Effects of visit-to-visit variability in systolic blood pressure on macrovascular and microvascular complications in patients with type 2 diabetes mellitus: The advance trial

Jun Hata, Hisatomi Arima, Peter M. Rothwell, Mark Woodward, Sophia Zoungas, Craig Anderson, Anushka Patel, Bruce Neal, Paul Glasziou, Pavel Hamet, Giuseppe Mancia, Neil Poulter, Bryan Williams, Stephen MacMahon, John Chalmers

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Abstract

BACKGROUND-: Recent evidence suggests that visit-to-visit variability in systolic blood pressure (SBP) and maximum SBP are predictors of cardiovascular disease. However, it remains uncertain whether these parameters predict the risks of macrovascular and microvascular complications in patients with type 2 diabetes mellitus. METHODS AND RESULTS-: The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) was a factorial randomized controlled trial of blood pressure lowering and blood glucose control in patients with type 2 diabetes mellitus. The present analysis included 8811 patients without major macrovascular and microvascular events or death during the first 24 months after randomization. SBP variability (defined as standard deviation) and maximum SBP were determined during the first 24 months after randomization. During a median 2.4 years of follow-up from the 24-month visit, 407 major macrovascular (myocardial infarction, stroke, or cardiovascular death) and 476 microvascular (new or worsening nephropathy or retinopathy) events were observed. The association of major macrovascular and microvascular events with SBP variability was continuous even after adjustment for mean SBP and other confounding factors (both P<0.05 for trend). Hazard ratios (95% confidence intervals) for the highest tenth of SBP variability were 1.54 (0.99-2.39) for macrovascular events and 1.84 (1.19-2.84) for microvascular events in comparison with the lowest tenth. For maximum SBP, hazard ratios (95% confidence intervals) for the highest tenth were 3.64 (1.73-7.66) and 2.18 (1.04-4.58), respectively. CONCLUSION-: Visit-to-visit variability in SBP and maximum SBP were independent risk factors for macrovascular and microvascular complications in type 2 diabetes mellitus.

Original languageEnglish
Pages (from-to)1325-1334
Number of pages10
JournalCirculation
Volume128
Issue number12
DOIs
Publication statusPublished - 17 Sep 2013

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Type 2 Diabetes Mellitus
Blood Pressure
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Random Allocation
Myocardial Infarction
Gliclazide
Confidence Intervals
Vascular Diseases

Cite this

Hata, Jun ; Arima, Hisatomi ; Rothwell, Peter M. ; Woodward, Mark ; Zoungas, Sophia ; Anderson, Craig ; Patel, Anushka ; Neal, Bruce ; Glasziou, Paul ; Hamet, Pavel ; Mancia, Giuseppe ; Poulter, Neil ; Williams, Bryan ; MacMahon, Stephen ; Chalmers, John. / Effects of visit-to-visit variability in systolic blood pressure on macrovascular and microvascular complications in patients with type 2 diabetes mellitus : The advance trial. In: Circulation. 2013 ; Vol. 128, No. 12. pp. 1325-1334.
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title = "Effects of visit-to-visit variability in systolic blood pressure on macrovascular and microvascular complications in patients with type 2 diabetes mellitus: The advance trial",
abstract = "BACKGROUND-: Recent evidence suggests that visit-to-visit variability in systolic blood pressure (SBP) and maximum SBP are predictors of cardiovascular disease. However, it remains uncertain whether these parameters predict the risks of macrovascular and microvascular complications in patients with type 2 diabetes mellitus. METHODS AND RESULTS-: The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) was a factorial randomized controlled trial of blood pressure lowering and blood glucose control in patients with type 2 diabetes mellitus. The present analysis included 8811 patients without major macrovascular and microvascular events or death during the first 24 months after randomization. SBP variability (defined as standard deviation) and maximum SBP were determined during the first 24 months after randomization. During a median 2.4 years of follow-up from the 24-month visit, 407 major macrovascular (myocardial infarction, stroke, or cardiovascular death) and 476 microvascular (new or worsening nephropathy or retinopathy) events were observed. The association of major macrovascular and microvascular events with SBP variability was continuous even after adjustment for mean SBP and other confounding factors (both P<0.05 for trend). Hazard ratios (95{\%} confidence intervals) for the highest tenth of SBP variability were 1.54 (0.99-2.39) for macrovascular events and 1.84 (1.19-2.84) for microvascular events in comparison with the lowest tenth. For maximum SBP, hazard ratios (95{\%} confidence intervals) for the highest tenth were 3.64 (1.73-7.66) and 2.18 (1.04-4.58), respectively. CONCLUSION-: Visit-to-visit variability in SBP and maximum SBP were independent risk factors for macrovascular and microvascular complications in type 2 diabetes mellitus.",
author = "Jun Hata and Hisatomi Arima and Rothwell, {Peter M.} and Mark Woodward and Sophia Zoungas and Craig Anderson and Anushka Patel and Bruce Neal and Paul Glasziou and Pavel Hamet and Giuseppe Mancia and Neil Poulter and Bryan Williams and Stephen MacMahon and John Chalmers",
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Hata, J, Arima, H, Rothwell, PM, Woodward, M, Zoungas, S, Anderson, C, Patel, A, Neal, B, Glasziou, P, Hamet, P, Mancia, G, Poulter, N, Williams, B, MacMahon, S & Chalmers, J 2013, 'Effects of visit-to-visit variability in systolic blood pressure on macrovascular and microvascular complications in patients with type 2 diabetes mellitus: The advance trial' Circulation, vol. 128, no. 12, pp. 1325-1334. https://doi.org/10.1161/CIRCULATIONAHA.113.002717

Effects of visit-to-visit variability in systolic blood pressure on macrovascular and microvascular complications in patients with type 2 diabetes mellitus : The advance trial. / Hata, Jun; Arima, Hisatomi; Rothwell, Peter M.; Woodward, Mark; Zoungas, Sophia; Anderson, Craig; Patel, Anushka; Neal, Bruce; Glasziou, Paul; Hamet, Pavel; Mancia, Giuseppe; Poulter, Neil; Williams, Bryan; MacMahon, Stephen; Chalmers, John.

In: Circulation, Vol. 128, No. 12, 17.09.2013, p. 1325-1334.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Effects of visit-to-visit variability in systolic blood pressure on macrovascular and microvascular complications in patients with type 2 diabetes mellitus

T2 - The advance trial

AU - Hata, Jun

AU - Arima, Hisatomi

AU - Rothwell, Peter M.

AU - Woodward, Mark

AU - Zoungas, Sophia

AU - Anderson, Craig

AU - Patel, Anushka

AU - Neal, Bruce

AU - Glasziou, Paul

AU - Hamet, Pavel

AU - Mancia, Giuseppe

AU - Poulter, Neil

AU - Williams, Bryan

AU - MacMahon, Stephen

AU - Chalmers, John

PY - 2013/9/17

Y1 - 2013/9/17

N2 - BACKGROUND-: Recent evidence suggests that visit-to-visit variability in systolic blood pressure (SBP) and maximum SBP are predictors of cardiovascular disease. However, it remains uncertain whether these parameters predict the risks of macrovascular and microvascular complications in patients with type 2 diabetes mellitus. METHODS AND RESULTS-: The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) was a factorial randomized controlled trial of blood pressure lowering and blood glucose control in patients with type 2 diabetes mellitus. The present analysis included 8811 patients without major macrovascular and microvascular events or death during the first 24 months after randomization. SBP variability (defined as standard deviation) and maximum SBP were determined during the first 24 months after randomization. During a median 2.4 years of follow-up from the 24-month visit, 407 major macrovascular (myocardial infarction, stroke, or cardiovascular death) and 476 microvascular (new or worsening nephropathy or retinopathy) events were observed. The association of major macrovascular and microvascular events with SBP variability was continuous even after adjustment for mean SBP and other confounding factors (both P<0.05 for trend). Hazard ratios (95% confidence intervals) for the highest tenth of SBP variability were 1.54 (0.99-2.39) for macrovascular events and 1.84 (1.19-2.84) for microvascular events in comparison with the lowest tenth. For maximum SBP, hazard ratios (95% confidence intervals) for the highest tenth were 3.64 (1.73-7.66) and 2.18 (1.04-4.58), respectively. CONCLUSION-: Visit-to-visit variability in SBP and maximum SBP were independent risk factors for macrovascular and microvascular complications in type 2 diabetes mellitus.

AB - BACKGROUND-: Recent evidence suggests that visit-to-visit variability in systolic blood pressure (SBP) and maximum SBP are predictors of cardiovascular disease. However, it remains uncertain whether these parameters predict the risks of macrovascular and microvascular complications in patients with type 2 diabetes mellitus. METHODS AND RESULTS-: The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) was a factorial randomized controlled trial of blood pressure lowering and blood glucose control in patients with type 2 diabetes mellitus. The present analysis included 8811 patients without major macrovascular and microvascular events or death during the first 24 months after randomization. SBP variability (defined as standard deviation) and maximum SBP were determined during the first 24 months after randomization. During a median 2.4 years of follow-up from the 24-month visit, 407 major macrovascular (myocardial infarction, stroke, or cardiovascular death) and 476 microvascular (new or worsening nephropathy or retinopathy) events were observed. The association of major macrovascular and microvascular events with SBP variability was continuous even after adjustment for mean SBP and other confounding factors (both P<0.05 for trend). Hazard ratios (95% confidence intervals) for the highest tenth of SBP variability were 1.54 (0.99-2.39) for macrovascular events and 1.84 (1.19-2.84) for microvascular events in comparison with the lowest tenth. For maximum SBP, hazard ratios (95% confidence intervals) for the highest tenth were 3.64 (1.73-7.66) and 2.18 (1.04-4.58), respectively. CONCLUSION-: Visit-to-visit variability in SBP and maximum SBP were independent risk factors for macrovascular and microvascular complications in type 2 diabetes mellitus.

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U2 - 10.1161/CIRCULATIONAHA.113.002717

DO - 10.1161/CIRCULATIONAHA.113.002717

M3 - Article

VL - 128

SP - 1325

EP - 1334

JO - Circulation

JF - Circulation

SN - 0009-7322

IS - 12

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