To examine droxidopa titration schedules, daily dosage, and treatment persistence in patients with neurogenic orthostatic hypotension (nOH) treated in clinical practice settings

Droxidopa is approved to treat nOH symptoms in patients with autonomic dysfunction and requires titration to an individualized effective dose (total daily dosage, 300–1800 mg [100–600 mg 3 times daily]). Per the product label, droxidopa should be titrated every 24–48 hours to an optimum maintenance dose based on symptomatic response. In clinical trials, 82% of patients received a daily droxidopa dosage ≥900 mg (mean, 1170–1314 mg).

Patient data were collected from the central NORTHERA^® specialty pharmacy hub. Average daily titration and maintenance dosages (total milligrams/days supplied) were calculated from total drug dispensed on first 30-day dispense (assumed titration period) and subsequent dispenses (assumed post-titration). The relationship between maintenance dose and treatment persistence was examined by number of refills (used as a surrogate for persistence).

53% of patients were titrated with custom schedules (ie, different from product labeling recommendation) and had an average daily titration dosage of 567 mg; 47% were titrated according to the product label schedule (48-hours, 37%; 24-hours, 10%) and had daily titration dosages of 1500–1650 mg. Average daily maintenance dosages in patients who received 2, 3–6, 7–24, and >25 dispenses were 938, 969, 1069, and 1167 mg (P<0.0001).

In this analysis, >50% of patients treated with droxidopa were titrated differently from the recommended titration schedule (ie, not 24–48 hours) and received lower daily dosages of droxidopa than those treated using recommended titration schedules. A lower daily maintenance dosage of droxidopa was associated with shorter treatment persistence (fewer dispenses); patients titrated to higher dosages received more follow-up dispensing. Reasons for discontinuation could not be examined in this study, but further investigation is warranted.