Randomized withdrawal study of patients with symptomatic neurogenic orthostatic hypotension responsive to droxidopa

Hypertension

Volumn 65, Issue 1, 2015, Pages 101-107

  Biaggioni, Italo ^a   Freeman, Roy ^b   Mathias, Christopher J ^c   Low, Phillip ^d   Arthur Hewitt, L ^e   Kaufmann, Horacio ^f  

^a VANDERBILT UNIVERSITY   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d MAYO CLINIC   (United States)

^e LUNDBECK RESEARCH USA   (United States)

^f NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Autonomic Nervous System; Droxidopa; Multiple System Atrophy; Norepinephrine; Parkinson Disease

Indexed keywords

PLACEBO; THREO 3,4 DIHYDROXYPHENYLSERINE; ANTIPARKINSON AGENT; DROXIDOPA;

ADULT; AGED; ARTICLE; AUTONOMIC NEUROPATHY; BLOOD PRESSURE MEASUREMENT; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HEADACHE; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; ORTHOSTATIC HYPOTENSION; ORTHOSTATIC HYPOTENSION DAILY ACTIVITY SCALE; ORTHOSTATIC HYPOTENSION QUESTIONNAIRE; ORTHOSTATIC HYPOTENSION SYMPTOM ASSESSMENT; PARKINSON DISEASE; PURE AUTONOMIC FAILURE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SHY DRAGER SYNDROME; STANDING; SYMPTOMATIC NEUROGENIC ORTHOSTATIC HYPOTENSION; SYSTOLIC BLOOD PRESSURE; TREATMENT RESPONSE; URINARY TRACT INFECTION; BLOOD PRESSURE; BODY POSTURE; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; FOLLOW UP; HYPOTENSION, ORTHOSTATIC; MIDDLE AGED; PATHOPHYSIOLOGY; PHASE 3 CLINICAL TRIAL; PHYSIOLOGY; QUESTIONNAIRE; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTIPARKINSON AGENTS; BLOOD PRESSURE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DROXIDOPA; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYPOTENSION, ORTHOSTATIC; MALE; MIDDLE AGED; POSTURE; QUESTIONNAIRES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84919461672     PISSN: 0194911X     EISSN: 15244563     Source Type: Journal    
DOI: 10.1161/HYPERTENSIONAHA.114.04035     Document Type: Article

References (19)

1. Freeman R, Wieling W, Axelrod FB, et al. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011;21:69-72
2. Gangavati A, Hajjar I, Quach L, Jones RN, Kiely DK, Gagnon P, Lipsitz LA. Hypertension, orthostatic hypotension, and the risk of falls in a community-dwelling elderly population: the maintenance of balance, independent living, intellect, and zest in the elderly of Boston study. J Am Geriatr Soc. 2011;59:383-389
3. Freeman R. Clinical practice. Neurogenic orthostatic hypotension. N Engl J Med. 2008;358:615-624
4. Ooi WL, Hossain M, Lipsitz LA. The association between orthostatic hypotension and recurrent falls in nursing home residents. Am J Med. 2000;108:106-111
5. Luukinen H, Koski K, Laippala P, Kivel SL. Prognosis of diastolic and systolic orthostatic hypotension in older persons. Arch Intern Med. 1999;159:273-280
6. Kaufmann H, Brannan T, Krakoff L, Yahr MD, Mandeli J. Treatment of orthostatic hypotension due to autonomic failure with a peripheral alphaadrenergic agonist (midodrine). Neurology. 1988;38:951-956
7. Low PA, Gilden JL, Freeman R, Sheng KN, McElligott MA. Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension: a randomized, double-blind multicenter study. JAMA. 1997;277:1046-1051
8. Biaggioni I, Robertson D. Endogenous restoration of noradrenaline by precursor therapy in dopamine-beta-hydroxylase deficiency. Lancet. 1987;2:1170-1172
9. Kaufmann H, Freeman R, Biaggioni I, Low P, Pedder S, Hewitt LA, Mauney J, Feirtag M, Mathias CJ; NOH301 Investigators. Droxidopa for neurogenic orthostatic hypotension: a randomized, placebo-controlled, phase 3 trial. Neurology. 2014;83:328-335
10. US Dept of Health and Human Services Food and Drug Administration. Guidance for industry: enrichment strategies for clinical trials to support approval of human drugs and biological products. December 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Gu idances/UCM332181.pdf. Accessed August 28, 2014
11. Goldstein DS, Holmes C, Kaufmann H, Freeman R. Clinical pharmacokinetics of the norepinephrine precursor L-threo-DOPS in primary chronic autonomic failure. Clin Auton Res. 2004;14:363-368
12. Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012;22:79-90
13. Freeman R, Landsberg L, Young J. The treatment of neurogenic orthostatic hypotension with 3,4-DL-threo-dihydroxyphenylserine: a randomized, placebo-controlled, crossover trial. Neurology. 1999;53:2151-2157
14. Mathias CJ, Senard JM, Braune S, Watson L, Aragishi A, Keeling JE, Taylor MD. L-threo-dihydroxyphenylserine (L-threo-DOPS; droxidopa) in the management of neurogenic orthostatic hypotension: a multinational, multi-center, dose-ranging study in multiple system atrophy and pure autonomic failure. Clin Auton Res. 2001;11:235-242
15. Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003;108:724-728
16. Hauser RA, Holford NH. Quantitative description of loss of clinical benefit following withdrawal of levodopa-carbidopa and bromocriptine in early Parkinsons disease. Mov Disord. 2002;17:961-968
17. Cedarbaum JM. Clinical pharmacokinetics of anti-parkinsonian drugs. Clin Pharmacokinet. 1987;13:141-178
18. Arnold AC, Biaggioni I. Management approaches to hypertension in autonomic failure. Curr Opin Nephrol Hypertens. 2012;21:481-485
19. Shibao C, Lipsitz LA, Biaggioni I; American Society of Hypertension Writing Group. Evaluation and treatment of orthostatic hypotension. J Am Soc Hypertens. 2013;7:317-324.