Disodium edetate 0.4% ophthalmic solution

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.

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Parenteral N-acetylcysteine has a wide variety of clinical applications, but its use can be limited by a poor chemical stability. We managed to control parenteral N-acetylcysteine stability, and to study the influence of additives on the decrease of N-acetylcysteine degradation. First, an HPLC-UV dosing method of N-acetylcysteine and its main degradation product, a dimer, was validated and the stability without additive was studied. Then, the influence of several additives (ascorbic acid, sodium edetate, tocopherol and zinc) and of temperature on N-acetylcysteine dimerization was evaluated. Finally, the influence of zinc gluconate at different concentrations (administrable to patients) was investigated. Zinc gluconate at 62.5 µg·mL-1 allows the stabilization of 25 mg·mL-1 N-acetylcysteine solution for at least 8 days when stored at 5 ± 3 °C.

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Background/Objectives: The objective of this in vitro study was to compare and evaluate the in vitro antimicrobial effectiveness of Endosal, Octenisolv, and Endoxal against intracanal Enterococcus faecalis. Methods: The study sample consisted of 84 extracted single-rooted human teeth, which were divided into seven groups (12 roots in each group): Group 1—Endoxal, Group 2—Octenisolv, Group 3—Endosal, Group 4—15% ethylenediaminetetraacetic acid (EDTA), Group 5—2% sodium hypochlorite (NaOCl), Group 6—0.9% sterile saline solution (NaCl), and one positive control group where no irrigant was used. The roots were sterilized within an autoclave for 30 min at 121 °C and then contaminated with E. faecalis bacteria, after instrumentation and removing the smear layer from canals. The root canals were irrigated using a side-vented needle, and then ISO size 40 H-file was used to obtain fine dentine chips. Aliquots taken from the canals were plated on blood agar broth and the plates were incubated for 36 h. Results: In this study, significant differences were observed between the antimicrobial activity of Endoxal, Octenisolv, Endosal, 2% NaOCl, and sterile saline solution. Conclusions: The compound irrigants Endosal, Endoxal, and a novel irrigant containing disodium edetate and octenidine, which were evaluated in this study, exhibited relatively good antimicrobial properties against Enterococcus faecalis. The use of Endosal, Octenisolv or Endoxal appears promising, yet their clinical efficacy remains to be confirmed through further studies.

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