Table 4.
Absolute and percent change from baseline in MRI measurements of plaque burden after 6, 12, and 24 months (average carotid) and PET/CT measurements of inflammation after 3 and 6 months (index vessel)
| Variable | Absolute values, mean (SE) | Least squares mean (SE) absolute or percent change from baseline | Absolute or percent change from baseline relative to placebo (90% CI) | p value* | ||
|---|---|---|---|---|---|---|
|
|
|
|||||
| Placebo | Dalcetrapib | Placebo | Dalcetrapib | |||
|
MRI (average carotid)—absolute change
| ||||||
| Total vessel area† (mm2) | ||||||
| Baselinet‡ | 61·71 (2·26) | 59·56 (1·86) | ·· | ·· | ·· | ·· |
| Month 6 | 62·03 (2·11) | 60·99 (2·01) | 1·12 (1·38) | −0·79 (1·32) | −1·91 (−4·92 to 1·10) | 0·29 |
| Month 12 | 63·04 (1·97) | 61·88 (2·14) | 1·37 (1·30) | 1·16 (1·26) | −0·21 (−3·05 to 2·63) | 0·90 |
| Month 24 | 67·53 (2-34) | 61·44 (1·87) | 5·72 (1·45) | 1·71 (1·43) | −4·01 (−7·23 to−0·80) | 0·04 |
| Wall area† (mm2) | ||||||
| Baselinet‡ | 30·33 (1·53) | 28·10 (1·01) | ·· | ·· | ·· | ·· |
| Month 6 | 27·69 (1·11) | 28·03 (1·17) | −2·14 (0·86) | −1·66 (0·83) | 0·48 (−1·39 to 2·35) | 0·67 |
| Month 12 | 28·09 (1·02) | 28·58 (1·06) | −1·88 (0·89) | −0·22 (0·87) | 1·66 (−0·30 to 3·61) | 0·16 |
| Month 24 | 32·28 (1·43) | 28·57 (0·86) | 2·69 (1·05) | 0·49 (1·04) | −2·20 (−4·54 to 0·13) | 0·12 |
| Normalised wall index† (%) | ||||||
| Baseline‡ | 48·0 (1·0) | 47·0 (1·0) | ·· | ·· | ·· | ·· |
| Month 6 | 44·0 (1·0) | 45·0 (1·0) | −3·90 (0·80) | −1·90 (0−80) | 2·0 (0·20 to 3·80) | 0·07 |
| Month 12 | 44·0 (1·0) | 46·0 (1·0) | −3·20 (0·70) | −0·70 (0·70) | 2·60 (0·90 to 4·20) | 0·01 |
| Month 24 | 47·0 (1·0) | 47·0 (1·0) | −0·40 (0·80) | 0·30 (0·80) | 0·60 (−1·20 to 2·50) | 0·57 |
|
| ||||||
|
PET/CT (index vessel)—absolute change
| ||||||
| Most diseased segment mean of maximum TBR§ | ||||||
| Baselinet‡ | 2·78 (0·10) | 2·73 (0·10) | ·· | ·· | ·· | ·· |
| Month 3 | 2·65 (0·07) | 2·55 (0·08) | −0·16 (0·06) | −0·21 (0·06) | −0·04 (−0·18 to 0·10) | 0·62 |
| Month 6 | 2·54 (0·08) | 2·56 (0·10) | −0·26(0·08) | −0·19 (0·08) | 0·07 (−0·11 to 0·25) | 0·51 |
|
| ||||||
|
MRI (average carotid)—percent change
| ||||||
| Total vessel area† | ||||||
| Month 6 | ·· | ·· | 2·3 | 0·5 | −1·9 (−5·7to 1·9) | 0·41 |
| Month 12 | ·· | ·· | 3·1 | 2·3 | −0·8 (−5·3 to 3·8) | 0·78 |
| Month 24 | ·· | ·· | 10·7 | 3·6 | −7·1 (−12·8 to −1·3) | 0·04 |
| Wallarea† | ||||||
| Month 6 | ·· | ·· | −6·0 | −3·1 | 2·9(−2·8 to 8·5) | 0·40 |
| Month 12 | ·· | ·· | −3·5 | 2·1 | 5·6 (−0·9 to 12·2) | 0·16 |
| Month 24 | ·· | ·· | 12·4 | 5·6 | −6·9(−l6·0 to 2·3) | 0·22 |
| Normalised wall index† | ||||||
| Month 6 | ·· | ·· | −7·3 | −3·3 | 4·0 (0·2 to 7·8) | 0·08 |
| Month 12 | ·· | ·· | −6·0 | 0·4 | 5·6 (2·0 to 9·2) | 0·01 |
| Month 24 | ·· | ·· | 0·3 | 1·9 | 1·6 (−2·5 to 6·0) | 0·52 |
|
| ||||||
|
PET/CT (index vessel)—percent change
| ||||||
| Most diseased segment mean of maximum TBR§ | ||||||
| Month 3 | ·· | ·· | −4·3 | −5·3 | −1·0 (−6·3 to 4·2) | 0·75 |
| Month 6 | ·· | ·· | −7·4 | −3·6 | 3·8 (−3·0 to 10·6) | 0·35 |
SE=standard error. TBR=target-to-background ratio.
p values (2-sided) are presented for the difference between groups.
For total vessel area, wall area, and normalised wall index, n=39 for placebo and n=44 for dalcetrapib at baseline and month 24; n=37 for placebo and n=44 for dalcetrapib at month 6; and n=40 for placebo and n=45 for dalcetrapib at month 12.
Baseline based on patients having 24 months (6 months) assessment for MRI (PET/CT). Comparisons between timepoints were restricted to patients with data available at both timepoints.
For most diseased segment mean of maximum TBR: n=52 for placebo and n=54 for dalcetrapib at baseline and month 6 and n=55 for placebo and n=56 for dalcetrapib at month 3.