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Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study).
Sleep Med. 2008 Jul; 9(5):537-41.SM

Abstract

BACKGROUND AND OBJECTIVE

To demonstrate the long-term efficacy and safety of pramipexole for Restless Legs Syndrome (RLS) using physician and patient RLS ratings, along with subjective assays of sleep parameters, in a 26-week, open-label trial.

PATIENTS AND METHODS

Among 107 Finnish adults with moderate to severe RLS, pramipexole initiated at 0.125 mg/day was titrated to a maximum 0.75 mg/day. Efficacy evaluations included the International RLS Study Group Rating Scale (IRLS), Patient Global Impression (PGI) scale, Clinical Global Impressions-Improvement (CGI-I) scale, Epworth Sleepiness Scale (ESS), and Short Form-36 (SF-36) Health Survey. Subjective Sleep Quality was assessed by patient ratings of sleep and morning tiredness. Safety was documented by Adverse Events reported in >5% of patients.

RESULTS

The mean reduction in IRLS score was 73.5% (P<0.05). The IRLS responder rate, defined by score reduction of >or= 50%, was 81.3%. On the PGI scale, 89.7% of patients rated themselves as "very much" or "much" better. By CGI-I assessment, 94.8% of patients were considered either "very much" or "much" improved. Mean ESS score showed a modest but statistically significant reduction (P<0.05) within the normal range, indicating that long-term pramipexole did not increase daytime sleepiness. On the SF-36 all 8 domains showed improvement, 5 of them statistically significant (P<0.05) and 4 of these 5 (role-physical, bodily pain, vitality, and role-emotional) by >10 points on a 100-point scale. Subjective Sleep Quality also improved. The most frequent Adverse Events were influenza (17.8%), headache (15.0%), and fatigue (10.3%).

CONCLUSION

Pramipexole is well tolerated and effective for long-term treatment of RLS.

Authors+Show Affiliations

Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 1, 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18276187

Citation

Partinen, Markku, et al. "Open-label Study of the Long-term Efficacy and Safety of Pramipexole in Patients With Restless Legs Syndrome (extension of the PRELUDE Study)." Sleep Medicine, vol. 9, no. 5, 2008, pp. 537-41.
Partinen M, Hirvonen K, Jama L, et al. Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study). Sleep Med. 2008;9(5):537-41.
Partinen, M., Hirvonen, K., Jama, L., Alakuijala, A., Hublin, C., Tamminen, I., Koester, J., & Reess, J. (2008). Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study). Sleep Medicine, 9(5), 537-41. https://doi.org/10.1016/j.sleep.2007.12.004
Partinen M, et al. Open-label Study of the Long-term Efficacy and Safety of Pramipexole in Patients With Restless Legs Syndrome (extension of the PRELUDE Study). Sleep Med. 2008;9(5):537-41. PubMed PMID: 18276187.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of 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 - 2008/02/13/ PY - 2007/07/02/received PY - 2007/12/10/revised PY - 2007/12/12/accepted PY - 2008/2/16/pubmed PY - 2008/12/17/medline PY - 2008/2/16/entrez SP - 537 EP - 41 JF - Sleep medicine JO - Sleep Med VL - 9 IS - 5 N2 - BACKGROUND AND OBJECTIVE: To demonstrate the long-term efficacy and safety of pramipexole for Restless Legs Syndrome (RLS) using physician and patient RLS ratings, along with subjective assays of sleep parameters, in a 26-week, open-label trial. PATIENTS AND METHODS: Among 107 Finnish adults with moderate to severe RLS, pramipexole initiated at 0.125 mg/day was titrated to a maximum 0.75 mg/day. Efficacy evaluations included the International RLS Study Group Rating Scale (IRLS), Patient Global Impression (PGI) scale, Clinical Global Impressions-Improvement (CGI-I) scale, Epworth Sleepiness Scale (ESS), and Short Form-36 (SF-36) Health Survey. Subjective Sleep Quality was assessed by patient ratings of sleep and morning tiredness. Safety was documented by Adverse Events reported in >5% of patients. RESULTS: The mean reduction in IRLS score was 73.5% (P<0.05). The IRLS responder rate, defined by score reduction of >or= 50%, was 81.3%. On the PGI scale, 89.7% of patients rated themselves as "very much" or "much" better. By CGI-I assessment, 94.8% of patients were considered either "very much" or "much" improved. Mean ESS score showed a modest but statistically significant reduction (P<0.05) within the normal range, indicating that long-term pramipexole did not increase daytime sleepiness. On the SF-36 all 8 domains showed improvement, 5 of them statistically significant (P<0.05) and 4 of these 5 (role-physical, bodily pain, vitality, and role-emotional) by >10 points on a 100-point scale. Subjective Sleep Quality also improved. The most frequent Adverse Events were influenza (17.8%), headache (15.0%), and fatigue (10.3%). CONCLUSION: Pramipexole is well tolerated and effective for long-term treatment of RLS. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/18276187/Open_label_study_of_the_long_term_efficacy_and_safety_of_pramipexole_in_patients_with_Restless_Legs_Syndrome__extension_of_the_PRELUDE_study__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(07)00449-2 DB - PRIME DP - Unbound Medicine ER -