Tag: NICE

NICE: SGLT2 inhibitors will have an increased role in type two diabetes management

kaitiscotland2 Comments
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Adapted from BMJ 18 June 2022: Type 2 diabetes: summary of updated NICE guidance

When type 2 patients eventually get their diabetes checks, they can expect a few changes to management if their practices are keeping up with NICE guidelines.

Instead of looking at the 10 year risk for cardiovascular disease, type 2 diabetics over the age of 40 will be assessed for lifetime risk. This is usually a pathway to the initiation of statins, if they are not already being taken. If the cardiovascular risk is raised you will also be considered for an SGLT inhibitor.

If you have chronic heart failure or have already been diagnosed with atherosclerosis you will be considered for an SGLT2 inhibitor. These give a proven cardiovascular benefit.

SGLT2 inhibitors work well with Metformin if a glucose lowering drug is needed.

Modifiable risk factors for diabetic ketoacidosis should be assessed before prescribing SGLT2 inhibitors.

Such factors are: Alcohol limit above 14 units a week, use of illegal drugs, use of other medicines, concurrent illness, injury or planned surgery, very low carbohydrate or ketogenic diet.

There is a decision aid available at:

https://bit.ly/hba1c-nice

NICE: Key points on chronic fatigue syndrome management

kaitiscotland2 Comments
Adapted from NICE Clinical Guidance Summaries 11 Nov 2020

Diagnosis of CFS is based on a clinical diagnosis. It is characterised by debilitating fatigue not caused by excessive exertion and is not significantly relieved by rest. The symptoms get worse after activity, sleep is unrefreshing and their are cognitive problems.

It should be suspected if this pattern of symptoms goes on for over 4 weeks in children and 6 weeks in adults, were there is significantly reduced ability to engage in usual activities and the symptoms are new and have a specific onset.

There may also be associated symptoms such as pain, hypersensitivity to light, noise, touch, movement, temperature and smells, extreme weakness, difficulties in speaking and swallowing, sleep disturbance, gastrointestinal symptoms, and fainting when standing up or reduced blood pressure on standing.

The doctor is advised to take a full history of what makes symptoms better or worse, sleep quality, physical functioning and current and past use of medicines, vitamins and mineral supplements.

Doctors are advised NOT to offer medicines or supplements to cure or treat CFS but to develop a management plan with the patient that addresses information and support needs, support for the activities of daily living, education, training and employment support, self management, physical maintenance, symptom management, managing flares and relapse and ways to contact their clinical team.

My comment: this sounds much more in the realm of the Occupational Therapist than the GP!

The doctor assesses for and advises on the prevention of long term immobility. Unrestricted exercise is NOT advised. The patient is advised to take part in a supervised programme. My comment: The is what Physiotherapists do.

The doctor is advised to monitor for malnutrition, especially in severe cases. My comment: This is what dieticians do.

Doctors are further more advised to conduct a safeguarding assessment, help patients understand their energy envelope, help patients understand that they are approaching their limit, use a flexible tailored approach that allows for the need to pull back when symptoms worsen. Physio and OT again.

The doctor is meant to help the patient establish an individual activity pattern for example: reduce activity as a first step, plan periods of rest and activity, incorporate pre-emptive rest, alternate different types of activity, and break activities into small chunks. OT

Doctors are meant to emphasise adequate fluid intake and a balanced diet. Minimise nutritional complications of nausea, swallowing problems and difficulties in buying and preparing food. Dietician and Speech and Language Therapists.

They should refer to a dietician if weight plateaus in children or is lost in adults. It is recognised that patients with ME /CFS may be at risk of vitamin D deficiency, but otherwise there is insufficient evidence for routine vitamin and mineral supplementation. Vitamin D is available online for about £10 per year per patient.

To aid rest and sleep relaxation techniques may be helpful. Physiotherapy, OT, Mental health Mindfulness Apps.

If there is orthostatic intolerance the patient should be referred to secondary care and the GP should avoid prescribing unless advised by an expert in this.

For nausea, small and regular feeding and adequate fluids are advised.

For psychological support, Cognitive behavioural therapy may improve well being, quality of life, functioning and psychological stress. Explain that offering CBT does not indicated that beliefs or behaviours are the underlying cause. Mental health nurses. Psychology

Patients with CFS may be more intolerant to medication and may have more severe adverse effects so GPs should consider starting at a lower dose, have a more gradual increase in doses. Drug treatment for children should only be given under the care of a paediatrician.

Patients should respond to flares promptly by identifying possible triggers, temporarily reducing activity and monitoring their symptoms as some flares develop into a relapse.

For a relapse, the doctor or clinician or Physio or OT needs to review the management plan, reduce or stop some activities, increase rest periods and re-establish a new energy envelope.

My comment: There has been a huge increase in CFS due to Covid. With primary and secondary care services at well past broken point, it seems madness for a GP to attempt to follow this NICE guideline. There wasn’t the resources to do so before Covid and there are far less now with a much increased patient group. The most useful thing about this guideline is that it emphasises that there is no magic bullet for this condition. Medications don’t work. It looks to me like the establishment of online zoom classes for patients led by Occupational Therapists would be the most useful way to implement this. Patients could be diverted away from their GPs and referred to the appropriate other health care professionals such as physios, dieticians, social and mental health workers.

What can diabetic women expect when they are expecting?

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NICE have come up with some sensible improvements for the management of diabetic pregnancies that should reduce complications for mothers and babies in the future. None of these changes are radical and indeed they are already considered best practice, but what is different is that they want to see if best practice can be made routine.

Frequency

Approximately 700,000 women give birth in England and Wales each year, and up to 5% of these women have either pre‑existing diabetes or gestational diabetes. Of women who have diabetes during pregnancy, it is estimated that approximately 87.5% have gestational diabetes (which may or may not resolve after pregnancy), 7.5% have type 1 diabetes and the remaining 5% have type 2 diabetes. The prevalence of all 3 types of diabetes is increasing. The incidence of gestational diabetes is also increasing as a result of higher rates of obesity in the general population and more pregnancies in older women.

Risks

Diabetes in pregnancy is associated with risks to the woman and to the developing fetus. Miscarriage, pre‑eclampsia and preterm labour are more common in women with pre‑existing diabetes. In addition, diabetic retinopathy can worsen rapidly during pregnancy. Stillbirth, congenital malformations, macrosomia, birth injury, perinatal mortality and postnatal adaptation problems (such as hypoglycaemia) are more common in babies born to women with pre-existing diabetes. For women diagnosed with gestational diabetes, hyperglycaemia usually resolves after pregnancy, but a proportion of these women will have type 2 diabetes after the birth. Therefore, before a woman is discharged to the care of her GP, her blood glucose levels should be tested to ensure that they have returned to normal.  Women with pre-existing diabetes will be managed in general adult diabetes services after the birth.

List of recommendations

  1. Women with diabetes planning a pregnancy are prescribed 5mg/day folic acid until 12 weeks gestation.

High-dose folic acid supplements should be prescribed for women with diabetes from at least 3 months before conception until 12 weeks of gestation, because they are at greater risk of having a baby with a neural tube defect. The benefits of high-dose folic acid supplementation should be discussed with the woman during preconception counselling as part of her preparation for pregnancy. If a woman with diabetes has an unplanned pregnancy, she should be prescribed high-dose folic acid as soon as the pregnancy is confirmed.

  1. Pregnant women with diabetes are supported to self-monitor their blood glucose levels during pregnancy.

Women with diabetes need to be able to self-monitor their blood glucose levels at an increased frequency during pregnancy. This will help them to maintain good blood glucose control throughout pregnancy, which in turn will reduce the risk of adverse outcomes such as fetal macrosomia, trauma during birth, induction of labour and/or caesarean section, neonatal hypoglycaemia and perinatal death. Support should be provided to ensure that women have access to blood glucose monitors and enough testing strips, and know how to use them.

  1. Women with pre-existing diabetes are seen at the joint diabetes and antenatal care clinic within 1 week of their pregnancy being confirmed.

Women with diabetes who become pregnant need additional care in addition to routine antenatal care. A joint diabetes and antenatal clinic is able to ensure that specialist care is delivered in order to minimise adverse pregnancy outcomes. Immediate access to a joint diabetes and antenatal clinic within 1 week will help to ensure that a woman’s diabetes is controlled during early pregnancy, when there in an increased risk of fetal loss and anomalies. It will also help to ensure that the woman’s care is planned appropriately throughout her pregnancy.

  1. Pregnant women with pre-existing diabetes have their HbA1c levels measured at their booking appointment.

A woman’s HbA1c levels can be used to determine the level of risk for her pregnancy. Women who had diabetes before they became pregnant should have their HbA1c levels measured during early pregnancy to identify the risk of potential adverse pregnancy outcomes and to ensure that any identified risks are managed.

  1. Pregnant women with pre-existing diabetes are referred for retinal assessment at their booking appointment.

Pregnant women with diabetes can have an increased risk of progression of diabetic retinopathy. Pregnant women should therefore be screened more often for diabetic retinopathy. Retinal assessment should be offered at the booking appointment unless the woman has had an assessment in the last 3 months.

  1. Pregnant women diagnosed with gestational diabetes are reviewed at the joint diabetes and antenatal care clinic within 1 week of diagnosis.

Pregnant women diagnosed with gestational diabetes should have specialist advice and treatment in a timely manner, and should be reviewed by members of the joint diabetes and antenatal care team within 1 week of being diagnosed. The joint clinic should provide the woman with advice, including why gestational diabetes occurs, potential risks and complications, and treatments aimed at reducing those risks.

  1. Women who have had gestational diabetes have annual HbA1c testing

Women who have had gestational diabetes are at increased risk of getting it again in future pregnancies. They are also at higher risk of type 2 diabetes: if they are not diagnosed with type 2 diabetes in the immediate postnatal period (up to 13 weeks after the birth), they are still at high risk of developing it in the future. Early detection of type 2 diabetes by annual HbA1c testing in primary care can delay disease progression and reduce the risk of complications. Annual testing can also reduce the risk of uncontrolled or undetected diabetes in future pregnancies.

Readers of our book can find information of the blood sugar targets that are optimal in pre-pregnancy and pregnancy and of course the type of food and menus that will help them achieve these targets. Detailed insulin administration tips are also described to optimise insulin to meal matching.

Forthcoming Drug Recommendations for Type 2 Diabetics from NICE

kaitiscotland2 Comments

NICE have some drug recommendations to make for diabetics in their forthcoming guidelines later this year. It can be seen that NICE are heavily influenced by drug costs. So what could these new guidelines mean for you?

The blood pressure recommendations have scarcely changed but the use of Repaglinide first or second line for blood sugar control is a change from previously. Blood sugar targets have tightened up a bit and structured education is expected for insulin users. Cheaper, older insulins are favoured. Blood sugar testing is being rationed considerably. Aspirin is out of favour but drugs for erectile dysfunction are in. Erythromycin is being adopted for the very difficult to manage problem of gastroparesis.

The medications you will need to take to improve your life with diabetes will depend on many factors. Primarily, what do you want a medication to do for you?

The answer to this will depend on how well you are managing lifestyle changes, how long you have had the condition, the presence of any complications, and how tight you want glycaemic control, blood pressure and lipids to be. The targets need to be individualised to you, and this can be done by becoming more informed about your condition and discussing it with other health care providers and people with diabetes. We discuss these factors in our book, the Diabetes Diet, and I will be updating you on some of the new recommendations in further articles.

This article covers the changes to blood pressure medications, glycaemic targets and drugs to control blood sugar, self-monitoring of blood sugar, insulin initiation and the management of complications.

Blood pressure

For diabetics the BP target is 140/80 if there are no blood vessel complications such as kidney, eye or cerebrovascular disorders. If these are present the target is 130/80. BP lowering can improve peripheral neuropathy as well as stroke, MI, blindness and renal failure. 25% of those with type 2 diabetes develop nephropathy within 20 years of diagnosis.

Because ACE inhibitors and sartans reduce progression to renal disease better than other classes of anti-hypertensive agent they should be used first in diabetics unless they are a woman who could get pregnant as this class of drug is teratogenic. First line for women in this situation is a Calcium channel blocker CCB instead.

For Afro-Caribbean use ACE + diuretic or ACE + Calcium channel blocker. This is because this group respond less well to ACEs and sartans so should have add on drugs right from the start.

For those who can’t tolerate an ACE use a sartan unless there is renal deterioration or hyperkalaemia.

If BP is still not controlled add a CCB or thiazide diuretic.

If still not controlled use any of an alpha blocker e.g. Doxasozin or a beta blocker e.g. Bisoprolol or potassium sparing diuretic e.g. Spironolactone.

If someone has already had a heart attack or heart failure they will probably be on a beta blocker anyway. Carvedilol was superior to metoprolol in metabolic terms for renal protection in one study.

Use spironolactone with caution if someone is already on a sartan or ACE because they all can raise potassium.

Glycaemic control

 

All-cause mortality rises as hbaic rises and decreases as hbaic reduces. The risk of microvascular complications increase over hba1c of 6.5% (48 mmol/mol) or 7% (53) for macrovascular complications. Fasting blood glucose levels influence MI but not stroke or angina.  Amputation rates rise over the age of 60 for any given hbaic. Therefore it can be seen that to improve life expectancy and the quality of life that in general the tighter the blood sugar control the better.  At the same time doctors are asked to adopt an individualised approach to blood sugar targets and consider life expectancy, personal preferences, co-morbidities, risks of polypharmacy and they should consider stopping ineffective drugs.

Targets:

NICE felt they could not comment on hba1c under 6% because only one study they looked at achieved this. Hba1cs in the 4s or 5s are not uncommon in low carbing diabetics however so don’t let this put you off your stride. NICE do say that if adults reach a lower blood sugar target than they were expecting and are not having hypoglycaemia the doctor should encourage them to maintain it.

They suggest:

6.5% for non-drug using diabetics or on drugs that don’t cause hypos e.g. metformin, pioglitazone, gliptins, victoza.

7% for the rest e.g. repaglinide, sulphonylureas, insulin.

7.5% intensify treatment, but individual circumstances e.g. life expectancy, co-morbidities, hypos need to be taken into account.

Drug step-laddering:

The first step for most diabetics is to offer metformin as the initial drug treatment.  But don’t give or stop metformin if the kidney test, the egfr is below 30 and use with caution if under 45. Regular metformin can give diarrhoea and if this is a problem the long acting version can be used.

If there is symptomatic hyperglycaemia, such as thirst and weight loss consider a sulphonylurea or insulin first. Other drugs may be considered once the blood sugars have stabilised. .

Next they suggest Repaglinide on its own or with metformin. Repaglinide is not licenced with other drugs. For people who could not tolerate metformin and repaglinide are the most cost effective treatment option.

If repaglinide was not suitable or is not achieving the desired blood sugar target any of pioglitazone, a sulphonylurea or a gliptin can be used.  The choice can be tailored to the patient.

Sulphonylureas had the most hypos and gliptins the least. Metformin had the best weight loss. Sulphonylurea and Pioglitazone had the most weight gain. NICE prefer doctors to use the lowest cost gliptin because they are relatively expensive.

Reducing hypoglycaemia should be a particular aim for those on insulin or a sulphonylurea. As blood sugar monitoring is necessary for these drugs, this factor can increase the cost considerably over and above the costs of the medication.

Consider GLP1 mimetic i.e. Byetta or Victoza if the BMI is over 35.  Only continue it if hba1c goes down by 1% and weight goes down by 3% over six months.

Insulin is considered to be the “last option”. There is currently research being carried out on the effects of early use of insulin in type two diabetes and this may change practice in the future.

Only offer insulin + Victoza in specialist care setting.

Insulin initiation

When starting insulin use support from an appropriately trained health professional and give:

Structured education

Telephone support

Frequent self monitoring

Dose titration to target

Dietary understanding

Hypoglycaemia management

Management of acute rises in blood sugar

Continue metformin

The usual first choice insulin is NPH insulin at bedtime or twice daily.

The more expensive Lantus or Levemir may be considered if a carer would be able to cut to once daily injections or if hypoglycaemia is a problem or otherwise the patient would need twice daily NPH and oral drugs or they can’t use the NPH device.

If hbaic is 9% (75) consider twice daily pre-mixed bi-phasic insulin.

Blood sugar testing

NICE recommends that self- monitoring of blood sugars is to be avoided unless a person is on insulin, has symptomatic hypoglycaemia, or oral medication that causes hypos or driving or operating machinery, pregnant or trying for a baby.  It may be worth considering if a patient is on oral or intravenous steroids.

Doctors or nurses should reassess the need for self monitoring annually to see if it remains worthwhile.

Self monitoring produced only a 0.22% reduction in hbaic. It was considered by NICE to be not helpful for most people with type two diabetes though more hypos were detected with it.

 

Anti-platelet therapy for cardiovascular protection

There is no overall benefit to taking aspirin or clopidogrel in type 2 diabetes unless they already have cardiovascular disease.

Managing complications

Autonomic neuropathy symptoms are: gastroparesis, diarrhoea, faecal incontinence, erectile dysfunction, bladder disturbance, orthostatic hypotension, gustatory and other sweating disorders, dry feet and ankle oedema.

Treatments for gastroparesis are metoclopramide, domperidone and erythromycin.

Refer to a specialist if severe or persistent vomiting occurs or the diagnosis is in doubt.

Nocturnal diarrhoea may indicate autonomic neuropathy.

Tricyclics are often given for neuropathic pain but can increase postural hypotension.

Erectile dysfunction

Offer men the chance to speak about this at their annual review. Offer Viagra, Cialis and similar and refer if these don’t work.

Eye damage

Diabetic eye damage is the single largest cause of blindness before old age.

Refer to the emergency ophthalmologist if:

Sudden loss of vision

Rubeus’s Iridis

Pre-retinal or vitreous haemorrhage

Retinal detachment

Send for rapid review if there is new vessel formation.

So what do you think of the new NICE recommendations?  Do you think these changes will affect your medications?