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 Merson: West Brom a 'banana skin' for Arsenal
Mar 18, 2017 - 01:38
Although they remain in 8th position, they have lost their last two matches and that will fill Arsenal with confidence. So overall that's our targets. "They have experienced, organised and efficient from set pieces", Wenger said.

isis-killer-beheading-video-story-top Guardiola exposed by Monaco
Mar 18, 2017 - 01:37
We wanted to show personality, not to let them think, but they could pass and pass the ball. "Our job is to do as we well can". The result actually meant that, for the first time, Guardiola has failed to take a side to at least the semi-finals.

isis-killer-beheading-video-story-top Jonjo O'Neill delighted with Minella Rocco's run in Cheltenham Gold Cup
Mar 18, 2017 - 01:32
Djakadam , twice the runner-up, travelled well for most of the race and looked as though he might finally win for Willie Mullins. When you're on the best horse you can go anywhere. "He had it over two miles behind Douvan and he has that bit of speed".

isis-killer-beheading-video-story-top Journalists Caught in Mount Etna Eruption Capture It on Video
Mar 18, 2017 - 01:28
Amongst those hurt near the summit of Etna on the island of Sicily were members of a television crew filming for the BBC. Kiss added that her guide told her the lava was around 1,000 degrees Celsius (1,800 Fahrenheit).

Secretary of State Tillerson used e-mail alias as Exxon CEO
Mar 17, 2017 - 01:40
PricewaterhouseCoopers and Exxon Mobil Corporation , was filed in New York State Supreme Court, New York County. Tillerson used an alias to send and receive global warming data via email, Reuters and NBC News are reporting.

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 Manchester City Supporters Club dismayed at Champions League exit
Mar 17, 2017 - 01:32
On the eve of the game, Guardiola had also warned his players to concentrate hard on set-pieces. "It's simple. The difference was between the first and the second half".

isis-killer-beheading-video-story-top Trump wants billions to build a border wall and ramp up deportations
Mar 17, 2017 - 01:31
Various estimates put the cost for the 30-foot (nine-meter) wall at between United States dollars 8 billion and USD 40 billion. The budget request did not include a way for Mexico to pay for constructing the barrier, as Trump pledged during the campaign.

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 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 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.

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 Pandora Premium Music Streaming Launched For $10 A Month
Mar 16, 2017 - 00:47
Pandora Premium is an on-demand music streaming service in the same vein as Spotify and Apple Music . Every song thumbed up on Pandora is immediately available in a "My Thumbs Up" playlist.

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.