Published: Tue, August 29, 2017
Medical | By Garry George

New finding on heart disease 'biggest breakthrough since statins'

New finding on heart disease 'biggest breakthrough since statins'

Harvard researchers have found that the drug Canakinumab, which targets inflammation without impacting cholesterol, significantly cuts a person's risk from recurrent heart attacks, strokes, and cardiovascular death.

Medicine targeting the body's natural inflammatory response to illness has been shown to protect heart patients from further life-threatening complications.

Physicians not involved in the study described the results as a scientific triumph, calling the implications for drug treatment of heart disease "huge".

"For the first time, we've been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk". Typically, about 25% of patients who survive a heart attack will experience another cardiac event within five years, despite regular medication.

"We suddenly know we can address the inflammation itself, the same way we learned nearly 25 years ago that we could address cholesterol".

For 6 of the last 10 years that Novartis' canakinumab has been available, the company has been conducting a study created to vastly expand the market for the drug, which is now sold under the name Ilaris to a small group of patients with rare inflammatory diseases.

27 in The Lancet, is a randomized, double-blinded trial of canakinumab to test if the drug lowered the rates of heart attack, stroke and cardiovascular death. Trial results indicate that about 1 of every 1,000 patients treated with the drug stood the risk of infections with older people and diabetics being the most vulnerable. All patients received aggressive standard care, which included high doses of cholesterol-lowering statins.

The researchers enrolled more than 10,000 patients who had had a heart attack and had a positive blood test for inflammation into the trial, known as the Cantos study.

Anti-inflammatory injections could not only lower the risk of heart attacks but may slow the progression of cancer, a study has found, in what researchers say is the biggest breakthrough since the discovery of statins. "It's very exciting", said the study's leader, Dr. Paul Ridker of Brigham and Women's Hospital in Boston.

In addition, participants were randomised to receive 50, 150, or 300 milligrammes (mg) of canakinumab (or a placebo for the control group), injected once every three months. There was no overall difference in death rates between patients on canakinumab and those given placebo injections, and the drug did not change cholesterol levels.

Canakinumab's benefit was comparable to Repatha, a powerful new type of cholesterol-lowering drug called a PCSK9 inhibitor. Older people and diabetics were most vulnerable.

The federal agency had no role in the heart attack study but sponsors one underway now testing methotrexate, a pill long used to treat cancer and rheumatoid arthritis.

Novartis said it's premature to discuss price for any use as a heart medicine.

Jeffrey Holford, an analyst at Jefferies, believes the CANTOS study results could drive net peak sales of over $3 billion for canakinumab - even after factoring in $500 million in lost revenue from Ilaris rare disease sales due to a price reduction. Yet there are no strictly anti-inflammatory drugs now approved for atherosclerosis. But they work in a different way, do not reduce CRP, and can affect blood clot formation.

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