Table 2.
Baseline, 12 months, and adjusted difference for primary and secondary outcomes by intervention group
|
Placebo group (n=106) |
Losartan group (n=105) |
Adjusted mean difference*, mL (95% CI; n=171) | p value | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
12 months |
Baseline |
12 months |
|||||||
| n | Mean (SD) or median (IQR) | n | Mean (SD) or median (IQR) | n | Mean (SD) or median (IQR) | n | Mean (SD) or median (IQR) | |||
| Primary outcome | ||||||||||
| Brain volume, mL | 106 | 1036 (111) | 87 | 1018 (113) | 105 | 1022 (99) | 84 | 1002 (98) | −2·29 (−6·46 to 0·89) | 0·14 |
| Brain BSI reduction, mL | 106 | .. | 87 | 19·1 (10·3) | 105 | .. | 84 | 20·0 (10·8) | 1·23 (−1·72 to 4·19) | 0·41 |
| Secondary outcomes | ||||||||||
| ADAS-cog | 104 | 19 (7) | 92 | 24 (12) | 103 | 20 (8) | 90 | 23 (12) | −0·52 (−2·71 to 1·66) | 0·64 |
| MMSE | 106 | 22 (3) | 97 | 19 (6) | 105 | 22 (4) | 95 | 19 (6) | −0·33 (−1·43 to 0·78) | 0·56 |
| NPI | 106 | 6 (2–15) | 99 | 8 (3–17) | 105 | 8 (3–18) | 92 | 8 (3–18) | 0·88† (0·68–1·13) | 0·30 |
| BADLS | 106 | 5 (2–9) | 100 | 7 (3–14) | 105 | 7 (2–13) | 94 | 10 (3–17) | 1·00† (0·83–1·21) | 0·98 |
| DEMQOL | 106 | 96 (85–102) | 95 | 94 (85–101) | 105 | 96 (87–102) | 91 | 96 (87–105) | 0·98† (0·89–1·09) | 0·74 |
| DEMOL-proxy | 106 | 92 (83–99) | 98 | 93 (82–100) | 105 | 91 (82–100) | 92 | 93 (83–99) | 1·43 (−1·43 to 4·28) | 0·33 |
| White matter hyperintensities | 51 | 7354 (3418–20 019) | 51 | 9793 (4788–20 263) | 54 | 10 910 (2361–24 129) | 54 | 11992 (2548–24 039) | 0·99† (0·93–1·05) | 0·70 |
| Systolic blood pressure, mm Hg | 84 | 136 (15) | 98 | 139 (17) | 83 | 138 (13) | 95 | 133 (21) | −6·96 (−10·15 to −3·78) | <0·0001 |
| Diastolic blood pressure, mm Hg | 84 | 79 (8) | 98 | 81 (9) | 83 | 79 (9) | 95 | 78 (13) | −3·59 (−5·29 to −1·89) | <0·0001 |
Data are n, median (SD), or median (IQR). BSI=boundary shift interval. ADAS-cog=Alzheimer's Disease Assessment Scale–cognitive subscale. MMSE=Mini-Mental State Examination. NPI=Neuropsychiatric Inventory. BADLS=Bristol Activities of Daily Living Scale. DEMQOL=dementia quality of life. DEMQOL-proxy=carer-reported version of DEMQOL.
*
Adjusted for baseline measure of the outcome, minimisation variables, and centre.
†
Ratio of geometric means.