title: Meta-analysis of the safety and efficacy of droxidopa for neurogenic orthostatic hypotension.
abstract: Droxidopa has been approved for the treatment of neurogenic orthostatic hypotension (NOH) under the US Food and Drug Administration accelerated approval program, which warrants confirmatory evidence on long-term efficacy of droxidopa. Hereby, we synthesize evidence from published randomized controlled trials (RCTs) about the safety and efficacy of droxidopa for patients with neurogenic orthostatic hypotension.
  
  
  
  A computer literature search of PubMed, Scopus, Web of Science, and Cochrane Central was conducted using relevant keywords. Records were screened for eligible studies and data were extracted and synthesized using Review Manager version 5.3 for Windows. Subgroup analysis and sensitivity analysis were conducted to investigate long-term durability of droxidopa against placebo.
  
  
  
  Four RCTs with a total of 485 patients (droxidopa, n = 246; placebo, n = 239) were eligible for the final analysis. The mean difference (MD) of change in the main outcomes from baseline to endpoint favored droxidopa than placebo [Orthostatic Hypotension Questionnaire (OHQ) MD -0.61, P = 0.004; dizziness/lightheadedness score MD -0.83, P = 0.008; and standing systolic blood pressure (SBP) MD 4.09, P = 0.03]. The efficacy of droxidopa decreased gradually after 2 weeks, and its statistical significance was lost after 8 weeks (OHQ score MD -0.18, P = 0.61; dizziness/lightheadedness score MD -0.71, P = 0.11; and standing SBP MD 2.96, P = 0.29). None of the adverse events were significantly higher in the case of droxidopa compared to placebo.
  
  
  
  Droxidopa is a safe and effective drug for the short-term management of NOH symptoms. However, current evidence is insufficient to confirm the efficacy of droxidopa for long-term use. Therefore, further studies with increased sample size are needed.
authors.affiliation: Faculty of Medicine, Al Azhar University, Cairo, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Elgebaly
authors.affiliation: Medical Research Society, Cairo University, Cairo, Egypt.|Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
authors.forename: Bassant
authors.initials: B
authors.lastname: Abdelazeim
authors.affiliation: Medical Research Society, Cairo University, Cairo, Egypt.|Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
authors.forename: Omar
authors.initials: O
authors.lastname: Mattar
authors.affiliation: Faculty of Medicine, Alexandria University, Alexandria, Egypt.|Medical Research Group of Egypt, Cairo, Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Gadelkarim
authors.affiliation: Medical Research Group of Egypt, Cairo, Egypt.|Faculty of Medicine, Benha University, Benha, Egypt.
authors.forename: Rehab
authors.initials: R
authors.lastname: Salah
authors.affiliation: Medical Research Group of Egypt, Cairo, Egypt. ahmed01251@medicine.zu.edu.eg.|Faculty of Medicine, Zagazig University, Zagazig, Egypt. ahmed01251@medicine.zu.edu.eg.|Student Research Unit, TICO-Zagazig University, Zagazig, 44519, El-Sharkia, Egypt. ahmed01251@medicine.zu.edu.eg.|, El nogoom street, El Kawmia Square, Zagazig, 44523, El-Sharkia, Egypt. ahmed01251@medicine.zu.edu.eg.
authors.forename: Ahmed
authors.identifier: 0000-0001-5363-6369
authors.initials: A
authors.lastname: Negida
mesh_terms: D015103:Droxidopa / Q000592:standards* / Q000627:therapeutic use*; D006801:Humans; D007024:Hypotension, Orthostatic / Q000188:drug therapy*; D010300:Parkinson Disease / Q000188:drug therapy; D012449:Safety; D016896:Treatment Outcome
chemical_list: D015103:Droxidopa
keywords: Dizziness; Droxidopa; Orthostatic hypotension; Parkinson’s disease; Pure autonomic failure