However, study did not meet primary objective of reducing odds of vasovagal syncope by 40 percent
FRIDAY, July 1, 2016 (HealthDay News) — Fludrocortisone is associated with a reduction in the risk of vasovagal syncope, according to a study published in the July 5 issue of the Journal of the American College of Cardiology.
Robert Sheldon, M.D., Ph.D., from the University of Calgary in Canada, and colleagues examined whether fludrocortisone treatment reduces the risk of recurrent vasovagal syncope by at least 40 percent. A total of 210 patients with a median of 15 syncopal spells over a median of nine years were randomized to fludrocortisone or placebo; 14 patients were lost to follow-up before syncopal recurrence.
The researchers found that 96 patients had one or more syncope recurrences. The fludrocortisone group had a marginally nonsignificant reduction in syncope (hazard ratio, 0.69; 95 percent confidence interval, 0.46 to 1.03). Fludrocortisone correlated with a significant reduction in the likelihood of syncope in a multivariable model (hazard ratio, 0.63; 95 percent confidence interval, 0.42 to 0.94). There was a significant benefit due to fludrocortisone when analysis was restricted to outcomes after two weeks of dose stabilization (hazard ratio, 0.51; 95 percent confidence interval, 0.28 to 0.89).
“The study did not meet its primary objective of demonstrating that fludrocortisone reduced the likelihood of vasovagal syncope by the specified risk reduction of 40 percent,” the authors write. “The study demonstrated a significant effect after dose stabilization, and there were significant findings in post hoc multivariable and on-treatment analyses.”
Several authors disclosed financial ties to the pharmaceutical and medical device industries.
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