1 / 12

HOPE-TOO: Results of the HOPE Study Extension

HOPE-TOO: Results of the HOPE Study Extension. HOPE-TOO: Rationale. HOPE-TOO was an extension of the HOPE trial, which examined the effects of ACE inhibition in reducing major CV events in high-risk patients with vascular disease or diabetes

byron-pena
Download Presentation

HOPE-TOO: Results of the HOPE Study Extension

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. HOPE-TOO: Results of the HOPE Study Extension

  2. HOPE-TOO: Rationale • HOPE-TOO was an extension of the HOPE trial, which examined the effects of ACE inhibition in reducing major CV events in high-risk patients with vascular disease or diabetes • HOPE-TOO was designed to assess whether the CV and metabolic benefits of ramipril were sustained over time and occurred in subgroups based on varying risk and concomitant treatment HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  3. HOPE-TOO: Study design Heart Outcomes Prevention Evaluation–The Ongoing Outcomes • 4528 HOPE patients at 174 centers who agreed to further follow-up • Blinded treatment ended and patients were advised to use ACEI • 2.6-year post-trial extension • ACEI use during extension • HOPE ramipril arm (n = 2317): 72% • HOPE placebo arm (n = 2211): 68% • >90% of all HOPE-TOO patients used ramipril HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  4. Major CV events and new diagnosis of diabetes for combined in-trial and post-trial periods No. of patients (%) Ramipril (n = 3393) Placebo (n = 3393) RR (95% CI) P* MI, stroke, or CV death 0.83 (0.75–0.91) 699 (20.6) 820 (24.2) 0.0002 485 (14.3) 0.81 (0.72–0.92) 581 (17.1) 0.0007 MI 0.79 (0.65–0.97) 174 (5.1) 215 (6.3) Stroke 0.023 327 (9.6) 0.86 (0.74–1.00) 374 (11.0) 0.045 CV death 0.84 (0.76–0.92) 880 (25.9) 0.0003 Revascularization 767 (22.6) New diagnosis of diabetes 152 (7.3) 0.69 (0.56–0.85) 216 (10.3) 0.0006 *Calculated by log-rank test and data on all participants in the study extension, censored for period of observation HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  5. HOPE-TOO begins Main HOPE study ends n PlaceboRamipril HOPE-TOO: Primary outcome (CV death, MI, stroke) 30 25 20 Primary outcome(% HOPE-TOO patients) 15 Placebo 10 RRR = 17% P = 0.0002 Ramipril 5 0 Years 4 5 6 0 1 2 3 7 46524645 44324456 15501731 42044256 39814079 36473789 27192819 19232075 RRR = relative risk reduction HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  6. HOPE-TOO: Effect of ACEI on major CV events and new-onset diabetes No. of HOPE patients (%) Ramipril (n = 2317) Placebo (n = 2211) Event* MI, stroke, or CV death 220 (7.9) 225 (8.4) 146 (5.1) 169 (6.1) MI 56 (1.9) 59 (2.0) Stroke 133 (4.4) 126 (4.2) CV death 259 (10.5) Revascularization 235 (9.1) New diagnosis of diabetes 48 (2.7) 70 (4.0) 1.4 1.5 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 *Event rates were calculated as proportions of events in those study participants who were event-free at the end of the in-trial period. RR (95% CI) HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  7. HOPE-TOO begins Main HOPE study ends 20 15 10 5 2 3 4 5 6 0 1 7 n PlaceboRamipril HOPE-TOO: Additional reduction in MI 25 MI(% HOPE-TOO patients) Placebo RRR = 19%P = 0.0007 Ramipril 0 Years 46524645 44744484 16121791 42824309 40884159 37703875 28142900 19992137 HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  8. HOPE-TOO begins Main HOPE study ends n PlaceboRamipril HOPE-TOO: Additional reduction in new-onset diabetes 12 10 8 New-onsetdiabetes(% HOPE-TOO patients) 6 Placebo 4 RRR 31% P = 0.0006 2 Ramipril 0 5 Years 1 2 3 4 6 7 28832837 28032763 10211092 27042672 26002587 23922431 18131853 12691324 HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  9. HOPE-TOO begins Main HOPE study ends 8 6 4 2 2 3 4 5 6 0 1 7 n PlaceboRamipril HOPE-TOO: Sustained reduction in stroke 10 Stroke(% HOPE-TOO patients) Placebo RRR = 21%P = 0.023 Ramipril 0 Years 46524645 45234539 17341876 43674391 41884263 38874000 29533011 21152225 HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  10. HOPE-TOO begins Main HOPE study ends 2 3 4 5 6 0 1 7 n PlaceboRamipril HOPE-TOO: Sustained reduction in CV death 15 10 CV death(% HOPE-TOO patients) Placebo 5 RRR = 14%P = 0.045 Ramipril 0 Years 46524645 45694567 18081946 44534448 43094346 40274097 30613100 22032295 HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  11. HOPE/HOPE-TOO: Benefits at all levelsof risk and with other life-saving drugs Primary outcome = CV death/MI/stroke HOPE HOPE-TOO Group No. of patients Placebo rate Interaction P-value Group No. of patients Placebo rate Interaction P-value Overall 9297 17.7 Overall 6786 24.2 Low 3083 9.8 Low 2299 15.2 0.51 0.67 Medium 3100 16.1 Medium 2247 22.6 High 3114 26.9 High 2240 34.5 0.0019 0.0043 ASA + 6813 17.3 ASA + 4974 23.5 ASA – 2484 19.1 ASA – 1812 26.0 0.89 0.20 3673 18.2 2712 26.2 BB + BB + BB – 5624 17.4 BB – 4074 22.8 0.68 0.78 Lipid meds + 2658 14.0 Lipid meds + 1960 18.7 Lipid meds – 6639 19.3 Lipid meds – 4826 26.4 0.6 0.8 1.0 1.2 0.6 0.8 1.0 1.2 RR (95% CI) RR (95% CI) HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

  12. HOPE-TOO: Study conclusions • The benefits of ramipril were maintained during post-trial follow-up for CV death, stroke, and hospitalization for heart failure • Additional reductions in MI, revascularization and new-onset diabetes were also observed despite similar rates of ACEI use in the randomized groups • The reduction in CV outcomes demonstrated in the HOPE trial is most likely an underestimate of the full effects of long-term ramipril therapy • Subgroup analyses demonstrate the benefits observed are additive to those of other life-saving therapies, and extend to all patients with vascular disease, independent of their baseline risk HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:1339-46.

More Related