Tags

Type your tag names separated by a space and hit enter

Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial.
Sleep Med. 2008 Dec; 9(8):874-81.SM

Abstract

BACKGROUND

Patients with Restless Legs Syndrome (RLS) often seek treatment because of sleep problems related to nocturnal symptoms. Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms.

METHODS

Adults with moderate or severe RLS were randomized to receive placebo or pramipexole (flexibly titrated from 0.25 to 0.75mg), 2-3h before bedtime for 12 weeks. The co-primary outcome measures were change in Medical Outcomes Study (MOS) sleep disturbance score and International RLS Study Group Rating Scale (IRLS) score at 12 weeks.

RESULTS

The intent-to-treat population included 357 patients: 178 received pramipexole and 179 received placebo. At 12 weeks, the adjusted mean change from baseline was greater for pramipexole (vs. placebo) for IRLS score (-13.4+/-0.7 vs. -9.6+/-0.7) and MOS sleep disturbance score (-25.3+/-1.5 vs. -16.8+/-1.5) (p<or=0.0001; ANCOVA). Responder rates (clinical and patient global impression and IRLS) were also significantly higher in the pramipexole group. RLS-QOL score was improved over placebo at Week 12 (p<0.01) as were MOS sleep adequacy (p=0.0008) and quantity (p=0.08) scores. Nine percent of patients in each group withdrew because of adverse events.

CONCLUSIONS

Pramipexole is effective and well-tolerated for RLS and related sleep disturbance.

Authors+Show Affiliations

Institute San Raffaele Turro, Milan, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18952497

Citation

Ferini-Strambi, Luigi, et al. "Effect of Pramipexole On RLS Symptoms and Sleep: a Randomized, Double-blind, Placebo-controlled Trial." Sleep Medicine, vol. 9, no. 8, 2008, pp. 874-81.
Ferini-Strambi L, Aarskog D, Partinen M, et al. Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial. Sleep Med. 2008;9(8):874-81.
Ferini-Strambi, L., Aarskog, D., Partinen, M., Chaudhuri, K. R., Sohr, M., Verri, D., & Albrecht, S. (2008). Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial. Sleep Medicine, 9(8), 874-81. https://doi.org/10.1016/j.sleep.2008.09.001
Ferini-Strambi L, et al. Effect of Pramipexole On RLS Symptoms and Sleep: a Randomized, Double-blind, Placebo-controlled Trial. Sleep Med. 2008;9(8):874-81. PubMed PMID: 18952497.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial. AU - Ferini-Strambi,Luigi, AU - Aarskog,Dagfinn, AU - Partinen,Markku, AU - Chaudhuri,K Ray, AU - Sohr,Mandy, AU - Verri,Daniela, AU - Albrecht,Stefan, Y1 - 2008/10/25/ PY - 2008/05/02/received PY - 2008/08/28/revised PY - 2008/09/11/accepted PY - 2008/10/28/pubmed PY - 2009/2/20/medline PY - 2008/10/28/entrez SP - 874 EP - 81 JF - Sleep medicine JO - Sleep Med. VL - 9 IS - 8 N2 - BACKGROUND: Patients with Restless Legs Syndrome (RLS) often seek treatment because of sleep problems related to nocturnal symptoms. Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms. METHODS: Adults with moderate or severe RLS were randomized to receive placebo or pramipexole (flexibly titrated from 0.25 to 0.75mg), 2-3h before bedtime for 12 weeks. The co-primary outcome measures were change in Medical Outcomes Study (MOS) sleep disturbance score and International RLS Study Group Rating Scale (IRLS) score at 12 weeks. RESULTS: The intent-to-treat population included 357 patients: 178 received pramipexole and 179 received placebo. At 12 weeks, the adjusted mean change from baseline was greater for pramipexole (vs. placebo) for IRLS score (-13.4+/-0.7 vs. -9.6+/-0.7) and MOS sleep disturbance score (-25.3+/-1.5 vs. -16.8+/-1.5) (p<or=0.0001; ANCOVA). Responder rates (clinical and patient global impression and IRLS) were also significantly higher in the pramipexole group. RLS-QOL score was improved over placebo at Week 12 (p<0.01) as were MOS sleep adequacy (p=0.0008) and quantity (p=0.08) scores. Nine percent of patients in each group withdrew because of adverse events. CONCLUSIONS: Pramipexole is effective and well-tolerated for RLS and related sleep disturbance. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/18952497/Effect_of_pramipexole_on_RLS_symptoms_and_sleep:_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(08)00266-9 DB - PRIME DP - Unbound Medicine ER -