Droxidopa for orthostatic hypotension: A systematic review andmeta-Analysis

Journal of Hypertension

Volumn 34, Issue 10, 2016, Pages 1933-1941

  Strassheim, Victoria ^a   Newton, Julia L ^a,b   Tan, Maw Pin ^c   Frith, James ^a,b  

^a NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c UNIVERSITY OF MALAYA   (Malaysia)

Author keywords

Droxidopa; Meta Analysis; Orthostatic hypotension; Systematic review

Indexed keywords

DROXIDOPA; ANTIPARKINSON AGENT;

DAILY LIFE ACTIVITY; DIZZINESS; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; HEADACHE; HUMAN; HYPERTENSION; META ANALYSIS; MULTICENTER STUDY (TOPIC); NAUSEA; ORTHOSTATIC HYPOTENSION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SUPINE HYPERTENSION; SYMPTOM ASSESSMENT; SYSTEMATIC REVIEW; SYSTOLIC BLOOD PRESSURE; BLOOD PRESSURE; BODY POSITION; DRUG EFFECTS; HYPOTENSION, ORTHOSTATIC; PATHOPHYSIOLOGY; PHYSIOLOGY; REGISTER;

ANTIPARKINSON AGENTS; BLOOD PRESSURE; DROXIDOPA; HUMANS; HYPOTENSION, ORTHOSTATIC; POSTURE; REGISTRIES;

EID: 84978975456     PISSN: 02636352     EISSN: 14735598     Source Type: Journal    
DOI: 10.1097/HJH.0000000000001043     Document Type: Review

References (39)

1. Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, 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. Senard JM, Brefel-Courbon C, Rascol O, Montastruc JL. Orthostatic hypotension in patients with Parkinson's disease: pathophysiology and management. Drugs Aging 2001; 18:495-505.
3. Wu JS, Yang YC, Lu FH, Wu CH, Wang RH, Chang CJ. Populationbased study on the prevalence and risk factors of orthostatic hypotension in subjects with prediabetes and diabetes. Diabetes Care 2009; 32:69-74.
4. Frith J, Ng WF, Day CP, Payne B, Sheerin N, Gorman G, et al. Orthostatic intolerance is common in chronic disease: A clinical cohort study. Int J Cardiol 2014; 174:861-863.
5. Applegate WB, Davis BR, Black HR, Smith WM, Miller ST, Burlando AJ. Prevalence of postural hypotension at baseline in the Systolic Hypertension in the Elderly Program (SHEP) cohort. J Am Geriatr Soc 1991; 39:1057-1064.
6. Logan IC, Witham MD. Efficacy of treatments for orthostatic hypotension: A systematic review. Age Ageing 2012; 41:587-594.
7. Mills PB, Fung CK, Travlos A, Krassioukov A. Nonpharmacologic management of orthostatic hypotension: A systematic review. Arch Phys Med Rehabil 2015; 96:366-375.
8. Ong AC, Myint PK, Shepstone L, Potter JF. A systematic review of the pharmacological management of orthostatic hypotension. Int J Clin Pract 2013; 67:633-646.
9. Parsaik AK, Singh B, Altayar O, Mascarenhas SS, Singh SK, Erwin PJ, Murad MH. Midodrine for orthostatic hypotension: A systematic review and meta-Analysis of clinical trials. J Gen Intern Med 2013; 28:1496-1503.
10. Mathias CJ. L-dihydroxyphenylserine (Droxidopa) in the treatment of orthostatic hypotension. Clin Auton Res 2008; 18:25-29.
11. Goldenberg MM. Pharmaceutical approval update. P T 2014; 39:337-344.
12. Biaggioni I, Robertson D. Endogenous restoration of noradrenaline by precursor therapy in dopamine-beta-hydroxylase deficiency. Lancet 1987; 2:1170-1172.
13. Hoeldtke RD, Cilmi KM, Mattis-Graves K. DL-Threo-3, 4-dihydroxyphenylserine does not exert a pressor effect in orthostatic hypotension. Clin Pharmacol Ther 1984; 36:302-306.
14. Kaufmann H, Oribe E, Yahr MD. Differential effect of L-Threo-3, 4-dihydroxyphenylserine in pure autonomic failure and multiple system atrophy with autonomic failure. J Neural Transm Park Dis Dement Sect 1991; 3:143-148.
15. Freeman R, Landsberg L. The treatment of orthostatic hypotension with dihydroxyphenylserine. Clin Neuropharmacol 1991; 14:296-304.
16. 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, multicenter, dose-ranging study in multiple system atrophy and pure autonomic failure. Clin Auton Res 2001; 11:235-242.
17. 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.
18. Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, et al. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation 2003; 108:724-728.
19. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions. The Cochrane Collaboration 2011; version 5.1.0.(Available from www.cochrane-handbook.org).
20. Review Manager (RevMan) [Computer program], version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
21. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann HJ. GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336:924-926.
22. GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2015 (developed by Evidence Prime, Inc.). Available from gradepro.org.
23. Hauser RA, Hewitt LA, Isaacson S. Droxidopa in patients with neurogenic orthostatic hypotension associated with Parkinson's disease (NOH306A). J Parkinsons Dis 2014; 4:57-65.
24. Hauser RA, Isaacson S, Lisk JP, Hewitt LA, Rowse G. Droxidopa for the short-Term treatment of symptomatic neurogenic orthostatic hypotension in Parkinson's disease (nOH306B). Mov Disord 2015; 30:646-654.
25. Biaggioni I, Freeman R, Mathias CJ, Low P, Hewitt LA, Kaufmann H. Randomized withdrawal study of patients with symptomatic neurogenic orthostatic hypotension responsive to droxidopa. Hypertension 2015; 65:101-107.
26. Kaufmann H, Freeman R, Biaggioni I, Low P, Pedder S, Hewitt LA, et al. Droxidopa for neurogenic orthostatic hypotension: A randomized, placebo-controlled, phase 3 trial. Neurology 2014; 83:328-335.
27. 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.
28. Kaufmann H. A clinical study of patients with symptomatic NOH to assess sustained effects of droxidopa therapy NCT01927055. Secondary a clinical study of patients with symptomatic NOH to assess sustained effects of droxidopa therapy NCT01927055 2015. http://www.webcitation.org/6aD0EScZg.
29. Pavy-Le Traon A. Efficacy of L-Threo DOPS on orthostatic hypotension symptoms and other nonmotor symptoms in patients with MSA (DOPSAMS) NCT02071459. Secondary efficacy of L-Threo DOPS on orthostatic hypotension symptoms and other nonmotor symptoms in patients with MSA (DOPS-AMS) NCT02071459 2015. http://www.webcitation.org/6aBOHRKvY.
30. Khandelwal E, Jaryal AK, Deepak KK. Cardiovascular autonomic functions & cerebral autoregulation in patients with orthostatic hypotension. Indian J Med Res 2011; 134:463-469.
31. Suzuki T, Sakoda S, Ueji M, Kishimoto S, Hayashi A, Kondo T, Narabayashi H. Treatment of Parkinsonism with L-Threo-3, 4-dihydroxyphenylserine: A pharmacokinetic study. Neurology 1984; 34:1446-1450.
32. 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. Midodrine Study Group. JAMA 1997; 277:1046-1051.
33. Smit AA, Halliwill JR, Low PA, Wieling W. Pathophysiological basis of orthostatic hypotension in autonomic failure. J Physiol 1999; 519:1-10.
34. Hauer K, Lamb SE, Jorstad EC, Todd C, Becker C. Systematic review of definitions and methods of measuring falls in randomised controlled fall prevention trials. CB PROFANE-Group. Age Ageing 2006; 35:5-10.
35. Lamb SE, Jorstad-Stein EC, Hauer K, Becker C, Prevention of Falls Network Europe and Outcomes Consensus Group. Development of a common outcome data set for fall injury prevention trials: The Prevention of Falls Network Europe consensus. J Am Geriatr Soc 2005; 53:1618-1622.
36. Straube S, Derry S, McQuay HJ, Moore RA. Enriched enrolment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain. A systematic review. Br J Clin Pharmacol 2008; 66:266-275.
37. Frith J, Elliott CS, Bashir A, Newton JL. Public and patient research priorities for orthostatic hypotension. Age Ageing 2014; 43:865-868.
38. Lahrmann H, Cortelli P, Hilz M, Mathias CJ, Struhal W, Tassinari M. EFNS guidelines on the diagnosis and management of orthostatic hypotension. Eur J Neurol 2006; 13:930-936.
39. Davey J, Turner RM, Clarke MJ, Higgins JP. Characteristics of metaanalyses and their component studies in the Cochrane Database of Systematic Reviews: A cross-sectional, descriptive analysis. BMC Med Res Methodol 2011; 11:160-260.