New Drug May Transform Treatment of Heart Failure

Study reports decline in deaths, hospitalizations

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A new drug is showing significant promise in improving the treatment of heart failure, after a clinical trial showed it lowered the chances of death or hospitalization by about 20 percent compared to the current standard drug treatment.

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Researchers recently released clinical trial results for the drug, called LCZ696. 

The data from the clinical trial was so compelling that an ethics council monitoring the trial data requested that the study end seven months early.

Results were showing that participants using LCZ696 lived longer without being hospitalized for heart failure compared to those using enalapril, the drug that is the current standard of care. The new medicine also had no serious side effects. 

Reduced risk 

Results from the clinical trial showed the drug: 

  • reduced the risk of death from cardiovascular causes by 20 percent
  • reduced heart failure hospitalizations by 21 percent
  • reduced the risk of all-cause mortality by 16 percent

Overall, the researchers also reported a 20 percent reduction in risk on the primary endpoint, a composite measure of cardiovascular death or heart failure hospitalization.

Cardiologist Randall C. Starling, MD, was one of the investigators who helped to test LCZ696 with patients at Cleveland Clinic. The findings should provide new hope for chronic heart failure patients, Dr. Starling says.

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“Results of the completed clinical trial that have been published show there is benefit to this new medication with a reduction in the death rate. More patients are kept out of the hospital and there is an improvement in quality of life,” Dr. Starling says. “This is potentially going to be a game-changer as far as the management of patients with chronic heart failure.”

“Having our patients participate in the research at Cleveland Clinic, our physicians know what the drug is and we understand it,” Dr. Starling says. “We know it was very well-tolerated, perhaps even better than what most patients are already taking now and we’ll work hard to get it to patients as soon as possible.” 

Largest-ever trial

LCZ696 is a combination of two medicines. It works by enhancing the heart’s protective neurohormonal systems while suppressing substances that harm heart function. Currently available medicines, such as enalapril, block only the detrimental effects.

Enalapril, which has been proven to increase survival rates for heart failure, belongs to a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently, according to the National Institutes of Health.

The double-blind study is the largest ever of a heart failure treatment, and involved 8,842 patients in 47 countries who were followed for 27 months. The study targeted heart patients who had reduced ejection fraction, in which the heart muscle does not contract effectively.

Launch expected in 2015

The study’s researchers say LCZ696 has the potential to replace drugs such as enalapril, which have been central to treating heart failure for the last 25 years. The drugmaker, Novartis, said in a news release that LCZ696 is expected to be launched in the United States next year.

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Heart failure is a debilitating and potentially life-threatening condition in which the heart cannot pump enough blood to meet the body’s needs. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly affecting quality of life.

Heart failure is a major health problem in the United States, affecting about 5.7 million Americans. About 550,000 new cases of heart failure occur each year. It is the leading cause of hospitalization in people older than 65.

Results on LCZ696 were released at the annual meeting of the European Society of Cardiology on Saturday and published in the New England Journal of Medicine.

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