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ADVANCE - post trial ObservatioNal Study Key results “Hot Topics in Diabetes” 50 th EASD, Vienna 2014
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BP Arm
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BP levels: in-trial and post trial (before and after stopping randomised treatment) BP armBP level (mmHg) Mean ActivePlacebo Pre-randomization145/81 Last randomized visit (after median of 4.4 years)136/74140/75 First ADVANCE-ON visit (a further 2.9 years later)137/75 Final ADVANCE-ON visit (a further 3 years later)137/74138/75
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Mortality (Overall follow-up: median of 9.9 years)
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Major Macrovascular Events (Overall Follow-up: median of 9.9 years)
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Effects by Subgroups (all cause mortality: overall follow-up: 9.9 years) P heterogeneity > 0.2 for all
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Effects on Mortality (by calendar year)
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Hazard ratios and event numbers (All-cause mortality) In-trial (4.4 years) n=11140 Post-trial (5.9 years) n=10261 Overall (9.9 years) n=11140 All-cause mortality HR (95%CI) p value 0.86 (0.75-0.98) 0.03 0.94 (0.85-1.05) 0.28 0.91 (0.84-0.99) 0.03 Event no. (active v placebo) (408 v 471) (-63) (684 v 702) (-18) (1092 v 1173) (-81)
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Glucose arm
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HbA1c level (%) Mean±SD StandardIntensive Pre-randomisation7.5±1.57.5±1.6 Last randomised visit7.2±1.16.5±0.8 First ADVANCE-ON visit7.3±1.37.3±1.4 Final ADVANCE-ON visit7.4±1.37.2±1.2 HbA1c levels Any effect observed during ADVANCE-ON is attributable to the glycaemic difference achieved during ADVANCE
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Mortality (overall in-trial and post-trial follow-up)
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Major Vascular events (overall in-trial and post-trial follow-up)
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Microvascular events (overall in-trial and post-trial follow-up) Microvascular events (overall in-trial and post-trial follow-up)
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End-stage kidney disease (overall in-trial and post-trial follow-up) End-stage kidney disease (overall in-trial and post-trial follow-up) In-trial (5.0 yrs) Post-trial (5.4 yrs) Overall (9.9 years) End-stage kidney disease HR (95%CI)0.35 (0.15- 0.83) 0.65 (0.38- 1.11) 0.54 (0.34- 0.85) Event no. (intensive vs standard) (7 vs 20) -13 (22 vs 33) -11 (29 vs 53) -24
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Effects on Mortality by calendar year
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Effects on Vascular Events by calendar year
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Effects on Microvascular events by calendar year
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Effects by Subgroups ( all cause death overall in-trial and post-trial follow-up ) P for heterogeneity >0.1
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ADVANCE - post trial ObservatioNal Study Key results “Hot Topics in Diabetes” 50 th EASD, Vienna 2014
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