Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Hewitt LA

PROVIDER: S-EPMC7817084 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Hewitt L Arthur LA Lindsten Annika A Gorny Stephen S Karnik-Henry Meghana M Kymes Steven S Favit Antonella A

Health science reports 20210120 1

<h4>Background and aims</h4>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.<h4>Methods</h4>This post hoc study examined changes in SBP in patients receiving droxidop ...[more]

PMID: 33521332

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Project description:BackgroundDroxidopa, a prodrug of norepinephrine, was approved for treatment of neurogenic orthostatic hypotension (nOH) due to primary autonomic disorders based on 3 randomized double-blind studies. We performed safety and efficacy analyses of this pooled dataset (n = 460).MethodsEfficacy was assessed using Orthostatic Hypotension Questionnaire (OHQ) scores (composite and individual items). Safety and tolerability were also examined.ResultsDroxidopa improved virtually all nOH symptom scores compared with placebo, significantly reducing OHQ composite score (-2.68 ± 2.20 vs -1.82 ± 2.34 units; P < 0.001), dizziness/lightheadedness score (-3.0 ± 2.9 vs -1.8 ± 3.1 units; P < 0.001), and 3 of 5 other symptom assessments (visual disturbances, weakness, and fatigue [P ≤ 0.010]). Droxidopa significantly improved 3 of 4 measures of activities of daily living (standing a long time, walking a short time, and walking a long time [P ≤ 0.003]) and significantly increased upright systolic blood pressure (11.5 ± 20.5 vs 4.8 ± 21.0 mmHg for placebo; P < 0.001). Droxidopa was effective in patients using inhibitors of dopa decarboxylase (DDCI; the enzyme that converts droxidopa to norepinephrine), but its efficacy was numerically greater in non-DDCI users. Droxidopa was well-tolerated. Rates of most adverse events were similar between groups. Supine hypertension rates were low, but slightly higher in patients receiving droxidopa (≤7.9% vs ≤4.6% for placebo); patients with severe hypertension at screening were excluded from these studies.ConclusionsDroxidopa is effective for the treatment of nOH in patients with primary autonomic disorders and is generally well-tolerated. A longer trial is underway to confirm efficacy beyond the ≤2 to 10 - week period assessed in the current trials.Trial registrationClinicalTrials.gov identifiers: NCT00782340 , first received October 29, 2008; NCT00633880 , first received March 5, 2008; and NCT01176240 , first received July 30, 2010.

Dataset Information

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

Background and aims

Methods

Results

Conclusions

Publications

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

Similar Datasets

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