Table 1.
Summary of study demographics and urinary biomarkers at baseline.
| Treatment Sequence Assignment | |||
|---|---|---|---|
| Characteristics or Biomarkers | PEITC-Placebo | Placebo-PEITC | P-valuea |
| Number of subjectsb | 39 | 40 | |
| Age (years), mean (SD) | 41.6 (10.5) | 40.8 (9.6) | 0.74 |
| Body mass index (kg/m2), mean (SD)d | 28.2 (4.8) | 28.2 (6.3) | 0.97 |
| Gender, n (%) | 0.31 | ||
| Male | 23 (59.0) | 19 (47.5) | |
| Female | 16 (41.0) | 21 (52.5) | |
| Race, n (%) | >0.99 | ||
| Black | 8 (20.5) | 9 (22.5) | |
| White | 26 (66.7) | 27 (67.5) | |
| Other | 5 (12.8) | 4 (10.0) | |
| Level of education, n (%) | 0.20 | ||
| High school or lower | 13 (33.3) | 19 (47.5) | |
| College or higher | 26 (66.7) | 21 (52.5) | |
| Cigarettes per day, mean (SD)e | 22.2 (9.4) | 21.1 (7.1) | 0.57 |
| Alcohol drinking, n (%)d | 0.69 | ||
| Never | 13 (34.2) | 17 (43.6) | |
| Monthly or less | 13 (34.2) | 12 (30.8) | |
| Weekly | 12 (31.6) | 10 (25.6) | |
| GSTM1 and GSTT1 genotypes, n (%) | 0.67 | ||
| Present and present | 19 (48.7) | 18 (45.0) | |
| Present and null | 3 (7.7) | 3 (7.5) | |
| Null and present | 13 (33.3) | 11 (27.5) | |
| Null and null | 4 (10.3) | 8 (20.0) | |
| Urinary biomarkersc, geometric mean (95% CI) | |||
| Total nicotine equivalents (TNE, nmol/mg Cr) | 45.7 (38.1, 54.8) | 59.3 (48.9, 71.8) | 0.05 |
| MHBMA (ng/mg Cr) | 15.2 (10.5, 22.1) | 13.4 (9.9, 18.3) | 0.60 |
| DHBMA (ng/mg Cr) | 753.3 (601.2, 943.9) | 642.7 (442.2, 934.1) | 0.46 |
a
P-value is for Student’s t-test for continuous variables and Chi-Square test or Fisher’s exact test for categorical variables.
b
There were 88 subjects, but nine were removed from all analyses: eight due to missing outcomes at baseline, and one due to values of DHBMA and LOD.
c
Urinary biomarkers are adjusted for creatinine and log-transformed. MHBMA and DHBMA were also adjusted for batch.
d
Two subjects were excluded from this analysis due to missing data.
e
Five subjects were excluded from this analysis due to missing data.