Table 1.
End Pointa | Time | BP Trial, Adjusted Mean (95% CI) | Lipid Trial, Adjusted Mean (95% CI) | ||||||
---|---|---|---|---|---|---|---|---|---|
INT Intervention | STD Intervention | Difference in Means |
P Valueb |
Fenofibratec | Placeboc | Difference in Means |
P Valueb |
||
DSSTd | Baselinee | 52.28 | 52.28 | 52.79 | 52.79 | ||||
20 mo | 50.94 (50.36 to 51.53) | 51.00 (50.41 to 51.60) | −0.06 (−0.90 to 0.78) | .89 | 51.39 (50.82 to 51.97) | 51.59 (51.00 to 52.18) | −0.20 (−1.02 to 0.63) | .64 | |
40 mo | 50.42 (49.82 to 51.01) | 50.67 (50.07 to 51.28) | −0.26 (−1.11 to 0.59) | .55c | 50.94 (50.35 to 51.53) | 51.02 (50.42 to 51.62) | −0.08 (−0.92 to 0.76) | .85c | |
40-mo change | −1.86 (−2.46 to −1.27) | −1.61 (−2.21 to −1.00) | −1.85 (−2.44 to −1.26) | −1.77 (−2.37 to −1.17) | |||||
RAVLTf | Baselinee | 7.51 | 7.51 | 7.51 | 7.51 | ||||
20 mo | 7.77 (7.64 to 7.91) | 7.89 (7.75 to 8.02) | −0.12 (−0.31 to 0.08) | .23 | 7.91 (7.78 to 8.04) | 7.86 (7.73 to 7.99) | 0.05 (−0.13 to 0.23) | .58 | |
40 mo | 7.98 (7.85 to 8.12) | 8.04 (7.89 to 8.18) | −0.05 (−0.26 to 0.15) | .58 | 7.98 (7.86 to 8.11) | 7.94 (7.80 to 8.07) | 0.05 (−0.14 to 0.23) | .61 | |
40-mo change | 0.47 (0.34 to 0.61) | 0.53 (0.39 to 0.67) | 0.47 (0.35 to 0.60) | 0.43 (0.29 to 0.56) | |||||
Stroopg | Baselinee | 32.60 | 32.60 | 31.46 | 31.46 | ||||
20 mo | 31.50 (30.51 to 32.48) | 31.35 (30.35 to 32.36) | 0.15 (−1.26 to 1.55) | .84 | 31.18 (30.20 to 32.16) | 30.69 (29.70 to 31.68) | 0.48 (−0.91 to 1.88) | .50 | |
40 mo | 31.10 (30.08 to 32.12) | 32.14 (31.09 to 33.19) | −1.04 (−2.51 to 0.42) | .16 | 31.62 (30.63 to 32.62) | 32.21 (31.19 to 33.22) | −0.59 (−2.01 to 0.84) | .42 | |
40-mo change | −1.50 (−2.52 to −0.48) | −0.46 (−1.51 to 0.59) | 0.16 (−0.83 to 1.16) | 0.75 (−0.27 to 1.76) | |||||
MMSEh | Baselinee | 27.25 | 27.25 | 27.53 | 27.53 | ||||
20 mo | 27.06 (26.89 to 27.23) | 27.17 (27.00 to 27.35) | −0.11 (−0.35 to 0.13) | .35 | 27.35 (27.18 to 27.52) | 27.47 (27.30 to 27.64) | −0.12 (−0.36 to 0.11) | .31 | |
40 mo | 27.00 (26.83 to 27.17) | 26.95 (26.77 to 27.11) | 0.05 (−0.20 to 0.29) | .70 | 27.17 (27.00 to 27.34) | 27.10 (26.93 to 27.27) | 0.07 (−0.17 to 0.31) | .58 | |
40-mo change | −0.25 (−0.42 to −0.08) | −0.30 (−0.48 to −0.13) | −0.36 (−0.53 to −0.19) | −0.43 (−0.60 to −0.26) |
Abbreviations: BP, blood pressure; DSST, Digit Symbol Substitution Test; INT, intensive; MMSE, Mini-Mental State Examination; RAVLT, Rey Auditory Verbal Learning Test; STD, standard.
For the DSST, RAVLT, and MMSE, higher values indicate better cognition; a negative change value, a decline in cognitive score. For the Stroop test, lower values indicate better cognition and a positive change value represents a decline in cognitive score.
Calculated as tests of differences between intervention group means at each follow-up visit, adjusted for the baseline level of the outcome. The P value for a comparison of the 40-month change between intervention groups is left blank because, when controlling for the baseline level, it will be identical to that provided for the comparison between means at the 40-month visit.
Calculated as result of test of prespecified primary outcome.
Indicates number of correct cells (possible range, 0–90).
Baseline mean indicates the overall mean for both groups combined as measured before randomization. This value is used to obtain the adjusted mean estimates at follow-up.
Indicates the total number of words recalled (possible range, 0–15).
Measured as the interference score.
Possible range, 0 to 30.