Amgen Says Repatha Reduces Risk Of Hard Major Adverse Cardiovascular Events

The study also showed a 15 percent reduction in the risk of an extended major adverse cardiovascular event.

"It is probably the most important trial result of a cholesterol lowering drug in over 20 years".

On the safety side, Amgen spotted no new risks of taking the drug. Investors might not agree, however; Amgen shares dropped in pre-market trading by 6%.

In the United Kingdom, the National Institute for Health and Care Excellence (NICE) has considered the drug for select cases only, such as patients with familial hypercholesterolaemia, a genetic condition that results in high cholesterol levels and which increases the risk of developing coronary heart disease. Evolocumab is a fully human monoclonal antibody that works by blocking proprotein convertase subtilisin-kexin 9 (PCSK9), a protein that reduces the liver's ability to remove LDL cholesterol from the blood. Symphony Health data shows that commercial insurers rejected nearly three-fourths of PCSK9 requests previous year, and Medicare coverage was denied at a rate of 61%.

Hegele has been studying PCSK9 inhibitors for several years and says while it has been known for some time that the drugs reduce cholesterol levels, there's been doubt about whether they actually cut the risk of heart attacks and deaths. Some cardiologists and researchers had anxious that very low LDL might have deleterious effects, just as excessively low blood pressure can.




"The unique dosing regimen virtually eliminates variability in LDL-C levels over time and inclisiran may, therefore, solve one of the most vexing challenges of cardiovascular medicine-namely, how to make sure everyone responds to treatment", said John J.P. Kastelein, MD, PhD, a professor of medicine and the chairman of the Department of Vascular Medicine at the Academic Medical Center at the University of Amsterdam. Earlier guidelines set an LDL target of 70 for such high-risk patients. "We really should be trying to get it as low as possible".

He prescribes the drug for patients who can't be helped by statins or other cholesterol-lowering drugs and said he would likely stick with that prescribing pattern.

Dr. Seth Baum, president of the American Society for Preventive Cardiology, said records from IMS Health, an information services company, show 83 percent of patients had claims rejected in the first year Repatha and Praluent were sold, and 26 percent of them won on appeal.

A key secondary endpoint of the study narrows the list of bad patient outcomes to cardiovascular death, heart attack and stroke. Almost half the patients saw LDL levels fall below 50, well below the common target of 70 for patients at high risk of a heart attack or stroke. The median baseline LDL cholesterol was 92 mg/dL. The benefit grew with longer use, and was 25 percent the second year, said Sabatine, who consults for Amgen and other drugmakers. It also cut the risk of hospitalization for chest pain or the need for angioplasty (an artery-opening procedure) by 15 per cent. When examining individual outcomes, there was no effect on cardiovascular mortality by itself, but there was a statistically significant 27 percent reduction in heart attack and a 21 percent reduction in stroke. Sixty-nine percent of patients were on a high-intensity statin and 30 percent were on moderate-intensity statin.

On November 1, 2016, the entire SPIRE clinical trials program was stopped when the sponsor, Pfizer, who manufactures bococizumab, discontinued the development of the drug when initial results from the LDL cholesterol lowering trials indicated that some trial participants had developed anti-drug antibodies, an immunologic response to the drug. Blood pressure has to be treated to a "normal range", not too high or low, while smoking is toxic and should be stopped altogether.

Related news:

Hot News

isis-killer-beheading-video-story-top Jobless claims dip in latest sign of job market improvement
Mar 18, 2017 - 01:38
The number of initial claims for unemployment insurance, a measure of new layoffs, rose by 138, or 17.7 percent, to 917. Ames, Iowa, held on to the title of the lowest unemployment rate in the nation, at just 2.3 percent in January.

isis-killer-beheading-video-story-top Google reinvents JPEG compression, tells Internet to take a load off
Mar 18, 2017 - 01:37
And although Google compared Guetzli to mozjpeg and another JPEG encoder called libjpeg , there are other options, too. For Google's Guetzli speed boost, researchers developed a test called Butteraugli created to model human vision.

isis-killer-beheading-video-story-top (NASDAQ:DRYS), Penn West Petroleum Ltd (USA) (NYSE:PWE)
Mar 17, 2017 - 01:37
November 02, 2016: Penn West Petroleum Ltd. (PWE ) reported Q2 earnings loss of -$1.43, missing consensus estimates of -$0.14. Important factors to focus when evaluating a stock's present and future value are the 52 week price high and low levels.

isis-killer-beheading-video-story-top How The US Deploying Troops To Syria Fits In The Wider Conflict
Mar 17, 2017 - 01:33
Special Operations forces operating alongside the SDF, in addition to about 250 Rangers and 200 Marines. Security Council to press Ankara to withdraw its troops.

isis-killer-beheading-video-story-top MEN'S BASKETBALL: Notre Dame narrowly escapes Princeton's upset bid in first round
Mar 17, 2017 - 01:29
The Longhorns are the fourth team to earn 30 tournament berths, joining Tennessee (36), Georgia (32) and Stanford (31). That's a combined 4-for-21 (19 percent) from a pair of players who both shoot better than 43 percent from the field.

isis-killer-beheading-video-story-top Trump to review Obama-era fuel efficiency standards
Mar 17, 2017 - 01:29
Trump knocked President Obama for an "11th hour executive action" putting stricter measures on federal fuel-efficiency standards. Trump said revising fuel economy targets could help keep and protect U.S auto industry jobs.

isis-killer-beheading-video-story-top US Charges 2 Russian FSB Officers, 2 Alleged Hackers Over Yahoo Attack
Mar 17, 2017 - 01:29
Besides orchestrating the breach, the indictment alleged that Yahoo accounts accessed without authorisation were used to launch a spam campaign.

isis-killer-beheading-video-story-top USA warns UN Human Rights Council: Either reform, or we leave
Mar 16, 2017 - 00:54
It replaced the UN Human Rights Commission, which was facing severe criticism because countries with poor rights records became members and blocked its mission.

isis-killer-beheading-video-story-top Australia resume bitter battle as 3rd Test begins in Ranchi today
Mar 16, 2017 - 00:51
This irked Australia coach Darren Lehmann even further as they were in no mood to leave without getting to see the entire pitch. Both men may have pledged to make cricket the No.1 focus in the third Test, however the tension between the pair is palpable.

isis-killer-beheading-video-story-top Stade Francais strike over merger
Mar 16, 2017 - 00:48
French rugby was stunned by the move to unite two of the biggest clubs in the game from next season. The presidency will rotate every two seasons, with Stade's Thomas Savare the first to serve.

isis-killer-beheading-video-story-top Syrian children suffered the worst war-related violations in 2016
Mar 16, 2017 - 00:47
Mr Geert added: "Each and every child is scarred for life with horrific consequences on their health, well-being, and future". More than 850 children were recruited to fight in the conflict in 2016 - over double the number recruited the year before.

DOJ Indicts Russian Spies For Hacking 500M Yahoo Accounts
Mar 16, 2017 - 00:45
The 2014 incident was in addition to a much larger theft that Yahoo disclosed in December and that dated back to 2013. They hired Alexsey Belan and Karim Baratov, described as "criminal hackers ", to carry out the attacks.

SA power plan released - 16-Mar
Mar 16, 2017 - 00:44
Asked whether the gas guarantee would make make any difference to the amount of money being paid by local industrial gas users, Turnbull said it would depend on the amount of gas available.

isis-killer-beheading-video-story-top EU Court Allows Employers to Ban Islamic Headscarves
Mar 16, 2017 - 00:44
The rulings come after courts in Belgium and France referred controversial domestic cases to Europe's top court. The court ruled that the firm was not guilty of discrimination, said a Reuters report.

isis-killer-beheading-video-story-top Elections in the Netherlands: Explainer
Mar 16, 2017 - 00:43
Most polling stations were to open Wednesday at 0630 GMT, and close at 2000 GMT with exit polls expected shortly after. Up to 13 million Dutch people took to the polls today to have their say in the momentous Dutch election 2017.