A new drug to replace statins? Don’t believe the hype

    5 April 2016

    A new drug can halve levels of bad cholesterol without the damaging side effects of statins, researchers writing in the online journal JAMA have claimed.

    Repatha works by removing ‘bad’ LDL cholesterol by blocking a naturally occurring protein called PCSK9. This protein inhibits the liver’s ability to remove cholesterol from the blood.

    The study, which was carried out by scientists at Glasgow, Oxford and Amsterdam universities, found that patients taking Repatha for 24 weeks experienced a drop of 52.8 per cent in levels of LDL cholesterol, compared with a 16.7 per cent drop experienced by those taking ezetimibe, an older statin alternative.

    Such drugs are sought because between five and 20 per cent of people who take statins have to stop because of severe muscle pain. During the trial period just 13 per cent of patients taking Repatha reported muscle pain, and only one came off the drug, reporting intolerable muscle pain.

    Patients who experience muscle pain often refuse to take statins despite the elevated risk of major cardiovascular events, and the researchers say they are putting themselves at unnecessary risk.

    Repatha was approved by the European Medicines Agency last summer, but it is yet to be made available by the NHS. The drug watchdog NICE is due to make a licensing decision at the end of April.

    Instant analysis
    There is lots of hype here. Repatha, or evolocumab, would only be appropriate treatment when diet intervention and statins have not sufficiently reduced LDL (‘bad’) cholesterol. For the vast majority of patients, statins and a change in diet and lifestyle will be enough. For those who suffer side effects there are various solutions, from switching type to slowly increasing a low intake or stopping and then reintroducing statins later. (The muscle pains related to statins may have an explanation away from pharmacology — studies have found muscle-based symptoms seemed to be very similar irrespective of whether the patients were treated with statins or a placebo.)

    To be clear, it is not a statin replacement. I have seen no trials comparing the two forms of medication. The standard modifiers of LDL cholesterol are fibrates, bile acid sequestrants and ezetimibe or nicotinic acid.

    Repatha is extremely expensive and not yet approved by NICE. A year’s worth costs £4,500 or £6,100. It is delivered in the form of injections, which is unlikely to please patients.

    The cost is significantly high given the drug’s questionable impact on cardiovascular disease. We have no evidence yet that the drug will reduce rates of stroke or heart attack. Perhaps more evidence of its usefulness will emerge over time. RM
    Research score: 1/5