Objective: To determine the long-term effects of droxidopa use on supine blood pressure (BP) in patients with neurogenic orthostatic hypotension (nOH).

Background: nOH is a sustained drop in BP upon standing, with little or no compensatory increase in heart rate. Many patients with nOH also experience supine hypertension, both due to baroreflex dysfunction. Droxidopa is approved by the FDA to treat symptoms of nOH in patients with autonomic failure. Pressor medications like droxidopa may increase standing and supine BP.

Method: We examined changes in BP over time among patients treated with droxidopa, focusing on those who transitioned to “high” supine BP, defined as >140 mmHg. Patients with symptomatic nOH who participated in a short-term, double-blind, randomized clinical trial (NOH301 or NOH302) were enrolled in a 12 month long-term extension study NOH303 (LTE). Patients enrolled in NOH303 received an individualized dose of 100–600 mg, TID. Supine BP was measured before treatment initiation (baseline) and at study visits and were classified as low, normal, or high supine systolic BP (SBP; <110, 110–140, and >140 mmHg, respectively).

Results: 102 patients participating in the LTE were analyzed (60% men; mean age, 66 years). At baseline, overall supine SBP (mean ± SEM) was 132±2 mmHg, grouped as follows: low (97±2 mmHg, n=15); normal (125±1 mmHg, n=49); and high (155±2 mmHg, n=38). Low and normal were combined for analysis (119±2 mmHg, n=64). Of patients with low/normal supine SBP at baseline, 29% (12/41) and 30% (10/33) had transitioned to high supine SBP at 6 and 12 months of treatment, respectively (155±3 and 162±4 mmHg; maximum, 171 and 187 mmHg). Of patients with high supine SBP at baseline, 38% (10/26) and 38% (9/24) had transitioned to low/normal supine SBP at 6 and 12 months (127±4 and 129±4 mmHg). Changes in supine SBP from baseline to 12 months in the baseline low/normal and high supine SBP groups were +12±4 and –3±6 mmHg, respectively. Supine hypertension, defined as supine SBP >180 mmHg, was observed in 14% (14/102) of patients at any time during the study (5% in baseline low/normal, 29% in baseline high).

Conclusion: In this study, roughly 1/3 of patients saw shifts in their SBP that were potentially clinically important. Patients treated with droxidopa can experience increases due to pressor activity or decreases due to the therapeutic effect of the drug. It is important to monitor and evaluate these changes during treatment.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/changes-in-supine-blood-pressure-with-long-term-use-of-droxidopa/