POST-2

Prevention of Syncope Trial 2

Patient / Population Intervention / Exposition Vergleich Endpunkt

In 210 patients with recurrent vasovagal syncope, fludrocortisone did not significantly reduce the first recurrence of syncope over one year compared with placebo, although a benefit emerged once the dose had been stabilised.

210

Design

Double-blind, placebo-controlled RCT

Endpunkt

Time to first recurrence of syncope over 1 year

Relevanz

ErgebnisHR 0.69 (95 % CI 0.46–1.03; p=0.069) — the prespecified 40 % relative risk reduction was not met. Restricted to the period after dose stabilisation, HR 0.51 (95 % CI 0.28–0.89; p=0.019).

Sheldon R, Raj SR, Rose MS, et al. J Am Coll Cardiol. 2016;68(1):1-9. 10.1016/j.jacc.2016.04.030

Diskussion & Kritik

It formally missed its primary endpoint and the supportive analyses are post hoc, so the effect is fragile. It is nonetheless the largest randomised evidence for fludrocortisone and underpins its class-IIb place in young patients with low blood pressure.