Key result
Selenium supplementation did not significantly reduce the primary composite outcome of persistent heart failure symptoms, unrecovered LVEF, or death (HR 0.69, p=0.113) in peripartum cardiomyopathy.
Why the study?
The efficacy and safety of selenium supplementation in patients with peripartum cardiomyopathy and selenium deficiency needed to be evaluated.
Does oral selenium supplementation reduce the composite of persistence of HF symptoms, unrecovered LV systolic function, or death in patients with peripartum cardiomyopathy and selenium deficiency?
RCT (n=100)
Open-label
Random number generator app
Yes
Does oral selenium supplementation reduce the composite of persistence of HF symptoms, unrecovered LV systolic function, or death in patients with peripartum cardiomyopathy and selenium deficiency?
Answers are grounded in this paper and cite their sources.
Selenium supplementation did not meet the primary composite endpoint in selenium-deficient PPCM; leaves open any role in symptom relief pending confirmatory trials.
BACKGROUND: We studied the efficacy and safety of selenium supplementation in patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency. METHODS: We randomly assigned 100 PPCM patients with left ventricular ejection fraction (LVEF) < 45% and selenium deficiency (< 70 μg/L) to receive either oral Selenium (L-selenomethionine) 200 μg/day for 3 months or nothing, in addition to recommended therapy, in an open-label randomised trial. The primary outcome was a composite of persistence of heart failure (HF) symptoms, unrecovered LV systolic function (LVEF < 55%) or death from any cause. RESULTS: Over a median of 19 months, the primary outcome occurred in 36 of 46 patients (78.3%) in the selenium group and in 43 of 54 patients (79.6%) in the control group (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.43-1.09; p = 0.113). Persistence of HF symptoms occurred in 18 patients (39.1%) in the selenium group and in 37 patients (68.5%) in the control group (HR 0.53; 95% CI 0.30-0.93; p = 0.006). LVEF < 55% occurred in 33 patients (71.7%) in the selenium group and in 38 patients (70.4%) in the control group (HR 0.91; 95% CI 0.57-1.45; p = 0.944). Death from any cause occurred in 3 patients (6.5%) in the selenium group and in 9 patients (16.7%) in the control group (HR 0.37; 95% CI 0.10-1.37; p = 0.137). CONCLUSIONS: In this study, selenium supplementation did not reduce the risk of the primary outcome, but it significantly reduced HF symptoms, and there was a trend towards a reduction of all-cause mortality. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03081949.
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Karaye et al. (2020) conducted an RCT in Peripartum cardiomyopathy with selenium deficiency (n=100). Selenium (L-selenomethionine) vs. Nothing (standard therapy only) was evaluated on Composite of persistence of heart failure symptoms, unrecovered LV systolic function (LVEF < 55%) or death from any cause (HR 0.69, 95% CI 0.43-1.09, p=0.113). Selenium supplementation did not significantly reduce the primary composite outcome of persistent heart failure symptoms, unrecovered LVEF, or death (HR 0.69, p=0.113) in peripartum cardiomyopathy.
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