Table 2.
Between-Group Statistical Analysis of Change From Baseline (Day 1) to Day 90 in Biomarkers of Exposure in the CEVal-Compliant Population
| Biomarker (units) | Study group | N | LS mean | Comparison | Difference (99.94% CI) | p |
|---|---|---|---|---|---|---|
| TNeq (mg/24 h) | Group A | 32 | −2.83 | B – A | −1.36 (−6.36, 3.65) | .33810 |
| Group B | 60 | −4.18 | ||||
| HEMA (µg/24 h) | Group A | 32 | −2.21 | B – A | −1.12 (−10.09, 7.86) | .65940 |
| Group B | 60 | −3.33 | ||||
| Total NNN (ng/24 h) | Group A | 32 | 1 | B – A | −4.61 (−25.77, 16.56) | .44070 |
| Group B | 60 | −3.61 | ||||
| Total NNAL (ng/24 h) | Group A | 32 | −5 | B – A | −105 (−193, −17) | <.0001 |
| Group B | 60 | −110 | ||||
| 3-HPMA (µg/24 h) | Group A | 32 | 249 | B – A | −926 (−1426, −426) | <.0001 |
| Group B | 60 | −677 | ||||
| o-tol (ng/24 h) | Group A | 32 | −2 | B – A | −112 (−257, 33) | .00730 |
| Group B | 60 | −114 | ||||
| 4-ABP (ng/24 h) | Group A | 32 | −2 | B – A | −9.5 (−15.9, −3.1) | <.0001 |
| Group B | 60 | −11.6 | ||||
| HMPMA (µg/24 h) | Group A | 32 | −28 | B – A | −285 (−440, −130) | <.0001 |
| Group B | 60 | −313 | ||||
| eCO (ppm) | Group A | 32 | 14.98 | B – A | −13.38 (−17.94, −8.82) | <.0001 |
| Group B | 60 | 1.61 | ||||
| MHBMA (µg/24 h) | Group A | 32 | 0.42 | B – A | −3.34 (−5.62, −1.07) | <.0001 |
| Group B | 60 | −2.92 | ||||
| 2-AN (ng/24 h) | Group A | 32 | −1.7 | B – A | −17.6 (−26.9, −8.4) | <.0001 |
| Group B | 60 | −19.4 | ||||
| S-PMA (µg/24 h) | Group A | 32 | −0.91 | B – A | −2.64 (−4.79, −0.5) | <.0001 |
| Group B | 60 | −3.55 | ||||
| CEMA (µg/24 h) | Group A | 32 | 0 | B – A | −151 (−219, −83) | <.0001 |
| Group B | 60 | −151 |
TNeq, total nicotine equivalents (nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates); HEMA, 2-hydroxyethylmercapturic acid; NNN, N-nitrosonornicotine; NNAL, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; 3-HPMA, 3-hydroxypropylmercapturic acid; o-tol, o-toluidine; 4-ABP, 4-aminobiphenyl; HMPMA, 3-hydroxy-1-methylpropylmercapturic acid; eCO, exhaled carbon monoxide; MHBMA, monohydroxybutenyl-mercapturic acid; 2-AN, 2-aminonaphthalene; S-PMA, S-phenylmercapturic acid; CEMA, 2-cyanoethylmercapturic acid; LS mean, least squares mean; CI, confidence interval.
Group A, continue to smoke combustible cigarettes; Group B, switch to glo. All analyses, except for eCO, were performed using biomarker levels from 24-h urine collections at baseline (day 1) and on day 90. Statistical analysis for the change in eCO levels was performed on data captured at baseline and the average of values obtained on days 120 and 150.