The American Heart Association's Scientific Sessions conference wrapped up Nov. 12 in Chicago after bringing together heart experts from around the world.
Several of the world's biggest pharmaceutical companies joined for a total of 800 sessions and 4,000 presented abstracts, highlighting established drugs and new treatments for cardiovascular conditions, as well as revamped guidelines to clear up some debate around cholesterol drugs.
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AstraZeneca's Farxiga
AstraZeneca PLC announced results from a five-year study of its type 2 diabetes drug Farxiga, demonstrating that the treatment reduced the risk of hospitalization for heart failure. In the study, which is called DECLARE and enrolled more than 17,000 patients across 33 countries, Farxiga demonstrated a 17% reduction in risk compared to placebo.
Farxiga is in a class of drugs called sodium-glucose cotransporter-2, or SGLT2, inhibitors, which lower blood sugar levels by making the kidneys remove it through urine.
Because of significant overlap in patients with both diabetes and heart failure, AstraZeneca is looking to expand the drug's indication to reach more patients. Competing drugs like Jardiance from Boehringer Ingelheim GmbH and Eli Lilly and Co. and Invokana from Johnson & Johnson have sought to do the same.
"Out of the 30 million diabetic patients in the United States, roughly 50% will get heart failure and 50% of that population will die within five years," Ruud Dobber, AstraZeneca's U.S. president, told S&P Global Market Intelligence.
The U.K.-based pharmaceutical giant is aiming to apply to the U.S. Food and Drug Administration for the new indication in the first half of 2019.
Novartis' Entresto
Novartis AG presented results from a follow-on study of its heart failure drug Entresto, demonstrating that it slowed disease progression in certain patients with heart failure whose condition worsened after leaving the hospital. The study, called Pioneer-HF, compared the drug against the commonly used treatment Vasotec from Bausch Health Cos. Inc.
Entresto reduced the disease's severity by 29% and demonstrated a 46% reduction in the risk of death, rehospitalization and the need for a ventricular device or cardiac transplant over eight weeks.
Regeneron and Sanofi's Praluent
Regeneron Pharmaceuticals Inc. and Sanofi announced findings from a study of their cholesterol drug Praluent, showing that it lowered the risk of death from any cause by 22% against placebo in more than 8,000 patients studied for at least three years.
Praluent is a proprotein convertase subtilisin/kexin type 9, or PCSK9, treatment designed to lower cholesterol levels by binding to receptors and allowing the liver to clear the molecule more efficiently.
The new results came from an ad hoc study that was part of a larger one called Odyssey Outcomes, which has enrolled almost 19,000 patients.
MyoKardia's mavacamten
MyoKardia Inc.'s mavacamten, a heart-relaxing treatment for patients with hypertrophic cardiomyopathy, demonstrated clinical improvement in a mid-stage study.
The rare disease is characterized by restricted blood flow due to a thickening of the left ventricle and can result in heart failure, sudden death and stroke. No treatments exist for the underlying cause of the condition.
MyoKardia's drug addresses how the heart fills with blood, called diastolic function, in patients whose hearts can not relax. About half of patients with the disease who die of heart failure die from diastolic dysfunction.
Amarin's Vascepa
Amarin Corp. PLC announced results from a study of its fish oil-based drug Vascepa that showed the treatment reduced cardiovascular death by 20%, heart attacks by 31% and stroke by 28%. Overall, in the study called Reduce-It, Vascepa reduced the risk of first occurrence of major adverse cardiovascular events by 25%.
"We have known for many years that controlling LDL-cholesterol levels reduces the risk of major cardiovascular events, which is why it was important to study patients who are stabilized on statin medications, and yet still have residual risk factors such as high triglycerides," said Jean-Claude Tardif, director of the Montreal Heart Institute Research Centre. "The Reduce-It study gives us new evidence that icosapent ethyl can further contribute to the prevention of a major cardiovascular event in these patients."
A controversy in the trial design, though, has critics wondering if the drug is as effective as it seems. The placebo in the trial was based on mineral oil and might have contributed to side effects, boosting Vascepa's relative performance, according to a report from Vantage.
Anti-inflammatory drugs
Of particular interest to cardiologists at the moment is the effect of anti-inflammatory drugs in patients with cardiovascular conditions, and whether these medications could provide for better cardiovascular outcomes.
Researchers from Brigham and Women's Hospital in Boston are studying a commonly used anti-inflammatory drug, methotrexate, to determine whether it could reduce cardiovascular events.
Results presented at the AHA meeting showed that the inexpensive treatment did not lower cardiovascular event rates, despite the success of a Novartis study called CANTOS presented last year that showed its anti-inflammatory drug canakinumab lowered rates of heart attack and cardiovascular death.
"The contrasting results between these two contemporary clinical trials demonstrate the importance of considering the mechanistic diversity of inflammatory pathways and of approaches to their inhibition," said Paul Ridker, director of the Center for Cardiovascular Prevention at Brigham said. "Understanding these differences will be crucial for future studies targeting inflammation in atherosclerosis."
Switzerland-based Novartis in October did not gain the FDA's approval of a cardiovascular indication for canakinumab, sold as Ilaris to treat arthritis. Anti-inflammatory drugs thus remain a debated topic as a treatment for cardiovascular conditions.
Johnson & Johnson's Xarelto
A study of Johnson & Johnson's Xarelto failed to meet the primary endpoint of preventing cardiovascular events, according to an abstract from the New England Journal of Medicine.
Although the blood thinner showed the potential to prevent blood clots, called thromboembolism, the post hoc study from a larger Commander HF trial showed that Xarelto, otherwise known as rivaroxaban, did not prevent major adverse cardiovascular events versus placebo.
"Rivaroxaban at a dose of 2.5 mg twice daily was not associated with a significantly lower rate of death, myocardial infarction or stroke than placebo among patients with worsening chronic heart failure, reduced left ventricular ejection fraction, coronary artery disease and no atrial fibrillation," the study said in its conclusion.
Earlier in 2018 at the European Society of Cardiology Congress in Munich, Johnson & Johnson revealed disappointing results from the Commander HF trial and another late-stage trial for the drug.
New cholesterol guidelines
The American College of Cardiology and the AHA revealed new guidelines for cholesterol management, reflecting advances in knowledge since the guidelines were first created in 2013.
According to a report from the ACC, the guidelines set out a plan for physicians to consider the strength of some drugs in relation to a patient's need, as well as the cost of those drugs. PCSK9 drugs like Regeneron and Sanofi's Praluent and Amgen Inc.'s Repatha, for instance, should be reserved for patients with exceptional need and for whom common blood thinners are not effective, the organization wrote.
"High cholesterol treatment is not one size fits all, and this guideline strongly establishes the importance of personalized care," ACC President C. Michael Valentine said. "Over the past five years, we've learned even more about new treatment options and which patients may benefit from them. By providing a treatment roadmap for clinicians, we are giving them the tools to help their patients understand and manage their risk and live longer, healthier lives."
The guidelines took into account the mid-2018 price of these drugs, but Amgen recently reduced the price of Repatha by 60% to increase use.
The 2018 American Heart Association Scientific Sessions meeting was held Nov. 10-12 in Chicago.

