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August 2, 2021Annals of Internal Medicine

Midodrine for the Prevention of Vasovagal Syncope

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Key result

Midodrine reduced the risk of at least 1 syncope episode compared to placebo (42% vs 61%; RR 0.69; 95% CI 0.49-0.97; P=0.035) in patients with recurrent vasovagal syncope.

Why the study?

Recurrent vasovagal syncope is common and responds poorly to treatment. Although midodrine prevents hypotension and syncope during tilt tests, whether it prevents vasovagal syncope in usual clinical conditions was unknown.

Does midodrine prevent recurrent syncope in patients with vasovagal syncope?

Population

133 patients with recurrent vasovagal syncope and no serious comorbid conditions

Comparison

Midodrine vs placebo

Design

Multicenter randomized double-blind placebo-controlled clinical trial

Follow-up

12 months

Authors

RSRobert S. SheldonPFPeter FarisATAnthony Tang

Discussion

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Overview

Supports midodrine for recurrent vasovagal syncope; confirms benefit in dedicated RCT.

Study Design

Type

RCT (n=133)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Does midodrine prevent recurrent syncope in patients with vasovagal syncope?

P
Population
133 patients (median age 32, 73% female) with recurrent vasovagal syncope and no serious comorbid conditions, followed for 12 months.
I
Intervention
Midodrine for 12 months
C
Comparator
Placebo for 12 months
O
Outcome
Proportion of patients with at least 1 syncope episode during 12 months follow-uphard clinical

Main Result

Relative Risk: 0.69 (95% CI 0.49–0.97)

Absolute Event Rate: 42% vs 61%

Absolute Risk Reduction: 19%

Number Needed to Treat: 5.3

p-value: p=0.035

Midodrine significantly reduces the recurrence of syncope in young, healthy patients with a high burden of vasovagal syncope.

Limitations

  • Small study size
  • Young and healthy patients
  • Relatively short observation period
  • High proportion of patients from 1 center
  • young and healthy patients
  • relatively short observation period
  • high proportion of patients from 1 center

Cite This Study

Sheldon et al. (2021) conducted an RCT in Recurrent vasovagal syncope (n=133). Midodrine vs. Placebo was evaluated on Proportion of patients with at least 1 syncope episode during follow-up (RR 0.69, 95% CI 0.49 to 0.97, p=0.035). Midodrine reduced the risk of at least 1 syncope episode compared to placebo (42% vs 61%; RR 0.69; 95% CI 0.49-0.97; P=0.035) in patients with recurrent vasovagal syncope.

synapsesocial.com/papers/6a8c19d2bb5c03e832c46063https://doi.org/10.7326/m20-5415
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Salt supplement increases plasma volume and orthostatic tolerance in patients with unexplained syncope.1996 · 265 citations
  2. 2Usefulness of Midodrine in Patients with Severely Symptomatic Neurocardiogenic Syncope: A Randomized Control Study2001 · 165 citations
  3. 3Midodrine in neurally mediated syncope: A double‐blind, randomized, crossover study2002 · 138 citations
  4. 4Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope2017 · 130 citations
  5. 5Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole2020 · 119 citations