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TRANSCEND

TRANSCEND: T elmisartan R andomized A ssesme N t S tudy in a CE i N tolerant S ubjects with C ardiovascular D isease ONTARGET / TRANSCEND Investigators Koon K. Teo, MB, PhD, FRCPC Disclosure Statement: Received Research Grants and Honoraria from Boehringer Ingelheim. TRANSCEND. Question:

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TRANSCEND

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  1. TRANSCEND:Telmisartan RandomizedAssesmeNt Study in aCE iNtolerant Subjects with Cardiovascular DiseaseONTARGET / TRANSCEND InvestigatorsKoon K. Teo, MB, PhD, FRCPCDisclosure Statement:Received Research Grants and Honoraria from Boehringer Ingelheim

  2. TRANSCEND Question: • Is telmisartan superior to placebo in patients at high risk of CV events who are intolerant of ACE-I? Outcome: • Primary: CV death, MI, stroke, CHF hosp • Key secondary: CV death, MI, stroke (HOPE trial outcome) Design: Single blind run-in (n=6,666) Randomized, double blind, placebo controlled study conducted in 630 centers in 40 countries (n=5,926) 56 months follow-up with 99.7% outcome ascertainment

  3. Trial Profile TRANSCEND 6666 entered Run-in 5926 patients randomized 2954 assigned telmisartan (80mg) 2972 assigned placebo 10 lost to follow-up 8 lost to follow-up 2944 completed study 2964 completed study

  4. History at Randomization (%)

  5. Change in Sitting Systolic BP (mm Hg)From Pre-Run-in Over Time

  6. Concomitant Medications by Visit (%) *P<0.0001, compared to Telmisartan

  7. TRANSCEND Time to Permanent Discontinuation of Study Medication 0.4 # at Risk Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 T 2954 2784 2663 2547 2271 1086 Pl 2972 2814 2629 2509 2242 1063 0.3 Telmisartan Cumulative Hazard Rates Placebo 0.2 0.1 0.0 0 1 2 3 4 5 Years of Follow-up

  8. Reasons for Permanently Stopping Study Medications

  9. Primary Outcome & HOPE Primary Outcome

  10. Time to Primary Outcome TRANSCEND 0.20 Telmisartan 0.15 Placebo Cumulative Incidence Rates 0.10 0.05 HR: 0.92 (0.81-1.05) p-value = 0.2158 0.0 0 1 2 3 4 5 Years of Follow-up No. at Risk T 2954 2807 2699 2577 2278 1091 Pl 2972 2839 2713 2575 2253 1069

  11. Time to Secondary Outcome TRANSCEND 0.20 Telmisartan Placebo 0.15 Cumulative Incidence Rates 0.10 HR: 0.87 (0.76 – 1.00) p-value = 0.0475 0.05 0.0 0 1 2 3 4 5 Years of Follow-up No. at Risk T 2954 2839 2745 2634 2344 1127 Pl 2972 2866 2745 2626 2306 1103

  12. Primary and Key Secondary Outcomes

  13. TRANSCEND Subgroup Analysis of Primary Outcome Incidence (%) p for Placebo Group interaction No. Patients Primary Composite 5926 17.0 Hx of CVD 5418 17.2 0.6102 505 14.1 No Hx of CVD SBP <= 133 1955 16.2 133 < SBP <= 149 1996 15.8 0.7956 SBP > 149 1969 18.8 Diabetes 2118 19.9 0.3109 No Diabetes 3805 15.3 HOPE Score <= 3.624 1978 9.3 3.624<= HOPE Score <= 4.034 1934 16.1 0.4615 HOPE Score > 4.034 2014 25.4 Age < 65 2375 13.5 65 <= Age < 75 2576 16.9 0.8945 Age >= 75 975 25.7 Male 3379 18.9 0.0842 Female 2547 14.4 Statin 3272 16.2 0.2867 No Statin 2654 17.9 Telmisartan better Placebo better 0.4 0.7 1.0 1.3 1.6 HR(95% CI)

  14. Conclusions: Telmisartan vs. Placebo • Telmisartan reduces the primary outcome by 8% (p=0.22), but reduces significantly the main secondary outcome of CV death, MI or stroke by 13% (p=0.048). • There is no impact on heart failure events with telmisartan. • Telmisartan is well tolerated and there is no excess of adverse events

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