Rotigotine transdermal system for long-term treatment of patients with advanced Parkinson’s disease: results of two open-label extension studies, CLEOPATRA-PD and PREFER

Autor: Lewitt, P, Boroojerdi, B, Surmann, E, Poewe, W, Calabrese, V, Cleeremans, B, Curran, T, Chang, F, Dewey, R, Elmer, L, Higgins, D, Gazda, S, Glyman, S, Golbe, L, Grimes, D, Kostyk, S, Jankovic, J, Jennings, D, Taber, L, Kishner, R, Singer, C, Leopold, N, Margolin, D, Martin, W, Camicioli, R, Murphy, J, Panisset, M, Truong, D, Patton, J, Petzinger, G, Lew, M, Racette, B, Rajput, A, Rao, J, Scott, B, Singer, R, Samanta, J, Suchowersky, O, Tarsy, D, Waters, C, Evatt, M, Wendt, J, Pahwa, R, Siegel, K, Banas, T, Nausieda, P, Hull, K, Hull, R, Chumley, W, Cohen, S, Brew, B, Crimmins, D, Fung, V, Hayes, M, Thyagarajan, D, Brinar, V, Demarin, V, Bar, M, Ehler, E, Polivka, J, Rektor, I, Ruzicka, E, Svatova, J, Broussolle, E, Destee, A, Viallet, F, Jolma, T, Myllyla, V, Kronenbuerger, M, Mueller, T, Rózsa, C, Pal, E, Takacs, A, Valikovics, A, Djaldetti, R, Giladi, N, Anderson, T, Mossman, S, Snow, B, Aasly, J, Hestnes, A, Larsen, J, Tysnes, O, Chmielewska, B, Kotowicz, J, Nyka, W, Pruchnik Wolinska, D, Szczudlik, A, Tutaj, A, Badenhorst, F, Carr, J, Fine, J, Guldenphennig, W, Kies, B, Smuts, J, Hallström, Y, Barone, P, Battistin, U, Bonucceli, L, Pezzoli, G, Ruggieri, S, Stanzione, P, Aguilar, M, Balaguer, M, Francesc, E, Grandas, F, Kulisevsky, J, Linazasoro, G, Tolosa, E, Boothman, B, Grosset, D, Sagar, H
Rok vydání: 2012
Předmět:
Male
Time Factors
Parkinson's disease
Severity of Illness Index
law.invention
Randomized controlled trial
law
Outcome Assessment
Health Care
Activities of Daily Living
80 and over
Medicine
Open-label
Longitudinal Studies
Rotigotine transdermal system
Aged
80 and over
Administration
Cutaneous
Double-Blind Method
Humans
Aged
Outcome Assessment (Health Care)
Thiophenes
Dopamine Agonists
Parkinson Disease
Adult
Tetrahydronaphthalenes
Middle Aged
Female
Clinical trial
Psychiatry and Mental health
Neurology
Tolerability
Administration
Settore MED/26 - Neurologia
medicine.symptom
Somnolence
medicine.drug
medicine.medical_specialty
Clinical Neurology
Neurology and Preclinical Neurological Studies - Original Article
rotigotine
Parkinson´s disease
cleopatra-pd study
prefer study
Internal medicine
Severity of illness
Adverse effect
Biological Psychiatry
business.industry
Rotigotine
medicine.disease
Cutaneous
Parkinson’s disease
Physical therapy
Neurology (clinical)
business
Zdroj: Journal of Neural Transmission
ISSN: 1435-1463
0300-9564
DOI: 10.1007/s00702-012-0925-5
Popis: Open-label extensions [studies SP516 (NCT00501969) and SP715 (NCT00594386)] of the CLEOPATRA-PD and PREFER studies were conducted to evaluate the safety, tolerability and efficacy of the dopaminergic agonist, rotigotine, over several years of follow-up in patients with advanced Parkinson’s disease (PD). Eligible subjects completing the double-blind trials received open-label adjunctive rotigotine (≤16 mg/24 h) for up to 4 and 6 years in Studies SP516 and SP715, respectively. Safety and tolerability were assessed using adverse events, vital signs and laboratory parameters, and efficacy assessed using the unified Parkinson’s disease rating scale (UPDRS). Of the 395 and 258 patients enrolled in the SP516 and SP715 studies, 48 and 45 % completed, respectively. Adverse events were typically dopaminergic effects [e.g., somnolence (18–25 %/patient-year), insomnia (5–7 %/patient-year), dyskinesias (4–8 %/patient-year) and hallucinations (4–8 %/patient-year)], or related to the transdermal application of a patch (application site reactions: 14–15 %/patient-year). There were no clinically relevant changes in vital signs or laboratory parameters in either study. Mean UPDRS part II (activities of daily living) and part III (motor function) total scores improved from double-blind baseline during dose titration, then gradually declined over the maintenance period. In study SP516, mean UPDRS part II and III total scores were 0.8 points above and 2.8 points below double-blind baseline, respectively, at end of treatment. In study SP715, mean UPDRS part II and III total scores were 4.1 points above and 0.2 points below baseline, respectively, at end of treatment. In these open-label studies, adjunctive rotigotine was efficacious with an acceptable safety and tolerability profile in patients with advanced PD for up to 6 years.
Databáze: OpenAIRE
Externí odkaz: