![]() ![]() The recently completed FOURIER (TIMI 59) trial demonstrated that a powerful PCSK9 inhibitor called evolocumab, which reduces LDL cholesterol levels by up to 60 percent, also reduces the risk of heart attack and stroke in patients with a history of cardiovascular disease who are already on optimized statin therapy. More recent research has zeroed in on creative ways to lower LDL cholesterol even further by targeting PCSK9, a protein which controls recycling of the LDL receptor, which is responsible for clearing LDL cholesterol from the bloodstream. Founding chairman Eugene Braunwald, MD, the former clinical director and first chief of the National Heart Institute, the forerunner of the NHLBI, leading investigations that demonstrated the efficacy of statins in lowering CVD risks. LDL cholesterol-lowering therapies have been a subject the group’s research for decades. “But we showed that by adding a second drug beyond the first year, we could significantly reduce the risk of patients dying from cardiovascular causes, or having a heart attack or stroke.” An Arsenal of Therapies for Bad CholesterolĮvaluating drugs that target low-density lipoprotein (LDL) cholesterol, which accumulates in blood vessels and increases heart disease and stroke risks, is another major focus of TIMI’s work. “One year seems like a reasonable, round number,” Sabatine said. When the researchers conducted a randomized experiment in which one group continued to take the additional antiplatelet drug beyond one-year post-heart attack, they found a significant reduction in these patients’ future risk of cardiovascular events. Another recent study, the PEGASUS-TIMI 54 trial, focused on improving post-heart attack care by evaluating a traditional treatment practice that prescribes patients aspirin and one year of an additional blood thinner to prevent platelet-clumping. Re-examining established treatments is a central tenet of TIMI’s work. “We’ve been happy to be a part of that radical rethinking of how we treat patients with diabetes.” “DECLARE-TIMI 58 and similar data from other SGLT2 inhibitor trials has led to a sea-change in how guidelines for diabetes drugs are now being written,” Sabatine said. The findings provide more treatment options for those with heart failure, while also offering physicians treating patients with diabetes more insight into the effects of the drugs they prescribe. These findings led dapagliflozin to be the first SGLT2 inhibitor to be approved by the FDA for both those indications. ![]() Further studies of dapagliflozin showed it reduced the risk of cardiovascular death or hospitalization for heart failure in patients with and without diabetes who have heart failure with a reduced ejection fraction. In one recent study, DECLARE-TIMI 58, investigators demonstrated that dapagliflozin, a blood-sugar-lowering drug that belongs to the SGLT2 inhibitor class, reduces diabetes patients’ risk of hospitalization for heart failure by 27 percent. Groups like TIMI are well-suited to fill these knowledge gaps. Food and Drug Administration’s (FDA) primary evaluation metric for diabetes drugs was a demonstrated reduction of blood sugar level, but now, increased emphasis is placed on uncovering the potential cardiovascular health effects associated with diabetes drugs. Over the last decade, cardiology researchers involved in the TIMI Study Group and beyond have increasingly examined the long-term cardiovascular risks and benefits associated with therapies originally developed to treat diabetes. Revolutionizing Practices: Recent TIMI Breakthroughs Through its research, TIMI has become an authority on cardiovascular disease (CVD) and a leading influence shaping cardiovascular medical care worldwide. The types of interventions under investigation have evolved too, from the thrombolytic (clot-dissolving) to the anti-inflammatory (immune response-modulating). Over the decades, the TIMI Study Group, which is supported by federal and industry funding, has proceeded to examine a vast array of diseases, including heart attacks and strokes, as well as cardiovascular risk factors like high cholesterol and diabetes. TIMI’s first initiative established the blood-clot-busting drug called tissue plasminogen activator as the preferred method for treating heart attacks and strokes. National Heart, Lung, and Blood Institute in 1984, the Thrombolysis in Myocardial Infarction (TIMI) Study Group, which Sabatine now chairs, has conducted over 70 trials across 5,000 different sites around the world. For Marc Sabatine, MD, MPH, of the Division of Cardiovascular Medicine, going through all the clinical trials spearheaded by one of the Brigham’s premier cardiovascular research centers is like “keeping track of all of one’s children.” Since its founding by the U.S. ![]()
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