Relation Between Benchmark Dose and No-Observed-Adverse-Effect Level in Clinical Research: Effects of Daily Alcohol Intake on Blood Pressure in Japanese Salesmen

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Abstract:

The benchmark dose (BMD) is defined as the dose that corresponds to a specific change in an adverse response compared to the response in unexposed subjects, and the lower 95% confidence limit is termed the benchmark dose level (BMDL). In this study, the threshold of daily ethanol intake affecting blood pressure was calculated by both the BMD approach and multiple logistic regression analysis to clarify the relation between the BMDL and no-observed-adverse-effect level (NOAEL). Systolic and diastolic blood pressures (SBP and DBP) and daily ethanol intake were explored in 1,100 Japanese salesmen. The SBP and DBP were positively related to daily ethanol intake (p < 0.001) when adjusting for possible confounders such as age, body mass index, and smoking status. The adjusted risk for hypertension (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) increased significantly when daily ethanol intake exceeded 60 g/day, and the categorical dose of interest was 60.1–90 g/day. The BMDL and BMD of ethanol intake for increased SBP and DBP were estimated to be approximately 60 and 75 g/day, respectively. These findings suggest that the BMDL and BMD correspond to the NOAEL and lowest-observed-adverse-effect level, respectively, if the sample number of clinical data is large enough to confirm the dose-response association.

Keywords: Benchmark dose calculation; blood pressure; clinical research; daily ethanol intake; no-observed-adverse-effect level

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1539-6924.2006.00722.x

Affiliations: Department of Environmental Health Sciences, Akita University School of Medicine, Akita, Japan.

Publication date: February 1, 2006

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