Predicting the effects of blood pressure-lowering treatment on major cardiovascular events for individual patients with type 2 diabetes mellitus: Results from Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation

Joep van der Leeuw, Frank L J Visseren, Mark Woodward, Sophia Zoungas, Andre Pascal Kengne, Yolanda van der Graaf, Paul Glasziou, Pavel Hamet, Stephen MacMahon, Neil Poulter, Diederick E Grobbee, John Chalmers

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Abstract

Blood pressure-lowering treatment reduces cardiovascular risk in patients with diabetes mellitus, but the effect varies between individuals. We sought to identify which patients benefit most from such treatment in a large clinical trial in type 2 diabetes mellitus. In Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) participants (n=11 140), we estimated the individual patient 5-year absolute risk of major adverse cardiovascular events with and without treatment by perindopril-indapamide (4/1.25 mg). The difference between treated and untreated risk is the estimated individual patient's absolute risk reduction (ARR). Predictions were based on a Cox proportional hazards model inclusive of demographic and clinical characteristics together with the observed relative treatment effect. The group-level effect of selectively treating patients with an estimated ARR above a range of decision thresholds was compared with treating everyone or those with a blood pressure <140/90 mm Hg using net benefit analysis. In ADVANCE, there was wide variation in treatment effects across individual patients. According to the algorithm, 43% of patients had a large predicted 5-year ARR of 1% (number-needed-to-treat [NNT5] 100) and 40% had an intermediate predicted ARR of 0.5% to 1% (NNT5=100-200). The proportion of patients with a small ARR of 0.5% (NNT5200) was 17%. Provided that one is prepared to treat at most 200 patients for 5 years to prevent 1 adverse outcome, prediction-based treatment yielded the highest net benefit. In conclusion, a multivariable treatment algorithm can identify those individuals who benefit most from blood pressure-lowering therapy in terms of ARR of major adverse cardiovascular events and may be used to guide treatment decisions in individual patients with diabetes.

Original languageEnglish
Pages (from-to)115-121
Number of pages7
JournalHypertension
Volume65
Issue number1
DOIs
Publication statusPublished - 20 Jan 2015

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perindopril drug combination indapamide
Gliclazide
Vascular Diseases
Type 2 Diabetes Mellitus
Numbers Needed To Treat
Blood Pressure
Therapeutics
Indapamide
Perindopril

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van der Leeuw, Joep ; Visseren, Frank L J ; Woodward, Mark ; Zoungas, Sophia ; Kengne, Andre Pascal ; van der Graaf, Yolanda ; Glasziou, Paul ; Hamet, Pavel ; MacMahon, Stephen ; Poulter, Neil ; Grobbee, Diederick E ; Chalmers, John. / Predicting the effects of blood pressure-lowering treatment on major cardiovascular events for individual patients with type 2 diabetes mellitus : Results from Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation. In: Hypertension. 2015 ; Vol. 65, No. 1. pp. 115-121.
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abstract = "Blood pressure-lowering treatment reduces cardiovascular risk in patients with diabetes mellitus, but the effect varies between individuals. We sought to identify which patients benefit most from such treatment in a large clinical trial in type 2 diabetes mellitus. In Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) participants (n=11 140), we estimated the individual patient 5-year absolute risk of major adverse cardiovascular events with and without treatment by perindopril-indapamide (4/1.25 mg). The difference between treated and untreated risk is the estimated individual patient's absolute risk reduction (ARR). Predictions were based on a Cox proportional hazards model inclusive of demographic and clinical characteristics together with the observed relative treatment effect. The group-level effect of selectively treating patients with an estimated ARR above a range of decision thresholds was compared with treating everyone or those with a blood pressure <140/90 mm Hg using net benefit analysis. In ADVANCE, there was wide variation in treatment effects across individual patients. According to the algorithm, 43{\%} of patients had a large predicted 5-year ARR of 1{\%} (number-needed-to-treat [NNT5] 100) and 40{\%} had an intermediate predicted ARR of 0.5{\%} to 1{\%} (NNT5=100-200). The proportion of patients with a small ARR of 0.5{\%} (NNT5200) was 17{\%}. Provided that one is prepared to treat at most 200 patients for 5 years to prevent 1 adverse outcome, prediction-based treatment yielded the highest net benefit. In conclusion, a multivariable treatment algorithm can identify those individuals who benefit most from blood pressure-lowering therapy in terms of ARR of major adverse cardiovascular events and may be used to guide treatment decisions in individual patients with diabetes.",
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Predicting the effects of blood pressure-lowering treatment on major cardiovascular events for individual patients with type 2 diabetes mellitus : Results from Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation. / van der Leeuw, Joep; Visseren, Frank L J; Woodward, Mark; Zoungas, Sophia; Kengne, Andre Pascal; van der Graaf, Yolanda; Glasziou, Paul; Hamet, Pavel; MacMahon, Stephen; Poulter, Neil; Grobbee, Diederick E; Chalmers, John.

In: Hypertension, Vol. 65, No. 1, 20.01.2015, p. 115-121.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Woodward, Mark

AU - Zoungas, Sophia

AU - Kengne, Andre Pascal

AU - van der Graaf, Yolanda

AU - Glasziou, Paul

AU - Hamet, Pavel

AU - MacMahon, Stephen

AU - Poulter, Neil

AU - Grobbee, Diederick E

AU - Chalmers, John

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