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Meta-analysis of the safety and efficacy of droxidopa for neurogenic orthostatic hypotension

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Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

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Acknowledgments

We would like to thank our colleagues in Medical Research Society (MRS, Kasr Al ainy School of Medicine, Cairo University, Egypt) and Medical Research Group of Egypt (MRGE; the nationwide student-led medical research team of Egypt) for their encouragement. We are grateful to the two anonymous reviewers for their positive inputs to the content of this manuscript. We would like also to thank Manuscriptedit Company for providing professional language editing service.

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Author notes

  1. Ahmed Negida

    Present address: , El nogoom street, El Kawmia Square, Zagazig, 44523, El-Sharkia, Egypt

Authors and Affiliations

  1. Faculty of Medicine, Al Azhar University, Cairo, Egypt

    Ahmed Elgebaly

  2. Medical Research Society, Cairo University, Cairo, Egypt

    Bassant Abdelazeim & Omar Mattar

  3. Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt

    Bassant Abdelazeim & Omar Mattar

  4. Faculty of Medicine, Alexandria University, Alexandria, Egypt

    Mohamed Gadelkarim

  5. Medical Research Group of Egypt, Cairo, Egypt

    Mohamed Gadelkarim, Rehab Salah & Ahmed Negida

  6. Faculty of Medicine, Benha University, Benha, Egypt

    Rehab Salah

  7. Faculty of Medicine, Zagazig University, Zagazig, Egypt

    Ahmed Negida

  8. Student Research Unit, TICO-Zagazig University, Zagazig, 44519, El-Sharkia, Egypt

    Ahmed Negida

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  1. Ahmed Elgebaly
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Correspondence to Ahmed Negida.

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Elgebaly, A., Abdelazeim, B., Mattar, O. et al. Meta-analysis of the safety and efficacy of droxidopa for neurogenic orthostatic hypotension. Clin Auton Res 26, 171–180 (2016). https://doi.org/10.1007/s10286-016-0349-7

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  • DOI: https://doi.org/10.1007/s10286-016-0349-7

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