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ONTARGET TRIAL |
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| Problem | CAD, stroke, PVD or DM |
| Format | Double-blinded multi-center RCT |
| Treatment | Telmisartan or Ramipril or both |
| Control | Nil |
| Population | 25620 |
| Inclusion criteria | Previous history of -CAD -PVD -CVA -DM with end-organ damage |
| Exclusion criteria | CCF EF < 40% |
| Follow-up | Median 56 months |
| Primary endpoint | Composite of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure. |
| Secondary endpoint(s) | Composite of death from cardiovascular causes, myocardial infarction, or stroke (N.B. Primary outcome of HOPE) |
| Details | After written informed consent was obtained, patients entered a single-blind run-in period in which they received 2.5 mg of ramipril once daily for 3 days, followed by 40 mg of telmisartan and 2.5 mg of ramipril once daily for 7 days and then 5 mg of ramipril plus 40 mg of telmisartan for 11 to 18 days. Of the 29,019 patients who entered the run-in period, 3399 (11.7%) were excluded from the study: 1123 (3.9%) had poor compliance, 597 (2.1%) withdrew from the study, 492 (1.7%) had symptomatic hypotension, 223 (0.8%) had an elevated potassium level, 64 (0.2%) had an elevated creatinine level, 872 (3.0%) had other reasons for exclusion, and 27 (0.1%) died. |
| Brief summary: | Telmisartan non-inferior to Ramipril. No benefit from both agents. |
| PAPER: Telmisartan, ramipril, or both in patients at high risk for vascular events. | |
|---|---|
| Date | 10 Apr 2008 |
| Journal | N Engl J Med. 2008 Apr 10;358(15):1547-59. |
| Information | Termisartan vs. Ramipril vs. BOTH -No significant difference in composite of CV death/MI/CVA/CCF admission -No significant difference in secondary outcomes --EXCEPT rate of renal impairment - Combination vs. Ramipril RR 1.33; p<0.001 Impression of telmisartan -Equally as effective as ramipril (non-superior) -Reduced cough/angioedema; increased hypotensive symptoms -No advantage in combination; increased risk of harm vs. ramipril |