PMID- 28239615
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2330-1619 (Print)
IS  - 2330-1619 (Electronic)
IS  - 2330-1619 (Linking)
VI  - 4
IP  - 1
DP  - 2017 Jan-Feb
TI  - Apomorphine Subcutaneous Injection for the Management of Morning Akinesia in 
      Parkinson's Disease.
PG  - 78-83
LID - 10.1002/mdc3.12350 [doi]
AB  - BACKGROUND: In patients with motor fluctuations complicating Parkinson's disease 
      (PD), delays in time-to-ON with levodopa are common. This open-label study aimed 
      to assess the effect of apomorphine on time-to-ON in PD patients with morning 
      akinesia. METHODS: The safety population included 127 enrolled patients, and the 
      full analysis set (FAS) included 88 patients. Patients completed a 7-day levodopa 
      baseline period recording their time-to-ON following each morning dose of 
      levodopa. Patients were titrated to an optimal dose of apomorphine (2-6 mg) while 
      taking trimethobenzamide antiemetic therapy. Apomorphine was injected each 
      morning for a 7-day treatment period and time-to-ON was self-recorded in 5-minute 
      blocks. The primary efficacy variable was time-to-ON in the apomorphine treatment 
      period versus the baseline levodopa period. Secondary assessments included and 
      global impression scales. Safety and tolerability were assessed through adverse 
      events (AEs). RESULTS: Patients receiving apomorphine achieved mean +/- standard 
      deviation (SD) time-to-ON 23.72 +/- 14.55 minutes, reduced from 60.86 +/- 18.11 
      minutes with levodopa (P < 0.0001). Dose failures (defined as time-to-ON >60 
      minutes) were more commonly reported with levodopa versus apomorphine (46% vs. 7% 
      of diary entries, respectively). Secondary endpoints supported the primary 
      efficacy findings, with significant improvements from levodopa baseline to 
      apomorphine treatment period (all P < 0.0001). The most common AEs were nausea 
      and dizziness. Most patients who discontinued because of AEs did so in the 
      titration phase. CONCLUSIONS: Apomorphine injections significantly reduced 
      time-to-ON in PD patients experiencing delayed onset of their morning levodopa 
      dose, and was well tolerated in most patients. After apomorphine treatment, 
      fluctuating patients with morning akinesia experienced rapid and reliable 
      improvement of time-to-ON.
FAU - Isaacson, Stuart
AU  - Isaacson S
AD  - Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton FL 
      USA.
FAU - Lew, Mark
AU  - Lew M
AD  - USC School of Medicine Los Angeles CA USA.
FAU - Ondo, William
AU  - Ondo W
AD  - Methodist Neuroscience Institute Houston TX USA.
FAU - Hubble, Jean
AU  - Hubble J
AD  - US WorldMeds LLC Louisville KY USA.
FAU - Clinch, Thomas
AU  - Clinch T
AD  - US WorldMeds LLC Louisville KY USA.
FAU - Pagan, Fernando
AU  - Pagan F
AD  - Georgetown University Medical Center Washington DC USA.
LA  - eng
PT  - Journal Article
DEP - 20160525
PL  - United States
TA  - Mov Disord Clin Pract
JT  - Movement disorders clinical practice
JID - 101630279
PMC - PMC5298032
OTO - NOTNLM
OT  - Parkinson's disease
OT  - apomorphine
OT  - l-dopa
OT  - morning akinesia
EDAT- 2017/02/28 06:00
MHDA- 2017/02/28 06:01
PMCR- 2017/05/25
CRDT- 2017/02/28 06:00
PHST- 2015/12/03 00:00 [received]
PHST- 2016/02/22 00:00 [revised]
PHST- 2016/02/23 00:00 [accepted]
PHST- 2017/02/28 06:00 [entrez]
PHST- 2017/02/28 06:00 [pubmed]
PHST- 2017/02/28 06:01 [medline]
PHST- 2017/05/25 00:00 [pmc-release]
AID - MDC312350 [pii]
AID - 10.1002/mdc3.12350 [doi]
PST - ppublish
SO  - Mov Disord Clin Pract. 2017 Jan-Feb;4(1):78-83. doi: 10.1002/mdc3.12350. Epub 
      2016 May 25.