NHS to Pioneer Inclisiran Trial - British Heart Fou...

British Heart Foundation
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NHS to Pioneer Inclisiran Trial

MichaelJH
MichaelJHHeart Star
29 Replies

The NHS are going to trial about 40,000 with Inclisiran. Rather than take daily statins they will receive twice yearly injection of this new drug. The report is here:

bbc.co.uk/news/health-51091083

The photo is a bit dramatic - it looks as if the guy has taken a bullet from a .44 Magnum!

29 Replies
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Deano_H

Wonder how you get on the trial, is it names in a hat 🙋‍♂️

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Calliope153
Calliope153
in reply to Deano_H

Look up Orion 4 - a number of my rehab group are on it. Not quite as this article writes it up!

1 like
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Milkfairy
MilkfairyHeart Star
in reply to Deano_H
1 like
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NorthantsSteve

I was invited to take part in the Orion 4 trial but my cholesterol levels were too low.

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Alison_L

Can I ask what your cholesterol is? I've been invited, but I'm currently 3.9 (mostly bad LDL).

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NorthantsSteve

Mine is 2.8. I think the limit was 4 - but I could be wrong. You might squeak in though. Worth a call if you’re interested.

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Alison_L

Thanks, Steve. I might speak to my Rehab nurses before doing anything.

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d4dave
d4dave
in reply to Alison_L

Mine was 3.9 and I was rejected - 4.0 is the minimum they will accept for the trial.

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Alison_L
Alison_L
in reply to d4dave

Ah, OK, thanks, Dave :)

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Deano_H
Deano_H
in reply to Deano_H

I’m not I’d risk the chance of ending up in the placebo test group, and having no cholesterol therapy

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Fortepiano
Fortepiano
in reply to Deano_H

In earlier Orion trials participants are either intolerant to statins or on maximum dose but nevertheless with high cholesterol. They still took statins during the trial.

Thus in the placebo group you would still be on statins, just not on inclisiran as well.

The info sheet says patients continue taking statins.

isrctn.com/editorial/retrie...

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Milkfairy
MilkfairyHeart Star
in reply to Fortepiano

The inclusion criteria for Orion 4 are slightly different

orion4trial.org/faq-1/what-...

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Fortepiano

Does this affect the position on taking statins which I was talking about?

My link is also to Orion4 and it says 'During the study you should continue any cholesterol lowering treatment prescribed by your own doctor such as a statin'

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Milkfairy
MilkfairyHeart Star
in reply to Fortepiano

People who have had a heart attack, stroke , had stents inserted or bypass surgery are being invited to take part.

The participants will continue as you quoted their usual cholesterol lowering drugs.

The study's website I thought was very informative and has a nice video clip by the Principal Investigator Prof Louise Bowman explaining the study.

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Kristin1812
Kristin1812Heart Star
in reply to Deano_H

No worries. I am on the trial and the trial drug (or placebo) is in addition to your existing meds, including statins,

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SpiritoftheFloyd

NHS patients who have not had a heart attack or stroke but are at high risk of having one will be invited to take part in the latest trial.

Well I guess that excludes most of us on this forum! although the article does say it may be assessed for more routine use next year

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Stuart2441

I was invited to the Orion 4 trial, bearing in mind there are many trials for the Orion project up to Orion 11 I think. My cholesterol was too low so was not eligible to take part as it had to be above 4. I believe they were looking to test around 15.000 people. All in all I was paid £17 travel and parking expenses when I attended my screening. Not bad for 20 mins. 😏

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Heythrop51

I fit the criteria but as things are moving in the right direction with Atorvastatin without side effects will stay where I am. If a statin were the only tablet then maybe but I still have to remember to take the others.

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SPV123

I also was invited to take part, my CHL levels were also too low, and the Nurse I spoke to said they were struggling to find suitable participants, but I noticed it was reported on BBC news last night about the drug, However no mention of the fact that it was a trial, there's probably a big group of people asking their GPs for it this Morning.

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Goldfish7

I decided not to take part as I had very bad reactions to all the statins I was given - exhaustion, aching etc. I would be worried that taking a 6 monthly 'trial 'drug being injected that I could have a similarly bad reaction or even worse and be stuck with it for 6 months. My health is not good at the moment and I hate to think what would happen to me if it all went wrong. Also I'm not overly sure about people playing around with my genes. - I think it is still very early days for these gene therapies.

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Qualipop
Qualipop
in reply to Goldfish7

I agree. I have reacted really badly to every tablet I wsa given after my heart attack. The thought of having something injected to last for so long, horrifies me.

1 like
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lamina_128

I have participated in a number of medical trials some involving ingesting medications and others invoving hours in MRI/CT/PET scanners having injections of all sorts of stuff. My default position is - yes, sounds interesting , and I enthusiastically enrol. I have videos of all the operations I have had since video cameras were available and have copies of all scans, test results etc. I like to know about MY body.

But I shall not be participating in the ORION-4 trial .

Firstly, I am of the opinion that lowering good bad or indifferent 'cholesterol' is not going to prolong my life one iota. I will not take statins but I was prepared to give inclisiran a 'go' since it works in a different way to statins and I have no problem 'experimenting' with my body. Re: my default position.

But the 'killer' for me was the statement that "The results of your blood tests will not be routinely provided to you or your GP. However, the ORION-4 team may write to your GP about your blood results if there is a cause of concern".

My blood is my blood. The blood tests are my blood tests. If the ORION-4 team MAY(!!!!) communicate MY results to MY GP if there is a concern then they can communicate with ME about my results- on every occasion. I am expected to have six monthly blood tests for five years and be kept completely in the dark about what is happening to MY BODY.

Absolutely no chance. If the results were sent to me after every test then yes, otherwise no.

And its not good enough to say if you want to know about your blood - get your blood tests done by your GP - thats not the point and I don't waste NHS money on pointless re-testing.

Richard

5 likes
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autumnsonnet

I often wonder about this, too.

Research projects expect you to participate for free, You would be expected to sign their waiver that participants will have absolutely no access to the results/findings, which could be useful.

You would have thought it would be useful to have some sort of access to your own data. You are nothing more than a "specimen -number" in these research projects.

For this reason, I tend to walk away.

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Pastime

I agree you should be kept informed personally It's your body their experimenting with

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JonathanH

From my brief research it seems that PCSK9 inhibitors have so far been found to reduce the risk of cardiovascular events but not lower the risk of all-cause or cardiovascular mortality. It has been reported that, in the Netherlands, there is even “some tension” among neurologists who are worried about the cognitive risks of pushing LDL cholesterol to very low levels. “All the safety studies up until now have shown no detrimental effects,” said Seijkens. But again, follow-up is too short to assess the long-term cognitive effects, he said. See cochrane.org/CD011748/VASC_... and tctmd.com/news/clear-cvd-ri...

The above-linked Cochrane study says "Finally, estimated risk differences indicate that PCSK9 inhibitors only modestly change absolute risks (often to less than 1%)." Is there any basis for suspecting that Inclisiran will be markedly better?

The prospect of gene silencing for 6 months naturally raises questions about what would happen if bad stuff started happening after administration. At the least, I would want to know what testing has been done so far and what the outcome has been. You might also want to know about the current assessment of all-cause mortality with PCSK9 inhibitors.

Overall, my feeling is that this will be a very interesting study that I would be glad for others to volunteer for.

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wiltsgirl

I think this is limited to England. I'm in Wales.

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Magz117

Looks like it’s just England?

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seasider18
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lamina_128

Hmmm....

300,000 people take it for 10 years and this 'saves' 30,000 lives - (I've never understood what this actually means and how anyone can arrive at this number is beyond me and is probably an extrapolation on minimal data). That's a maximum of 3000 per year, or less than 1% therefore 99% of those taking it don't benefit. The trial lasts five years and this medication will be approved 4 years before the end of the trial. Why bother with a trial? Doesn't seem like a game changer to me and costs are around 100 times higher than statins. Injection very six months anyone?

I bet Novartis are very happy since this should improve their share price.

Richard

1 like
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