Droxidopa: A Review of Its Use in Symptomatic Neurogenic Orthostatic Hypotension
- 853 Downloads
The norepinephrine prodrug droxidopa (NORTHERA™) is approved in the US for the treatment of orthostatic dizziness, lightheadedness, or the ‘feeling that you are about to black out’ in adults with symptomatic neurogenic orthostatic hypotension associated with primary autonomic failure (e.g. Parkinson’s disease, multiple system atrophy or pure autonomic failure), dopamine β-hydroxylase deficiency or nondiabetic autonomic neuropathy. This article reviews the clinical efficacy and tolerability of droxidopa in symptomatic neurogenic orthostatic hypotension, as well as summarizing its pharmacological properties. Oral droxidopa was effective in the shorter-term treatment of patients with symptomatic neurogenic orthostatic hypotension, with improvements seen in symptoms, the impact of symptoms on daily activities and standing systolic blood pressure. More data are needed to confirm the longer-term efficacy of droxidopa. Droxidopa was generally well tolerated, although patients should be monitored for supine hypertension.
KeywordsPlacebo Recipient Multiple System Atrophy Midodrine Study 306a Study 306b
The preparation of this review was not supported by any external funding. Gillian Keating is a salaried employee of Adis/Springer. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.
- 4.Lundbeck NA Ltd. NORTHERA™ (droxidopa) capsules, for oral use: US prescribing information. 2014. http://www.northera.com. Accessed 10 Dec 2014.
- 14.US Food and Drug Administration. Droxidopa: medical review. Application number: 203202Orig1s000. 2014. http://www.fda.gov. Accessed 10 Dec 2014.
- 15.LeWitt P, Gorny S. Analysis of efficacy and safety outcomes in patients treated with droxidopa in combination with other drug classes [abstract no. 1294]. Mov Disord. 2012;27(Suppl 1):S425–6.Google Scholar
- 17.Mathias CJ, Senard J-M, Braune S, et al. L-threo-dihydroxyphenylserine (L-threo-DOPS; droxidopa) in the management of neurogenic orthostatic hypotension: a multi-national, multi-center, dose-ranging study in multiple system atrophy and pure autonomic failure. Clin Auton Res. 2001;11:235–42.PubMedCrossRefGoogle Scholar
- 18.Mathias CJ, Senard JM, Cortelli P. A double-blind, randomized, placebo-controlled study to determine the efficacy and safety of droxidopa in the treatment of orthostatic hypotension associated with multiple system atrophy or Parkinson’s disease [abstract]. Clin Auton Res. 2007;17:272.Google Scholar
- 21.Biaggioni I, Freeman R, Mathias CJ, et al. Randomized withdrawal study of patients with symptomatic neurogenic orthostatic hypotension responsive to droxidopa. Hypertension. 2014. doi: 10.1161/HYPERTENSIONAHA.114.04035.
- 23.Hauser RA, Isaacson S, Lisk JP, et al. Droxidopa for the short-term treatment of symptomatic neurogenic orthostatic hypotension in Parkinson’s disease (nOH306B). Mov Disord. 2014. doi: 10.1002/mds.26086.
- 24.Isaacson S, Shill H, Vernino S, et al. Durability of effect with long-term, open-label droxidopa treatment in patients with symptomatic neurogenic orthostatic hypotension (NOH 303) [abstract no. 1291]. Mov Disord. 2012;27(Suppl 1):S424–5.Google Scholar
- 25.Mathias C, Low P, Freeman R, et al. Integrated efficacy analysis of droxidopa in 2 double-blind, placebo-controlled phase 3 studies in patients with neurogenic orthostatic hypotension [abstract no. 1296]. Mov Disord. 2012;27(Suppl 1):S426.Google Scholar
- 26.Isaacson S, Hauser R, Szakacs C, et al. Droxidopa treatment impact on orthostatic symptoms and standing systolic blood pressure in patients with Parkinson’s disease (PD) and symptomatic neurogenic orthostatic hypotension (NOH) [abstract]. Neurology. 2013;80(19):e203.Google Scholar
- 27.Hauser RA, Jerome LP, Schwieterman WD, et al. Impact of droxidopa treatment on falls and fall related injuries in patients with Parkinson’s disease and symptomatic neurogenic orthostatic hypotension (study 306) [abstract no. 481]. Mov Disord. 2013;28(Suppl 1):S171.Google Scholar
- 28.Shill H, Vernino S, Hutchman R, et al. A multicenter, open-label study to assess the long-term safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension (NOH 304) [abstract no. 1302]. Mov Disord. 2012;27(Suppl 1):S428.Google Scholar
- 30.Upsher-Smith Laboratories Inc. Midodrine HCl tablets: US prescribing information. 2012. http://www.upsher-smith.com/. Accessed 10 Dec 2014.