Characterization of the changes in supine blood pressure with long-term use of droxidopa in patients with neurogenic orthostatic hypotension.

Background And Aims: Patients with neurogenic orthostatic hypotension (nOH) due to autonomic dysfunction may also experience supine hypertension (defined as supine systolic blood pressure [SBP] ≥140 mmHg). Because pressor agents used to improve nOH symptoms by increasing standing blood pressure (BP) may exacerbate or cause supine hypertension, changes in supine BP with nOH treatments are of interest.

Methods: This post hoc study examined changes in SBP in patients receiving droxidopa (100-600 mg, three times daily) during a 12-month long-term extension study based on whether patients had supine hypertension (ie, supine SBP ≥140 mmHg) at baseline. Shifts from baseline in supine hypertension categorization and mean supine and standing SBP after 6 and 12 months of treatment with droxidopa were determined.

Results: At baseline, 64 patients did not have supine hypertension (mean supine SBP, 120 mmHg) and 38 patients had supine hypertension (mean supine SBP, 157 mmHg). A similar percentage of patients shifted from their respective baseline supine hypertension categorization (ie, with or without supine hypertension) to the other category after receiving droxidopa for 6 or 12 months. After 12 months of droxidopa treatment, patients with supine hypertension at baseline had a mean supine SBP decrease of 3 mmHg and a mean standing SBP increase of 9 mmHg. Patients without supine hypertension at baseline had mean supine and standing SBP increases of 12 and 15 mmHg, respectively.

Conclusions: There was no consistent or progressive elevation in supine SBP over time during the 12-month treatment with droxidopa in patients either with or without supine hypertension at baseline. These data suggest that long-term droxidopa treatment for nOH does not adversely affect supine BP.