Efficacy and augmentation during 6months of double-blind pramipexole for restless legs syndrome

Sleep Medicine

Volumn 12, Issue 4, 2011, Pages 351-360

  Högl, Birgit ^a   Garcia Borreguero, Diego ^b   Trenkwalder, Claudia ^c   Ferini Strambi, Luigi ^d   Hening, Wayne ^e   Poewe, Werner ^a   Brenner, Stefanie S ^f   Fraessdorf, Mandy ^f   Busse, Michael ^f   Albrecht, Stefan ^g   Allen, Richard P ^h  

^a INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^b SLEEP RESEARCH INSTITUTE   (Spain)

^c UNIVERSITY OF GÖTTINGEN   (Germany)

^d VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^e UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^f BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^g MERZ PHARMACEUTICALS GMBH   (Germany)

^h JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Augmentation; Dopamine agonists; Long term treatment; Pramipexole; Restless legs syndrome; Therapy; Withdrawal

Indexed keywords

PLACEBO; PRAMIPEXOLE; ANTIPARKINSON AGENT; BENZOTHIAZOLE DERIVATIVE; PRAMIPEXOL;

ADULT; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DISEASE EXACERBATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MUSCLE SPASM; NAUSEA; OPTIMAL DRUG DOSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESS LEGS SYNDROME; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; ADOLESCENT; AGED; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; MALE; MIDDLE AGED; MULTICENTER STUDY; QUALITY OF LIFE; TREATMENT OUTCOME; WITHDRAWAL SYNDROME;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIPARKINSON AGENTS; BENZOTHIAZOLES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; QUALITY OF LIFE; RESTLESS LEGS SYNDROME; SUBSTANCE WITHDRAWAL SYNDROME; TREATMENT OUTCOME; YOUNG ADULT;

EID: 79953057218     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2010.12.007     Document Type: Article

References (24)

1. Silber M.H., Ehrenberg B.L., Allen R.P., et al. An algorithm for the management of restless legs syndrome. Mayo Clin Proc 2004, 79:916-922.
2. Oertel W.H., Trenkwalder C., Zucconi M., et al. State of the art in restless legs syndrome therapy: practice recommendations for treating restless legs syndrome. Mov Disord 2007, 22:S466-S475.
3. 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, 7:407-417.
4. Oertel W.H., Stiasny-Kolster K., Bergtholdt B., et al. Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study). Mov Disord 2006, 21:343-353.
5. Trenkwalder C., Stiasny-Kolster K., Kupsch A., Oertel W.H., Koester J., Reess J. Controlled withdrawal of pramipexole after 6months of open-label treatment in patients with restless legs syndrome. Mov Disord 2006, 21:1404-1410.
6. Winkelman J.W., Sethi K.D., Kushida C.A., et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology 2006, 67:1034-1039.
7. Allen R.P., Picchietti D., Hening W.A., et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med 2003, 4:101-119.
8. Walters A.S., LeBrocq C., Dhar A., et al. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med 2003, 4:121-132.
9. National Institute of Mental Health (NIMH). Early clinical drug evaluation unit (ECDEU). Clinical global impressions. In: Guy W, editor. ECDEU assessment manual for psychopharmacology, revised ed. Rockville, MD: NIMH USA; 1976. p. 216-22.
10. Abetz L., Vallow S.M., Kirsch J., Allen R.P., Washburn T., Earley C.J. Validation of the restless legs syndrome quality of life questionnaire. Value Health 2005, 8:157-167.
11. Kohnen R., Oertel W.H., Stiasny-Kolster K., Benes H., Trenkwalder C. Severity rating of restless legs syndrome: validation of the RLS-6 scales. Sleep 2004, 27(Suppl.):A304. Abstract 680.
12. Garcia-Borreguero D., Allen R.P., Kohnen R., et al. Diagnostic standards for dopaminergic augmentation of restless legs syndrome: report from a World Association of Sleep Medicine-International Restless Legs Syndrome Study Group consensus conference at the Max Planck Institute. Sleep Med 2007, 8:520-530.
13. Garcia-Borreguero D., Kohnen R., Högl B., et al. Validation of the augmentation severity rating scale (ASRS): a multicentric, prospective study with levodopa on restless legs syndrome. Sleep Med 2007, 8:455-463.
14. Baker W.L., White C.M., Coleman C.I. Effect of nonergot dopamine agonists on symptoms of restless legs syndrome. Ann Fam Med 2008, 6:253-262.
15. Fulda S., Wetter T.C. Where dopamine meets opioids: a meta-analysis of the placebo effect in restless legs syndrome treatment studies. Brain 2008, 131:902-917.
16. de la Fuente-Fernandez R., Lidstone S., Stoessl A.J. Placebo effect and dopamine release. J Neural Trans Suppl 2006, 70:415-418.
17. Perlis M.L., McCall W.V., Jungquist C.R., Pigeon W.R., Matteson S.E. Placebo effects in primary insomnia. Sleep Med Rev 2005, 9:381-389.
18. Allen R.P., Earley C.J. Augmentation of the restless legs syndrome with carbidopa/levodopa. Sleep 1996, 19:205-213.
19. Trenkwalder C., Högl B., Benes H., Kohnen R. Augmentation in restless legs syndrome is associated with low ferritin. Sleep Med 2008, 9:572-574.
20. Frauscher B., Gschliesser V., Brandauer E., et al. The severity range of restless legs syndrome (RLS) and augmentation in a prospective patient cohort: association with ferritin levels. Sleep Med 2009, 10:611-615.
21. Ferini-Strambi L. Restless legs syndrome augmentation and pramipexole treatment. Sleep Med 2002, 3(Suppl.):S23-S25.
22. Silber M.H., Girish M., Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep 2003, 26:819-821.
23. Winkelman J.W., Johnston L. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS). Sleep Med 2004, 5:9-14.
24. Högl B., Garcia-Borreguero D., Kohnen R., et al. Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: results of a prospective multi-center study. J Neurol 2010, 257:230-237.