Predicting the Effects of Blood Pressure – Lowering Treatment on Major Cardiovascular Events for Individual Patients With Type 2 Diabetes Mellitus

Abstract

T ype 2 diabetes mellitus (T2DM) is a growing worldwide health problem, with an estimated 439 million people living with diabetes mellitus in 2030 1. The lifelong incidence of vascular complications is extremely high, and >80% of patients with diabetes will die from a vascular cause. 2 Blood pressure (BP) is strongly related to nonfatal vascular events, vascular, and all-cause mortality in patients with T2DM. 3 The risk associated with BP already starts well below the BP level used to define hypertension, and BP-lowering agents have been shown to reduce vascular risk in patients with and without hypertension by an average of ≈15%. 4–6 Yet, based on benefit and costs considerations , treatment with BP-lowering medication is only recommended according to guidelines if BP is >140/90 mm Hg. 7–9 This BP threshold serves as a marker to identify patients who potentially benefit from treatment. 10 However, even above this threshold, individual patients vary greatly in the combinations 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 [NNT 5 ] ≤100) and 40% had an intermediate predicted ARR of 0.5% to 1% (NNT 5 =100–`200). The proportion of patients with a small ARR of ≤0.5% (NNT 5 ≥200) 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 …

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Cite this paper

@inproceedings{Visseren2014PredictingTE, title={Predicting the Effects of Blood Pressure – Lowering Treatment on Major Cardiovascular Events for Individual Patients With Type 2 Diabetes Mellitus}, author={Frank L. J. Visseren and Mark Woodward and Sophia Zoungas and Andre Pascal Kengne and Yolanda van der Graaf and Paul Phillip Glasziou and Neil R . Poulter and Diederick E Grobbee}, year={2014} }