Eplerenone not beneficial for treatment of central serous chorioretinopathy: Lancet
UK: Eplerenone, a drug widely used for the treatment of central serous chorioretinopathy (CSCR), is not beneficial and should no longer be used, a recent study published in The Lancet has suggested.
"Ophthalmologists who currently prescribe eplerenone for CSCR should discontinue this practice," wrote the authors.
Chronic central serous chorioretinopathy is an eye condition characterized by fluid accumulation in the subretinal space. It is a common visually disabling condition that develops in individuals up to 60 years of age, and there is no definitive treatment.
Eplerenone, primarily used to treat heart failure, is currently offered widely by ophthalmologists as a treatment for CSCR based on limited clinical data. This drug, however, is not licensed for the treatment of patients with CSCR.
Andrew Lotery, Faculty of Medicine, University of Southampton, Southampton, UK, and colleagues aimed to evaluate whether eplerenone was superior to placebo in terms of improving visual acuity in patients with chronic CSCR.
This randomized, double-blind, parallel-group multicentre placebo-controlled trial was performed at 22 hospitals in the UK. Patients aged 18–60 years and having treatment-naive CSCR for 4 months or more were eligible to be included in the study. 114 patients were assigned to receive either oral eplerenone (25 mg/day for 1 week, increasing to 50 mg/day for up to 12 months) plus usual care (n=57) or placebo plus usual care for up to 12 months (n=57). All participants, care teams, outcome assessors, pharmacists, and members of the trial management group were masked to the treatment allocation. The primary outcome was BCVA, measured as letters read, at 12 months.
All outcomes apart from safety were analyzed on a modified intention-to-treat basis (participants who withdrew consent without contributing a post-randomization BCVA measurement were excluded from the primary analysis population and from most secondary analysis populations).
Key findings of the study include:
- Three participants in the placebo group withdrew consent without contributing a post-randomisation BCVA measurement and were excluded from the primary outcome analysis population.
- All patients from the eplerenone group and 54 patients from the placebo group were included in the primary outcome.
- Modelled mean BCVA at 12 months was 79·5 letters (SD 4·5) in the placebo group and 80·4 letters (4·6) in the eplerenone group, with an adjusted estimated mean difference of 1·73 letters at 12 months.
- Hyperkalaemia occurred in eight (14%) patients in each group.
- No serious adverse events were reported in the eplerenone group and three unrelated serious adverse events were reported in the placebo group (myocardial infarction [anticipated], diverticulitis [unanticipated], and metabolic surgery [unanticipated]).
"Eplerenone was not superior to placebo for improving BCVA in people with chronic CSCR after 12 months of treatment," concluded the authors.
The study, "Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial," is published in The Lancet.