TABLE 2.
Variable | Pre‐dose value, placebo; mean (SD) | Pre‐dose value, tadalafil; mean (SD) | Change following placebo;mean(95% CI) | Change following Tadalafil.Mean(95% CI) | Treatment effect.Mean (95% CI) |
---|---|---|---|---|---|
Deep gray matter CBF (mL/min/100 g) |
24.2 (6.1) |
24.5 (7.0) |
1.75 (0.74, 2.76) P = .0010 |
1.79 (0.71, 2.88) p=0.0016 |
0.11 (−1.27, 1.48) p=0.881 |
Normal appearing white matter CBF (mL/min/100 g) |
13.5 (4.5) |
13.5 (5.2) |
0.80 (0.14, 1.47) P = .0185 |
1.15 (0.49, 1.80) p=0.0009 |
0.33 (−0.54, 1.21) p=0.458 |
White matter hyperintensities CBF (mL/min/100 g) |
9.5 (5.6) |
9.4 (5.9) |
0.32 (–0.48, 1.12) P = .424 |
1.29 (0.21, 2.38) p=0.0203 |
0.95 (−0.15, 2.05) p=0.0960 |
Total gray matter CBF (mL/min/100 g) |
33.0 (7.8) |
33.4 (8.7) |
2.05 (0.93, 3.17) P = .0006 |
2.54 (1.48, 3.61) p<0.0001 |
0.56 (−0.90, 2.02) p=0.456 |
SBP (mmHg) |
145 (16.0) |
145 (15.6) |
2.9 (–0.6, 6.4) p = 0.107 |
−5.0 (−8.6, −1.4) p=0.0068 |
−7.8 (−11.8, ‐3.9) p=0.0004 |
DBP (mmHg) |
80.6 (8.6) |
79.6 (9.4) |
0.6 (–1.6, 2.7) P = .619 |
−4.0 (−6.0, −2.0) p=0.0002 |
−4.9 (−7.3, −2.4) p=0.0003 |
Notes: Changes are presented with effect estimate, 95% confidence intervals, and associated P‐values. SBP and DBP data were derived from post hoc exploratory analyses (not prespecified endpoints). P‐values were not adjusted for age or sex. Analyses were based on 55 participants who completed the protocol. One participant had incomplete placebo CBF data and one other incomplete tadalafil CBF data, hence n = 53 for CBF data. For SBP and DBP, n = 55.
Abbreviations: CBF, cerebral blood flow; CI, confidence interval; DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation.