Chelsea Therapeutics
International, Ltd. CHTP today announced results from a study of
Northera™ (droxidopa) in hypotensive individuals with spinal cord injury at
the 23^rd International Symposium on the Autonomic Nervous System, which took
place October 31 through November 3, 2012 in Paradise Island, Bahamas.
The poster, titled "Blood Pressure Effect of Droxidopa in Hypotensive
Individuals with Spinal Cord Injury," (poster #62) highlighted results of a
clinical study designed to determine the blood pressure effect of escalating
doses of droxidopa (100 mg, 200 mg & 400 mg) during three laboratory visits in
hypotensive subjects (n=10) with spinal cord injury (SCI). The level of SCI
ranged from cervical to low thoracic lesions, all were chronically injured and
non-ambulatory and 8 were motor complete.
Subjects were hypotensive at baseline (systolic BP: 87±14 mmHg; diastolic BP:
54±8 mmHg), and baseline BP did not differ among the 3 visits. Upon supine
repositioning prior to drug administration, BP increased significantly (SBP:
101±11 mmHg; DBP: 62±7 mmHg; p<0.0001 versus seated baseline), regardless of
dose, droxidopa did not augment the increase in BP upon supine
repositioning. Seated BP was significantly increased from baseline after
droxidopa in a dose-dependent manner (100 mg: 94±14/61±8 mmHg; 200 mg:
99±15/62±9 mmHg; 400 mg: 106±16/58±9 mmHg; p<0.0001). Although the elevation
in seated BP was relatively modest, average 4-hour seated SBP & DBP were
significantly increased with 400 mg droxidopa compared to 100 mg (p<0.001) and
200 mg (p<0.05).
"These preliminary data indicate that droxidopa increases seated BP in a
dose-dependent manner without worsening supine increases in BP in hypotensive
persons with SCI, suggesting a greater normalization of pressure across
positional changes," said lead author Jill M. Wecht, Ed.D, Associate Professor
of Medicine and Rehabilitation Medicine, the Mount Sinai School of
Medicine. "Increasing seated blood pressure is an important clinical outcome
in these individuals, because hypotension has been linked to deficits in
memory and attention processing in the general population and in individuals
with SCI. Further study of droxidopa is warranted in the SCI population."
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