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Trial Programme

ON going T elmisartan A lone and in combination with R amipril G lobal E ndpoint T rial The telmisartan trial in cardiovascular protection Sponsored by Boehringer Ingelheim.

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Trial Programme

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  1. ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint TrialThe telmisartan trial in cardiovascular protectionSponsored by Boehringer Ingelheim

  2. ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint TrialThe Micardis trial in cardiovascular protectionSponsored by Boehringer Ingelheim

  3. Trial Programme ONTARGET Trial Programme 28,400 patients ONTARGET TRANSCEND The principal trial The parallel trial 23,400 patients 5000 patients

  4. Background Telmisartan is: • an angiotensin II AT1 receptor blocker (ARB) • approved for hypertension, alone or in combination with another antihypertensive agent

  5. Background Ramipril is: • an angiotensin converting enzyme (ACE) inhibitor • approved for • hypertension • congestive heart failure post myocardial infarction • reduction of cardiovascular risk in high-risk patients aged 55 years

  6. From HOPE to • ONTARGET will be the largest ARB clinical trial ever conducted • It will build on the positive results from the landmark Heart Outcomes Prevention Evaluation (HOPE) trial, which investigated the effect of ramipril on cardiovascular risk

  7. The HOPE study • Double-blind, randomized, placebo-controlled trial • Over 9500 patients at high risk of cardiovascular disease • 4.5-year treatment period • Compared the risk of cardiovascular events with the ACE inhibitor, ramipril (10 mg/day), vs placebo, both given as add-on to existing antihypertensive therapy

  8. HOPE study results – primary endpoints Combined cardiovascular endpoint Cardiovascular mortality, myocardial infarction, stroke Cardiovascular mortality Myocardial infarction Stroke -20% p<0.001 -22% p<0.001 -26% p<0.001 -32% p<0.001 Ramipriln=4645, Placebon=4652 The HOPE Study Investigators, 2000

  9. HOPE study results – secondary endpoints All-cause mortality Need for revascularization Hospitalization for heart failure Complications relating to diabetes -12% p=0.25 -15% p=0.002 -16% p=0.005 -16% p=0.03 Ramipriln=4645, Placebon=4652 The HOPE Study Investigators, 2000

  10. Rationale ANGIOTENSIN I Bradykinin Inactive fragments ACE inhibitor ANGIOTENSIN II ARB AT1 RECEPTOR Vasoconstriction Sodium retention Water retention SNS activation Growth-promoting effects AT2 RECEPTOR Tissue regeneration Inhibitor of inappropriate cell proliferation SNS = Sympathetic Nervous System

  11. Rationale ANGIOTENSIN I Bradykinin Inactive fragments Angiotensin II escape ACE inhibitor ANGIOTENSIN II ARB AT1 RECEPTOR Vasoconstriction Sodium retention Water retention SNS activation Growth-promoting effects AT2 RECEPTOR Tissue regeneration Inhibitor of inappropriate cell proliferation SNS = Sympathetic Nervous System

  12. Rationale Telmisartan and ramipril combination therapy should: • avert the negative consequences of angiotensin II escape associated with ramipril treatment • prevent any excess angiotensin II acting at AT1 receptors • retain potential tissue-protective benefits associated with increased bradykinin levels

  13. Objectives • To compare the efficacy of telmisartan with the ACE inhibitor, ramipril, in preventing cardiovascular morbidity and mortality • To determine any additional benefit of combining telmisartan with an ACE inhibitor, compared with the ACE inhibitor alone

  14. A global trial Europe 23 countries North America 2 countries Asia 9 countries South America 3 countries Africa 1 country Australasia 2 countries

  15. Participating countries Argentina France Netherlands Spain Australia Germany New Zealand Sweden Austria Greece Norway Switzerland Belgium Hong Kong Philippines Taiwan Brazil Hungary Poland Thailand Canada Ireland Portugal Turkey China Italy Russia UK Czech Republic Korea Singapore Ukraine Denmark Malaysia Slovakia United Arab Emirates Finland Mexico South Africa USA

  16. will be the largest ARB trial to date Patient treatment years 

  17. Patient profile • 55 years of age • At high risk of cardiovascular disease • No patients with congestive heart failure

  18. Study design • Double-blind, double dummy, parallel-group study with three treatment arms: • telmisartan 80 mg once daily • ramipril 10 mg once daily • telmisartan 80 mg + ramipril 10 mg once daily

  19. Study design Screening/enrolment Double-blind treatment Micardis® 80 mg/day 7800 patients Ramipril 10 mg/day 7800 patients Micardis® 80 mg/day + ramipril 10 mg/day 7800 patients 5.5 years

  20. Timeline Randomization begins 2001 2002 2003 2004 2005 2006 2007 2008 Year

  21. Primary endpoint Composite primary endpoint of: • cardiovascular mortality • stroke • acute myocardial infarction • hospitalization for congestive heart failure

  22. Secondary endpoints • Newly diagnosed congestive heart failure • Revascularization procedures • Newly diagnosed diabetes • Dementia • New-onset atrial fibrillation • Microvascular complications of diabetes

  23. Telmisartan Randomized AssessmeNt Study in ACE-I INtolerant Subjects with Cardiovascular DiseaseSponsored by Boehringer Ingelheim

  24. Background • In HOPE, ramipril reduced the risk of cardiovascular events (cardiovascular mortality, myocardial infarction and stroke) by 22% • But, many patients cannot tolerate ACE inhibitor treatment due to side-effects, such as cough • TRANSCEND is the parallel study of ONTARGET to assess the protective effects of telmisartan in ACE inhibitor intolerant patients

  25. Objectives • To evaluate the efficacy of telmisartan 80 mg monotherapy vs placebo in reducing cardiovascular morbidity and mortality in high-risk patients who are intolerant to ACE inhibitors

  26. Patient profile • 55 years of age • At high risk of cardiovascular disease • No patients with congestive heart failure • Intolerant to ACE inhibitors

  27. Study design • Double-blind, parallel-group study • Two treatment arms: • telmisartan 80 mg once daily • placebo

  28. Study design Screening/enrolment Double-blind treatment Micardis® 80 mg/day 2500 patients Placebo 2500 patients 5.5 years

  29. Primary endpoint Composite primary endpoint of: • cardiovascular mortality • stroke • acute myocardial infarction • hospitalization for congestive heart failure

  30. Secondary endpoints • Newly diagnosed congestive heart failure • Revascularization procedures • Newly diagnosed diabetes • Dementia • New-onset atrial fibrillation • Microvascular complications of diabetes

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