Primum non nocere

Hipócrates, ao redor do ano 430 aC, propôs aos médicos, no parágrafo 12 do primeiro livro da sua obra Epidemia:
"Pratique duas coisas ao lidar com as doenças; auxilie ou não prejudique o paciente" - ou seja, primum non nocere - primeiro de tudo, não provoque nenhum dano.

quinta-feira, 15 de maio de 2008

57th Annual Scientific Sessions of the American College of Cardiology

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.


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