High Doses of Rotigotine Transdermal Patch: Results of an
Open-Label, Dose-Escalation Trial in Patients With
Advanced-Stage, Idiopathic Parkinson Disease

J 2009

High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease

REKTOR, Ivan, Tomislav BABIC, Bernard BOOTHMANN, Jiří POLÍVKA, Babak BOROOJERDI et. al.

Základní údaje

Originální název

High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease

Název česky

Vysoké dávkování ratigiotinu v transdermální náplasti.

Autoři

REKTOR, Ivan (203 Česká republika, garant, domácí), Tomislav BABIC (826 Velká Británie a Severní Irsko), Bernard BOOTHMANN (826 Velká Británie a Severní Irsko), Jiří POLÍVKA (203 Česká republika), Babak BOROOJERDI (276 Německo) a Olaf RANDERATH (276 Německo)

Vydání

Clinical Neuropharmacology, 2009, 0362-5664

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30000 3. Medical and Health Sciences

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 2.349

Kód RIV

RIV/00216224:14110/09:00051287

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1097/WNF.0b013e31819a689f

UT WoS

000268841600004

Klíčová slova česky

rotigotin; transdermální náplast

Klíčová slova anglicky

dopamine agonist; dose escalation; Parkinson disease; rotigotine transdermal patch

Příznaky

Mezinárodní význam

Změněno: 10. 4. 2012 10:27, Mgr. Michal Petr

Anotace

V originále

Objective: The objective of the study was to determine the maximal achievable dose of rotigotine by assessing the tolerability of escalating doses of rotigotine transdermal patch in patients with advanced-stage Parkinson disease. Methods: Thirty-four patients aged 30 years or older oil a stable dose of L-dopa with all off time of at least 2.5 h/d were randomized to 2-titration schemes. The patients started on a dosage of 4 mg/24 h and received an incremental dosage of 4 mg/24 h per week: in the fast-titration group and 2 mg/24 h per week in the slow-titration group to the maximal target dosage of 24 mg/24 h (patch size of 120 cm(2)). Thereafter, both groups entered a maintenance period of 42 days or longer for the rapid-titration group and 7 days or longer for the slow titration group followed by a 2-week safety follow-up period with stepwise dosage de-escalation of 4 mg/24 h for 4 days. Results: Twenty-seven patients completed the trial, of whom 24 completed without dose reduction. Twenty-six patients (76%) were titrated to the maximum target dose and thus had a maximal achievable dosage of at least 24 mg/24 h. Adverse events, generally mild or moderate, included application site reaction (12%), nausea, dyskinesia, and visual hallucinations (9% each). The mean time spent off decreased by 2 to 3 h/d. Duration of oil without dyskinesia periods increased (2 h/d). The mean total (SD) Unified Parkinson's Disease Rating Score decreased by 18.9 (14.2) in the fast-titration group and 17.8 (14.0) in the slow titration group. A shift from off to on without dyskinesias in status after waking up was observed. Conclusions: Rotigotine transdermal patch, Lip to 24 mg/24 It, was effective and well tolerated by patients with advanced-stage Parkinson disease.

Návaznosti

MSM0021622404, záměr

Název: Vnitřní organizace a neurobiologické mechanismy funkčních systémů CNS

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, Vnitřní organizace a neurobiologické mechanismy funkčních systémů CNS

Citovat

REKTOR, Ivan, Tomislav BABIC, Bernard BOOTHMANN, Jiří POLÍVKA, Babak BOROOJERDI a Olaf RANDERATH. High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease. Clinical Neuropharmacology. 2009, roč. 32, č. 4, s. 193-198. ISSN 0362-5664. Dostupné z: https://dx.doi.org/10.1097/WNF.0b013e31819a689f.

@article{870390,
   author = {Rektor, Ivan and Babic, Tomislav and Boothmann, Bernard and Polívka, Jiří and Boroojerdi, Babak and Randerath, Olaf},
   article_number = {4},
   doi = {http://dx.doi.org/10.1097/WNF.0b013e31819a689f},
   keywords = {dopamine agonist; dose escalation; Parkinson disease; rotigotine transdermal patch},
   language = {eng},
   issn = {0362-5664},
   journal = {Clinical Neuropharmacology},
   title = {High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease},
   volume = {32},
   year = {2009}
}

TY  - JOUR
ID  - 870390
AU  - Rektor, Ivan - Babic, Tomislav - Boothmann, Bernard - Polívka, Jiří - Boroojerdi, Babak - Randerath, Olaf
PY  - 2009
TI  - High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease
JF  - Clinical Neuropharmacology
VL  - 32
IS  - 4
SP  - 193-198
EP  - 193-198
SN  - 03625664
KW  - dopamine agonist
KW  - dose escalation
KW  - Parkinson disease
KW  - rotigotine transdermal patch
N2  - Objective: The objective of the study was to determine the maximal achievable dose of rotigotine by assessing the tolerability of escalating doses of rotigotine transdermal patch in patients with advanced-stage Parkinson disease. Methods: Thirty-four patients aged 30 years or older oil a stable dose of L-dopa with all off time of at least 2.5 h/d were randomized to 2-titration schemes. The patients started on a dosage of 4 mg/24 h and received an incremental dosage of 4 mg/24 h per week: in the fast-titration group and 2 mg/24 h per week in the slow-titration group to the maximal target dosage of 24 mg/24 h (patch size of 120 cm(2)). Thereafter, both groups entered a maintenance period of 42 days or longer for the rapid-titration group and 7 days or longer for the slow titration group followed by a 2-week safety follow-up period with stepwise dosage de-escalation of 4 mg/24 h for 4 days. Results: Twenty-seven patients completed the trial, of whom 24 completed without dose reduction. Twenty-six patients (76%) were titrated to the maximum target dose and thus had a maximal achievable dosage of at least 24 mg/24 h. Adverse events, generally mild or moderate, included application site reaction (12%), nausea, dyskinesia, and visual hallucinations (9% each). The mean time spent off decreased by 2 to 3 h/d. Duration of oil without dyskinesia periods increased (2 h/d). The mean total (SD) Unified Parkinson's Disease Rating Score decreased by 18.9 (14.2) in the fast-titration group and 17.8 (14.0) in the slow titration group. A shift from off to on without dyskinesias in status after waking up was observed. Conclusions: Rotigotine transdermal patch, Lip to 24 mg/24 It, was effective and well tolerated by patients with advanced-stage Parkinson disease.
ER  -

REKTOR, Ivan, Tomislav BABIC, Bernard BOOTHMANN, Jiří POLÍVKA, Babak BOROOJERDI a Olaf RANDERATH. High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease. \textit{Clinical Neuropharmacology}. 2009, roč.~32, č.~4, s.~193-198. ISSN~0362-5664. Dostupné z: https://dx.doi.org/10.1097/WNF.0b013e31819a689f.

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