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• W4281842011 abstract "To the Editor: In our published article “The Association Between Dimethylacetamide Exposure and Liver Toxicity: A Large Retrospective Analysis in Workers From Four European Factories” by your journal, we used the 90th percentile of the N,N-Dimethylacetamide (DMAc) exposure distribution based on 8-hour time-weighted average (TWA) measurements to investigate the association between DMAc exposure and liver toxicity. As a sensitivity analysis, we reanalyzed the data using the DMAc median distribution. The conclusions of the published article remain unchanged: “This study found no association between DMAc exposure and hepatoxicity among European workers. The prevalence of elevated liver values was lower compared to the general population without occupational exposure.” This was expected because it is based on identical data as before but now evaluated with the lower median values (up to 6 ppm) based on 8-hour TWA measurements of all DMAc air exposures in parts per million for each year. Sensitivity Statistical Analysis Using DMAc Median Values All analyses were repeated using the median distribution based on 8-hour TWA measurements of all DMAc air exposures in parts per million for each year. The following groups, which were used as dummy variables in the statistical analysis, were constructed based on DMAc exposure measured in parts per million: (1) 0.00 to 0.50 ppm, (2) 0.51 to 1.00 ppm, (3) 1.01 to 1.50 ppm, (4) 1.51 to 2.00 ppm, (5) 2.01 to 2.50 ppm, (6) 2.51 to 3.00, (7) 3.01 to 4.00 ppm, and (8) 4.01 to 6.00 ppm. RESULTS Descriptive Statistics Table 1 presents the number of observations, means, medians, and range of values for the two liver enzymes based on ppm group exposure. Mean values of alanine aminotrasferease (ALT) and alkaline phosphatase (AP) were generally within the reference range (ie, less than the upper normal limit). Slightly higher ALT means, compared with the other groups, were observed for the groups with exposure between 1.01 and 1.5 (mean [SD], 30.4 [20.2] IU/L). TABLE 1 - Descriptive Characteristics of ALT and AP Values Based on Median ppm Exposure Categories DMAc Group [Median] ALT, IU/L (n = 1844) AP, IU/L (n = 951) Observations, n Mean (SD) Median (IQR) Range Observations, n Mean (SD) Median (IQR) Range 0.00–0.50 499 27.7 (14.4) 24 (18–33) 5–100 496 66.1 (18.2) 64 (53–77) 27–136 0.51–1.00 209 28.0 (14.5) 24 (18–32) 8–98 154 65.1 (16.1) 64 (54–74) 28–115 1.01–1.50 299 30.4 (20.2) 26 (17–37) 6–201 100 66.1 (14.9) 64 (56–76) 29–102 1.51–2.00 320 27.8 (18.3) 23 (16–34) 6–139 38 66.8 (18.6) 63 (51–78) 38–101 2.01–2.50 253 28.1 (17.1) 23 (17–33) 6–100 27 65.1 (12.8) 65 (60–73) 35–96 2.51–3.00 120 25.5 (13.4) 22 (16–31) 11–98 28 68.2 (13.2) 70 (62–73) 36–93 3.01–4.00 69 25.1 (16.6) 21 (15–30) 6–125 45 65.5 (11.7) 66 (58–75) 40–95 4.01–6.00 75 25.3 (10.6) 23 (18–32) 10–67 63 69.5 (13.9) 67 (62–77) 39–123 ALT, alanine aminotransferease; AP, alkaline phosphatase; DMAc, N,N-Dimethylacetamide; IQR, interquartile range; ppm, parts per million. Elevated Liver Values Regression Analyses The results of the logistic regression (Table 2) showed a nonsignificant inverse association between DMAc exposure and ALT values for continuous ppm exposure (odds ratio, 0.96 [95% confidence interval, 0.57 to 1.62]; P = 0.88) and for groups of exposure (odds ratios ranging from 1.15 to 4.18, P values ranging from 0.06 to 0.91) (Table 3). TABLE 2 - Effect of Continuous Exposure on Elevated ALT Valuesa ALT Odds Ratio Standard Error 95% Confidence Interval P ppm median 0.96 0.26 0.57–1.62 0.88 ALT, alanine aminotransferease; ppm, parts per million.aNumber of observations included in the regression model: 1844. TABLE 3 - Effect of Groups of Exposure on Elevated ALT Valuesa ALT DMAc Group [Median] Observations, n Odds Ratio Standard Error 95% Confidence Interval P 0.00–0.50 499 Reference 0.51–1.00 209 1.63 1.65 0.23–11.83 0.63 1.01–1.50 299 4.18 3.19 0.94–18.64 0.06 1.51–2.00 320 3.20 2.46 0.71–14.48 0.13 2.01–2.50 253 3.50 2.79 0.73–16.70 0.12 2.51–3.00 120 1.15 1.44 0.10–13.52 0.91 3.01–4.00 69 2.50 3.24 0.19–32.32 0.49 4.01–6.00 75 – – – – ALT, alanine aminotransferease; DMAc, N,N-Dimethylacetamide.aNumber of observations included in the regression model: 1769 (because no elevations were observed for the group with exposure between 4.01 and 6.00 ppm, and 75 observations were not included in the logistic model); odds ratio [OR]: an OR of 1 suggests no association between exposure and liver values; P value: if P value is >0.05, then the association is not statistically significant. Patterns of Liver Injury Twenty-nine observations (1.5%) with more or equal than twice the upper limit normal of ALT and four observations (0.2%) with more or equal than 3 times the upper limit normal of ALT were identified. When the 5×ULN threshold for ALT was used, one observation (0.05%) with a clearly elevated ALT value was identified. On the basis of the criteria for the identification of liver injury, two observations (0.1%) of hepatocellular liver injuries and five observations (0.3%) of mixed injury were detected (Table 4). No observations of cholestatic injury were identified. TABLE 4 - Number of Indicative Cases DMAc Group [Median] Elevated ALT Levelsc Indication for Liver Injury(≥2×ULN and R Criteria Met)c Observations, n Observations ALT ≥ 2×ULN,a n Observations ALT ≥ 3×ULN, n Observations Hepatocellular,b n Observations Mixed, n Observations Cholestatic, n 0.00–0.50 499 4 0 0 3 0 0.51–1.00 209 2 0 1 1 0 1.01–1.50 299 8 1 0 0 0 1.51–2.00 320 7 2 0 1 0 2.01–2.50 253 6 0 0 0 0 2.51–3.00 120 1 0 0 0 0 3.01–4.00 68 1 1 1 0 0 4.01–6.00 75 0 0 0 0 0 Total 1844 29 4 2 5 0 aULN = 40 IU/L.bBecause of a limited number of cases, only logistic regression analyses for 2×ULN cases could be performed.cDetailed information about the observations with elevated ALT and indications of liver injury is available upon request.±One elevated observation was observed when the threshold was set to 5×ULN. Continuous ALT Values Regression Analysis The results from the random effects linear regression analysis showed a significant decrease of 0.77 IU/L (SE = 0.38, P = 0.04) in ALT enzyme for every ppm increase of DMAc, that is, an inverse relationship between exposure and liver injury (Table 5). TABLE 5 - Effect of Continuous Exposure on Continuous ALT Valuesa ALT β Coefficient Standard Error 95% Confidence Interval P ppm median −0.77 0.38 −1.51 to −0.03 0.04 ALT, alanine aminotranferease; ppm, parts per million.aNumber of observations in the regression model = 1844.β Coefficient: the degree of IU/L change in ALT for every ppm increase of DMAc. When we used groups of ppm exposure as the categorical exposure, we observed a nonsignificant (full model P = 0.14) decrease of the ALT mean values for every category of ppm exposure (Table 6). TABLE 6 - Effect of Groups of Exposure on Continuous ALT Values ALT DMAc Group [Median] Observations, n Mean Standard Error 95% Confidence Interval P 0.00–0.50 499 29.1 1.14 26.85–31.31 0.14 0.51–1.00 209 28.7 1.01 26.75–30.70 1.01–1.50 299 28.4 0.92 26.55–30.17 1.51–2.00 320 28.0 0.90 26.24–29.77 2.01–2.50 253 27.6 0.94 25.79–29.49 2.51–3.00 120 27.3 1.04 25.24–29.32 3.01–4.00 69 26.9 1.18 24.60–29.24 4.01–6.00 75 26.6 1.35 24.01–29.22 ALT, alanine aminotranserease; DMAc, N,N-Dimethylacetamide. For the separate exposure categories, all P values were less than 0.001. Evangelia E. Antoniou, PhD MetaAnalyses.com Hees, BelgiumHeinz-Peter Gelbke, PhD CinTox Mannheim, GermanyBallach Jochen, PhD Industrievereinigung Chemiefaser e.V. (IVC) and Treuhandgemeinschaft Deutscher Chemiefasererzeuger (TDC) Frankfurt am Main, GermanyMaurice P. Zeegers, PhD School of Nutrition and Translational Research in Metabolism Maastricht University Maastricht, the Netherlands Care and Public Health Research Institute Maastricht University Maastricht, the Netherlands MyBasePair Holding Heerlen, the NetherlandsArnhild Schrage, PhD BASF SE Ludwigshafen am Rhein, Germany" @default.
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• W4281842011 title "The Association Between Dimethylacetamide Exposure and Liver Toxicity: A Large Retrospective Analysis in Workers From Four European Factories" @default.
• W4281842011 doi "https://doi.org/10.1097/jom.0000000000002589" @default.
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