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.

Basic information

Original name

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

Name in Czech

Vysoké dávkování ratigiotinu v transdermální náplasti.

Authors

REKTOR, Ivan (203 Czech Republic, guarantor, belonging to the institution), Tomislav BABIC (826 United Kingdom of Great Britain and Northern Ireland), Bernard BOOTHMANN (826 United Kingdom of Great Britain and Northern Ireland), Jiří POLÍVKA (203 Czech Republic), Babak BOROOJERDI (276 Germany) and Olaf RANDERATH (276 Germany)

Edition

Clinical Neuropharmacology, 2009, 0362-5664

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30000 3. Medical and Health Sciences

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 2.349

RIV identification code

RIV/00216224:14110/09:00051287

Organization unit

Faculty of Medicine

DOI

UT WoS

000268841600004

Keywords (in Czech)

rotigotin; transdermální náplast

Keywords in English

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

Tags

International impact
Změněno: 10/4/2012 10:27, Mgr. Michal Petr

Abstract

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.

Links

MSM0021622404, plan (intention)
Name: Vnitřní organizace a neurobiologické mechanismy funkčních systémů CNS
Investor: Ministry of Education, Youth and Sports of the CR, The internal organisation and neurobiological mechanisms of functional CNS systems under normal and pathological conditions.