cloudy
Saturday December 15th, 2018 11:11PM

Study: Cholesterol drug lowers risk of death, heart attack

By The Associated Press
Related Articles
  Contact Editor

ORLANDO, Fla. (AP) — A newer cholesterol drug, used with older statin medicines, modestly lowered heart risks and deaths in a big study of heart attack survivors that might persuade insurers to cover the pricey treatment more often.

Results on the drug, Praluent (PRALL-yoo-ent), were announced Saturday at an American College of Cardiology conference in Florida. It's the first time a cholesterol-lowering drug has reduced deaths since statins such as Lipitor and Crestor came out decades ago.

"It's the ultimate outcome; it's what matters to patients," said study leader Dr. Philippe Gabriel Steg of Hospital Bichat in Paris.

But the benefit was small — 167 people would need to use Praluent for nearly three years to prevent a single death.

"That's a high cost" that may still hinder its use, said one independent expert, Dr. Amit Khera, a preventive cardiologist at UT Southwestern Medical Center in Dallas and a spokesman for the American Heart Association.

The drug's makers, Sanofi and Regeneron Pharmaceuticals, sponsored the study and said they would work with insurers on pricing to get the medicine to those who need it the most.

ABOUT THE STUDY

Doctors focus on lowering LDL, or bad cholesterol, to prevent heart problems. Statins are the main medicines for this, but some people can't tolerate or get enough help from them.

Praluent and a similar drug, Amgen's Repatha, work in a different way and lower cholesterol much more. Patients give themselves shots of the medicine once or twice a month. The drugs have been sold since 2015 but cost more than $14,000 a year, and insurers have balked at paying without proof that they reduce health problems, not just the cholesterol number.

Last year, a study showed Repatha cut heart problems but did not improve survival. The new study tested the rival drug, Praluent, for a longer time and in patients at higher risk — nearly 19,000 people who in the previous year had a heart attack or chest pain serious enough to put them in the hospital.

All had LDL over 70 despite maximum statin use. Half were given Praluent and the rest, dummy shots. Praluent was started at a lower dose and increased if LDL did not drop below 50.

After nearly three years, 9.5 percent of those on Praluent and 11.1 percent of those on dummy medicine had suffered a heart attack, stroke, heart-related death or serious chest pain; 3.5 percent on Praluent and 4.1 percent on dummy medicine died.

That worked out to a 15 percent lower risk with Praluent. Benefits were greater for those whose LDL was 100 or more at the start of the study. The drug had no major safety issues.

WHAT DOCTORS SAY

"We need to reset our expectations" and realize that benefits for any new drug are going to be fairly small when added to already good treatments such as statins, said Dr. Jeffrey Kuvin, conference leader and cardiology chief at Dartmouth-Hitchcock Medical Center. The new drugs clearly help people at high risk and are not aimed at people at low risk, such as those who have high cholesterol but have never had a heart attack, he said.

"I've been unconvinced" of the drugs' benefits but now may prescribe them for certain very high risk patients, said Duke University cardiologist Dr. Christopher Granger. But preventing fewer than one heart problem a year at the drug's current price is not cost-effective, he said.

PRESSURE ON PRICE

An independent group, the Institute for Clinical and Economic Review, on Saturday released a new range for what Praluent should cost, based on the new results — $2,300 to $3,400 per year for people like those in the study. A price of $4,500 to $8,000 per year would be justified for patients at higher risk, with LDL over 100.

From 300,000 to 400,000 people in the U.S. each year fall in that second category. Praluent's makers say they will aim for those price ranges for insurers that remove barriers to coverage for people at the highest risk.

___

Marilynn Marchione can be followed on Twitter at http://twitter.com/MMarchioneAP

  • Associated Categories: Associated Press (AP), AP National News, AP Online National News, Top General short headlines, AP Health, AP Business, AP Business - Industries, AP Business - Health Care
© Copyright 2018 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
California gunman in veteran center killings was ex-patient
California authorities and a relative of one of three women killed after devoting their lives to helping traumatized veterans say the gunman was a patient who had been kicked out of their program
9:04AM ( 35 minutes ago )
Rohingya living in 'no man's land' insist they will stay
At the cloudiest edges of the Myanmar-Bangladesh border, thousands of Rohingya refugees who live inside a no man's land insist they will stay, despite pressure from Myanmar.
9:04AM ( 36 minutes ago )
Debate stirs over 'America's Harvest Box,' food benefit plan
The Trump administration says the plan is meant to streamline how healthy food gets to those who need it most, but state officials say the push to replace some cash benefits with a pre-assembled package of shelf-stable goods is full of holes
8:51AM ( 48 minutes ago )
Associated Press (AP)
'Pharma Bro' gets 7 years in prison in securities fraud case
A federal judge has wiped the smirk off Martin Shkreli's face, sentencing the pharmaceutical executive to seven years in prison for securities fraud
4:27PM ( 17 hours ago )
Insurers get into care, but is it good for your health?
As costs spiral and traditional boundaries blur in health care, insurers are taking more control over monitoring customer health and delivering care
4:07PM ( 17 hours ago )
'Pharma Bro' tearfully apologizes, then sentenced to prison
'Pharma Bro' Martin Shkreli sentenced to 7 years in prison
2:09PM ( 19 hours ago )
AP Health
Putin on alleged US election interference: I don't care
Vladimir Putin says he doesn't care about alleged Russian interference in the US presidential election because the actions weren't connected to the government
7:24AM ( 2 hours ago )
Steel standoff: EU, Japan trade chiefs meet Trump envoy
U.S. President Donald Trump's trade envoy is meeting with top officials from the European Union and Japan amid steel dispute
7:19AM ( 2 hours ago )
Indigenous, environmental leaders protest Canada pipeline
Indigenous people and environmental activists are converging in Vancouver Saturday to protest a $5.7 billion pipeline expansion project that would pump oil from Canada's tar sands to the Pacific Coast
1:57AM ( 7 hours ago )
AP Business
California gunman in veteran center killings was ex-patient
California authorities and a relative of one of three women killed after devoting their lives to helping traumatized veterans say the gunman was a patient who had been kicked out of their program
9:04AM ( 35 minutes ago )
Rohingya living in 'no man's land' insist they will stay
At the cloudiest edges of the Myanmar-Bangladesh border, thousands of Rohingya refugees who live inside a no man's land insist they will stay, despite pressure from Myanmar.
9:04AM ( 36 minutes ago )
Debate stirs over 'America's Harvest Box,' food benefit plan
The Trump administration says the plan is meant to streamline how healthy food gets to those who need it most, but state officials say the push to replace some cash benefits with a pre-assembled package of shelf-stable goods is full of holes
8:51AM ( 48 minutes ago )
India, France to work for Indian Ocean freedom of navigation
India and France have pledged to work together to ensure freedom of navigation in the Indian Ocean and have signed an agreement to expedite construction of a big nuclear power plant in India by a French company
8:27AM ( 1 hour ago )
Syrian troops cut major roads in suburbs of Damascus
Sources say Syrian government forces have succeeded in their deepest push yet into the eastern suburbs of the capital Damascus
8:24AM ( 1 hour ago )