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Estimation of individual beneficial and adverse effects of intensive glucose control for patients with type 2 diabetes

Aims/hypothesis: Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes. Methods: We perform... Full description

Journal Title: Diabetologia 2016, Vol.59 (12), p.2603–2612-2612
Main Author: van der Leeuw, Joep
Other Authors: Visseren, Frank L J , Woodward, Mark , van der Graaf, Yolanda , Grobbee, Diederick E , Harrap, Stephen , Heller, Simon , Mancia, Giuseppe , Marre, Michel , Poulter, Neil , Zoungas, Sophia , Chalmers, John
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: Berlin/Heidelberg: Springer Berlin Heidelberg
ID: ISSN: 0012-186X
Link: https://www.ncbi.nlm.nih.gov/pubmed/27586250
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6518074
title: Estimation of individual beneficial and adverse effects of intensive glucose control for patients with type 2 diabetes
format: Article
creator:
  • van der Leeuw, Joep
  • Visseren, Frank L J
  • Woodward, Mark
  • van der Graaf, Yolanda
  • Grobbee, Diederick E
  • Harrap, Stephen
  • Heller, Simon
  • Mancia, Giuseppe
  • Marre, Michel
  • Poulter, Neil
  • Zoungas, Sophia
  • Chalmers, John
subjects:
  • Aged
  • Analysis
  • Antihypertensive Agents - adverse effects
  • Antihypertensive Agents - therapeutic use
  • Article
  • Cardiovascular Diseases - prevention & control
  • Care and treatment
  • Clinical Sciences
  • Complications and side effects
  • Dextrose
  • Diabetes
  • Diabetes Mellitus, Type 2 - drug therapy
  • Diabetes therapy
  • Drug Combinations
  • Endocrinology
  • Endocrinology & Metabolism
  • Endocrinology, Diabetes and Metabolism
  • Female
  • Gliclazide - adverse effects
  • Gliclazide - therapeutic use
  • Glucose
  • Glycaemic target
  • Glycated Hemoglobin A - metabolism
  • Human Physiology
  • Humans
  • Hypoglycaemia
  • Hypoglycemia - drug therapy
  • Hypoglycemic Agents - adverse effects
  • Hypoglycemic Agents - therapeutic use
  • Indapamide - adverse effects
  • Indapamide - therapeutic use
  • Internal Medicine
  • Journal Article
  • Male
  • Medicine
  • Medicine & Public Health
  • Medicine(all)
  • Metabolic Diseases
  • Metabolism
  • Middle Aged
  • Net benefit
  • Paediatrics And Reproductive Medicine
  • Perindopril - adverse effects
  • Perindopril - therapeutic use
  • Personalised medicine
  • Precision Medicine - methods
  • Public Health And Health Services
  • Risk Factors
  • Risk Reduction Behavior
  • Type 2 diabetes
  • Vascular complications
ispartof: Diabetologia, 2016, Vol.59 (12), p.2603–2612-2612
description: Aims/hypothesis: Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes. Methods: We performed a post hoc analysis of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial, a randomised controlled trial evaluating standard vs intensive glucose control (HbA1c target ≤6.5% [48 mmol/mol]). In 11,140 participants, we estimated the individual 5 year absolute risk reduction (ARR) for the composite outcome of major micro- and macrovascular events and absolute risk increase (ARI) for severe hypoglycaemia for intensive vs standard glucose control. Predictions were based on competing risks models including clinical characteristics and randomised treatment. Results: Based on these models, 76% of patients had a substantial estimated 5 year ARR for major vascular events (>1%, 5 year number-needed-to-benefit [NNTB5] 5 >200). Similarly, 36% of patients had a substantial estimated ARI for severe hypoglycaemia (5 year number-needed-to-harm [NNTH5] 5 >200). When assigning similar or half the weight to severe hypoglycaemia compared with a major vascular event, net benefit was positive in 85% or 99% of patients, respectively. Limiting intensive treatment to the 85% patient subgroup had no significant effect on the overall incidence of major vascular events and severe hypoglycaemia compared with treating all patients. Conclusions/interpretation: Taking account of the effects of intensive glucose control on major micro- and macrovascular events and severe hypoglycaemia for individual patients, the estimated net benefit was positive in the majority of the participants in the ADVANCE trial. The estimated individual effects can inform treatment decisions once individual weights assigned to positive and adverse effects have been specified. Trial registration:: ClinicalTrials.gov NCT00145925
language: eng
source:
identifier: ISSN: 0012-186X
fulltext: no_fulltext
issn:
  • 0012-186X
  • 1432-0428
url: Link


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titleEstimation of individual beneficial and adverse effects of intensive glucose control for patients with type 2 diabetes
creatorvan der Leeuw, Joep ; Visseren, Frank L J ; Woodward, Mark ; van der Graaf, Yolanda ; Grobbee, Diederick E ; Harrap, Stephen ; Heller, Simon ; Mancia, Giuseppe ; Marre, Michel ; Poulter, Neil ; Zoungas, Sophia ; Chalmers, John
creatorcontribvan der Leeuw, Joep ; Visseren, Frank L J ; Woodward, Mark ; van der Graaf, Yolanda ; Grobbee, Diederick E ; Harrap, Stephen ; Heller, Simon ; Mancia, Giuseppe ; Marre, Michel ; Poulter, Neil ; Zoungas, Sophia ; Chalmers, John
descriptionAims/hypothesis: Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes. Methods: We performed a post hoc analysis of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial, a randomised controlled trial evaluating standard vs intensive glucose control (HbA1c target ≤6.5% [48 mmol/mol]). In 11,140 participants, we estimated the individual 5 year absolute risk reduction (ARR) for the composite outcome of major micro- and macrovascular events and absolute risk increase (ARI) for severe hypoglycaemia for intensive vs standard glucose control. Predictions were based on competing risks models including clinical characteristics and randomised treatment. Results: Based on these models, 76% of patients had a substantial estimated 5 year ARR for major vascular events (>1%, 5 year number-needed-to-benefit [NNTB5] 5 >200). Similarly, 36% of patients had a substantial estimated ARI for severe hypoglycaemia (5 year number-needed-to-harm [NNTH5] 5 >200). When assigning similar or half the weight to severe hypoglycaemia compared with a major vascular event, net benefit was positive in 85% or 99% of patients, respectively. Limiting intensive treatment to the 85% patient subgroup had no significant effect on the overall incidence of major vascular events and severe hypoglycaemia compared with treating all patients. Conclusions/interpretation: Taking account of the effects of intensive glucose control on major micro- and macrovascular events and severe hypoglycaemia for individual patients, the estimated net benefit was positive in the majority of the participants in the ADVANCE trial. The estimated individual effects can inform treatment decisions once individual weights assigned to positive and adverse effects have been specified. Trial registration:: ClinicalTrials.gov NCT00145925
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subjectAged ; Analysis ; Antihypertensive Agents - adverse effects ; Antihypertensive Agents - therapeutic use ; Article ; Cardiovascular Diseases - prevention & control ; Care and treatment ; Clinical Sciences ; Complications and side effects ; Dextrose ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes therapy ; Drug Combinations ; Endocrinology ; Endocrinology & Metabolism ; Endocrinology, Diabetes and Metabolism ; Female ; Gliclazide - adverse effects ; Gliclazide - therapeutic use ; Glucose ; Glycaemic target ; Glycated Hemoglobin A - metabolism ; Human Physiology ; Humans ; Hypoglycaemia ; Hypoglycemia - drug therapy ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Indapamide - adverse effects ; Indapamide - therapeutic use ; Internal Medicine ; Journal Article ; Male ; Medicine ; Medicine & Public Health ; Medicine(all) ; Metabolic Diseases ; Metabolism ; Middle Aged ; Net benefit ; Paediatrics And Reproductive Medicine ; Perindopril - adverse effects ; Perindopril - therapeutic use ; Personalised medicine ; Precision Medicine - methods ; Public Health And Health Services ; Risk Factors ; Risk Reduction Behavior ; Type 2 diabetes ; Vascular complications
ispartofDiabetologia, 2016, Vol.59 (12), p.2603–2612-2612
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1Visseren, Frank L J
2Woodward, Mark
3van der Graaf, Yolanda
4Grobbee, Diederick E
5Harrap, Stephen
6Heller, Simon
7Mancia, Giuseppe
8Marre, Michel
9Poulter, Neil
10Zoungas, Sophia
11Chalmers, John
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descriptionAims/hypothesis: Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes. Methods: We performed a post hoc analysis of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial, a randomised controlled trial evaluating standard vs intensive glucose control (HbA1c target ≤6.5% [48 mmol/mol]). In 11,140 participants, we estimated the individual 5 year absolute risk reduction (ARR) for the composite outcome of major micro- and macrovascular events and absolute risk increase (ARI) for severe hypoglycaemia for intensive vs standard glucose control. Predictions were based on competing risks models including clinical characteristics and randomised treatment. Results: Based on these models, 76% of patients had a substantial estimated 5 year ARR for major vascular events (>1%, 5 year number-needed-to-benefit [NNTB5] 5 >200). Similarly, 36% of patients had a substantial estimated ARI for severe hypoglycaemia (5 year number-needed-to-harm [NNTH5] 5 >200). When assigning similar or half the weight to severe hypoglycaemia compared with a major vascular event, net benefit was positive in 85% or 99% of patients, respectively. Limiting intensive treatment to the 85% patient subgroup had no significant effect on the overall incidence of major vascular events and severe hypoglycaemia compared with treating all patients. Conclusions/interpretation: Taking account of the effects of intensive glucose control on major micro- and macrovascular events and severe hypoglycaemia for individual patients, the estimated net benefit was positive in the majority of the participants in the ADVANCE trial. The estimated individual effects can inform treatment decisions once individual weights assigned to positive and adverse effects have been specified. Trial registration:: ClinicalTrials.gov NCT00145925
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11Diabetes Mellitus, Type 2 - drug therapy
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15Endocrinology & Metabolism
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17Female
18Gliclazide - adverse effects
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22Glycated Hemoglobin A - metabolism
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27Hypoglycemic Agents - adverse effects
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44Personalised medicine
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titleEstimation of individual beneficial and adverse effects of intensive glucose control for patients with type 2 diabetes
authorvan der Leeuw, Joep ; Visseren, Frank L J ; Woodward, Mark ; van der Graaf, Yolanda ; Grobbee, Diederick E ; Harrap, Stephen ; Heller, Simon ; Mancia, Giuseppe ; Marre, Michel ; Poulter, Neil ; Zoungas, Sophia ; Chalmers, John
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7Clinical Sciences
8Complications and side effects
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11Diabetes Mellitus, Type 2 - drug therapy
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13Drug Combinations
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45Precision Medicine - methods
46Public Health And Health Services
47Risk Factors
48Risk Reduction Behavior
49Type 2 diabetes
50Vascular complications
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abstractAims/hypothesis: Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes. Methods: We performed a post hoc analysis of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial, a randomised controlled trial evaluating standard vs intensive glucose control (HbA1c target ≤6.5% [48 mmol/mol]). In 11,140 participants, we estimated the individual 5 year absolute risk reduction (ARR) for the composite outcome of major micro- and macrovascular events and absolute risk increase (ARI) for severe hypoglycaemia for intensive vs standard glucose control. Predictions were based on competing risks models including clinical characteristics and randomised treatment. Results: Based on these models, 76% of patients had a substantial estimated 5 year ARR for major vascular events (>1%, 5 year number-needed-to-benefit [NNTB5] 5 >200). Similarly, 36% of patients had a substantial estimated ARI for severe hypoglycaemia (5 year number-needed-to-harm [NNTH5] 5 >200). When assigning similar or half the weight to severe hypoglycaemia compared with a major vascular event, net benefit was positive in 85% or 99% of patients, respectively. Limiting intensive treatment to the 85% patient subgroup had no significant effect on the overall incidence of major vascular events and severe hypoglycaemia compared with treating all patients. Conclusions/interpretation: Taking account of the effects of intensive glucose control on major micro- and macrovascular events and severe hypoglycaemia for individual patients, the estimated net benefit was positive in the majority of the participants in the ADVANCE trial. The estimated individual effects can inform treatment decisions once individual weights assigned to positive and adverse effects have been specified. Trial registration:: ClinicalTrials.gov NCT00145925
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pmid27586250
doi10.1007/s00125-016-4082-5
orcididhttps://orcid.org/0000-0002-2425-9565
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