Effectiveness of midodrine treatment in patients with recurrent vasovagal syncope not responding to non-pharmacological treatment (STAND-trial).

Abstract

AIMS:

Initial treatment of vasovagal syncope (VVS) consists of advising adequate fluid and salt intake, regular exercise, and physical counterpressure manoeuvres. Despite this treatment, up to 30% of patients continue to experience regular episodes of VVS. We investigated whether additional Midodrine treatment is effective in these patients.

METHODS AND RESULTS:

In our study, patients with at least three syncopal and/or severe pre-syncopal recurrences during non-pharmacological treatment were eligible to receive double-blind cross-over treatment starting either with Midodrine or placebo. Treatment periods lasted for 3 months with a wash-out period of 1 week in-between. At baseline and after each treatment period, we collected data about the recurrence of syncope and pre-syncope, side effects, and quality of life (QoL). Twenty-three patients (17% male, mean age 32) included in the cross-over trial received both Midodrine and placebo treatment. The proportion of patients who experienced syncopal and pre-syncopal recurrences did not differ significantly between Midodrine and placebo treatment (syncope: 48 vs. 65%, P= 0.22; pre-syncope: 74 vs. 78%, P> 0.99). The median number of syncopes and pre-syncopes per 3 months were also not significantly different during Midodrine and placebo treatment (0 vs. 1; P= 0.57; and 6 vs. 8; P= 0.90). The occurrence of side effects was similar during Midodrine and placebo treatment (48 vs. 57%; P= 0.75). Also, QoL did not differ significantly.

CONCLUSION:

Our findings indicate that additional Midodrine treatment is less effective in patients with VVS not responding to non-pharmacological treatment than reported as first-line treatment.

• Authors: Jacobus J C M Romme, Nynke van Dijk, Ingeborg K Go-Schön, Johannes B Reitsma, Wouter Wieling
• Journal: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology (Europace) Vol. 13 Issue 11 Pg. 1639-47 (Nov 2011) ISSN: 1532-2092 [Electronic] England
• PMID: 21752826 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic alpha-1 Receptor Agonists
• Midodrine

Topics

• Adrenergic alpha-1 Receptor Agonists (adverse effects, therapeutic use)
• Adult
• Cross-Over Studies
• Double-Blind Method
• Exercise
• Female
• Fluid Therapy
• Humans
• Male
• Middle Aged
• Midodrine (adverse effects, therapeutic use)
• Outcome Assessment, Health Care
• Quality of Life
• Recurrence
• Syncope, Vasovagal (drug therapy, epidemiology)
• Treatment Outcome