Medicos toast tests of new cholesterol drug

21 March, 2017, 00:35 | Author: Garry Little
  • Pricey new cholesterol drug scrapes by in heart risk study

But back in 2015 there was no data to show the drug actually reduced cardiovascular events, and the data from the FOURIER study, involving more than 27,000 patients, resolves this issue.

The drug, Repatha, is called a PCSK9 inhibitor and can make cholesterol tumble to levels nearly never seen naturally in adults, or even in people taking cholesterol-lowering statins.

"There has always been a debate that low LDL cholesterol levels could lead to negative effects on memory or other cognitive functions", saidRobert P. Giugliano, M.D., S.M., Brigham and Women's Hospital, Boston and lead study investigator. ( AMGN ) announced results from the Repatha or evolocumab cognitive function trial (EBBINGHAUS) evaluating the impact on cognitive function in 1,974 patients enrolled in the Repatha cardiovascular outcomes study, FOURIER.

Not necessarily, say analysts, who reckon TMC and Alnylam can learn from experiences with the established drugs for their phase 3 program, which is due to start mid-year, and set themselves up for success.

The results of a two-year clinical trial on the drug sold as Repatha by Amgen Phamaceuticals that costs more than $14,000 a year were released at the American College of Cardiology annual conference in the U.S. capital.

This made "a dramatic difference", even if the drug could save just two percent of patients' lives, said Kevin Marzo, chief of the division of cardiology at Winthrop-University Hospital in Mineola, New York, who was not involved in the study.

The British Heart Foundation said the findings were a significant advance in fighting the biggest killer in the world, with about 15 million people dying each year from heart attacks or stroke.

The two clinical trials were funded by the drugs' respective makers - Amgen for evolocumab and the Medicines Company/Alnylam Pharmaceuticals for inclisiran. But any new cholesterol drug faces stiff competition from cheaper statins, which have been used to control LDL levels for decades.

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The study mainly revolves around the severe major adverse cardiovascular event (MACE), which refers to events like first heart attack, strokes or cardiovascular death. In clinical trials, both Repatha and its competitor, a drug called Praluent developed by Sanofi and Regeneron, reduced LDL cholesterol by about 60% in patients already taking statins. The rest of the patients, due to narrowed arteries, were suffering from pain in their legs and had a stroke.

The cost varies, but it is thought to cost the UK's NHS about £2,000 per year per patient where it is already being given to people who do not respond to statins.

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

Safety-wise, Repatha patients didn't see some of the side effects that other lipid therapies produce, he said.

However, Prof Sever said: "They will probably not [replace statins], there are an terrible lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down".

Sean Harper, executive vice president at Amgen, added: 'This is a game changer for high-risk patients'.

"It would be hard for me to look a patient in the eye, if they've had a couple of heart attacks and is scared to death, and say it's not worth you taking this medication", Nissen said. The fresh evidence could mean many more patients become eligible. A similar drug to Repatha, called Praluent, costs about as much.

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