromocriptine in comparison with placebo. The induced sleepiness was not associated with an increase in subjective somnolence scaling, indicating that this adverse event may occur without prior warning.

CONCLUSIONS

These results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2675044

DOI: 10.1111/j.1365-2125.2008.03310.x
PubMed: 19220275
PubMed Central: 2675044

Affiliations:

France

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PMC:2675044

Le document en format XML

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<author><name sortKey="Micallef, Joelle" sort="Micallef, Joelle" uniqKey="Micallef J" first="Joëlle" last="Micallef">Joëlle Micallef</name>
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<author><name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name>
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<author><name sortKey="Audebert, Christine" sort="Audebert, Christine" uniqKey="Audebert C" first="Christine" last="Audebert">Christine Audebert</name>
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<front><div type="abstract" xml:lang="en"><sec><title>AIMS</title>
<p>To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.</p>
</sec>
<sec sec-type="methods"><title>METHODS</title>
<p>Placebo, bromocriptine (2.5 mg), L-dopa (100 mg) and pramipexole (0.5 mg) were administered in a single oral dose on four separate days, with at least a 2-week wash-out period in a randomized cross-over design. Induced somnolence was assessed using Multiple Sleep Latency Test (MSLT) and subjective scaling of vigilance. Twelve male subjects (26.3 ± 5.5 years old) without anxiety, mood, sleep or sedation disorders were enrolled.</p>
</sec>
<sec><title>RESULTS</title>
<p>Pramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [−6.1 min (−9.8, −2.4), <italic>P</italic>
 = 0.002] and 5 h 30 min [−5.6 min (−7.7, −3.5), <italic>P</italic>
 = 0.003] after administration. In addition, the total duration of sleep during the tests was higher with pramipexole than with placebo [+6.0 min (2.3, 9.7), <italic>P</italic>
 < 0.001]. These differences were not observed with L-dopa and bromocriptine in comparison with placebo. The induced sleepiness was not associated with an increase in subjective somnolence scaling, indicating that this adverse event may occur without prior warning.</p>
</sec>
<sec><title>CONCLUSIONS</title>
<p>These results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.</p>
</sec>
</div>
</front>
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<tree><country name="France"><noRegion><name sortKey="Micallef, Joelle" sort="Micallef, Joelle" uniqKey="Micallef J" first="Joëlle" last="Micallef">Joëlle Micallef</name>
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<name sortKey="Audebert, Christine" sort="Audebert, Christine" uniqKey="Audebert C" first="Christine" last="Audebert">Christine Audebert</name>
<name sortKey="Blin, Oliver" sort="Blin, Oliver" uniqKey="Blin O" first="Oliver" last="Blin">Oliver Blin</name>
<name sortKey="Blin, Oliver" sort="Blin, Oliver" uniqKey="Blin O" first="Oliver" last="Blin">Oliver Blin</name>
<name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name>
<name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name>
<name sortKey="Jouve, Elisabeth" sort="Jouve, Elisabeth" uniqKey="Jouve E" first="Elisabeth" last="Jouve">Elisabeth Jouve</name>
<name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
<name sortKey="Rouby, Frank" sort="Rouby, Frank" uniqKey="Rouby F" first="Frank" last="Rouby">Frank Rouby</name>
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Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects

Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects

Source :

Abstract

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Links to Exploration step

Le document en format XML

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Pour générer des pages wiki