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

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Presentation transcript:

VBWG HOPE-TOO: Results of the HOPE Study Extension

VBWG 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:

VBWG HOPE-TOO: Study design 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 Heart Outcomes Prevention Evaluation–The Ongoing Outcomes HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:

VBWG Major CV events and new diagnosis of diabetes for combined in-trial and post-trial periods No. of patients (%) New diagnosis of diabetes Revascularization Stroke CV death MI MI, stroke, or CV death Ramipril (n = 3393) Placebo (n = 3393) 699 (20.6) 485 (14.3) 174 (5.1) 327 (9.6) 767 (22.6) 152 (7.3) 820 (24.2) 581 (17.1) 215 (6.3) 374 (11.0) 880 (25.9) 216 (10.3) RR (95% CI) P* 0.83 (0.75–0.91) 0.81 (0.72–0.92) 0.79 (0.65–0.97) 0.86 (0.74–1.00) 0.84 (0.76–0.92) 0.69 (0.56–0.85) *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:

VBWG HOPE-TOO: Primary outcome (CV death, MI, stroke) RRR = relative risk reduction HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112: RRR = 17% P = Placebo Ramipril Years Primary outcome (% HOPE-TOO patients) Placebo Ramipril n HOPE-TOO begins Main HOPE study ends

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

VBWG HOPE-TOO: Additional reduction in MI HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112: RRR = 19% P = Placebo Ramipril MI (% HOPE-TOO patients) Years Placebo Ramipril n HOPE-TOO begins Main HOPE study ends

VBWG HOPE-TOO: Additional reduction in new-onset diabetes HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112: Placebo Ramipril Years RRR 31% P = HOPE-TOO begins Main HOPE study ends New-onset diabetes (% HOPE-TOO patients) Placebo Ramipril n

VBWG HOPE-TOO: Sustained reduction in stroke HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112: RRR = 21% P = Placebo Ramipril Years Placebo Ramipril n Stroke (% HOPE-TOO patients) HOPE-TOO begins Main HOPE study ends

VBWG HOPE-TOO: Sustained reduction in CV death HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112: RRR = 14% P = Placebo Ramipril 10 5 Years Placebo Ramipril n CV death (% HOPE-TOO patients) HOPE-TOO begins Main HOPE study ends

VBWG HOPE/HOPE-TOO: Benefits at all levels of risk and with other life-saving drugs GroupNo. of patients Lipid meds – Lipid meds + BB – BB + ASA – ASA + High Medium Low Overall Placebo rate Interaction P-value Lipid meds – Lipid meds + GroupNo. of patients BB – BB + ASA – ASA + High Medium Low Overall Placebo rate Interaction P-value HOPEHOPE-TOO Primary outcome = CV death/MI/stroke RR (95% CI) HOPE/HOPE-TOO Study Investigators. Circulation. 2005;112:

VBWG 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: