Slide Source: www.lipidsonline.org Primary and Other Outcomes: DREAM Rosiglitazone group (n=2635) Placebo group (n=2634)HR (95% CI)p Composite primary.

Slides:

Advertisements

Similar presentations

1. 2 The primary Objective of IDEAL LDL-C Simvastatin mg/d Atorvastatin 80 mg/d risk CHD In stable CHD patients IDEAL: The Incremental Decrease.

Advertisements

Slide Source: Lipids Online Slide Library Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT): Design Cannon CP.

The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) The LIPID Study Group N Engl J Med 1998;339:

Cholesterol quintile (mg/dL)

The ONTARGET Trial Reference The ONTARGET investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008;358:15.

Treating to New Targets Study TNT Trial Presented at The American College of Cardiology Scientific Sessions 2005 Presented by Dr. John C. LaRosa.

Diabetes Trials Unit University of Oxford WebSite: Lipids in Diabetes Study.

COURAGE: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Purpose To compare the efficacy of optimal medical therapy (OMT)

BEAUTI f UL: morBidity-mortality EvAlUaTion of the I f inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction Purpose.

Results of Monotherapy in ALLHAT: On-treatment Analyses ALLHAT Outcomes for participants who received no step-up drugs.

Slide Source: Lipids Online Slide Library Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT)

Pravastatin in Elderly Individuals at Risk of Vascular Disease Presented at Late Breaking Clinical Trials AHA 2002 PROSPER.

Clinical Outcomes with Newer Antihyperglycemic Agents

VBWG HPS. Lancet. 2003;361: Gæde P et al. N Engl J Med. 2003;348: Recent statin trials: Reduction in primary outcome in patients with diabetes.

The Prospective Pravastatin Pooling Project L I P I D CARECARE PPP Project Investigators Am J Cardiol 1995; 76:899–905.

Aim To determine the effects of a Coversyl- based blood pressure lowering regimen on the risk of recurrent stroke among patients with a history of stroke.

WOSCOPS: West Of Scotland Coronary Prevention Study Purpose To determine whether pravastatin reduces combined incidence of nonfatal MI and death due to.

Study Design Scirica BM, Bhatt DL Braunwald et al, Sexagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med

SPARCL Stroke Prevention by Aggressive Reduction in Cholesterol Levels trial.

LIPID: Long-term Intervention with Pravastatin in Ischemic Disease Purpose To determine whether pravastatin will reduce coronary mortality and morbidity.

HOPE: Heart Outcomes Prevention Evaluation study Purpose To evaluate whether the long-acting ACE inhibitor ramipril and/or vitamin E reduce the incidence.

SPARCL – Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Jim McMorran Coventry GP GP with Specialist Interest in Diabetes and.

A Diabetes Outcome Progression Trial

Collaborative Atorvastatin Diabetes Study CARDS Dr Sachin Kadoo.

ALLHAT 6/5/ CARDIOVASCULAR DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED BY BASELINE GLOMERULAR FILTRATION RATE (3 GROUPS by GFR)

4S: Scandinavian Simvastatin Survival Study

Clinical Outcomes with Newer Antihyperglycemic Agents FDA-Mandated CV Safety Trials 1.

Trial profile The FIELD study investigators, Lancet Published online November 14, 2005.

Baseline Characteristics of the Patients* - Part I The ONTARGET Investigators. N Engl J Med 2008 [Epub on Mar 31]

6/5/ CARDIOVASCULAR DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED BY BASELINE GLOMERULAR FILTRATION RATE (4 GROUPS by GFR) ALLHAT.

Rosuvastatin 10 mg n=2514 Placebo n= to 4 weeks Randomization 6weeks3 monthly Closing date 20 May 2007 Eligibility Optimal HF treatment instituted.

Enrollment and Outcomes Duckworth W, et al. N Engl J Med 2009;360:

The JUPITER Trial Reference Ridker PM. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195–2207.

1 Effect of Ramipril on the Incidence of Diabetes The DREAM Trial Investigators N Engl J Med 2006;355 FM R1 윤나리.

Anemia in CKD The TREAT Trial Reference Pfeiffer MA. A trial of Darbepoetin alpha in type II diabetes and chronic kidney disease. N Engl J Med. 2009;361:2019–2032.

CHEST 2013; 144(3): R3 김유진 / Prof. 장나은. Introduction 2  Cardiovascular diseases  common, serious comorbid conditions in patients with COPD cardiac.

Over Time Additional Risk Factors Can Progress: Effect of Cholesterol and BP on CHD Risk in MRFIT Trial

1 Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled.

R1. 이정미 / prof. 이상열. INTRODUCTION Type 2 diabetes is a major risk factor for cardiovascular disease The presence of both type 2 diabetes and.

Statins The AURORA Trial Reference Fellstrom BC. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360. A.

Clinical Outcomes with Newer Antihyperglycemic Agents

FOURIER Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

Clinical Outcomes with Newer Antihyperglycemic Agents

Hypertension in the Post SPRINT era

Trial profile SAS denotes the Simvastatin in Aortic Stenosis Study

HOPE: Heart Outcomes Prevention Evaluation study

REVEAL: Randomized placebo-controlled trial of anacetrapib in 30,449 patients with atherosclerotic vascular disease Louise Bowman on behalf of the HPS.

Pravastatin in Elderly Individuals at Risk of Vascular Disease

Effects of Anacetrapib on the Incidence of New-Onset Diabetes Mellitus and on Vascular Events in People With Diabetes Louise Bowman & Martin Landray on.

AIM HIGH Niacin plus Statin to prevent vascular events

HDL cholesterol and cardiovascular risk Epidemiological evidence

First time a CETP inhibitor shows reduction of serious CV events

SPIRE Program: Studies of PCSK9 Inhibition and the Reduction of Vascular Events Unanticipated attenuation of LDL-c lowering response to humanized PCSK9.

AIM-HIGH Niacin Plus Statin to Prevent Vascular Events

TNT: Baseline and final LDL cholesterol levels

Jane Armitage on behalf of the HPS2-THRIVE Collaborative Group

Baseline characteristics of HPS participants by prior diabetes

The Hypertension in the Very Elderly Trial (HYVET)

Lipid-Lowering Arm (ASCOT-LLA): Results in the Subgroup of Patients with Diabetes Peter S. Sever, Bjorn Dahlöf, Neil Poulter, Hans Wedel, for the.

These slides highlight a presentation from a Special Session of the Late-Breaking Clinical Trials sessions during the American College of Cardiology 2005.

Flow diagram for exclusions of trials identified RCT indicates randomized controlled trial Hulten E, et al. Arch Intern Med 2006;166:

Volume 368, Issue 9541, Pages (September 2006)

PROSPER: trial design

The following slides highlight a report on a presentation at the American College of Cardiology 2004, Scientific Sessions, in New Orleans, Louisiana on.

The ACCORD Study Group. NEJM 2010; Epub March 14

SPIRE Program: Studies of PCSK9 Inhibition and the Reduction of Vascular Events Unanticipated attenuation of LDL-c lowering response to humanized PCSK9.

Cumulative incidence of cardiovascular events according to medication group in participants of the 4D study with an LDL-C in its fourth quartile at baseline.

EMPA-REG OUTCOME: Cumulative incidence of the primary outcome

FIELD: Primary outcome

Presentation transcript:

Slide Source: Primary and Other Outcomes: DREAM Rosiglitazone group (n=2635) Placebo group (n=2634)HR (95% CI)p Composite primary outcome*306 (11.6%)686 (26.0%)0.40 ( )< Diabetes280 (10.6%)658 (25.0%)0.38 ( ) < Diagnosed by FPG/OGTT231 (8.8%)555 (21.1%)0.38 ( )< Physician diagnosed49 (1.9%)103 (3.9%)0.47 ( )< Death30 (1.1%)33 (1.3%)0.91 ( )0.7 Regression (FPG <6.1 mmol/L)†1330 (50.5%)798 (30.3%)1.71 ( )< Regression (FPG <5.6 mmol/L)†1016 (38.6%)540 (20.5%)1.83 ( )< DREAM investigators. Lancet 2006;368: Data are number (%). *Rows are not mutually exclusive for components of the composite—if a participant had more than one component of the composite then they are counted in the relevant row. †Regression implies achieving a normal fasting glucose concentration (as defined in both rows) and 2-h plasma glucose level. FPG = fasting plasma glucose. OGTT = oral glucose tolerance test.

Slide Source: Primary and Other Outcomes: DREAM (cont’d) Rosiglitazone group (n=2635) Placebo group (n=2634) HR (95% CI)p Cardiovascular events composite*75 (2.9%)55 (2.1%)1.37 ( )0.08 Myocardial infarction15 (0.6%)9 (0.3%)1.66 ( ) 0.2 Stroke7 (0.3%)5 (0.2%)1.39 ( )0.6 Cardiovascular death12 (0.5%)10 (0.4%)1.20 ( )0.7 Confirmed heart failure‡14 (0.5%)2 (0.1%)7.03 ( )0.01 New angina24 (0.9%)20 (0.8%)1.20 ( )0.5 Revascularization35 (1.3%)27 (1.0%)1.29 ( )0.3 Myocardial infarction, stroke, or cardiovascular death 32 (1.2%)23 (0.9%)1.39 ( )0.2 DREAM investigators. Lancet 2006;368: Data are number (%). *Rows are not mutually exclusive for components of the composite—if a participant had more than one component of the composite then they are counted in the relevant row. †Regression implies achieving a normal fasting glucose concentration (as defined in both rows) and 2-h plasma glucose level. ‡Defined as acute treatment with at least two of the following criteria: typical signs and symptoms, typical radiological evidence, use of diuretics, vasodilators, or inotropes.

Slide Source: Adverse Events, Hospitalization, and Death: ADOPT Variable Rosiglitazone (N=1456)Metformin (N=1454)Glyburide (N=1441) Serious Events Total Events Serious Events Total Events Serious Events Total Events Adverse events — number of patients (%) Total events346 (23.8)1338 (91.9)331 (22.8)1341 (92.2)308 (21.4)1321 (91.7) Cardiovascular disease49 (3.4)62 (4.3)46 (3.2)58 (4.0)26 (1.8)†41 (2.8) Myocardial Infarction Fatal2 (0.1) 3 (0.2) Nonfatal22 (1.5)25 (1.7)18 (1.2)21 (1.4)11 (0.8)15 (1.0) Congestive heart failure (investigator-reported)12 (0.8)22 (1.5)12 (0.8)19 (1.3)3 (0.2)†9 (0.6)† Stroke13 (0.9)16 (1.1)17 (1.2)19 (1.3)12 (0.8)17 (1.2) Peripheral vascular disease7 (0.5)36 (2.5)6 (0.4)27 (1.9)4 (0.3)31 (2.2) Gastrointestinal events8 (0.5)335 (23.0)7 (0.5)557 (38.3)‡3 (0.2)316 (21.9) Death and Hospitalization Hospitalization for any reason Patients — no. (%)169 (11.6)172 (11.8)150 (10.4) Events — no Deaths from any cause—no.3431 ADOPT study group. N Engl J Med 2006;355: † P<0.05 for the comparison between this treatment group and the rosiglitazone group; ‡ P<0.01 for the comparison between this treatment group and the rosiglitazone group.

Slide Source: Laboratory Assessment and Concomitant Use of Cardiovascular Drugs: ADOPT Variable Rosiglitazone (N=1456)Metformin (N=1454)Glyburide (N=1441) Serious Events Total Events Serious Events Total Events Serious Events Total Events Laboratory assessment¶ ALT—IU/liter Mean ‡27.2‡ 95% CI20.6– – –28.1 ALT >3 times upper limit of normal — no. of patients (%)14 (1.0)16 (1.1)11 (0.8) LDL cholesterol — mg/dl Mean ‡99.3‡ 95% CI101.7– – –101.9 HDL cholesterol — mg/dl Mean ‡48.9‡ 95% CI51.3– – –49.5 Triglycerides — mg/dl Mean † 95% CI159.2– – –176.9 Drugs used concomitantly — no. of patients (%) Lipid-lowering agents803 (55.2) 708 (48.7)‡ 651 (45.2)‡ Statins750 (51.5) 632 (43.5)‡ 579 (40.2)‡ Antihypertensive agents970 (66.6)969 (66.6)944 (65.5) ¶ All laboratory values are mean values at 4 years; † P<0.05 for the comparison between this treatment group and the rosiglitazone group; ‡ P<0.01 for the comparison between this treatment group and the rosiglitazone group. ADOPT study group. N Engl J Med 2006;355:

Slide Source: Rates of Myocardial Infarction and Death from Cardiovascular Causes Rosiglitazone Group Control Group Odds Ratio (95% CI)P Value no. of events/total no. (%) Myocardial Infarction Small trials combined44/10,285 (0.43)22/6106 (0.36)1.45 (0.88–2.39)0.15 DREAM 15/2,635 (0.57) 9/2634 (0.34)1.65 (0.74–3.68)0.22 ADOPT 27/1,456 (1.85)41/2895 (1.42)1.33 (0.80–2.21)0.27 Overall1.43 (1.03–1.98)0.03 Death from Cardiovascular Causes Small trials combined25/6,845 (0.36) 7/3980 (0.18)2.40 (1.17–4.91) 0.02 DREAM12/2,635 (0.46)10/2634 (0.38)1.20 (0.52–2.78)0.67 ADOPT2/1,456 (0.14)5/2895 (0.17)0.80 (0.17–3.86)0.78 Overall1.64 (0.98–2.74)0.06 Nissen and Wolski. N Engl J Med 2007;356: