Change in maximum carotid IMT by BPV strata, overall and by treatment arm (PREVENT, BPV, and ultrasound evaluable population). IMT, intima-media thickness; BPV, blood pressure variability; PREVENT, Prospective Randomized Evaluation of the Vascular Effects of Norvasc Trial.
Analysis of the BPV effect on change in maximum carotid IMT
| IMT (mm) | Average of LCF and RCF (mm) ANCOVA modela | All of LCF and RCF (mm) mixed-effect analysisb | ||
|---|---|---|---|---|
| BPV < median (N = 175) | BPV ≥ median (N = 189) | BPV < median (N = 175) | BPV ≥ median (N = 189) | |
| Model 1 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.01 (0.02) |
| LS mean difference (SE) | 0.06 (0.02) | 0.07 (0.02) | ||
| [95% CI] | [0.01, 0.11] | [0.02, 0.11] | ||
| P value | 0.0126 | 0.0061 | ||
| Model 2 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.00 (0.02) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0234 | 0.0188 | ||
| Model 3 | ||||
| LS mean (SE) | –0.07 (0.03) | –0.01 (0.03) | –0.07 (0.03) | –0.02 (0.03) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0302 | 0.0271 | ||
| IMT (mm) | Average of LCF and RCF (mm) ANCOVA modela | All of LCF and RCF (mm) mixed-effect analysisb | ||
|---|---|---|---|---|
| BPV < median (N = 175) | BPV ≥ median (N = 189) | BPV < median (N = 175) | BPV ≥ median (N = 189) | |
| Model 1 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.01 (0.02) |
| LS mean difference (SE) | 0.06 (0.02) | 0.07 (0.02) | ||
| [95% CI] | [0.01, 0.11] | [0.02, 0.11] | ||
| P value | 0.0126 | 0.0061 | ||
| Model 2 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.00 (0.02) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0234 | 0.0188 | ||
| Model 3 | ||||
| LS mean (SE) | –0.07 (0.03) | –0.01 (0.03) | –0.07 (0.03) | –0.02 (0.03) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0302 | 0.0271 | ||
BPV and ultrasound evaluable population: patients received ≥1 dose of study medication and had ≥2 post-baseline SBP measurements from 12 weeks [or 3 months (84 days)] onwards and had baseline and final ultrasound measurements (including early discontinuation).
BPV, blood pressure variability; IMT, intima-media thickness; PREVENT, Prospective Randomized Evaluation of the Vascular Effects of Norvasc Trial; ANCOVA, analysis of covariance; LCF, left common carotid artery far wall; RCF, right common carotid artery far wall; SE, standard error; CI, confidence interval; LS, least squares.
aUsing average values of LCF and RCF segments. Model 1: based on ANCOVA model including BPV strata and treatment as factors and baseline maximum average IMT as a covariate. Model 2: as Model 1 additionally including mean BP as a covariate. Model 3: as Model 2 additionally including study stratification factor, gender, and cardiovascular risk factors as factors and baseline BP, age, and body weight as covariates.
bUsing all values from LCF and RCF segments. Model 1: based on mixed-effects model including BPV strata, segment, and treatment as factors and baseline maximum IMT as a covariate. Model 2: as per Model 1 additionally including mean BP as covariate. Model 3: as per Model 2 additionally including study stratification factor, gender, and cardiovascular risk factors as factors, and baseline BP, age, and body weight as covariates. Subject is included as a random effect in the mixed-effects model.
Analysis of the BPV effect on change in maximum carotid IMT
| IMT (mm) | Average of LCF and RCF (mm) ANCOVA modela | All of LCF and RCF (mm) mixed-effect analysisb | ||
|---|---|---|---|---|
| BPV < median (N = 175) | BPV ≥ median (N = 189) | BPV < median (N = 175) | BPV ≥ median (N = 189) | |
| Model 1 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.01 (0.02) |
| LS mean difference (SE) | 0.06 (0.02) | 0.07 (0.02) | ||
| [95% CI] | [0.01, 0.11] | [0.02, 0.11] | ||
| P value | 0.0126 | 0.0061 | ||
| Model 2 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.00 (0.02) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0234 | 0.0188 | ||
| Model 3 | ||||
| LS mean (SE) | –0.07 (0.03) | –0.01 (0.03) | –0.07 (0.03) | –0.02 (0.03) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0302 | 0.0271 | ||
| IMT (mm) | Average of LCF and RCF (mm) ANCOVA modela | All of LCF and RCF (mm) mixed-effect analysisb | ||
|---|---|---|---|---|
| BPV < median (N = 175) | BPV ≥ median (N = 189) | BPV < median (N = 175) | BPV ≥ median (N = 189) | |
| Model 1 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.01 (0.02) |
| LS mean difference (SE) | 0.06 (0.02) | 0.07 (0.02) | ||
| [95% CI] | [0.01, 0.11] | [0.02, 0.11] | ||
| P value | 0.0126 | 0.0061 | ||
| Model 2 | ||||
| LS mean (SE) | –0.06 (0.02) | 0.00 (0.02) | –0.06 (0.02) | 0.00 (0.02) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0234 | 0.0188 | ||
| Model 3 | ||||
| LS mean (SE) | –0.07 (0.03) | –0.01 (0.03) | –0.07 (0.03) | –0.02 (0.03) |
| LS mean difference (SE) | 0.06 (0.03) | 0.06 (0.03) | ||
| [95% CI] | [0.01, 0.11] | [0.01, 0.11] | ||
| P value | 0.0302 | 0.0271 | ||
BPV and ultrasound evaluable population: patients received ≥1 dose of study medication and had ≥2 post-baseline SBP measurements from 12 weeks [or 3 months (84 days)] onwards and had baseline and final ultrasound measurements (including early discontinuation).
BPV, blood pressure variability; IMT, intima-media thickness; PREVENT, Prospective Randomized Evaluation of the Vascular Effects of Norvasc Trial; ANCOVA, analysis of covariance; LCF, left common carotid artery far wall; RCF, right common carotid artery far wall; SE, standard error; CI, confidence interval; LS, least squares.
aUsing average values of LCF and RCF segments. Model 1: based on ANCOVA model including BPV strata and treatment as factors and baseline maximum average IMT as a covariate. Model 2: as Model 1 additionally including mean BP as a covariate. Model 3: as Model 2 additionally including study stratification factor, gender, and cardiovascular risk factors as factors and baseline BP, age, and body weight as covariates.
bUsing all values from LCF and RCF segments. Model 1: based on mixed-effects model including BPV strata, segment, and treatment as factors and baseline maximum IMT as a covariate. Model 2: as per Model 1 additionally including mean BP as covariate. Model 3: as per Model 2 additionally including study stratification factor, gender, and cardiovascular risk factors as factors, and baseline BP, age, and body weight as covariates. Subject is included as a random effect in the mixed-effects model.
