PMID- 35107750
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220318
IS  - 2193-8253 (Print)
IS  - 2193-6536 (Electronic)
IS  - 2193-6536 (Linking)
VI  - 11
IP  - 1
DP  - 2022 Mar
TI  - Durability of the Clinical Benefit of Droxidopa for Neurogenic Orthostatic 
      Hypotension During 12 Weeks of Open-Label Treatment.
PG  - 459-469
LID - 10.1007/s40120-021-00317-5 [doi]
AB  - INTRODUCTION: Droxidopa is approved to treat neurogenic orthostatic hypotension 
      (nOH) symptoms in patients with autonomic failure based on short-term clinical 
      trial data. Additional data on the long-term efficacy of droxidopa are needed. We 
      have evaluated the 12-week efficacy and tolerability of droxidopa in patients 
      with nOH in an open-label period of an ongoing phase 4 study . METHODS: Patients 
      received 12 weeks of open-label treatment with an individually optimized 
      droxidopa dose (100-600 mg, 3 times daily) as identified during a preceding 
      titration period. Patient-reported outcomes included the Orthostatic Hypotension 
      Symptom Assessment (OHSA), Orthostatic Hypotension Daily Activity Scale (OHDAS), 
      and clinician- and patient-rated Clinical Global Impression-Severity (CGI-S) 
      scales. Supine blood pressure (BP) and adverse events (AEs) were recorded. 
      RESULTS: Data from 114 patients enrolled into the 12-week open-label period were 
      available for analyses. After 12 weeks of droxidopa treatment, patients reported 
      significant (P < 0.0001) improvements from baseline in OHSA and OHDAS composite 
      and individual item scores and on clinician and patient CGI-S scores. Mean +/- SD 
      supine systolic and diastolic BP at week 12 increased by 15.5 +/- 22.9 and 
      7.8 +/- 11.7 mmHg from baseline, respectively (P < 0.0001 for both). The most 
      frequently reported AEs were falls (17%), headache (13%), and dizziness (9%); one 
      (0.9%) patient reported an AE of supine hypertension. CONCLUSION: During 12 weeks 
      of open-label treatment, droxidopa was associated with significant improvement 
      from baseline in nOH symptoms and activities of daily living. No clinically 
      important changes in supine hypertension or AEs of concern were observed. These 
      results support the efficacy of droxidopa beyond 2 weeks of treatment. TRIAL 
      REGISTRATION: NCT02586623.
CI  - (c) 2022. The Author(s).
FAU - Hauser, Robert A
AU  - Hauser RA
AUID- ORCID: 0000-0002-6369-1203
AD  - Parkinson Foundation Center of Excellence, University of South Florida 
      Parkinson's Disease and Movement Disorders Center, 4001 E Fletcher Avenue, Tampa, 
      FL, 33613, USA. rhauser@usf.edu.
FAU - Favit, Antonella
AU  - Favit A
AD  - Lundbeck, Deerfield, IL, 60015, USA.
FAU - Hewitt, L Arthur
AU  - Hewitt LA
AD  - Lundbeck, Deerfield, IL, 60015, USA.
FAU - Lindsten, Annika
AU  - Lindsten A
AD  - Lundbeck A/S, 2500, Copenhagen, Denmark.
FAU - Gorny, Stephen
AU  - Gorny S
AD  - Lundbeck, Deerfield, IL, 60015, USA.
FAU - Kymes, Steven
AU  - Kymes S
AD  - Lundbeck, Deerfield, IL, 60015, USA.
FAU - Isaacson, Stuart H
AU  - Isaacson SH
AD  - Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, 
      33486, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02586623
PT  - Journal Article
DEP - 20220202
PL  - New Zealand
TA  - Neurol Ther
JT  - Neurology and therapy
JID - 101637818
PMC - PMC8857381
OTO - NOTNLM
OT  - Droxidopa
OT  - Durability
OT  - Efficacy
OT  - Neurogenic orthostatic hypotension
OT  - Safety
OT  - Treatment
EDAT- 2022/02/03 06:00
MHDA- 2022/02/03 06:01
PMCR- 2022/02/02
CRDT- 2022/02/02 12:15
PHST- 2021/06/21 00:00 [received]
PHST- 2021/12/21 00:00 [accepted]
PHST- 2022/02/03 06:00 [pubmed]
PHST- 2022/02/03 06:01 [medline]
PHST- 2022/02/02 12:15 [entrez]
PHST- 2022/02/02 00:00 [pmc-release]
AID - 10.1007/s40120-021-00317-5 [pii]
AID - 317 [pii]
AID - 10.1007/s40120-021-00317-5 [doi]
PST - ppublish
SO  - Neurol Ther. 2022 Mar;11(1):459-469. doi: 10.1007/s40120-021-00317-5. Epub 2022 
      Feb 2.