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Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials.

Abstract

BACKGROUND

Angiotensin-converting enzyme (ACE) inhibitors reduce mortality, myocardial infarction, stroke, heart failure, need for revascularization, nephropathy, and diabetes and its complications. Although angiotensin-II receptor blockers (ARBs) have been less extensively evaluated, theoretically they may have "protective" effects similar to those of ACE inhibitors, but with better tolerability. Currently, there is uncertainty about the role of ARBs when used alone or in combination with an ACE inhibitor in high-risk populations with controlled hypertension.

OBJECTIVES

Primary objectives of the ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) are to determine if the combination of the ARB telmisartan and the ACE inhibitor ramipril is more effective than ramipril alone, and if telmisartan is at least as effective as ramipril. The Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects with cardiovascular Disease (TRANSCEND) will determine if telmisartan is superior to placebo in patients who are intolerant of ACE inhibitors. The primary outcome for both trials is the composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure.

METHOD

High-risk patients with coronary, peripheral, or cerebrovascular disease or diabetes with end-organ damage are being recruited and followed for 3.5 to 5.5 years in 2 parallel, randomized, double-blind clinical trials.

PROGRESS

Recruitment from 730 centers in 40 countries for ONTARGET (n = 25,620) was completed in July 2003. For TRANSCEND, 5776 patients (out of a projected total of 6000) have been recruited (by May 10, 2004). Baseline patient characteristics are comparable to the Heart Outcomes Prevention Evaluation (HOPE) trial, the basis of the design of the current study, confirming that patients are at high-risk.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5. teok@mcmaster.ca

    , , , , , , , ,

    Source

    American heart journal 148:1 2004 Jul pg 52-61

    MeSH

    Aged
    Angiotensin-Converting Enzyme Inhibitors
    Benzimidazoles
    Benzoates
    Cardiovascular Diseases
    Diabetes Mellitus
    Double-Blind Method
    Drug Therapy, Combination
    Humans
    Middle Aged
    Patient Selection
    Ramipril
    Randomized Controlled Trials as Topic
    Research Design
    Telmisartan

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15215792

    Citation

    Teo, Koon, et al. "Rationale, Design, and Baseline Characteristics of 2 Large, Simple, Randomized Trials Evaluating Telmisartan, Ramipril, and Their Combination in High-risk Patients: the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease (ONTARGET/TRANSCEND) Trials." American Heart Journal, vol. 148, no. 1, 2004, pp. 52-61.
    Teo K, Yusuf S, Sleight P, et al. Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials. Am Heart J. 2004;148(1):52-61.
    Teo, K., Yusuf, S., Sleight, P., Anderson, C., Mookadam, F., Ramos, B., ... Schumacher, H. (2004). Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials. American Heart Journal, 148(1), pp. 52-61.
    Teo K, et al. Rationale, Design, and Baseline Characteristics of 2 Large, Simple, Randomized Trials Evaluating Telmisartan, Ramipril, and Their Combination in High-risk Patients: the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease (ONTARGET/TRANSCEND) Trials. Am Heart J. 2004;148(1):52-61. PubMed PMID: 15215792.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials. AU - Teo,Koon, AU - Yusuf,Salim, AU - Sleight,Peter, AU - Anderson,Craig, AU - Mookadam,Farouk, AU - Ramos,Barbara, AU - Hilbrich,Lutz, AU - Pogue,Janice, AU - Schumacher,Helmut, AU - ,, PY - 2004/6/25/pubmed PY - 2004/10/6/medline PY - 2004/6/25/entrez SP - 52 EP - 61 JF - American heart journal JO - Am. Heart J. VL - 148 IS - 1 N2 - BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors reduce mortality, myocardial infarction, stroke, heart failure, need for revascularization, nephropathy, and diabetes and its complications. Although angiotensin-II receptor blockers (ARBs) have been less extensively evaluated, theoretically they may have "protective" effects similar to those of ACE inhibitors, but with better tolerability. Currently, there is uncertainty about the role of ARBs when used alone or in combination with an ACE inhibitor in high-risk populations with controlled hypertension. OBJECTIVES: Primary objectives of the ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) are to determine if the combination of the ARB telmisartan and the ACE inhibitor ramipril is more effective than ramipril alone, and if telmisartan is at least as effective as ramipril. The Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects with cardiovascular Disease (TRANSCEND) will determine if telmisartan is superior to placebo in patients who are intolerant of ACE inhibitors. The primary outcome for both trials is the composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure. METHOD: High-risk patients with coronary, peripheral, or cerebrovascular disease or diabetes with end-organ damage are being recruited and followed for 3.5 to 5.5 years in 2 parallel, randomized, double-blind clinical trials. PROGRESS: Recruitment from 730 centers in 40 countries for ONTARGET (n = 25,620) was completed in July 2003. For TRANSCEND, 5776 patients (out of a projected total of 6000) have been recruited (by May 10, 2004). Baseline patient characteristics are comparable to the Heart Outcomes Prevention Evaluation (HOPE) trial, the basis of the design of the current study, confirming that patients are at high-risk. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/15215792/Rationale_design_and_baseline_characteristics_of_2_large_simple_randomized_trials_evaluating_telmisartan_ramipril_and_their_combination_in_high_risk_patients:_the_Ongoing_Telmisartan_Alone_and_in_Combination_with_Ramipril_Global_Endpoint_Trial/Telmisartan_Randomized_Assessment_Study_in_ACE_Intolerant_Subjects_with_Cardiovascular_Disease__ONTARGET/TRANSCEND__trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002870304001462 DB - PRIME DP - Unbound Medicine ER -