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The effect of intensive control of blood glucose levels on mortality and morbidity in diabetic patients with acute coronary syndrome: a meta-analysis of.

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Presentation on theme: "The effect of intensive control of blood glucose levels on mortality and morbidity in diabetic patients with acute coronary syndrome: a meta-analysis of."— Presentation transcript:

1 The effect of intensive control of blood glucose levels on mortality and morbidity in diabetic patients with acute coronary syndrome: a meta-analysis of clinical trials 1Introdução a Medicina II Baraças, C. (; Cardoso, M. (; Cerqueira, M. (; Dantas, S. (; Esteves, G. (; Ferrão, J. (; Ferreira, R. (; Lopes, R. (; Marcos, A. (; Moreira, A. (; Oliveira, N. ( Advisers: Almeida, F. (; Pereira, A. ( Class number: 7 Key-words (MeSH): Diabetes Mellitus; Coronary Arteriosclerosis; Myocardial Infarction; Myocardial Revascularization; Insulin; Review; Meta-Analysis.

2 2Introdução a Medicina II 0. Summary 1. Introduction 1.1. Evolution of a long-term case of DM How could DM culminate in MI? 2. Objective 3. Participants and methods 3.1. Study Participants Inclusion and exclusion criteria 3.2. Data collection methods 3.3. Variables description 3.4. Statistical analysis 4. Results, tables and graphics 5. References

3 CAD is one of the major long-term consequences of diabetes mellitus (DM) and the main cause of death among diabetic subjects (Sprafka et al. 1991). Diabetes affects many metabolic pathways causing a group of correlated diseases, known as the metabolic syndrome. Fig. 1 – The Minnesota Heart Survey. The search for effective therapies is, therefore, imperative. 3Introdução a Medicina II Fig. 2 – Myocardial Infarction. 1. Introduction

4 A longstanding case of diabetes progressively aggravates, causing complications in the cardiovascular system – microangiopathy and macroangiopathy (Lars Rydén et al. 2007). Microvascular disease is the first to be developed and conduces to the failure of blood supply and dysfunction of organs like kidneys and retina (Auryan Szalat et al. 2006). 4Introdução a Medicina II In a more developed stage of arteriosclerosis, the diabetic patient might be subjected to cardiovascular disease, affecting the blood vessels that reach the heart (macrovascular disease). Diabetics are at higher risk of suffering from MI than nondiabetic subjects (Liviu Klein et al. 2004). 1.1. Evolution of a long-term case of DM

5 5Introdução a Medicina II Fig. 3 – Development of atherosclerosis.

6 There is no cure for diabetes; therefore, the treatment of diabetic patients must be based on the reduction of mortality and morbidity rates and on the preservation of their quality of life [1]. [1] California Healthcare Foundation/American Geriatrics Society (AGS) Panel on Improving Care of Elders with Diabetes. Guidelines for Improving the Care of the Older Person with Diabetes Mellitus. JAGS. 2003; 51: S265–S280. 6Introdução a Medicina II Fig. 4 and 5 – Atherosclerotic plaque: its evolution and degree of severity.

7 Introdução a Medicina II7 2. Objective The aim of this study is, via a systematic review of randomized controlled trials followed by a meta-analysis, to analyse: - Mortality - Morbidity - Quality of life Tight BGL control (glucose-insulin, insulin and glucose-insulin-potassium methods) Standard glucose lowering therapy Diabetic/hyperglycaemic patients with aCAD Time

8 Introdução a Medicina II8 3. Participants and methods 3.1. Study participants Randomized controlled trials that compare strict medical blood glucose monitoring with a standard treatment in reducing the morbidity/mortality of diabetic patients with an acute coronary event. Inclusion criteria:  Type I and/or type II diabetic or hyperglycemic patients;  Hospital-admission of patients with macroangiopathy which have already had their first MI event (or are probably prone to it);  Insulin infusion treatment after hospitalization;  Insulin treatment period up to 1,5 years (1 year + 6 months). Exclusion criteria:  All articles which are not randomized and controlled clinical trials;  N on-diabetic control group;  Treatment other than insulin or glucose-insulin-potassium ones;  Language other than english or portuguese;  Repeated samples.

9 Introdução a Medicina II9 3.2. Data Collection Methods Research for primary studies in a general database (Medline) using the following query: (“Myocardial Ischemia” [Mesh] OR “acute coronary syndrome” OR “myocardial infarction” OR "Coronary Artery Bypass"[Mesh] OR “coronary surgery” OR “coronary artery bypass grafting”) AND ("Diabetes Mellitus, Type 2"[Mesh] OR “Hyperglycemia” [Mesh] OR “diabetes mellitus”) AND (“blood glucose control” OR “glucose monitor*” OR “insulin glucose infusion” OR “insulin dextrose infusion” OR “insulin infusion” OR “glycemic control” OR “intensive glycemic control” OR “intensive insulin therapy” OR “strict glycemic control” OR “intensive metabolic control”). Screening and inclusion phases.

10 Introdução a Medicina II10 Fig. 6 – Flowchart presenting screening and inclusion phases of the project.

11 Introdução a Medicina II11 3.3. Variables description General and follow-up variables  Study variables: - Author, Medline ID, year of publication and local where the study was developed.  Patient variables: - Total no. of patients included, no. of controls, no. of patients in the intervention group, no. of males/females, median age of patients and proportion of sexes in each group.  Type(s) of diabetes mellitus included (or minimal BGL accepted);  Follow-up and infusion periods;  Type of protocol (chemical and chronological characterization);  Biochemical substances measured (such as glycated hemoglobin and serum K + );  Evolution of patients’ glycaemia. Major outcomes  Mortality;  Re-infarction;  Arrhythmia;  Stroke (cerebrovascular disease).

12 Introdução a Medicina II12 3.4. Statistical analysis Test the heterogeneity of the trials (potential meta-analysis?). Odds ratio for individual trials and combined data. SPSS ® (descriptive analysis) and RevMan ® (pooled statistics). α = 0,05.

13 Introdução a Medicina II13 4. Results, tables and graphics 355 (μ c =96%) + 17 Excluded articles 233 weren’t randomized and controlled clinical trials 77 were not related with the theme 9 had a follow-up period > 1.5 years 13 weren’t written in English or Portuguese 14 had different clinical endpoints 5 included non-diabetic patients 3 included drugs in the protocol 1 included patients without MI or macroangiopathy 4 weren’t randomized and controlled clinical trials 2 weren’t written in English or Portuguese 4 were not related with the theme 5 had different clinical endpoints 1 included non-diabetic patients 1 was unavailable in full text version (?) 1 included patients without MI or macroangiopathy

14 Introdução a Medicina II14 Article Medline ID No. (I) No. (C) Male % (I) Male % (C) Mean age (I) Mean age (C) Statistical significance Malmberg K. et al 779777630631462636768NS** Cheung N. et al 16567812126114797761.963.4NS** D’Alessandro C. et al 17599483120*108*777666 NS** Pache J. et al1521581235*37*71.675.360.864.1NS** * Subgroup of patients. ** Sex and age. Article Year of publication Local of study Total follow-up period (years) Patients included Malmberg K. et al 1995Sweden1DM I and II Cheung N. et al2006Australia0.5 DM II and hyperglycemia D’Alessandro C. et al 2007France1.5DM I and II Pache J. et al2004Germany0.5DM I and II

15 Introdução a Medicina II15 4.1. DIGAMI study – Malmberg, K. et al Inclusion criteria: - Suspected aMI within the previous 24 hours, combined with BGL>11 mmol/L; - Not diagnosed DM, but BGL>11 mmol/L. TIME Total (%) Control group (%) Infusion group (%) Mortality reduction %p In-hospital10.211.19.118NS 3 months14.015.612.421NS 1 year22.426.118.6290.0273

16 ~ Introdução a Medicina II16 4.2. HI-5 study – Cheung, N. et al ITG (%)CTG (%)p In-hospital mortality 3 months mortality 1 year mortality In-hospital cardiac failure 12.722.80.04 3 months re-infarction 24h-BGL ≤ 8 (mmol/L) 24h-BGL ≥ 8.1 (mmol/L) Significancep In-hospital mortality (%) 070.050.07 3 months mortality (%) 290.05 1 year mortality (%) 2110.020.03 x (μ 24h-BGL ) = 8.1 mmol/L Inclusion criteria: - Suspected aMI within the previous 24 hours; - Not diagnosed DM, but BGL>7.8 mmol/L.

17 Introdução a Medicina II17 4.3. EuroSCORE study – D’Alessandro, C. et al * p = 0,03. ** p = 0,01. Preoperative characteristics: Group P (%) Group NP (%) p Unstable angina 1280.08 Recent MI (<90 d) 92< 0.01 Euro SCORE 0-4 60640.31 Euro SCORE > 4 40360.31 Overall mortality 1.34.0< 0.05 Postoperative results:

18 Introdução a Medicina II18 4.4. REVIVAL study – Pache, J. et al Inclusion criteria: - aMI within 48 hours after the onset of typical symptoms. GIK (%) Control (%) p DM22.623.60.85 Prior MI9.711.50.61 Preoperative characteristics:

19 Introdução a Medicina II19 Genuth S, et al. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care. 2003;26:3160-3167. Liviu Klein MD, Mihai Gheorghiade MD. Management of the Patient with Diabetes Mellitus and Myocardial Infarction: Clinical Trials Update. Am J Med. 2004;116(5A):47S–63S. Sprafka JM, et al. Trends in prevalence of diabetes mellitus in patients with myocardial infarction and effect of diabetes on survival. The Minnesota Heart Survey. Diabetes Care. 1991 Jul;14(7):537–543. Cohen ND, Shaw JE. Diabetes: advances in treatment. Internal Medicine Journal. 2007 Jun;37(6):383–388. Joshua A Beckman MD MS, Mark A Creager MD, Peter Libby MD. Diabetes and Atherosclerosis: Epidemiology, Pathophysiology and Management. JAMA. 2002;287:570–2581. John W Baynes PhD, Marek H Dominiczak MD FRCPath FRCP(Glasg) FACB. Medical Biochemistry. 2nd ed. Elsevier Mosby; 2005. Chapter 17, Lipids and Lipoproteins; p. 236–239. Chapter 20, Glucose Homeostasis, Fuel Metabolism, and Insulin; p. 286–293. K C R Baynes, et al. Molecular mechanisms of inherited insulin resistance. Q J Med. 1997;90:557–562. Julie Nigro, et al. Insulin Resistance and Atherosclerosis. Endocrine Reviews. 2006;27(3):242–259. Bartnik M, et al. Newly detected abnormal glucose tolerance: an important predictor of long-term outcome after myocardial infarction. Eur Heart J. 2004;25:1990–1997. Malmberg K, et al. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995; 26: 57–65. Cheung N, et al. The Hyperglycemia: Intensive Insulin Infusion in Infarction (HI-5) study: a randomized controlled trial of insulin infusion therapy for myocardial infarction. Diabetes Care. 2006 Apr; 29(4): 765–770. D’Alessandro C, et al. Strict glycemic control reduces EuroSCORE expected mortality in diabetic patients undergoing myocardial revascularization. J Thorac Cardiovasc Surg. 2007 Jul; 134(1): 29–37. Pache J, et al. A randomized evaluation of the effects of glucose-insulin-potassium infusion on myocardial salvage in patients with acute myocardial infarction treated with reperfusion therapy. Am Heart J. 2004 Jul; 148(1): e3. 5. References

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