NHS to trial twice-yearly injection alternative... - Thyroid UK

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NHS to trial twice-yearly injection alternative to statins

helvella profile image
helvellaAdministrator
18 Replies

Will be interesting to know if there has been, or will be, any mention of thyroid in relation to inclisiran.

NHS to trial twice-yearly injection alternative to statins

Mass trial of drug inclisiran comes after health service strikes deal with Novartis

The NHS is to launch a mass trial of an as-yet unapproved twice-yearly cholesterol-lowering injection, which it hopes will save lives and cut medical bills for thousands of people who do not take statins.

About 40,000 people with high “bad” or low-density lipoprotein cholesterol will be invited to join the trial of inclisiran by NHS England via their GPs. The NHS has struck a novel deal with drugmaker Novartis, which will provide the injections free in exchange for the results of the five-year trial, which will be run by the NHS staff.

The trial will get the drug to many of those at risk of heart attacks and strokes before it is licensed and has gone through the cost-effectiveness assessment of the National Institute for Health and Care Excellence (Nice), which is expected in 2021. At that point, a price will have to be negotiated with the company.

Smaller trials have shown the injectable drug to be very effective in lowering cholesterol. Statins, which perform the same job in a different way, are also very effective, but many people fail to take them on a daily basis – whether because they forget, they do not like taking pills or they are anxious about potential side-effects, even though these are generally mild.

theguardian.com/society/202...

Have checked PubMed and found 56 papers with mentions of inclisiran - not one of which appears to include "thyroid", "hypothyroid", "hyperthyroid" or "thyroxine" (or various synonyms that are automatically added to any search).

Given that they have even used thyroid hormones and analogues to try to change lipid levels, I find that quite astonishing.

pubmed.ncbi.nlm.nih.gov/?te...

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helvella
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18 Replies
shaws profile image
shawsAdministrator

What next - my heart dropped when I read about your post.

Considering that a 'higher cholesterol level' is quite usual if someone has undiagnosed hypothyroidism (or too low a dose) yet may well be prescribed this new product instead of a decent dose of thyroid hormones. Keeping in mind the person has to wait until the TSH reaches 10 before being diagnosed as hypo due to doctors not knowing any clinical symptoms either.

Moneymakers indeed - profits are required by the company and for shareholders so it doesn't pay to heal patients.

Also the above statement:-

" or they are anxious about potential side-effects, even though these are generally mild".

We, on this forum are aware that - for dysfunctions of the thyroid gland - that T3 will reduce cholesterol levels.

Excerpt:

" How does the thyroid cause cholesterol problems?

Your body needs thyroid hormones to make cholesterol and to get rid of the cholesterol it doesn’t need. When thyroid hormone levels are low (hypothyroidism), your body doesn’t break down and remove LDL cholesterol as efficiently as usual. LDL cholesterol can then build up in your blood.

Thyroid hormone levels don’t have to be very low to increase cholesterol. Even people with mildly low thyroid levels, called subclinical hypothyroidism, can have higher than normal LDL cholesterol. A 2012 study found that high TSH levels alone can directly raise cholesterol levels, even if thyroid hormone levels aren’t low.

Hyperthyroidism has the opposite effect on cholesterol. It causes cholesterol levels to drop to abnormally low levels.

and

How does the thyroid cause cholesterol problems?

Your body needs thyroid hormones to make cholesterol and to get rid of the cholesterol it doesn’t need. When thyroid hormone levels are low (hypothyroidism), your body doesn’t break down and remove LDL cholesterol as efficiently as usual. LDL cholesterol can then build up in your blood.

Thyroid hormone levels don’t have to be very low to increase cholesterol. Even people with mildly low thyroid levels, called subclinical hypothyroidism, can have higher than normal LDL cholesterol. A 2012 study found that high TSH levels alone can directly raise cholesterol levels, even if thyroid hormone levels aren’t low.

Hyperthyroidism has the opposite effect on cholesterol. It causes cholesterol levels to drop to abnormally low levels.

healthline.com/health/thyro...

in reply toshaws

Exactly!

Forcing cholesterol levels down with medication, whatever drug they use, is highly unlikely to improve health in any way whatsoever. Mainly because cholesterol itself is not the problem

in reply toshaws

"Your body needs thyroid hormones to make cholesterol and to get rid of the cholesterol it doesn’t need"

….."Your body needs thyroid hormones to make cholesterol and to get rid of the cholesterol it doesn’t need"

And it's so important that it's worth saying twice. Or more :-P

Lora7again profile image
Lora7again in reply toshaws

I actually tweeted to him about this on his twitter feed and of course he ignored my question about untreated thyroid disease (Matt Hancock)

penny profile image
penny

When are they going to admit that lowering cholesterol is bad? I follow Dr Kendrick and every now and again he publishes extracts from scientific studies which show that lowering cholesterol reduces life span but these do not get headlines and do not stop the statin machine.

My very fit brother had a heart attack aged 60 and was immediately put on statins; no mention of CoQ10. I think that our mother was hypothyroid, as am I, but they’ve not tested his thyroid hormones. (Low T3 link to heart attack?) He now has prostate cancer but has not had his Vit D tested. I do my best but he slavishly follows his GP and won’t do any research.

I refused statins with good reason. The thought of an injectable statin is terrifying.

shaws profile image
shawsAdministrator in reply topenny

We definitely don't want stuff injected or swallowed into our body that we're not sure about. Especially if, after a while, we're not improving at all. Dr Kendrick has the right idea but he's not popular with the 'medical profession' for making patients aware of some dangers we may face when we swallow some medications. I assume also Big Pharma doesn't like his statements either as it may affect their profits.

helvella profile image
helvellaAdministrator

This paper, to my mind, questions whether we should be doing anything about PCSK9 without first addressing thyroid issues? In this paper, it is suggested that TSH has an impact.

I also wonder what the impact of PCSK9 inhibitors has on thyroid hormones and everything related?

(I started by doing a PubMed search: pubmed.ncbi.nlm.nih.gov/?te... )

Thyroid Stimulating Hormone Exhibits the Impact on LDLR/LDL-c via Up-Regulating Hepatic PCSK9 Expression

Yingyun Gong 1 , Yizhe Ma 1 , Zhengqin Ye 1 , Zhenzhen Fu 2 , Panpan Yang 2 , Beibei Gao 2 , Wen Guo 2 , Dandan Hu 2 , Jingya Ye 2 , Shuai Ma 2 , Fan Zhang 2 , Li Zhou 2 , Xinyu Xu 2 , Zhong Li 3 , Tao Yang 2 , Hongwen Zhou 4

Affiliations

• PMID: 28987238

• DOI: 10.1016/j.metabol.2017.07.006

Abstract

Context: Thyroid stimulating hormone (TSH) has received increasing attention as being closely associated with increased low-density lipoprotein cholesterol (LDL-c) level and higher atherosclerotic risks. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is known for increasing circulating LDL-c level by inducing LDL receptor degradation. However, whether TSH influences hepatic PCSK9 expression and LDL-c metabolism remains unclear.

Methods: First, the correlation between TSH and lipid profiles were investigated in euthyroid population and in subclinical hypothyroidism patients. Then, an in vitro study was conducted to validate the effects of TSH on hepatic PCSK9 expression in HepG2 cells.

Results: Serum TSH concentrations positively correlated with LDL-c levels in euthyroid subjects. Subclinical hypothyroidism patients with higher serum TSH levels showed significantly increased serum PCSK9 levels than the matched euthyroid participants (151.29 (89.51-293.03) vs. 84.70 (34.98-141.72) ng/ml, P<0.001), along with increased LDL-c concentrations. In HepG2 cells, LDLR expression on the plasma membrane was decreased, and PCSK9 mRNA and protein levels were synchronously upregulated after recombinant human TSH (rhTSH) treatment, while the effects could be blocked by TSH receptor blocking antibody K1-70. Sterol regulatory element binding protein (SREBP) 1c and SREBP2 mRNA expressions were enhanced after rhTSH treatment, and specific siRNAs significantly inhibited the effects of rhTSH. Furthermore, there was a noticeable induction of PCSK9 expression by rhTSH even though HMGCR gene expression was silenced.

Conclusion: We conclude a regulating role of TSH on hepatic PCSK9 expression, which further contributing to a higher LDL-c level.

Keywords: Low-density lipoprotein cholesterol; Proprotein convertase subtilisin kexin 9; Subclinical hypothyroidism; Thyroid stimulating hormone.

Copyright © 2017. Published by Elsevier Inc.

pubmed.ncbi.nlm.nih.gov/289...

shaws profile image
shawsAdministrator in reply tohelvella

If patients do have a higher cholesterol levels, they are blamed by the doctors/specialists who assume they eat 'the wrong food' and tell them to change their diet.

They seem completely unaware that a higher cholesterol level may well be due to being hypo or on an insufficient dose of hormones.

penny profile image
penny in reply toshaws

From my reading what one eats dose not affect cholesterol levels BUT the bigger issue is that ‘high’ cholesterol is not a problem at all; ‘low’ cholesterol is. Those with higher cholesterol levels live longest.

TSH110 profile image
TSH110 in reply toshaws

And it might actually be good for you!

shaws profile image
shawsAdministrator

Well, if in the UK they wont diagnose a patient until the TSH is 10, despite some disabling symptoms, or increase their dose of hormones to optimum, we cannot expect them to know anything else about anything else going wrong in our bodies.

I note the researchers of your paper seem to be Chinese - and seem more knowledgeable than our Endocrinologists.

helvella profile image
helvellaAdministrator in reply toshaws

The availability of research papers from around the globe is great. :-)

An awful lot of thyroid research is going on there. However, some of it is not relevant outside the area. And, even when potentially relevant, it is not always easy to understand and relate the information to the UK milieu.

TSH110 profile image
TSH110 in reply tohelvella

They seem open minded to NDT as I have seen a few Chinese papers on it. I think they were treating hypothyroidism long before we ever got there.

humanbean profile image
humanbean

This blog post entitled "Cholesterol and all-cause mortality" points out that lowering "bad" cholesterol is not good news - it actually increases the risk of death, particularly in older age groups and particularly in women.

vernerwheelock.com/179-chol...

A comprehensive review on the role of cholesterol in health and a critique of the use of statins has recently been published by a team of Japanese researchers (1). This pulls together information from a range of different sources. The focus is on all-cause mortality because fundamentally that is the key parameter most people understand and wish to control. Determination of individual diseases are subject to bias and lack of objectivity, which does not apply to death. The relationship between all-cause mortality and the cholesterol in the blood has now been investigated repeatedly in many different countries and the results which are incredibly consistent may come as a surprise to many people. In this blog I will refer to a selection of what is available.

Article continues : vernerwheelock.com/179-chol...

Angel_of_the_North profile image
Angel_of_the_North in reply tohumanbean

Well, perhaps that is a good thing for the NHS - more patients, sorry "customers", die and so fewer people to treat. Save money.

Another pointless waste of NHS money

TSH110 profile image
TSH110 in reply toAngel_of_the_North

Good for big pharma tho 😡🤯🤬

TSH110 profile image
TSH110

I can’t wait to see what Dr Malcolm Kendrick has to say about it in his blog. I expect a considerable amount of vetting of spleen. Sounds really frightening to me. Free human Guinnea pigs for big pharma. At least it give poor old lab rats a break. Why can’t they do this for us with T3 (may be not twice yearly annual injections tho!) to get better data on its efficacy? At least that would be beneficial to recipients.

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