Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of pramipexole in Japanese patients with primary restless legs syndrome: A polysomnographic randomized, double-blind, placebo-controlled study.
Sleep Med. 2010 Jan; 11(1):11-6.SM

Abstract

OBJECTIVE

To evaluate the efficacy of pramipexole on polysomnographic measures, patient ratings and a clinical rating in Japanese patients with primary restless legs syndrome (RLS).

METHODS

Patients with moderate to severe RLS having periodic limb movements in bed index (PLMI)>or=5 were randomly assigned to receive pramipexole or placebo in a 6-week, double-blind, placebo-controlled study with forced titration from 0.125 to 0.75mg/day. Both polysomnography (PSG) and the suggested immobilization test (SIT) were performed at baseline and 6weeks after starting treatment.

RESULTS

The analysis of covariance of log-transformed PLMI showed that the adjusted means at the end of study were significantly smaller in the pramipexole group than in the placebo group (p=0.0019). In all patients, variables on SIT did not show any differences between the two groups, whereas a significant improvement was shown in the pramipexole group compared with the placebo group for patients with a SIT-PLM index at baseline >or=15. Pramipexole group showed a significant reduction in the International Restless Legs Syndrome Study Group rating scale (IRLS; p=0.0005), a significant improvement in both Patient Global Impression (PGI; p<0.0001) and Clinical Global Impressions (CGI-I; p=0.0488), and a significantly greater mean reduction in the Pittsburgh Sleep Quality Index (PSQI; p=0.0016), when compared with those of placebo group at week 6.

CONCLUSIONS

Pramipexole is highly efficacious in the reduction of PLMI and in the improvement of subjective severity of RLS and subjective sleep disturbance caused by the disorder.

Authors+Show Affiliations

Japan Somnology Center, Neuropsychiatric Research Institute, Tokyo, Japan. inoue@somnology.comNo affiliation info availableNo affiliation info availableNo 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
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19962941

Citation

Inoue, Yuichi, et al. "Efficacy and Safety of Pramipexole in Japanese Patients With Primary Restless Legs Syndrome: a Polysomnographic Randomized, Double-blind, Placebo-controlled Study." Sleep Medicine, vol. 11, no. 1, 2010, pp. 11-6.
Inoue Y, Hirata K, Kuroda K, et al. Efficacy and safety of pramipexole in Japanese patients with primary restless legs syndrome: A polysomnographic randomized, double-blind, placebo-controlled study. Sleep Med. 2010;11(1):11-6.
Inoue, Y., Hirata, K., Kuroda, K., Fujita, M., Shimizu, T., Emura, N., Uchimura, N., Kagimura, T., Sha, K., & Nozawa, T. (2010). Efficacy and safety of pramipexole in Japanese patients with primary restless legs syndrome: A polysomnographic randomized, double-blind, placebo-controlled study. Sleep Medicine, 11(1), 11-6. https://doi.org/10.1016/j.sleep.2009.03.009
Inoue Y, et al. Efficacy and Safety of Pramipexole in Japanese Patients With Primary Restless Legs Syndrome: a Polysomnographic Randomized, Double-blind, Placebo-controlled Study. Sleep Med. 2010;11(1):11-6. PubMed PMID: 19962941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pramipexole in Japanese patients with primary restless legs syndrome: A polysomnographic randomized, double-blind, placebo-controlled study. AU - Inoue,Yuichi, AU - Hirata,Koichi, AU - Kuroda,Kenji, AU - Fujita,Masahiko, AU - Shimizu,Tetsuo, AU - Emura,Narutsugu, AU - Uchimura,Naohisa, AU - Kagimura,Tatsuo, AU - Sha,Koji, AU - Nozawa,Taneyoshi, Y1 - 2009/12/04/ PY - 2008/11/14/received PY - 2009/03/05/revised PY - 2009/03/10/accepted PY - 2009/12/8/entrez PY - 2009/12/8/pubmed PY - 2010/5/15/medline SP - 11 EP - 6 JF - Sleep medicine JO - Sleep Med. VL - 11 IS - 1 N2 - OBJECTIVE: To evaluate the efficacy of pramipexole on polysomnographic measures, patient ratings and a clinical rating in Japanese patients with primary restless legs syndrome (RLS). METHODS: Patients with moderate to severe RLS having periodic limb movements in bed index (PLMI)>or=5 were randomly assigned to receive pramipexole or placebo in a 6-week, double-blind, placebo-controlled study with forced titration from 0.125 to 0.75mg/day. Both polysomnography (PSG) and the suggested immobilization test (SIT) were performed at baseline and 6weeks after starting treatment. RESULTS: The analysis of covariance of log-transformed PLMI showed that the adjusted means at the end of study were significantly smaller in the pramipexole group than in the placebo group (p=0.0019). In all patients, variables on SIT did not show any differences between the two groups, whereas a significant improvement was shown in the pramipexole group compared with the placebo group for patients with a SIT-PLM index at baseline >or=15. Pramipexole group showed a significant reduction in the International Restless Legs Syndrome Study Group rating scale (IRLS; p=0.0005), a significant improvement in both Patient Global Impression (PGI; p<0.0001) and Clinical Global Impressions (CGI-I; p=0.0488), and a significantly greater mean reduction in the Pittsburgh Sleep Quality Index (PSQI; p=0.0016), when compared with those of placebo group at week 6. CONCLUSIONS: Pramipexole is highly efficacious in the reduction of PLMI and in the improvement of subjective severity of RLS and subjective sleep disturbance caused by the disorder. SN - 1878-5506 UR - https://www.unboundmedicine.com/medline/citation/19962941/Efficacy_and_safety_of_pramipexole_in_Japanese_patients_with_primary_restless_legs_syndrome:_A_polysomnographic_randomized_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(09)00345-1 DB - PRIME DP - Unbound Medicine ER -