The ONgoing Telmisartan Alone and in

Slides:



Advertisements
Similar presentations
Duality of interests S.Yusuf has received fees for lecturing and research grants from Cadilla Pharma, as well as from 6 other pharma companies that produce.
Advertisements

Statin Landmark Trials Across the Spectrum of Risk: Secondary CV Prevention.
ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial The telmisartan trial in cardiovascular protection Sponsored by Boehringer.
Atorvastatin in Type 2 diabetics on dialysis: 4D Study 1255 T2DM patients on dialysis for 8.3 mo; 29% with prior MI or revascularization or CHD; 35% CHF;
Valsartan Antihypertensive Long-Term Use Evaluation Results
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.
TRANSCEND: Telmisartan Randomized AssesmeNt Study in aCE iNtolerant Subjects with Cardiovascular Disease ONTARGET / TRANSCEND Investigators Koon K. Teo,
CHARM-Alternative: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Alternative Purpose To determine whether the angiotensin.
CHARM-Preserved: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Preserved Purpose To determine whether the angiotensin.
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ALLHAT study overview Double-blind, randomized trial to determine whether.
ONTARGET Risk factors and outcomes associated with nonadherence Background ONTARGET compared the efficacy of the ARB telmisartan, the ACE inhibitor ramipril,
Daily Dilemmas in Hypertension Management. Objectives Review the impact of hypertension on society Review the impact of hypertension on society Review.
Is It the Achieved Blood Pressure or Specific Medications that Make a Difference in Outcome, or Is the Question Moot? William C. Cushman, MD Professor,
Duality of interests S.Yusuf has received fees for lecturing and research grants from Cadilla Pharma, as well as from 6 other pharma companies that produce.
Irbesartan Diabetic Nephropathy Trial (IDNT) Collaborative Study Group N Eng J Med 345: , 2001 Edmund J. Lewis, M.D. Muehrcke Family Professor of.
Duality of interests S.Yusuf has received fees for lecturing and research grants from Cadilla Pharma, as well as from 6 other pharma companies that produce.
Dick de Zeeuw Department of Clinical Pharmacology University Medical Center Groningen The Netherlands Albuminuria; a tool for measuring non-blood pressure.
TRANSCEND: Telmisartan Randomized AssesmeNt Study in aCE iNtolerant Subjects with Cardiovascular Disease ONTARGET / TRANSCEND Investigators Koon K. Teo,
HOPE: Heart Outcomes Prevention Evaluation study Purpose To evaluate whether the long-acting ACE inhibitor ramipril and/or vitamin E reduce the incidence.
The Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial ONTARGET.
Background There are 12 different types of medications to lower blood sugar levels in patients with type 2 diabetes. It is widely agreed upon that metformin.
The Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. N Engl J Med 2006; available at: End pointActive therapy PlaceboRelative.
OVERTURE FDA Cardiovascular and Renal Drugs Advisory Committee Meeting July 19, 2002 Milton Packer, M.D., FACC Columbia University College of Physicians.
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.
Guidelines recommend, as first-line treatment for hypertension, a diuretic or the combination of diuretic ± ACE inhibitor. Prevention of Stroke in Patients.
Rosuvastatin 10 mg n=2514 Placebo n= to 4 weeks Randomization 6weeks3 monthly Closing date 20 May 2007 Eligibility Optimal HF treatment instituted.
COPERNICUS: Carvedilol Prospective Randomized Cumulative Survival trial Purpose To assess the effect of carvedilol, a β 1 -, β 2 - and α 1 -receptor blocker,
Date of download: 5/29/2016 Copyright © The American College of Cardiology. All rights reserved. From: Safety and Efficacy of Low Blood Pressures Among.
The Heart Outcomes Prevention Evaluation (HOPE) – 3 Trial
Results from ASCOT-BPLA: Anglo-Scandinavian Cardiac Outcomes Trial–Blood Pressure Lowering Arm VBWG.
The Heart Outcomes Prevention Evaluation (HOPE) – 3 Trial
Antonio Coca, MD, PhD, FRCP, FESC
Dr John Cox Diabetes in Primary Care Conference Cork
(p for noninferiority = 0.01)
Discontinuation of medication after nonfatal event: MI
What should the Systolic BP treatment goal be in patients with CKD?
Nephrology Journal Club The SPRINT Trial Parker Gregg
a cautionary note from SPRINT
a cautionary note from SPRINT
The SPRINT Research Group
Blood Pressure and Age in Controlling Hypertension
LEADER trial: Primary Outcome
CORAL Trial design: Patients with renal artery stenosis and hypertension or chronic kidney disease were randomized to renal artery stenting (n = 467) vs.
HOPE: Heart Outcomes Prevention Evaluation study
SOCRATES Trial design: Patients with acute ischemic stroke were randomized in a 1:1 fashion to receive either ticagrelor 180 mg load + 90 mg BID or aspirin.
Valsartan in Acute Myocardial Infarction Trial Investigators
TNT: Baseline and final LDL cholesterol levels
Relative mortality risk associated with quartiles of systolic blood pressure compared with systolic
Summary of Design Aim: Effect of Ramipril (up to 10mg/d) or Vit E (400 IU/d) vs its placebo on CV death, M I or stroke (primary) Design: Randomized double.
Combining ACEI and ARB Therapy: The Next Step?
The following slides highlight a report on a presentation at the Late-breaking Trials Session and a Satellite Symposium of the American Heart Association.
EMPA-REG OUTCOME Trial design: Patients with type 2 diabetes mellitus (DM2) at high risk for CV events were randomized to receive in a 1:1:1 fashion either.
The Hypertension in the Very Elderly Trial (HYVET)
Time to Primary Outcome
Rounded incidence values (%) of renal and nonrenal events
PRECISION Trial design: Patients with arthritis and increased cardiovascular risk were randomized to celecoxib 100 mg twice daily (n = 8,072) vs. ibuprofen.
Insights from the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)
ATMOSPHERE Trial design: Patients with symptomatic heart failure were randomized in a 1:1:1 fashion to either aliskiren 300 mg once daily, enalapril 5.
Outcome Relative risk with beta blockers 95% CI Stroke –1.30
SUSTAIN-6 Trial design: Patients with DM2 at high risk for CV events were randomized in a 1:1:1:1 fashion to either semaglutide 0.5 mg, semaglutide 1 mg,
ONTARGET Non-inferiority Comparison
Cystatin C levels and risk of death from all causes
Inclusion Criteria for Patients with Multiple Atherothrombotic Risk Factors and for Those with Established Cardiovascular Disease Deepak L.Bhatt, et al,
HOPE-3 Trial design: Patients without known cardiovascular disease, and with an intermediate risk of cardiovascular events, were randomized in a 2 x 2.
Clinical Trial Commentary
An ACCORD BP sub-analysis HR: 1.06; 95%CI: ; P=0.61
EMPA-REG OUTCOME: Cumulative incidence of the primary outcome
An ACCORD BP sub-analysis HR: 1.06; 95%CI: ; P=0.61
End Points: ONTARGET vs. HOPE *
Presentation transcript:

The ONgoing Telmisartan Alone and in ONTARGET The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial Salim Yusuf, Koon K. Teo, Janice Pogue, Leanne Dyal, and Ingrid Copland, Population Health Research Institute and Investigators Yusuf, et al. N ENGL J MED.358;15:1547-1559 1

Change in BP (mmHg) ONTARGET Ramipril Telmisartan Combination Systolic -6.0 -6.9 -8.4 Diastolic -4.6 -5.2 Yusuf, et al. N ENGL J MED.358;15:1547-1559 2

Time to Permanent Discontinuation ONTARGET Time to Permanent Discontinuation of Study Medication NO. at Risk Telmisartan 8542 7954 7384 6909 6478 Ramipril 8576 7796 7165 6681 6254 Years of Follow-up Cumulative Hazard Rates Yusuf, et al. N ENGL J MED.358;15:1547-1559

Reasons for Permanently Stopping Study Medications ONTARGET Reasons for Permanently Stopping Study Medications Ram N=8576 Tel N=8542 Tel vs. Ram RR P Hypotension 149 229 1.54 0.0001 Syncope 15 19 1.27 0.4850 Cough 360 93 0.26 <0.0001 Diarrhea 12 1.59 0.20 Angioedema 25 10 0.40 0.0115 Renal Impairment 60 68 1.14 0.46 Any Discontinuation 2099 1962 0.94 0.02 Yusuf, et al. N ENGL J MED.358;15:1547-1559

Time to Primary Outcome ONTARGET Time to Primary Outcome Telmisartan Cumulative Hazard Rates Ramipril Years of Follow-up NO. at Risk 8542 8176 7778 7420 7051 Telmisartan 8576 8214 7832 7473 7095 Ramipril Yusuf, et al. N ENGL J MED.358;15:1547-1559

Primary Outcome & HOPE Primary Outcome ONTARGET Primary Outcome & HOPE Primary Outcome Ram Tel Tel vs Ram N (%) RR (95% CI) P (non-inf) N 8576 8542 Primary Outcome CV Death, MI, Stroke, CHF Hosp 1412 (16.46%) 1423 (16.66%) 1.01 (0.94-1.09) 0.0038 (Adjusted for SBP) 1.02 (0.95-1.10) 0.0055 HOPE Primary Outcome CV Death, MI, Stroke 1210 (14.11%) 1190 (13.93%) 0.99 (0.91-1.07) 0.0009 0.0012 Yusuf, et al. N ENGL J MED.358;15:1547-1559 6

Time to Primary Outcome ONTARGET Time to Primary Outcome Ramipril Cumulative Hazard Rates Tel.&Ram. Years of Follow-up NO. at Risk 8576 8214 7832 7473 7095 Ramipril 8502 8134 7740 7377 7023 Tel.&Ram. Yusuf, et al. N ENGL J MED.358;15:1547-1559 7 7

Reasons for Permanently Stopping Study Medications ONTARGET Reasons for Permanently Stopping Study Medications Ram N=8576 Ram + Tel N=8502 Ram + Tel vs. Ram RR P Hypotension 149 406 2.75 <0.0001 Syncope 15 29 1.95 0.032 Cough 360 392 1.10 0.1885 Diarrhea 12 39 3.28 0.0001 Angioedema 25 18 0.73 0.30 Renal Impairment 60 94 1.58 0.0050 Any Discontinuation 2099 2495 1.20 Yusuf, et al. N ENGL J MED.358;15:1547-1559