Key result
Droxidopa was associated with small increases in cardiovascular adverse events compared to placebo, mostly minor atrial arrhythmias in patients with preexisting cardiac disorders, with no MACE or deaths.
Why the study?
Does droxidopa increase cardiovascular adverse events compared to placebo in patients with symptomatic neurogenic orthostatic hypotension?
Does droxidopa increase cardiovascular adverse events compared to placebo in patients with symptomatic neurogenic orthostatic hypotension?
Droxidopa is associated with a small increase in minor cardiovascular adverse events, primarily atrial arrhythmias, particularly in patients with preexisting cardiac disorders, but not with major adverse cardiovascular events.
Warrants arrhythmia vigilance in cardiac patients; leaves open need for confirmatory safety trials.
The norepinephrine prodrug droxidopa improves symptoms of neurogenic orthostatic hypotension, a condition that is associated with diseases of neurogenic autonomic failure (e.g., Parkinson disease, multiple system atrophy, pure autonomic failure). These conditions are more prevalent in older patients who also have cardiovascular co-morbidities. Hence, we evaluated the cardiovascular safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension who participated in randomized controlled studies (short-term studies of 1 to 2 weeks and an intermediate 8- to 10-week study) and long-term open-label studies. Rates of cardiovascular adverse events (AEs) for patients treated with droxidopa were 4.4% in the intermediate study and 10.8% in the long-term open-label studies. Adjusting for exposure time, cardiovascular AE rates were 0.30 events/patient-year in the short-term and intermediate studies and 0.15 events/patient-year in the long-term open-label studies. The incidence of treatment discontinuation due to blood pressure-related events was approximately 2.5%. Among patients with a history of cardiac disorders at baseline, the rates of cardiovascular-related and blood pressure-related AEs were nominally higher with droxidopa compared to placebo. Most of these events were minor atrial arrhythmias; none were major adverse cardiovascular events or deaths. In conclusion, small increases in cardiovascular AEs were observed with droxidopa compared to placebo; this was most evident in patients with preexisting cardiac disorders.
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White et al. (2017) studied Symptomatic neurogenic orthostatic hypotension. Droxidopa vs. Placebo was evaluated on Cardiovascular adverse events. Droxidopa was associated with small increases in cardiovascular adverse events compared to placebo, mostly minor atrial arrhythmias in patients with preexisting cardiac disorders, with no MACE or deaths.
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