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Thread: Invited to take part in Clinical Trial.

  1. #1
    Senior Member nukecad's Avatar
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    Invited to take part in Clinical Trial.

    Has anybody else received a letter from the NHS inviting them to take part in a phase-4 clinical trial of a new cholesterol reducing injection?
    It's called the Orion-4 trial.
    It's a six-monthly injection which is hoped could replace taking statins daily.
    More info for those interested:
    https://www.hra.nhs.uk/planning-and-...aries/orion-4/
    https://www.ctsu.ox.ac.uk/research/orion-4

    It's a 'double blind random trial' in which half the participants get the treatment and half get a placebo. (saline solution).
    Neither the patient or the staff know who is getting which.
    The drug is not yet approved for use in the UK, which is usual with trial treatments and is why they have trials to gain approval.
    All that is fair enough.

    (I'm already in one 10-year trial, UK-Cosmos, but that one is just monitoring neurological health long term not taking new drugs).

    I received the invitation letter this weekend, but it's slightly concerning on a number of fronts.

    To start with the invitation letter already includes a 'provisional' appointment to attend at a local hospital.
    Although it does clearly say that you don't have to attend or take part this would seem to be pressure to take part?
    People getting a 'hospital appointment' letter may not read further and simply assume that they have to attend.

    The included explanatory leaflet give more details of the trial, including the information that you will be given an injection (it doesn't say what of) at this first visit.
    Again undue pressure?
    You've turned up simply to find out what it's about, and find yourself pressured to be injected and so on the trial?

    The leaflet also includes why you have been chosen, what will happen in the trial, who is running and funding the trial, data protection, etc. etc.

    One thing it noticably neglects to tell you is the the drug being trialed, Inclisiran, is a "gene silencer". - It acts by modifying how your RNA works.
    (Note that this is not 'gene therapy' which permenantly alters DNA).
    There is nothing too alarming with gene silencing in itself, the technique has been know for a while and is now making it to the market.
    https://www.bbc.co.uk/news/health-47907971
    But it's something I feel should be clearly pointed out in the information leaflet.

    The new drug is claimed (by the manufacturers) to "reduce cholesterol by 50%".
    Err, no. The same was/is claimed for statins. Statistics can be easily manipulated.
    Reading the medical litrature Inclisiran is thought to be 50% more effective at reducing cholesterol than statins, which is where the manufacturers get that headline claim.
    Statins are thought to reduce the risk of heart attack or stroke in 4% of people who take them.
    So it may reduce the risk of heart attacks or stroke in 6% of all people who take the new drug. (Or it might not).

    And, although it's become widely accepted, there is still debate about whether cutting LDL (bad cholesterol) is actually of any use at all in preventing heart attacks and stroke.

    So I'm still undecided whether to take part in this trial, in particular I'm not impressed by the way this invitation has been done.

    I'd be interested in your thoughts, especially if you have also received the invitation.
    Last edited by nukecad; 09-29-2019 at 02:03 PM.
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  2. #2
    This caught my eye as I have the inherited form and in spite of taking 2 different drugs at maximum dose and a strict boring diet my cholesterol is virtually uncontrollable. Been taking statins for the last 40 years or so. Now my liver is showing signs of damage through them.
    I have taken part in the last few years as money became available, along with my family, in genetic research and it transpires there is only one other similar mutation been found to ours and that is in France. This research is taking place in Bristol.
    I have also had heart attacks and several emergency stentings.
    There is already a monthly injection available but my consultant advises against it for me because of the possible side effects as I had a nasty reaction to one particular statin that was more aggressive than the one I already take.

    Under my circumstances it would not be worth the risk of being given a placebo as that would put me at even more risk than I am already even with the drugs I already take.

  3. #3
    Senior Member nukecad's Avatar
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    Interesting beau,

    From my limited research I'm aware of the 2 types of monthly injections used cyrrently to treat familial hypercholesterolaemia, (Praluent and Repatha), and they use a different mechanism than gene silencing.

    They 'bind' to a protein (PCSK9) after it is produced to stop it working.
    By contrast this new one, Inclisiran, changes your RNA to prevent the protein from being produced in the first place.

    Whether that would be better in your particular case I wouldn't know?

    With this trial you continue to take your existing medications, statins included, so even if you got the placebo only you should be the same as currently.

    However it appears that, for now at least, this trial is by invitation only based on your age and previous cardiac history.
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  4. #4
    Quote Originally Posted by nukecad View Post
    With this trial you continue to take your existing medications, statins included, so even if you got the placebo only you should be the same as currently.
    Ah, I missed that one or didn't delve deep enough.

    I may just make some enquiries, they can only say no or the area may not be accessible for me. Age may be a problem too.

  5. #5
    Senior Member nukecad's Avatar
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    Quote Originally Posted by beau View Post
    I may just make some enquiries, they can only say no or the area may not be accessible for me. Age may be a problem too.
    It's a lower age limit not an upper one, however it does seem to be more with the non-hereditary types (Although inherited conditions were included in the first 3 phases):
    People are eligible to join the study if they are aged 55 years or older and have known vascular disease (that is they have had a heart attack, stroke or leg artery bypass or angioplasty, or aortic aneurysm repair).
    Like I say I think it's invitation only, but there is no harm in asking.
    Last edited by nukecad; 09-29-2019 at 03:08 PM.
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  6. #6
    I realise it was over the age of 55 but I am 70 now so may well be out of the age range they are looking at.
    Another thing, it could be where they are looking for participants from a certain area because of restrictions on where the trials can take place.

    I read it to mean the genetic type. Why treat folk for something where the solution could be in their own hands, ie stop eating the junk. I wish I could eat junk at times as my diet is very restricted and not particularly appetising.

    I am also interested because both my children and one grandchild that we know of are affected by the same mutated gene as I. It would be worth it if it was to do them some good, quite possibly too late for me.

    I have sent them an email and will wait and see what they say.

  7. #7
    Senior Member nukecad's Avatar
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    Quote Originally Posted by beau View Post
    Why treat folk for something where the solution could be in their own hands
    Because big pharma is already making a fortune from statins being given to people who don't need them and this new stuff currently costs 100 times more for a years dose.Even if they knock that down drastically it's still more money in their pockets.
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  8. #8
    Quote Originally Posted by nukecad View Post
    Because big pharma is already making a fortune from statins being given to people who don't need them and this new stuff currently costs 100 times more for a years dose.

    Even if they knock that down drastically it's still more money in their pockets.
    When I was first diagnosed at the age of 30 the 1st line of attack was diet, even though, in those days I ate healthily. Apparently diet makes very little difference if it is genetic.

    Yes, I know of folk who say "I take the tablets so I can eat what I want" No wonder money is pouring out of the NHS in millions. About time people stopped depending on drugs in that instance. I wonder if they realise Statins damage their liver over time?

    By taking statins for all those years my liver is now suffering. I don't know how much longer before my liver situation gets critical.

  9. #9
    Much to my amazement I actually got a reply from a doctor involved in the trial.
    This is the reply, quote

    "Thank you for your message regarding the ORION-4 study, and for providing us with this important medical information. Our study aims to test a new drug called inclisiran in patients who did not receive cholesterol-lowering injections in the recent past, and in whom this drugs are not recommended or being considered. In your situation (genetic-proven familial hypercholesterolemia), it seems like the cholesterol-lowering injections currently available could be considered. Therefore, our advice is for you to seek advice from your GP, and possibly a specialized lipid clinic. If they then decide that these medications are not suitable for you, we will be very happy to proceed with including you in our study."

    Seeing I have already done the things suggested and been told the currently available injections my consultant would be very reluctant to try I have replied. Just waiting to hear their response.

  10. #10
    Senior Member nukecad's Avatar
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    Looks like they are on the ball, that was a very quick reply.

    You might want to talk to your consultant before proceeding though.
    Your consultant knows your condition better than any trial doctor and may want to look into whether Inclisiran would be suitable for you.
    (Or maybe they already know about it but couldn't previously suggest it because it's not approved yet?).

    I'm still undecided myself, but am currently tending towards taking part in the trial.
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