Table 3

Individual patient data meta-analysis at the end of follow-up*

OutcomeModelInterventionControlMean difference
(95% CI)
P value for the difference
SBPRandom-effects model (1a)132.1 (128.7 to 135.5)133.4 (130.0 to 136.8)−1.3 (−5.4 to 2.7)0.5236
Fixed-effects model (2)131.3 (130.2 to 132.4)134.3 (133.2 to 135.4)−3.1 (−4.4 to −1.7)<0.0001
DBPRandom-effects model (1a)80.9 (79.4 to 82.4)81.7 (80.2 to 83.2)−0.8 (−2.5 to 1.0)0.3912
Fixed-effects model (2)80.6 (79.8 to 81.3)81.9 (81.2 to 82.6)−1.3 (−2.2 to −0.5)0.0018
BMIRandom-effects model (1b)30.6 (30.2 to 31.1)30.8 (30.4 to 31.3)−0.2 (−0.8 to 0.4)0.5200
Fixed-effects model (2)30.5 (30.3 to 30.7)31.0 (30.8 to 31.1)−0.5 (−0.7 to −0.3)<0.0001
  • Note: All randomised patients with both visits assessed at baseline and at month 6 have been included in this analysis.

  • Primary analysis—analysis of covariance, including randomised treatment and baseline value as fixed effect: model 1: (a) includes trial random effect and random treatment by trial interaction, (b) includes trial fixed effect and random treatment by trial interaction when model 1a estimates trial random effect to zero; model 2: only fixed effects, including trial effect; model 3: sensitivity analysis pooling the estimates from the five trials using a standard meta-analysis checking for data heterogeneity between trials.

  • *For the StAR study, 12 month data was used for follow-up. For all other studies, 6 month data was used for follow-up.

  • BMI, body mass index; DBP, diastolic blood pressure; SBP, systolic blood pressure.