Statins are the most effective treatment to reduce LDL levels and cardiovascular risk, 10-20% of patients are statin intolerant or present adverse effects at high doses (especially muscle damage). Ezetimibe is the alternative drug, though not as effective to reduce LDL, mainly in high risk patients. PSCK9 protein participates in LDL recycling, monoclonal antibody O…
PHS II Trial: Use of multivitamins in the prevention of cardiovascular disease in men.
Observational studies have shown contradicting results on the use of multivitamins. PHS II is the only randomized double blind placebo controlled trial to evaluate the long term effect of the use of multivitamins in the prevention of CVD. 14,641 physicians ≥50 were randomized in 1997 to receive placebo or an E, C and Centrum Silver…
DALCETRAPIB: Dalcetrabib for the treatment of ACS
High levels of HDL are known to exert a protective effect. In previous studies, dalcetrapib administration increased HDL 30% from baseline. The objective was to test dalcetrapib in the context of acute coronary syndrome (ACS). 15,871 ACS patients were randomized to receive dalcetrapib or placebo. Primary end point was cardiac death, myocardial infarction, ictus, new…
UMPIRE Trial: the polypill proves effective in treating high risk patients.
A polypill is an interesting strategy for cardiac patients requiring multiple drugs. This trial involved 2138 patients from 28 sites in India and Europe with an event risk higher than 15% at 5 years of conventional therapy or a polypill which combined aspirin, statin, lisinopril and atenolol/hydrochlorothiazide in fixed doses. At a 24 month follow…
OPERA Trial: Use of Omega 3 to prevent post-operative atrial fibrillation
Atrial fibrillation (AF) prolongues post-operative central vascular surgery, increasing morbidity and costs. Though smaller, a few trials have shown positive results for Omega-3 fatty acids. This multi-center trial randomized 1516 patients scheduled for cardiac surgery to receive Omega 3 or placebo. Primary end point was occurrence of AF. Follow up didn’t show difference between Omega…
FORWARD Trial: Use of Omega 3 to prevent recurring atrial fibrillation
Atrial fibrillation (AF) is a very prevalent arrhythmia and there is no known drug, device or ablation technique effective enough to treat it. Omega 3 fatty acids have electrophysiological, autonomic modulation and anti-inflammatory effects. In addition, they are well tolerated, which altogether makes them worth testing in the context of AF. 586 were randomized to…
Monoclonal antibodies for the treatment of dislipidemia in patients on maximal dose statins.
Statins are first-line therapy for hypercholesterolemia. However, many patients are not able to achieve their goals despite the maximal dose or because of adverse effects. Monoclonal antibody RN316 binds to PCSK9 increasing LDL clearance. This trial randomized 135 patients with an average LDL of 120 mg/dl despite the maximal dose statins to receive 4 different…