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.

Abstract

UNLABELLED:

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% (NNT5≥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 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.

CLINICAL TRIAL REGISTRATION URL:

http://www.clinicaltrials.gov. Unique identifier: NCT00145925.

• Authors: 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
• Journal: Hypertension (Dallas, Tex. : 1979) (Hypertension) Vol. 65 Issue 1 Pg. 115-21 (Jan 2015) ISSN: 1524-4563 [Electronic] United States
• PMID: 25312436 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 American Heart Association, Inc.

Chemical References

• Antihypertensive Agents
• Blood Glucose
• Drug Combinations
• Hypoglycemic Agents
• indapamide, perindopril drug combination
• Indapamide
• Gliclazide
• Perindopril

Topics

• Aged
• Antihypertensive Agents (therapeutic use)
• Blood Glucose (metabolism)
• Blood Pressure (drug effects)
• Cardiovascular Diseases (drug therapy, etiology, physiopathology)
• Diabetes Mellitus, Type 2 (complications, drug therapy, physiopathology)
• Drug Combinations
• Female
• Follow-Up Studies
• Gliclazide (administration & dosage)
• Humans
• Hypoglycemic Agents
• Indapamide (administration & dosage)
• Male
• Perindopril (administration & dosage)
• Risk Factors
• Time Factors
• Treatment Outcome