Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study.
Sleep Med 2006; 7(5):407-17SM

Abstract

BACKGROUND AND PURPOSE

To evaluate the effects of pramipexole (0.125-0.75 mg/d) on polysomnographic (PSG) measures and patient and clinician ratings of restless legs syndrome (RLS).

PATIENTS AND METHODS

Patients (n=109) with moderate to severe RLS were randomized to placebo or fixed doses of pramipexole during a 3-week, double-blind, placebo-controlled, dose-finding study.

RESULTS

In each pramipexole dose group, the periodic limb movements during time in bed index (PLMI) decreased significantly, compared with placebo (adjusted mean difference in log-transformed data: 0.125 mg, -1.54; 0.25 mg, -1.93; 0.50 mg, -1.89; and 0.75 mg, -1.52; P<0.0001). At all doses, International RLS Study Group Rating Scale (IRLS) scores were also significantly reduced, with the greatest adjusted mean reduction in the 0.50mg group (-17.01). At all but the lowest pramipexole dose, the percentage of responders (> or =50% reduction of IRLS score) was substantially higher than for placebo (61.9-77.3, vs 33.3%). In the pramipexole groups, 50.0-77.3% of patients rated their condition as 'much better' or 'very much better', compared with 38.1% of patients in the placebo group (P=0.0139 for the 0.50 mg dose). Clinical global impressions (CGI) scale ratings of 'much improved' or 'very much improved' were given to 61.9-86.4% of patients in the pramipexole groups, compared with 42.9% in the placebo group (P<0.05 for the 0.25, 0.50, and 0.75 mg groups). Pramipexole was well tolerated and did not produce somnolence at any dose.

CONCLUSION

Pramipexole is effective and safe in the treatment of both objective and subjective facets of RLS.

Authors+Show Affiliations

Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 3, FI-02980 Espoo, Finland. markku.partinen@rinnekoti.fiNo affiliation info availableNo 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

16815748

Citation

Partinen, Markku, et al. "Efficacy and Safety of Pramipexole in Idiopathic Restless Legs Syndrome: a Polysomnographic Dose-finding Study--the PRELUDE Study." Sleep Medicine, vol. 7, no. 5, 2006, pp. 407-17.
Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study. Sleep Med. 2006;7(5):407-17.
Partinen, M., Hirvonen, K., Jama, L., Alakuijala, A., Hublin, C., Tamminen, I., ... Reess, J. (2006). Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study. Sleep Medicine, 7(5), pp. 407-17.
Partinen M, et al. Efficacy and Safety of Pramipexole in Idiopathic Restless Legs Syndrome: a Polysomnographic Dose-finding Study--the PRELUDE Study. Sleep Med. 2006;7(5):407-17. PubMed PMID: 16815748.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study. AU - Partinen,Markku, AU - Hirvonen,Kari, AU - Jama,Leni, AU - Alakuijala,Anniina, AU - Hublin,Christer, AU - Tamminen,Ilkka, AU - Koester,Juergen, AU - Reess,Juergen, Y1 - 2006/07/03/ PY - 2005/11/22/received PY - 2006/02/16/revised PY - 2006/03/06/accepted PY - 2006/7/4/pubmed PY - 2006/12/15/medline PY - 2006/7/4/entrez SP - 407 EP - 17 JF - Sleep medicine JO - Sleep Med. VL - 7 IS - 5 N2 - BACKGROUND AND PURPOSE: To evaluate the effects of pramipexole (0.125-0.75 mg/d) on polysomnographic (PSG) measures and patient and clinician ratings of restless legs syndrome (RLS). PATIENTS AND METHODS: Patients (n=109) with moderate to severe RLS were randomized to placebo or fixed doses of pramipexole during a 3-week, double-blind, placebo-controlled, dose-finding study. RESULTS: In each pramipexole dose group, the periodic limb movements during time in bed index (PLMI) decreased significantly, compared with placebo (adjusted mean difference in log-transformed data: 0.125 mg, -1.54; 0.25 mg, -1.93; 0.50 mg, -1.89; and 0.75 mg, -1.52; P<0.0001). At all doses, International RLS Study Group Rating Scale (IRLS) scores were also significantly reduced, with the greatest adjusted mean reduction in the 0.50mg group (-17.01). At all but the lowest pramipexole dose, the percentage of responders (> or =50% reduction of IRLS score) was substantially higher than for placebo (61.9-77.3, vs 33.3%). In the pramipexole groups, 50.0-77.3% of patients rated their condition as 'much better' or 'very much better', compared with 38.1% of patients in the placebo group (P=0.0139 for the 0.50 mg dose). Clinical global impressions (CGI) scale ratings of 'much improved' or 'very much improved' were given to 61.9-86.4% of patients in the pramipexole groups, compared with 42.9% in the placebo group (P<0.05 for the 0.25, 0.50, and 0.75 mg groups). Pramipexole was well tolerated and did not produce somnolence at any dose. CONCLUSION: Pramipexole is effective and safe in the treatment of both objective and subjective facets of RLS. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/16815748/Efficacy_and_safety_of_pramipexole_in_idiopathic_restless_legs_syndrome:_a_polysomnographic_dose_finding_study__the_PRELUDE_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(06)00100-6 DB - PRIME DP - Unbound Medicine ER -