Droxidopa Effective, Safe for Symptomatic NOH Across Age Groups

Adverse event frequency was similar among patients <65, ≥65, or ≥75 years of age
Adverse event frequency was similar among patients <65, ≥65, or ≥75 years of age

VANCOUVER, BC—Use of the oral norepinephrine prodrug, droxidopa, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) is effective and “generally well tolerated across a range of ages,” including adults aged 75 years and older, investigators reported at the 68th AAN Annual Meeting.

Guangbin Peng, MS, of Lundbeck, Deerfield, IL, and colleagues analyzed change in orthostatic dizziness/lightheadedness after 1 week of treatment with droxidopa 100–600mg 3 times daily by patient age. A pooled analysis of data from two studies was used to determine frequency of adverse events by age in patients treated for 1–2 weeks, and from a third study for those treated for 10 weeks.

“Overall, when stratified by age, droxidopa treatment improved symptoms of neurogenic orthostatic hypotension,” Peng noted. “Treatment effects of droxidopa were consistently observed by age group despite some variability in the magnitude of the response in individual age groups.”

In the pooled analysis, 176 patients <65 years of age had a mean (SD) change in Orthostatic Hypotension Symptom Assessment (OHSA) scale Item 1 of -3.7 (2.7) compared with -1.8 (2.9) with placebo (P<0.001). In the 282 patients patients ≥65 years of age, the respective changes in OHSA Item 1 with droxidopa was -2.6 (3.0) compared with -1.8 (3.2) for placebo (P=0.016).

The 330 patients <75 years of age had a mean (SD) change in OHSA scale Item 1 of −3.1 (2.8), compared with −1.8 (3.1) with placebo (P<0.001). In the 128 patients aged ≥75 years of age, the respective changes in OHSA Item 1 with droxidopa was −2.7 (3.2), compared with -1.6 (3.2) for placebo (P=0.049).

“The pattern and frequency of treatment-emergent adverse events were similar among patients <65 years, ≥65 years, or ≥75 years of age,” he stated. “Of note, the incidence of supine hypertension (≥180mmHg systolic) was higher in patients treated with droxidopa, and no patients exhibited supine hypertension beyond 1 week of stable treatment.”

Droxidopa (Northera) is approved by the Food and Drug Administration (FDA) for the treatment of NOH caused by primary autonomic failure (eg, Parkinson disease, multiple system atrophy, and pure autonomic failure), dopamine β-hydroxylase deficiency, and nondiabetic autonomic neuropathy.

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