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Laufende Studien
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PROTECTION
Abbildung 2: The PROTECTION Programme1 includes ten trials that will recruit a total of more than 6,500 patients. Broadly, these trials can be grouped into renal studies and at-risk hypertension studies. Six of these studies have been completed, and the results are provided in this slide kit. These studies are: PRISMA I & II ARBs FDC ATHOS TRENDY DETAIL 1. Weber M. The telmisartan Programme of Research tO show Telmisartan End-organ proteCTION (PROTECTION) Programme. J Hypertens 2003; 21 (Suppl 6):S37–S46.


Keywords: PROTECTION

ProFESS
Abbildung 3: The PRoFESS(R)study is a randomized, controlled, double-blind study featuring an innovative 2 x 2 factorial design.1 There will be four treatment groups, each enrolling a planned 3875 patients. Each of the primary comparisons will compare patient populations of 7750 patients. The 2 x 2 factorial design provides high power to detect primary end-points. Telmisartan vs placebo. ER-DP + ASA versus clopidogrel. The inclusion criteria are: Ischaemic stroke within 90 days prior to study entry Neurologically and clinically stable Age >55 y Secondary outcomes are: Vascular events (composite of time to first stroke, myocardial infarction, or vascular death) Vascular events or congestive heart failure New onset diabetes 1. The PRoFESS Collaborative Group. Presented at the 30th International Stroke Conference, 2–4 February 2005, New Orleans, Louisiana, USA.


Keywords: PRoFESS-Studie

Ontarget/Transcend
Abbildung 4: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET) Programme is one of the largest cardiovascular protection trials ever undertaken.1,2 ONTARGET will compare telmisartan, ramipril and the combination over a study period of 5.5 years. The parallel Telmisartan Randomized AssessmeNt Study in ACE inhibitor-iNtolerant subjects with cardiovascular Disease (TRANSCEND) will compare telmisartan with placebo in patients intolerant of ACE inhibitors, and has the same endpoints. Patients enrolled are aged 55 years and are at high risk of cardiovascular events (i.e., they have a history of coronary artery disease, peripheral vascular disease, stroke or recent ischaemic attack, or diabetes mellitus type 1 or 2 with target-organ damage). ONTARGET will incorporate a number of endpoints, including cardiovascular mortality and morbidity, new cases of diabetes, nephropathy and cognitive decline. Zimmerman M, Unger T. Challenges in improving prognosis and therapy: the Ongoing Telmisartan Alone and in Combination with Ramipril Global End point Trial Programme. Exp Opin Pharmacother 2004;5:1201–1208. The ONTARGET/TRANSCEND Investigators. Rationale, design and baseline characteristics of two, large, simple, randomized trials evaluating telmisartan, ramipril and their combination in high-risk patients: the ONTARGET/TRANSCEND trials. Am Heart J 2004; 148: 52–61.


Keywords: Ontarget-Transcend-Studie

PROTECTION - Ontarget
Abbildung 5: This slide illustrates the cardiovascular continuum.1 Factors such as hypertension can trigger atherosclerosis and LVH.1 Ventricular wall remodelling, if untreated, may ultimately result in congestive heart failure, end-stage heart disease and death. These can be accompanied by cognitive dysfunction and, as the disease progresses, dementia.2 Hypertension and diabetes are also among the risk factors that lead to endothelial dysfunction. This can result in damage to the glomeruli, microalbuminuria and macroproteinuria, leading to progressive nephrosis and the development of renal failure.3-5 The studies of the PROTECTION Programme, along with the PRoFESS study and The ONTARGET Programme, are investigating the effects of telmisartan at many stages of this continuum. 1. Dzau V, Braunwald E. Resolved and unresolved issues in the prevention and treatment of coronary artery disease: a workshop consensus statement. Am Heart J 1991; 121: 1244–1263. 2. Hofman A, et al. Atherosclerosis, apolipoprotein E, and prevalence of dementia and Alzheimer’s disease in the Rotterdam study. Lancet 1997; 349: 151–154. 3. Cooper ME. Pathogenesis, prevention and treatment of diabetic nephropathy. Lancet 1998; 352: 213–219. 4. Taylor AA. Pathophysiology of hypertension and endothelial dysfunction in patients with diabetes mellitus. Endocrinol Metabol Clin North Am 2001; 30: 983–997. 5. Erhardt LR. Endothelial dysfunction and cardiovascular disease: the promise of blocking the renin-angiotensin system. Int J Clin Pract 2003; 57: 211–218.


Keywords: Ontarget-Studie,  PROTECTION

Zusammenfassung
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