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POST 2: Fludrocortisone may be effective for some patients with vasovagal syncope
Despite not reaching the primary endpoint of 40% risk reduction, fludrocortisone may be effective in treating vasovagal syncope after dose stability in certain patients, according to results from the POST 2 trial.
Robert Sheldon, MD, PhD, from the division of cardiology, department of cardiac sciences at the University of Calgary, Alberta, Canada, and colleagues conducted a randomized, placebo-controlled, double blind trial to evaluate the effectiveness of fludrocortisone in treating vasovagal syncope.
Robert Sheldon
To be included in the study, patients had to be aged at least 14 years, have a score of greater than –3 on the Calgary Syncope Symptom Score and have had more than two lifetime syncopal spells. Patients were randomly assigned fludrocortisone or a matching placebo for 1 year. Two hundred ten patients at 17 university hospitals in Canada, the United States and Poland were initially given fludrocortisone 0.1 mg per day, which was increased to 0.2 mg per day within 5 to 14 days if tolerated well. For patients with side effects, the dose was reduced to 0.05 mg per day.
The outcome of interest was first recurrence of syncope. Median follow-up was 364 days.
The researchers found 96 patients had at least one syncopal spell and 56 patients did not have any spells during the study period. Fifty-eight patients withdrew before experiencing syncope. Syncope rates in the fludrocortisone group were 44% vs. 60.5% in the placebo group (HR = 0.69; 95% CI, 0.46-1.03). In the competing-risks analysis, the event rates were 41% in the fludrocortisone group and 54.5% in the placebo group (P = .082).
In an exploratory analysis of only syncopal spells that occurred after the 2-week dose stabilization, fludrocortisone was associated with significant reduction in the number of syncope events (HR = 0.51; 95% CI, 0.28-0.89). In an adjusted model, the HR for the fludrocortisone group was 0.63 (P = .024).
“Larger studies would be needed to determine the agent’s utility in specific subgroups of patients,” the researchers wrote.
In an accompanying editorial, Michele Brignole, MD, of the arrhythmologic center and syncope unit, department of cardiology, Ospedali del Tigullio, Lavagna, Italy, wrote,
“Despite several limitations and precautions, which are clearly acknowledged by the authors themselves, the POST 2 trial provided convincing data supporting the benefit of fludrocortisone for the prevention of syncopal recurrences, especially in young patients with low-normal values of arterial [BP] and without comorbidities.”
Brignole also wrote that “The study cannot be considered conclusive; indications, benefit and risk need to be assessed in larger studies with longer follow-up.” – by Tracey Romero
Disclosure : Sheldon and Brignole report no relevant financial disclosures. Please see full study for list of all other researchers’ relevant financial disclosures.