Article

OBJECTIVES: To determine the effect of an escalating dose of droxidopa (100, 200,
and 400 mg) compared with placebo on seated blood pressure (BP) in hypotensive
individuals with spinal cord injury (SCI). Secondarily, we aimed to determine the
effect of droxidopa on (1) supine BP and heart rate, (2) the change in BP and
heart rate when these individuals were transferred from the supine to the seated
position, and (3) adverse event (AE) reporting. DESIGN: Open-label dose titration
trial. SETTING: A Veterans Administration Medical Center. PARTICIPANTS:
Participants with SCI (C3-T12) (N=10) were studied during 4 laboratory visits.
Subjects visited the laboratory for about 5 hours on each visit, which
incorporated a 30-minute seated baseline, a 30- to 60-minute supine, and a 4-hour
seated postdrug observation. INTERVENTIONS: Placebo on visit 1, droxidopa 100 mg
on visit 2, droxidopa 200 mg on visit 3, and droxidopa 400 mg on visit 4. MAIN
OUTCOME MEASURES: BP and heart rate changes from baseline to the postdrug period,
orthostatic heart rate and BP responses, and subjective AE reporting. RESULTS:
Seated BP was significantly elevated with 400 mg droxidopa compared with placebo
and 100 mg droxidopa for 3 hours and was elevated for 2 hours compared with 200
mg droxidopa. Increase in supine BP was not worsened following droxidopa, and the
expected fall in BP when transferred to the seated position was prevented with
droxidopa 200 and 400 mg. There were no significant differences in the heart rate
response or AE reporting among the study visits.
CONCLUSIONS: Our preliminary
findings suggest that droxidopa, at the doses tested, does not cause excessive
increases in supine BP and the 400-mg dose appears to be effective at increasing
seated BP for up to 3 hours in persons with SCI.
CI - Copyright (c) 2013 American Congress of Rehabilitation Medicine. Published by
Elsevier Inc. All rights reserved.

Langue : ANGLAIS