Sodium calcium edetate 1g/5ml solution for injection ampoules

ImportanceIn 2013, the Trial to Assess Chelation Therapy (TACT) reported that in 1708 patients with stable coronary disease and prior myocardial infarction (MI), oral multivitamins and multiminerals (OMVMs), in a factorial design with edetate disodium (EDTA) chelation therapy, did not reduce cardiovascular events relative to placebo OMVMs, but active EDTA combined with active OMVMs was superior to placebo OMVM/placebo EDTA.ObjectiveTo compare OMVM vs placebo in terms of efficacy for reducing major adverse cardiovascular events in patients with diabetes and prior MI.Design, setting, and participantsThe TACT2 randomized, multicenter double-masked 2 × 2 factorial clinical trial took place across 88 sites in the US and Canada. Participants were 50 years or older, had diabetes, and had an MI 6 weeks ago or more. TACT2 participants were enrolled between September 2016 and December 2020. Data were collected between October 2016 and June 2023.InterventionsSix caplets daily of a 28 component OMVM or matching OMVM placebo, and 40 weekly infusions of an EDTA-based chelation solution or matching placebo, in a 1:1:1:1 allocation ratio.Main outcomes and measuresThe primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina.ResultsA total of 1000 participants were randomized (500 in the active OMVM group and 500 in the placebo group). The median (IQR) age was 67 (60-72) years, and 730 (73%) were male. Median (IQR) follow-up was 48 (34-58) months. The primary end point occurred in 175 participants (35%) in the active OMVM group and 175 (35%) in the placebo group (hazard ratio [HR], 0.99 [95% CI, 0.80-1.22]; P = .92). The 5-year event rate for the primary end point in the EDTA chelation + active OMVM group was 34.0%; in the EDTA chelation + placebo OMVM group, 35.7%; in the placebo infusion + active OMVM group, 36.0%; and in the placebo infusion + placebo OMVM group, 34.3%. The comparison of the active infusion + active OMVM with the placebo infusion + placebo OMVM was not significant (HR, 0.91 [95% CI, 0.67-1.23]; P = .54). Although nonsignificant, there was a numerically higher event rate of MI, stroke, mortality from cardiovascular causes in the active OMVM compared to placebo OMVM group.Conclusions and relevanceThe results of this randomized clinical trial demonstrated that, for participants with chronic coronary disease, diabetes, and a previous MI, high-dose OMVM alone or in conjunction with EDTA-based chelation did not reduce cardiovascular events.Trial registrationClinicalTrials.gov Identifier: NCT02733185.

Abstract licence: CC BY

PurposeTo compare the efficacy, safety, and rate of healing on the corneal epithelial defect after pterygium surgery through the application of either 0.18% or 0.3% sodium hyaluronate (SH).MethodsA randomized, double-blind clinical trial was performed on patients who had pterygium surgery. Eighty-six patients were randomized to 2 groups that would receive either 0.18% SH or 0.3% SH. Measurements of area of the corneal epithelial defect using ImageJ freeware were performed. All corneal epithelial defects were measured immediately after the operation (Day 0) and for the next 3 days.ResultsThe mean and SD of the area of corneal epithelial defect measured on postoperative Day 0, 1, and 2 were 9.13 ± 3.09 mm2, 5.61 ± 3.26 mm2, and 3.39 ± 2.70 mm2 for 0.18% SH group, and 8.96 ± 3.17 mm2, 4.03 ± 1.99 mm2, and 1.55 ± 1.23 mm2 for 0.3% SH group. There was no statistically significant difference of the initial area of the corneal epithelial defect on Day 0 between 0.18% and 0.3% SH group (p = 0.802). The area of the defects in the 0.3% SH group was significantly smaller than that of the 0.18% SH group on both Day 1 and Day 2 (p = 0.007, p ConclusionWith two commercial artificial tears, the corneal epithelial wound healing after pterygium surgery was faster in the 0.3% SH group than that of the 0.18% SH group. Superiority of 0.3% SH may be supported by the presence of epsilon-aminocaproic acid in this drug preparation. No significant adverse effects were exhibited during the short-term follow-up.

Abstract licence: CC BY-NC