Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: A prospective, open-label extension study

Parkinsonism and Related Disorders

Volumn 18, Issue 5, 2012, Pages 488-493

  Elmer, Lawrence W ^a   Surmann, Erwin ^b   Boroojerdi, Babak ^b   Jankovic, Joseph ^c  

^a MEDICAL COLLEGE OF OHIO   (United States)

^b UCB PHARMA   (Belgium)

^c BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

Long term; Parkinson's disease; Rotigotine; Safety; Transdermal

Indexed keywords

ARIPIPRAZOLE; BENSERAZIDE PLUS LEVODOPA; CARBIDOPA PLUS LEVODOPA; CHOLINESTERASE INHIBITOR; CLOZAPINE; ENTACAPONE; LEVODOPA; MODAFINIL; MONOAMINE OXIDASE B INHIBITOR; N METHYL DEXTRO ASPARTIC ACID RECEPTOR BLOCKING AGENT; OLANZAPINE; PLACEBO; QUETIAPINE; ROTIGOTINE; ZIPRASIDONE;

ADULT; AGED; ANXIETY DISORDER; APPLICATION SITE REACTION; ARTHRALGIA; ARTICLE; BACKACHE; CATARACT; CONSTIPATION; CONTROLLED STUDY; DEPRESSION; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSKINESIA; FALLING; FATIGUE; FEMALE; HALLUCINATION; HUMAN; HYPERTENSION; INCIDENCE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; NAUSEA; PARKINSON DISEASE; PERIPHERAL EDEMA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; TREATMENT DURATION; TREATMENT OUTCOME; UNIFIED PARKINSON DISEASE RATING SCALE; URINARY TRACT INFECTION; VOMITING;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; AGED, 80 AND OVER; DOPAMINE AGONISTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; PARKINSON DISEASE; SEVERITY OF ILLNESS INDEX; TETRAHYDRONAPHTHALENES; THIOPHENES; TREATMENT OUTCOME;

EID: 84861199463     PISSN: 13538020     EISSN: 18735126     Source Type: Journal    
DOI: 10.1016/j.parkreldis.2012.01.008     Document Type: Article

References (26)

1. Hauser R.A. New considerations in the medical management of early Parkinson's disease: impact of recent clinical trials on treatment strategy. Parkinsonism Relat Disord 2009, 15(Suppl. 3):S17-S21.
2. Reardon K.A., Shiff M., Kempster P.A. Evolution of motor fluctuations in Parkinson's disease: a longitudinal study over 6 years. Mov Disord 1999, 14:605-611.
3. Factor S.A. Current status of symptomatic medical therapy in Parkinson's disease. Neurotherapeutics 2008, 5:164-180.
4. Jankovic J. Motor fluctuations and dyskinesias in Parkinson's disease: clinical manifestations. Mov Disord 2005, 20(Suppl. 11):S11-S16.
5. Jenner P. A novel dopamine agonist for the transdermal treatment of Parkinson's disease. Neurology 2005, 65:S3-S5.
6. Boroojerdi B., Wolff H.M., Braun M., Scheller D.K. Rotigotine transdermal patch for the treatment of Parkinson's disease and restless legs syndrome. Drugs Today (Barc) 2010, 46:483-505.
7. Rascol O., Perez-Lloret S. Rotigotine transdermal delivery for the treatment of Parkinson's disease. Expert Opin Pharmacother 2009, 10:677-691.
8. Watts R.L., Jankovic J., Waters C., Rajput A., Boroojerdi B., Rao J. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 2007, 68:272-276.
9. Giladi N., Boroojerdi B., Korczyn A.D., Burn D.J., Clarke C.E., Schapira A.H. Rotigotine transdermal patch in early Parkinson's disease: a randomized, double-blind, controlled study versus placebo and ropinirole. Mov Disord 2007, 22:2398-2404.
10. Parkinson Study Group A controlled trial of rotigotine monotherapy in early Parkinson's disease. Arch Neurol 2003, 60:1721-1728.
11. Jankovic J., Watts R.L., Martin W., Boroojerdi B. Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease. Arch Neurol 2007, 64:676-682.
12. LeWitt P.A., Lyons K.E., Pahwa R. Advanced Parkinson disease treated with rotigotine transdermal system: PREFER Study. Neurology 2007, 68:1262-1267.
13. Poewe W.H., Rascol O., Quinn N., Tolosa E., Oertel W.H., Martignoni E., et al. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial. Lancet Neurol 2007, 6:513-520.
14. Pham D.Q., Nogid A. Rotigotine transdermal system for the treatment of Parkinson's disease. Clin Ther 2008, 30:813-824.
15. Pahwa R., Poewe W., Lyons K., Boroojerdi B. Changes in early morning motor status following adjunctive treatment of advanced Parkinson's disease with rotigotine transdermal system in two large, placebo-controlled trials (PREFER and CLEOPATRA-PD). Mov Disord 2009, 24:S280.
16. Trenkwalder C., Kies B., Rudzinska M., Fine J., Nikl J., Honczarenko K., et al. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord 2011, 26:90-99.
17. Parkinson Study Group Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease. Arch Neurol 2009, 66:563-570.
18. Hauser R.A., Rascol O., Korczyn A.D., Jon Stoessl A., Watts R.L., Poewe W., et al. Ten-year follow-up of Parkinson's disease patients randomized to initial therapy with ropinirole or levodopa. Mov Disord 2007, 22:2409-2417.
19. Holloway R.G., Shoulson I., Fahn S., Kieburtz K., Lang A., Marek K., et al. Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch Neurol 2004, 61:1044-1053.
20. Rascol O., Brooks D.J., Korczyn A.D., De Deyn P.P., Clarke C.E., Lang A.E. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. 056 Study Group. N Engl J Med 2000, 342:1484-1491.
21. Johns M.W. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991, 14:540-545.
22. Möller J.C., Oertel W.H., Köster J., Pezzoli G., Provinciali L. Long-term efficacy and safety of pramipexole in advanced Parkinson's disease: results from a European multicenter trial. Mov Disord 2005, 20:602-610.
23. Antonini A., Tolosa E., Mizuno Y., Yamamoto M., Poewe W.H. A reassessment of risks and benefits of dopamine agonists in Parkinson's disease. Lancet Neurol 2009, 8:929-937.
24. Sharma J.C., Bachmann C.G., Linazasoro G. Classifying risk factors for dyskinesia in Parkinson's disease. Parkinsonism Relat Disord 2010, 16:490-497.
25. Poewe W. The natural history of Parkinson's disease. J Neurol 2006, 253(Suppl. 7):VII2-6.
26. Oertel W., Trenkwalder C., Benes H., Ferini-Strambi L., Hogl B., Poewe W., et al. Long-term safety and efficacy of rotigotine transdermal system in moderate to severe idiopathic restless legs syndrome: a 5-year open-label extension study. Lancet Neurol 2011, 10:710-720.