New Drug Lowers Heart Attack Risk

Posted March 20, 2017

Experts say the drug is best for people who are genetically predisposed to extremely high LDL, or those with a history of heart disease. Evolocumab is a monoclonal antibody created to inhibit proprotein convertase subtillsin-kexin type 9 (PCSK9) and lower low-density lipoprotein (LDL) cholesterol levels to approximately 60%.

Excitement about Repatha - also called evolocumab - has been building in the past three years, with scientists predicting it could "switch off" heart disease.

An worldwide trial of 27,000 patients found that those who took the drug evolocumab saw their bad cholesterol levels fall by around 60% on average.

"It makes you scared, with lots of anxiety, knowing you had a heart attack and the statins are supposed to help people but aren't doing it".

Atara Biotherapeutics Inc. ( ATRA ) expects initial data from its phase I trial of autologous version of ATA188 in patients with primary and secondary progressive multiple sclerosis to be presented by its collaborating investigators at a medical conference in late April.

Dr Isla MacKenzie, Clinical Reader and Honorary Consultant Physician, University of Dundee and Ninewells Hospital, said: "It's an exciting advance in that we've found another treatment that lowers the risk of heart attacks and strokes in patients who are already at high risk and Scotland has one of the highest incidences of acute heart disease".

Stein noted that "these are the lowest lipid levels that have been achieved in a randomized controlled trial, I'm not surprised that it's not a flawless predictive relationship".

But for some people statins are not strong enough to reduce their levels, meaning the risk to their heart remains.

At that rate, after five years, just 17 high-risk patients would have to be treated, the authors said. The benefit of evolocumab started as early as six months and continued to accrue through the median 2.2 years of the study.

ACC scientific program chair Jeffrey Kuvin, MD, called the trials results game changing but, turning to those devilish details, he added, "The question is, is it going to be actually able to change practice".

Investors, however, were hoping for an upside surprise of something more than 20%.

The study, in the New England Journal of Medicine, tested Repatha on patients in 49 countries, 1,500 in Britain.

After an initial injection of 300 milligrams of inclisiran and another three months later, the drug is created to be taken just twice a year.

In order to reach their findings, the researchers conducted the study on around 27,564 patients, out of which almost 80 percent of them had suffered from a heart attack. About 80% had already had a heart attack, and the rest had had a stroke or had pain in their legs and feet from narrowed arteries.

The study results reported last November demonstrated that a single injection of Inclisiran (300 mg) lowered "bad cholesterol" (LDL-C) by an average of 51% at Day 60, which were durable to Day 90 (mean 45% and up to 76%) while two injections of Inclisiran (300 mg) lowered LDL-C by an average of 57% at Day 120, which was durable to Day 180 (mean 52% and up to 81%).

Repatha acts over the PCSK9 protein and reduces the number of liver receptors that cut the LDL cholesterol in the blood. Opening up the floodgates to all the patients who might benefit from the drug could prove to be a budget buster for many insurers.

Repatha costs about £4,400 per patient per year, although the NHS has agreed an undisclosed discount.

Prof Sir Nilesh Samani, medical director at the British Heart Foundation, said: "Coronary heart disease is the single biggest killer in the United Kingdom and worldwide and "bad" LDL-cholesterol is a major cause". Even though these patients were optimally treated with the latest therapies, they were still at high risk for an additional cardiac event.