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The On going T elmisartan A lone and in combination with R amipril G lobal E ndpoint T rial

ONTARGET. The On going T elmisartan A lone and in combination with R amipril G lobal E ndpoint T rial. The On going T elmisartan A lone and in combination with R amipril G lobal E ndpoint T rial.

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The On going T elmisartan A lone and in combination with R amipril G lobal E ndpoint T rial

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  1. ONTARGET The Ongoing Telmisartan Aloneand in combination with Ramipril Global Endpoint Trial

  2. The Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial ACE-inhibitors (e.g. ramipril in the HOPE trial) reduces CV death, MI, stroke and HF hosp in those with CVD or DM in the absence of ventricular dysfunction or heart failure. ACE-inhibitors are not tolerated by 15% to 25% of patients. Will an ARB (telmisartan) be as effective and better tolerated? Is the combination superior? Adapted from ACC 2008.

  3. ONTARGET Study Design • Questions: • Is telmisartan “non-inferior” to ramipril? • Is the combination superior to ramipril? • Outcome: • Primary: CV death, MI, stroke, CHF hosp • Key secondary: CV death, MI, stroke (HOPE trial outcome) • Design: • Single blind run-in (n=29, 019) • Randomized, double blind, double dummy study conducted in 733 centers in 41 countries (n=25,620) • 56 months of follow-up with 99.8% outcome ascertainment Adapted from ACC 2008.

  4. ONTARGET Study is Based on the Following Statistical Considerations Adapted from ACC 2008.

  5. ONTARGET Study Medications Titration Run-in (Single Blind) Day 1-3 Ram 2.5 mg + Tel Placebo Day 4-10 Ram 2.5 mg + Tel 40 mg Day 11-18 Ram 5.0 mg + Tel 40 mg Randomization (Double Blind) 2 weeks Ram Placebo + Tel 80 mg Ram 5. mg + Tel Placebo Ram 5 mg + Tel 80 mg Then Full doses (Tel 80 mg daily, Ram 10 mg daily) for the arms Adapted from ACC 2008.

  6. ONTARGET Study: Reasons for Not Randomizing Patients Adapted from ACC 2008.

  7. Key Baseline Characteristics in ONTARGET Study Adapted from ACC 2008.

  8. Change in BP (mmHg) in ONTARGET Study Adapted from ACC 2008.

  9. Time to Permanent Discontinuation of Study Medication Adapted from ACC 2008.

  10. Reasons for Permanently Stopping Study Medications in ONTARGET Study Adapted from ACC 2008.

  11. Time to Primary Outcome Telmisartan Adapted from ACC 2008.

  12. Primary Outcome & HOPE Primary Outcome Adapted from ACC 2008.

  13. ONTARGET Non-inferiority Comparison Adapted from ACC 2008.

  14. Time to Primary Outcome Adapted from ACC 2008.

  15. Reasons for Permanently Stopping Study Medications in ONTARGET Study Ram=ramipril; Tel=telmisartan Adapted from ACC 2008.

  16. ONTARGET Study Conclusions: Telmisartan vs. Ramipril • Telmisartan is clearly « non-inferior » to ramipril • Primary composite outcome (P=0.0038) • HOPE primary outcome (P=0.001) • Most (>90%) of the benefits or ramipril are preserved • 2. Consistent results on a range of: • Secondary outcomes • Subgroups • 3. Sensitivity analysis using a per protocol approach confirms this • 4. Telmisartan exhibits slightly superior tolerability • Less cough and angioneurotic edema • More mild hypotensive symptoms, but no difference in • severe hypotensive symptoms, such as syncope Adapted from ACC 2008.

  17. ONTARGET Study Conclusions: Telmisartan plus Ramipril vs. Ramipril • Combination therapy does not reduce the primary outcome to a greater extent compared to ramipril alone. • 2. Higher rates of adverse events: • hypotension related, including syncope • renal dysfunction Adapted from ACC 2008.

  18. Implication Regarding ONTARGET Findings • Telmisartan is as effective as ramipril, with a slightly better tolerability. • Combination therapy is not superior to ramipril and has increased side effects. Adapted from ACC 2008.

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