Abstract
BackgroundWe studied the efficacy and safety of selenium supplementation in patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency.MethodsWe 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.ResultsOver 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).ConclusionsIn 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 registrationClinicalTrials.gov Identifier: NCT03081949.
Highlights
We studied the efficacy and safety of selenium supplementation in patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency
Outcomes The primary outcome (composite of persistence of heart failure (HF) symptoms, unrecovered left ventricular (LV) systolic function (LVEF < 55%) or death from any cause) occurred in 36 of 46 patients (78.3%) in the selenium group and in 43 of 54 patients (79.6%) in the control group (HR: 0.69; 95% confidence intervals (CI) 0.43–1.09; p = 0.113) (Fig. 2 and Table 3)
Given that 32.6% and 18.5% of patients in the selenium and control groups respectively were asymptomatic at enrolment, we subjected the data to further analysis to ascertain the impact of that on the outcomes
Summary
We studied the efficacy and safety of selenium supplementation in patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency. Results from the peripartum cardiomyopathy in Nigeria (PEACE) registry showed significant variation in the burden of PPCM in the country [3]. Incidence rates as high as 1:96 and as low as 1:1350 deliveries were obtained in the Northern and Southern regions of the country respectively [4]. Reasons for the regional disparity are not yet clear, reports from Niamey (southern Niger Republic) and Kano (northern Nigeria) suggest that selenium deficiency is common in PPCM patients in the regions, with critically low levels of serum selenium in up to 76.9% of the patients [5, 6]. Quantification of one or more selenoproteins (such as glutathione peroxidase (GPX) and selenoprotein P) is used as a functional measure of selenium status [9]
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