Podcast - NICE News - December 2023
10m | Dec 30, 2023This podcast makes reference to guidelines produced by the "National Institute for Health and Care Excellence" in the UK, also referred to as "NICE". Please note that the content on this channel reflects my professional interpretation/summary of the guidance and that I am in no way affiliated with, employed by or funded/sponsored by NICE.
My name is Fernando Florido and I am a General Practitioner in the United Kingdom. In this video I will go through new and updated guidelines published in December 2023 by the National Institute for Health and Care Excellence (NICE), focusing on those that are relevant to Primary Care only.
I am not giving medical advice; this video is intended for health care professionals, it is only my summary and my interpretation of the guidelines and you must use your clinical judgement.
There is a podcast version of this and other videos that you can access here:
Primary Care guidelines podcast:
· Redcircle: https://redcircle.com/shows/primary-care-guidelines
· Spotify: https://open.spotify.com/show/5BmqS0Ol16oQ7Kr1WYzupK
· Apple podcasts: https://podcasts.apple.com/gb/podcast/primary-care-guidelines/id1608821148
There is a YouTube version of this and other videos that you can access here:
The Practical GP YouTube Channel:
https://youtube.com/@practicalgp?si=ecJGF5QCuMLQ6hrk
The Full NICE News bulletin for December 2023 can be found here:
The links to the update guidance covered can be found here:
Bipolar disorder: assessment and management:
· https://www.nice.org.uk/guidance/cg185
Empagliflozin for treating chronic kidney disease:
· https://www.nice.org.uk/guidance/ta942
Cardiovascular disease: risk assessment and reduction, including lipid modification:
· https://www.nice.org.uk/guidance/ng238
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Transcript
Hello and welcome, I am Fernando, a GP in the UK. Today, we are looking at the NICE updates published in December 2023, focusing on what is relevant in Primary Care only. We will be covering: valproate toxicity, empagliflozin for CKD, and cardiovascular risk reduction.
The episode is fairly short so let’s jump into it.
The first clinical area refers to the use of valproate in the bipolar disorder guideline, in line with new MHRA guidance published in November 2023.
And perhaps we should remember that the previous MHRA advice stated that valproate must not be used in women and girls of childbearing potential unless other options are unsuitable and a pregnancy prevention programme is in place.
But the new safety advice is much stricter and states that valproate must not be started in people (either male or female) younger than 55 years, unless 2 specialists independently consider that there is no other treatment, or that the reproductive risks do not apply.
So, let’s have a look at this in a bit more detail.
We know that valproate must not be used in pregnancy as well as in any female of child bearing age unless there is a Pregnancy Prevention Programme in place, which involves an annual review and the requirement for highly effective methods of contraception (such as a hormonal intrauterine device). This is because of the risks of malformations and developmental problems.
Valproate is a known teratogenic drug, resulting in both physical birth defects and neurodevelopmental harm including lower intellectual abilities, poor language skills and memory problems.
Although the risk of structural malformations is greatest in the first trimester, the risk of neurodevelopmental harm is thought to be present throughout, and therefore valproate is never safe in pregnancy.
But the new guidance also includes males. Why is this?
Well, although less information is available regarding reproductive risk in male patients; these risks remain an area of concern. The risks of impaired fertility or male infertility with valproate have been known for some years. Additionally, there is suspected testicular toxicity in younger males and further studies are being carried out in this respect.
Furthermore, it is thought that there is an unknown risk to the foetus from paternal exposure to valproate in respect of both congenital abnormalities and neurodevelopmental disorders, including autism spectrum disorders, and further studies are underway to evaluate this.
Finally, there is also a concern about possible transgenerational risk. Whilst we know about harm in the first-generation offspring, animal studies have shown that some behavioural changes are transmitted by both males and females in the second and third generations. The underlying mechanisms of these findings are unknown, although we know that valproate can induce DNA changes which could lead to this transmission.
At present, we still await more studies focusing on transgenerational risk as well as possible epigenetic effects of valproate.
The next area refers to empagliflozin for treating chronic kidney disease.
And we know that the management of CKD aims to slow its progression. Standard care is lifestyle changes, and usually ACE inhibitors or ARBs. In addition, dapagliflozin is also recommended as an add-on to optimised standard care if eGFR is between 25 and 75 and the patient has type 2 diabetes or an ACR of 22.6 or more.
Clinical trial evidence suggests that empagliflozin plus standard care is also beneficial. There are no clinical trials directly comparing empagliflozin with dapagliflozin in CKD but an indirect comparison suggests that empagliflozin has a similar effectiveness and safety to dapagliflozin. The main empagliflozin clinical trial did not include anyone with eGFR levels less than 20 and patients with eGFR between 45 and 90 were only included if they also had an ACR of 22.6 or more. Therefore, empagliflozin can also be recommended, but only:
· as an add-on to optimised standard care with an ACEi or ARB, unless contraindicated, and
· if eGFR is:
o more than 20 and but less than 45 or
o between 45 and 90 and either the patient has:
§ an ACR of > 22.6
§ or type 2 diabetes
And the third and final area refers to the risk reduction of cardiovascular disease. The main update affects the lipid targets in the secondary prevention of CVD. But there are also some other changes in the recommendations for primary prevention.
So, let’s look at the statin recommendations for primary prevention first:
People with and without type 2 diabetes should have atorvastatin 20 mg daily if they have a 10‑year QRISK3 score of 10% or more. But, and this is slightly different now, we should not exclude patients just because the 10‑year QRISK3 score is less than 10% if either the patient would like to take a statin or if we feel that the risk may be underestimated.
The lipid target for primary prevention is a greater than 40% reduction in non-HDL cholesterol.
For people with type 1 diabetes, the recommendations are slightly different. We will offer atorvastatin 20 mg if they:
· are over 40 or
· have had diabetes for > 10 years or
· have nephropathy or other CVD risk factors.
But equally, we should now consider statin treatment for those aged 18 to 40 with type 1 diabetes, including those who have had diabetes for 10 years or less.
NICE has changed the recommendations because evidence shows that statins are cost effective for people with 10‑year CVD risk scores of less than 10% because of the greater reduction in CV events. However, the recommendation to consider atorvastatin 20 mg for people with QRISK3 scores less than 10% is a change in practice and will have practical consequences in Primary Care in terms of both cost and workload.
Let’s now have a look at the recommendations for statin therapy for secondary prevention, which apply to people both with and without type 1 and 2 diabetes.
And the main change relates to a change in the lipid target. So, now, for secondary prevention, we need to aim for LDL cholesterol levels of 2.0 or less, or non-HDL cholesterol levels of 2.6 or less.
The initial treatment for secondary prevention is with atorvastatin 80 mg, whatever their cholesterol level, although we can consider a lower dose if:
· there are drug interactions
· there is a high risk of side effects or
· the person would prefer a lower dose.
In terms of escalating treatment for people on statins, there are also new recommendations.
First, if the person is on the maximum dose of a statin but the lipid target for secondary prevention is not met, we should consider additional lipid-lowering treatments with ezetimibe or the injectables alirocumab, evolocumab and inclisiran
This is because studies have shown that the combination of a statin and one of those other 4 lipid-lowering drugs produces reductions in both cholesterol and major CV events. The use of these drugs is also cost effective in people with an LDL of 2 or more or a non HDL cholesterol of 2.6 or more.
Second, we can also consider ezetimibe in addition to statins, even if the lipid target is met. This is because studies have shown that the combination is effective in reducing CV events and ezetimibe is cost effective regardless of cholesterol levels.
It is expected that the new recommendations will lead to an increased use of lipid-lowering treatments. This will result in higher costs to the NHS and also an increased workload in primary care. However, the extra cost of lipid-lowering treatment would be partly offset by savings due to a reduction in CVD events
There are also some new minor changes as to when to repeat blood tests. The guidance says that we should measure liver transaminase and full a lipid profile at 2 to 3 months after starting or changing the lipid-lowering treatment. A timeframe of 2 to 3 months offers more flexibility and is reflective of actual clinical practice, rather than at 3 months of treatment as recommended in the 2014 guideline. The requirement to check a full lipid profile instead of a random cholesterol level, will result in higher monitoring costs too.
After that, we will measure liver transaminase at 12 months, but not again unless clinically indicated. However, an annual medication review offering an annual full lipid profile is recommended for both primary and secondary prevention.
We have come to the end of this episode. Remember that this is not medical advice and it is only my summary and my interpretation of the guidelines. You must always use your clinical judgement.
Thank you for listening and goodbye.
