U.S. near bottom of wealthy nations in childbirth deaths November 22, 2015
American children with autism may have been undercounted November 14, 2015
Medicare to spend $9 billion on hepatitis C drugs November 14, 2015
What happens after you down an energy drink? November 14, 2015
U.S. adult cigarette smoking hits a new low November 13, 2015
U.S. sees alarming jump in newborns with syphilis November 12, 2015
DNA hunt on as Chipotle E. coli outbreak grows November 3, 2015
Experts urge reassessment of breast cancer screening November 1, 2015
At top hospital, almost half of surgeries have drug mishap October 30, 2015
Study: Want a younger brain? Eat fish, stay away from meat October 25, 2015
“We designed this study to try to change the cornerstone of treatment — to replace enalapril,” said the study’s lead co-author, Milton Packer, a cardiologist and heart failure researcher at University of Texas Southwestern Medical Center. “The results are not only compelling, but exceeded our expectations.”
In an editorial accompanying the study, published online Saturday in the New England Journal of Medicine, University of Pennsylvania cardiologist Mariell Jessup, wrote that the novel therapy may “represent a new threshold of hope for patients with heart failure.”
Heart failure, the only cardiovascular disease on the rise, affects 5 million people in the U.S.
A progressive disorder, it begins when heart cells are injured by a heart attack, infection, chemotherapy, or other causes. Healthy cells try to compensate by overworking and enlarging, while the body retains water and increases blood pressure in a futile effort to improve blood flow.
Until the 1980s, the standard treatments — digoxin, which strengthens heart contractions, and diuretics, which increase urine output — did nothing to reduce mortality, and little to relieve the symptoms of breathlessness, fatigue and swelling.
Then came enalapril, approved in 1985, the first in a class of drugs called ACE inhibitors. These compounds, which lower blood pressure by widening the blood vessels, improved symptoms and survival. Further progress was made by combining ACE inhibitors with drugs that block adrenaline, as well as more sophisticated diuretics.
Even with all this and more — heart failure patients typically take four to eight drugs — about 50 percent die within five years.
The latest advance involves blocking an enzyme, neprilysin, that plays a key role in the complex process of blood vessel constriction, fluid retention, and heart enlargement that makes the heart gradually fail.
“This is a new pathway. That’s what’s really exciting,” Jessup said, adding that other pharmaceutical companies are developing their own anti-neprilysin compounds.
Novartis’ new drug combines its neprilysin inhibitor with valsartan, a blood pressure-lowering drug that works somewhat differently from enalapril.
The pivotal study, begun in 2009, enrolled 8,400 patients with mild to moderately severe heart failure at more than 1,000 centers around the world, making it the largest clinical trial in heart failure ever undertaken. The patients were randomly assigned to take LCZ696 or enalapril, plus other medications that were part of their prescribed regimen.
The trial was stopped early, after following patients for a median of 27 months, because the new drug met criteria for “overwhelming benefit.”
Of 4,187 patients on the new drug, 914 died from cardiovascular causes or were hospitalized for worsening heart failure — 21.8 percent of the group. That compared with 1,117 deaths and hospitalizations (26.5 percent) among 4,212 people taking enalapril.
The Novartis drug was also better tolerated. Slightly less than 11 percent quit it because of side effects such as dangerously low blood pressure or worsening kidney function, compared with about 12 percent for enalapril.
On a questionnaire, patients taking LCZ696 reported more improvement in heart failure symptoms and physical limitations than the comparison group.
Novartis will now ask the U.S. Food and Drug Administration to approve the drug based on the results.
More Nation & World Headlines
Big balloons, heavy security for NYC Thanksgiving parade Farm recalls produce used in Costco salad linked to E. coli 6:05 p.m. Turkey-Russia spat over downed Russian warplane escalates Hollande and Putin agree on closer anti-IS coordination Where’s death penalty in Obama’s push for criminal justice overhaul? Holiday shoppers get a head start on Thanksgiving Pope says ‘catastrophic’ if interests derail climate talks Trump denies mocking disabled reporter, demands apology 6:04 p.m.
Our new comment system is not supported in IE 7. Please upgrade your browser here.