Apresentação de vários ensaios clínicos no Encontro Anual do Colégio Americano de Cardiologia em Chicago IL de 30 de Março a 02 de Abril de 2008, incluindo os ensaios ONTARGET, ACCOMPLISH, ENHANCE e (JUPITER).
JUPITER examined the role of rosuvastatin (20 mg/day) in the primary prevention of cardiovascular disease among patients with low levels of LDL-cholesterol and elevated high-sensitivity C-reactive protein.
The trial was stopped early as evidence clearly showed a reduction in cardiovascular morbidity and mortality in patients treated with rosuvastatin compared with placebo.
Full study details to be published once final analysis of data is complete.
STUDY OUTCOMES:
Over 5,000 patients without evidence of cardiovascular disease and low to normal LDL-C, but elevated C-reactive protein were enrolled in the trial. The trial was stopped early based on a recommendation from an independent Data and Safety Monitoring Board due to unequivocal evidence of a reduction in cardiovascular morbidity and mortality in patients treated with rosuvastatin compared with placebo.
ONTARGET enrolled 25,620 high risk subjects aged > 55 with either established vascular disease or DM and end-organ damage into a large international randomized trial of angiotensin modulating therapy. Subjects received either ramipril 10 mg, telmisartan 80 mg or the full dose combination daily. Over a mean follow up of 56 months, telmisartan was found to be statistically non-inferior, clinically equivalent and better tolerated than ramipril while the combination was no better than ramipril alone but with greater side-effects! The results were consistent for all major components of the primary end-point, including myocardial infarction, stroke, heart failure hospitalisation and cardiovascular death and across all pre-defined patient subgroups (age, gender, risk, BP, DM, Hx of CAD). Physicians now have a choice between an ACE inhibitor or an ARB in CVD prevention in the “HOPE-type” patient.
STUDY OUTCOME:
Telmisartan was found to be statistically non-inferior, clinically equivalent and better tolerated than ramipril while the combination was no better than ramipril alone but with greater side-effects.
ACCOMPLISH examined the role of amlodipine/benazapril (5 mg/40 mg), compared with hydrochlorothiazide (HCTZ)/benazapril (12.5 mg/40 mg) in reducing cardiovascular morbidity and mortality in high-risk patients with systolic hypertension.
The trial was stopped early with a finding of a 20% reduction in many of the primary endpoints with amlodipine/benazapril compared with HCTZ/benazapril
STUDY OUTCOME:
Trial was terminated early due to a finding of a 20% reduction in the primary endpoint of cardiovascular mortality, stroke, myocardial infarction (MI), coronary revascularization, unstable angina, and resuscitation from death in the amlodipine/benazapril arm compared with the HCTZ/benazapril arm (p = 0.002). Cardiovascular death, stroke, and MI was also reduced by 20% (p = 0.007). All other endpoints, including cardiovascular mortality, nonfatal MI, nonfatal stroke, and resuscitated sudden death were similar between the two groups.