American Heart Journal
Volume 148, Issue 1 , Pages 52-61 , July 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

  • The ONTARGET/TRANSCEND Investigators

      Affiliations

    • Hamilton, Ontario, Canada
    • Corresponding Author InformationReprint requests: Koon K. Teo, MD, Room 3U4, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5.
    • See Appendix for Writing Group.
    • Corresponding Author InformationReprint requests: Koon K. Teo, MD, Room 3U4, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5.
    • teok@mcmaster.ca

Received 7 October 2003 ,Accepted 26 March 2004.

References 

  1. Murray CJL, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020 (Global Burden of Disease Study). Lancet. 1997;349:1498–1504
  2. Martin MJ, Hulley SB, Browner WS, et al.  Serum cholesterol, blood pressure and mortality (implications from a cohort of 361,662 men). Lancet. 1986;ii:933–946
  3. Yusuf S. Two decades of progress in preventing vascular disease. Lancet. 2002;360:2–3
  4. Lonn E, Yusuf S, Jha P, et al.  Emerging role of angiotensin-converting enzyme inhibitors in cardiac and vascular protection. Circulation. 1994;90:2056–2069
  5. Flather MD, Yusuf S, Kober L, et al.  Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction (a systematic overview of data from individual patients). Lancet. 2000;355:1575–1581
  6. The HOPE Study Investigators . Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on CV events in high-risk patients. N Engl J Med. 2000;342:145–153
  7. Pedersen OD, Bagger H, Kolber L, et al.  Trandolapril reduces the incidence of atrial fibrillation after acute MI in patients with left ventricular dysfunction. Circulation. 1999;100:376–380
  8. The PROGRESS Collaborative Group . Effects of blood pressure lowering with perindopril and indapamide on dementia and cognitive decline in patients with cerebrovascular disease. Arch Intern Med. 2003;163:1069–1075
  9. Hollenberg NK, Sever PS. The past, present and future of hypertension management (a potential role for AT1-receptor blockers). J Renin Angiotensin Aldosterone Syst. 2000;1:5–10
  10. Strawn WB, Dean RH, Ferrario CM. Novel mechanisms linking angiotensin II and early atherogenesis. J Renin Angiotensin Aldosterone Syst. 2000;1:11–17
  11. Bunier M, Brunner HR. Angiotensin II receptor antagonists. Lancet. 2000;355:637–645
  12. Pitt B, Poole-Wilson PA, Segal R, et al.  Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure (randomised trial—the Losartan Heart Failure Survival Study ELITE II). Lancet. 2000;355:1582–1587
  13. Pfeffer MA, Swedberg K, Granger CB, et al.  Effects of candesartan on mortality and morbidity in patients with chronic heart disease (the CHARM-Overall programme). Lancet. 2003;362:759–766
  14. McMurray JJV, Ostergren J, Swedberg K, et al.  Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors (the CHARM-Added Trial). Lancet. 2003;362:767–771
  15. McKelvie RS, Yusuf S, Pericak D, et al.  Comparison of candesartan, enalapril, and their combination in congestive heart failure (Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study). Circulation. 1999;100:1056–1064
  16. Cohn JN, Tognoni G  Valsartan Heart Failure Trial Investigators . A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure (Val-HeFT). N Engl J Med. 2001;345:1667–1675
  17. Brenner BM, Cooper ME, De Zeeuw D, et al.  Effects of losartan on renal and cardiovascular outcomes in patients with type 2 DM and nephropathy. N Engl J Med. 2001;345:861–869
  18. Dahlöf B, Devereux R, Kjeldsen SE, et al.  Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE) (a randomised trial against atenolol). Lancet. 2002;359:995–1003
  19. Parving H-H, Lehnert H, Brochner-Mortensen J, et al.  The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001;345:870–878
  20. Lewis EJ, Hunsicker LG, Clarke WR, et al.  Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851–860
  21. Granger CB, McMurray JJV, Yusuf S, et al.  Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors (the CHARM-Added Trial). Lancet. 2003;362:772–776
  22. Yusuf S, Pfeffer MA, Swedberg K, et al.  Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction (the CHARM-Preserved Trial). Lancet. 2003;362:777–781
  23. Schieffer B, Schieffer E, Hilfiker-Kleiner D, et al.  Expression of angiotensin II and interleukin 6 in human coronary atherosclerotic plaques (potential implications for inflammation and plaque instability). Circulation. 2000;101:1372–1377
  24. Navalkar S, Parthasarathy S, Santanam N, et al.  Irbesartan, an angiotensin type I receptor inhibitor, regulates markers of inflammation in patients with premature atherosclerosis. J Am Coll Cardiol. 2001;37:440–444
  25. Stoll M, Steckelings UM, Paul M, et al.  The angiotensin AT2-receptor mediates inhibition of cell proliferation in coronary endothelial cells. J Clin Invest. 1995;95:651–657
  26. The European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease Investigators . Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease (randomized, double-blind, placebo-controlled, multicentre trial (the EUROPA study)). Lancet. 2003;362:782–788
  27. Sleight P, Yusuf S, Pogue J, et al.  Blood-pressure reduction and cardiovascular risk in the HOPE study. Lancet. 2001;358:2130–2131
  28. Wing L, Reid C, Ryan P, et al.  A comparison of outcomes with angiotensin-converting-enzyme inhibitors and diuretics for hypertension in the elderly. N Engl J Med. 2003;348:583–592
  29. Pitt B, Segal R, Martinez FA, et al.  Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet. 1997;349:747–752
  30. Pfeffer MA, McMurray JJV, Velazquez EJ, et al.  Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med. 2003;349:1893–1906
  31. Teo KK, Yusuf S, Pfeffer M, et al.  Effects of long-term treatment with angiotensin-converting-enzyme inhibitors in the presence or absence of aspirin (a systematic review). Lancet. 2002;360:1037–1043
  32. Hasselblad V, Kong DF. Statistical methods for comparison to placebo in active-control trials. Drug Inf J. 2001;35:435–449
  33. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457–481
  34. Cox DR. Regression models and life-tables. J R Stat Soc. 1972;34:187–220
  35. Peto R, Pike MC, Armitage P, et al.  Design and analysis of randomized clinical trials requiring prolonged observation of each patient, II (analysis and examples). Br J Cancer. 1977;35:1–39

☆ Boehringer-Ingelheim GmbH is the main sponsor and GlaxoSmithKline a cosponsor of the ONTARGET/TRANSCEND Trials.

PII: S0002-8703(04)00146-2

doi: 10.1016/j.ahj.2004.03.020

American Heart Journal
Volume 148, Issue 1 , Pages 52-61 , July 2004

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