Date of Award

2017

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

Objective: The objective of this selective EBM review is to determine whether or not droxidopa is safe and effective in reducing the symptoms of neurogenic orthostatic hypotension.

Study Design: Systemic review of three English-language primary studies, conducted in 2014 or later.

Data Sources: Three double-blind, randomized trials comparing the safety and efficacy of droxidopa to placebo in patients with diagnosed neurogenic orthostatic hypotension, found via PubMed in peer-reviewed journals.

Outcomes Measured: Improvement of symptoms was measured utilizing patient responses to the Orthostatic Hypotension Questionnaire (OHQ), which consists of a six item Orthostatic Hypotension Symptom Assessment (OSHA) and the four item Orthostatic Hypotension Daily Activity Scale (OHDAS), each measured on a 1-10 scale. Also utilized was the patient-rated Clinical Global Impression (CGI) severity and improvement 7-point scales. Safety was measured through incidence of adverse effects during the randomized trial.

Results: Biaggioni, et al, exhibited 46% of droxidopa recipients describing themselves as much or very much improved according to CGI ratings, compared to 27.5% of those receiving placebo, although with a p-score of 0.384. Hauser, et al, exhibited mean improvement in OSHA item 1 at week 1 as 2.3 for droxidopa, compared to 1.3 in the control group, with a p-value of 0.018. Kaufmann, et al, exhibited improvement of greater than 3 units in composite OHQ score in 27.2% of droxidopa recipients compared to 11.4% of placebo recipients, with a p score of 0.016. Numbers needed to harm were presented for each studied, obtained through measurement of adverse effects of experiment vs control during randomized trial, and consisted of -13 in Biaggioni, et al, 38 in Hauser, et al, and 28 in Kaufmann, et al.

Conclusions: These results indicate that droxidopa showed statistical improvement in symptoms in two studies and numerical improvement in another, in addition to being relatively well tolerated. However, the difference in end points measured in each studies and inconsistencies in study design prevent any strong conclusion, and further study is required.

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