Table 3.
Glycaemia intervention effect on cognitive function outcome
| Endpoint | Time point | n | Glycaemia intervention | Difference in mean changesb |
p value for difference in mean change |
|
|---|---|---|---|---|---|---|
|
| ||||||
| Intensivea | Standarda | |||||
| DSST | Baselinec | 2957 | 52.55 | 52.55 | ||
| 20 months | 2747 | 51.52 (51.10, 51.94) | 50.98 (50.56, 51.39) | |||
| 40 months | 2629 | 50.93 (50.51, 51.36) | 50.61 (50.18, 51.03) | |||
| 80 months | 1323 | 49.10 (48.52, 49.69) | 48.79 (48.19, 49.38) | |||
| 20 month change | 2747 | −1.03 (−1.45, −0.61) | −1.57 (−1.99, −1.16) | 0.54 (−0.04, 1.13) | 0.07 | |
| 40 month change | 2629 | −1.62 (−2.04, −1.19) | −1.94 (−2.37, −1.52) | 0.33 (−0.27, 0.93) | 0.29 | |
| 80 month change | 1323 | −3.45 (−4.03, −2.86) | −3.76 (−4.36, −3.17) | 0.32 (−0.52, 1.15) | 0.46 | |
| RAVLT | Baselinec | 2968 | 7.52 | 7.52 | ||
| 20 months | 2762 | 7.88 (7.79, 7.97) | 7.85 (7.76, 7.94) | |||
| 40 months | 2629 | 8.00 (7.90, 8.10) | 7.99 (7.90, 8.09) | |||
| 80 months | 1307 | 7.45 (7.32, 7.59) | 7.51 (7.38, 7.65) | |||
| 20 month change | 2762 | 0.36 (0.27, 0.45) | 0.33 (0.24, 0.42) | 0.03 (−0.10, 0.16) | 0.63 | |
| 40 month change | 2629 | 0.48 (0.38, 0.58) | 0.47 (0.38, 0.57) | −0.01 (−0.13, 0.14) | 0.92 | |
| 80 month change | 1307 | −0.07 (−0.20, 0.07) | −0.01 (−0.14, 0.13) | −0.06 (−0.25, 0.13) | 0.54 | |
| Stroop | Baselinec | 2941 | 32.0 | 32.0 | ||
| 20 months | 2705 | 30.86 (30.19, 31.54) | 31.46 (30.78, 32.12) | |||
| 40 months | 2590 | 31.46 (30.70, 32.22) | 32.07 (31.32, 32.82) | |||
| 80 months | 1286 | 35.21 (34.14, 36.28) | 35.80 (34.71, 36.89) | |||
| 20 month change | 2705 | −1.14 (−1.81, −0.46) | −0.54 (−1.20, 0.12) | −0.60 (−1.54, 0.35) | 0.22 | |
| 40 month change | 2590 | −0.54 (−1.30, 0.22) | 0.07 (−0.68, 0.82) | −0.61 (−1.67, 0.45) | 0.26 | |
| 80 month change | 1286 | 3.21 (2.14, 4.28) | 3.80 (2.71, 4.89) | −0.59 (−2.12, 0.94) | 0.45 | |
| MMSE | Baselinec | 2977 | 27.39 | 27.39 | ||
| 20 months | 2777 | 27.27 (27.16, 27.37) | 27.27 (27.17, 27.37) | |||
| 40 months | 2654 | 27.04 (26.90, 27.18) | 27.05 (26.92, 27.19) | |||
| 80 months | 1320 | 26.96 (26.82, 27.11) | 27.00 (26.85, 27.14) | |||
| 20 month change | 2777 | −0.12 (−0.23, −0.02) | −0.12 (−0.22, −0.02) | −0.01 (−0.15, 0.14) | 0.94 | |
| 40 month change | 2654 | −0.35 (−0.49, −0.21) | −0.34 (−0.47, −0.20) | −0.01 (−0.21, 0.18) | 0.90 | |
| 80 month change | 1320 | −0.43 (−0.57, −0.28) | −0.39 (−0.54, −0.25) | −0.03 (−0.24, 0.17) | 0.75 | |
a
Least squares mean (95% CI). For DSST, RAVLT and MMSE a negative change value represents a decline in cognitive score; for the Stroop test, a positive change value represents a worsening score
b
Difference calculated as intensive minus standard arm mean changes
c
Baseline mean is the overall mean for both groups combined as measured pre-randomisation. This value is used to obtain the least squares mean estimates at follow-up. Models are adjusted for baseline outcome measure, visit and the factors used to stratify randomisation: second trial assignment (BP or lipid), randomised group allocation within the BP and lipid trials, CCN and history of CVD