Efficacy and safety of pramipexole in idiopathic restless legs syndrome: A polysomnographic dose-finding study—The PRELUDE study

Practice guideline summary: Treatment of restless legs syndrome in adults

“…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 ).…”

“…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.…”

“…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 ).…”

Phototoxic Rash During Therapy with Pramipexole in a Patient with Restless Legs Syndrome = طفح عند التعرض لضوء الشمس خلال علاج المريض بمتلازمة تململ الساقين

“…It is suggested that the prevalence of side-effects decreases significantly in long-term treatment (2.6%) as compared with early treatment. [4][5][6] However, in our patient we decided to discontinue the therapy because of the severity of his rash. Systemic re-exposition to the offending drug remains the gold standard for diagnosis, but that was not considered in this case due to the possibility of a life-threatening adverse reaction.…”

“…3 Pramipexole is a nonergoline dopamine agonist with a high selectivity for D2 and D3 receptors whose efficacy for RLS has been confirmed in different studies. [4][5][6] It is usually well tolerated. In all the studies examined, the discontinuation rate (~20%) was similar, and the incidence of adverse events was not clearly dose-related.…”