Clinical Trials

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Grandad
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Clinical Trials

Post by Grandad »

I received a letter today under NHS heading inviting me to take part in a clinical trial for a new drug 'Inclisiran' which has been developed to reduce the level of LDL in the blood of people at risk of stroke or heart attack. I guess they selected me because I have had a heart attack and have also had recent investigation and treatment for heart conditions.
Checking on Google I find that a lot of work has already been done with smaller trials but this one, called Orion4, will have 15,000 taking part over a 5 year period.
When I had a heart attack at age 52 I was asked to take part in another drug trial called 'Isis'. Many years later I asked my doc what the outcome was. He said it was inconclusive, which I guess means the drug was not released for general use at that time.
I am completely happy to take part in this 5 year trial (that might be pushing it :lol: ) but my wife takes the opposite view.It is my opinion that, particularly at my age, we should take part to help with development of new drugs. I suppose the contra argument is that the more drugs that are developed, the longer we live and the more the burden on the state and tax payers.
I will be interested to hear your views folks before I accept my first appointment in early November. :stp :stp


:gg:
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LovelyLadyLux
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Re: Clinical Trials

Post by LovelyLadyLux »

If I was you I'd take part in a heartbeat however I'd have some conditions first being I'd participate so long as it guarantees that some form of treatment will be administered. Meaning - I would not want to take part in anything if I had a condition and I might end up with or on a placebo that would leave me in a worse place than I was prior to starting.

I'd also want to know if it would mean mean I'd have to stop what I'm taking now and totally go on a new regimen of medications. I'd want to know what they were looking for, hoping for and what results they'd gotten to date and if there were any side effects expected or possibly even unexpected.

I'd be asking too if they'd be sharing info with me as the study went on. Sometimes you hear nothing 'til the end and sometimes you never hear anything (and I would want to be left in the dark)

When my Father was diagnosed with colon cancer stage 4 he agreed to be put into a study they're doing and did donate lots of blood. He was pretty ill at the time and didn't really even get too many details about the study but thought it the minimal he could do to help the Researchers.

I think it would be exciting to be part of something like this. Sure it might add a bit of back and forth and few meetings to your life but personally I'd think that would be interesting.
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Grandad
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Re: Clinical Trials

Post by Grandad »

Thanks LLL, very helpful.
The leaflet on the study says that current medication continues as normal. This will not be interfered with.
After an initial assessment to confirm suitability for the study (people on some drugs are excluded) I would be given a blood test and first injection. This would be repeated in 3 months but from then on it is at 6 month intervals. I would have absolutely no problems with that.
As for possible side effects. They have already done sizable trials on a sample of 500 people so I would have expected any side effects to have shown in that sample. The results in that sample were positive and this is a large sample trial before approval can be sought.
As for the placebo, probably nothing more than saline so no worries. ;) I think I will sign up, at least it will give me a few runs to the hospital, on the scooter, which is 3 miles across town. That would be a marathon, never gone that far before
:lol:
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Re: Clinical Trials

Post by Grandad »

I have decided not to take part in this clinical trial. I am on a whole bunch of meds some of which contain beta blockers. In January the ophthalmologist that I saw changed my drops becausin his view I was having too much beta blocker which can have an adverse effect on eye conditions. This trial is for a new treatment for Angina so it is quite likely that beta blocker may be in the drug. I'm 85 in December so they can find someone else....
On another issue, you may remember that the cardiologist gave me a prescription for an 'Off List' drug which some of his patients have told him also helps their peripheral neuropathy.
I have not done anything about this drug and have not started taking it. However, my legs have been particularly bad today (could be crawling around in the bathroom) so I have decided to give them a try and start taking the tablets this evening. If I don't detect any improvement I shall simply stop......
:gg:
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Re: Clinical Trials

Post by FABlux »

I think you are wise not to take part in the trial Grandad. As the drug is given by injection, unlike tablets, you can't just stop if it doesn't suit you & you certainly don't want anything which could affect your eyes!

Hope the tablet helps your legs.
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