Table 4.
Arithmetic Mean (95% CI) of Biomarkers of Potential Harm—Per-Protocol Population
| n | mTHS | n | mCC | n | SA | Differencea mTHS–mCC [p value] |
Differencea mTHS–SA [p value] |
|
|---|---|---|---|---|---|---|---|---|
| Lipid metabolism | ||||||||
| LDL Cholesterol (mg/dL) | ||||||||
| Baseline | 47 | 114.9 (104.3; 125.6) | 32 | 122.7 (110.5; 134.9) | 9 | 117.7 (94.8; 140.6) | ||
| Day 90 | 47 | 108.4 (97.9; 118.8) | 32 | 118.1 (106.0; 130.2) | 9 | 115.4 (87.8; 143.1) | −3.3 (−12.0; 5.4) [.4489] | −5.1 (−18.9; 8.6) [.4560] |
| HDL cholesterol (mg/dL) | ||||||||
| Baseline | 47 | 48.7 (45.3; 52.1) | 32 | 55.0 (49.5; 60.5) | 9 | 52.8 (46.3; 59.3) | ||
| Day 90 | 47 | 52.1 (48.6; 55.7) | 32 | 56.3 (50.1; 62.6) | 9 | 54.1 (47.7; 60.5) | 1.4 (−2.3; 5.0) [.4547] | 1.3 (−4.4; 7.1) [.6397] |
| Triglycerides (mg/dL) | ||||||||
| Baseline | 47 | 145.7 (121.6; 169.9) | 32 | 121.6 (106.5; 136.8) | 9 | 106.6 (69.8; 143.3) | ||
| Day 90 | 47 | 146.3 (124.1; 168.4) | 32 | 125.7 (109.4; 142.0) | 9 | 102.1 (72.9; 131.3) | 0.9 (−12.8; 14.6) [.8963] | 11.6 (−10.1; 33.4) [.2891] |
| Total cholesterol (mg/dL) | ||||||||
| Baseline | 47 | 185.7 (173.4; 198.0) | 32 | 195.1 (182.3; 207.9) | 9 | 188.0 (158.2; 217.8) | ||
| Day 90 | 47 | 182.8 (171.0; 194.6) | 32 | 195.0 (181.6; 208.4) | 9 | 185.4 (149.6; 221.3) | −4.0 (−13.3; 5.2) [.3860] | −1.4 (−16.1; 13.2) [.8481] |
| Apolipoprotein A1 (mg/dL) | ||||||||
| Baseline | 47 | 140.2 (134.3; 146.1) | 32 | 147.8 (138.0; 157.6) | 9 | 141.1 (128.3; 153.7) | ||
| Day 90 | 47 | 148.7 (141.9; 155.6) | 32 | 152.6 (142.0; 163.2) | 9 | 146.0 (129.7; 162.3) | 3.1 (−4.6; 10.7) [.4281] |
3.7 (−8.3; 15.7) [.5414] |
| Apolipoprotein B (mg/dL) | ||||||||
| Baseline | 47 | 87.7 (79.5; 95.9) | 32 | 90.8 (83.0; 98.6) | 9 | 82.4 (69.1; 95.8) | ||
| Day 90 | 47 | 84.8 (76.4; 93.2) | 32 | 88.8 (80.3; 97.3) | 9 | 82.6 (63.3; 101.8) | −1.6 (−7.2; 4.1) [.5725] |
−3.2 (−12.1; 5.8) [.4829] |
| Inflammation | ||||||||
| WBC (GI/L) | ||||||||
| Baseline | 47 | 8.321 (7.800; 8.840) | 32 | 8.266 (7.610; 8.920) | 9 | 6.850 (5.190; 8.510) | ||
| Day 90 | 47 | 7.330 (6.840; 7.820) | 32 | 7.172 (6.460; 7.880) | 9 | 5.369 (4.330; 6.410) | 0.17 (−0.47; 0.81) [.5954] | 1.11 (0.07; 2.15) [.0364] |
| Cardiovascular risk | ||||||||
| Systolic blood pressure (mm Hg) | ||||||||
| Baseline | 45 | 118.8 (116.1; 121.5) | 31 | 119.7 (116.1; 123.4) | 6 | 116.8 (103.0; 130.6) | ||
| Day 90 | 47 | 116.8 (113.2; 120.3) | 32 | 117.9 (114.3; 121.5) | 9 | 114.1 (109.6; 118.7) | −0.7 (−4.5; 3.1) [.7101] | 1.7 (−4.3; 7.7) [.5753] |
| Diastolic blood pressure (mm Hg) | ||||||||
| Baseline | 45 | 71.3 (68.9; 73.7) | 31 | 73.5 (70.7; 76.3) | 6 | 71.2 (59.5; 82.9) | ||
| Day 90 | 47 | 70.1 (66.9; 73.3) | 32 | 71.0 (67.7; 74.2) | 9 | 68.6 (63.9; 73.2) | 0.2 (−3.7; 4.0) [.9314] | 2.4 (−3.7; 8.4) [.4337] |
| Metabolic syndrome | ||||||||
| Hemoglobin A1C (%) | ||||||||
| Baseline | 47 | 5.4 (5.3; 5.6) | 32 | 5.3 (5.2; 5.4) | 9 | 5.5 (5.3; 5.7) | ||
| Day 90 | 47 | 5.5 (5.3; 5.6) | 32 | 5.4 (5.3; 5.5) | 9 | 5.3 (5.1; 5.6) | −0.04 (−0.16; 0.09) [.5380] | 0.14 (−0.05; 0.32) [.1407] |
| Body weight (kg) | ||||||||
| Baseline | 47 | 78.94 (74.54; 83.34) | 32 | 77.64 (72.88; 82.40) | 9 | 67.97 (59.37; 76.56) | ||
| Day 90 | 47 | 79.60 (75.12; 84.08) | 32 | 78.39 (73.45; 83.34) | 9 | 68.94 (60.63; 77.25) | −0.12 (−1.35; 1.12) [.8507] | −0.59 (−2.60; 1.42) [.5615] |
| Waist circumference (cm) | ||||||||
| Baseline | 47 | 95.8 (91.4; 100.2) | 32 | 97.2 (89.9; 104.4) | 9 | 81.9 (75.3; 88.5) | ||
| Day 90 | 47 | 95.7 (91.0; 100.4) | 32 | 98.8 (90.4; 107.1) | 9 | 81.7 (75.6; 87.7) | −2.1 (−10.2; 6.1) [.6082] | 9.3 (−3.8; 22.5) [.1611] |
| Lung function | ||||||||
| FEV1 (%pred) | ||||||||
| Baseline | 47 | 92.7 (88.8; 96.7) | 32 | 96.5 (91.2; 101.8) | 9 | 95.7 (87.3; 104.0) | ||
| Day 90 | 47 | 90.0 (85.7; 94.2) | 31 | 92.6 (87.2; 98.0) | 9 | 94.1 (86.3; 101.9) | 0.53 (−2.79; 3.85) [.7499] | −1.46 (−6.63; 3.71) [.5748] |
Apo A1 = apolipoprotein A1; Apo B = apolipoprotein B; CI = confidence interval; FEV1 %pred = percentage of predicted forced expiratory volume in 1 second; HDL = high-density lipoprotein; LDL = low-density lipoprotein; LS = least square; mCC = menthol cigarettes; mTHS = menthol Tobacco Heating System 2.2; SA = smoking abstinence; WBC = white blood cells.
aOriginal scale LS mean difference from analysis of covariance conducted on day 90 values with baseline value, study arm, sex, and cigarette consumption reported at screening as fixed effect factors.