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New Drug Approved by NICE for Prediabetes

Discussion in 'Prediabetes' started by AndBreathe, Jun 1, 2017.

  1. AndBreathe

    AndBreathe I reversed my Type 2 · Expert
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    I don't know if anyone subscribes to MIMS, but this appeared in their reduglar update today. MIMS is a free subscription.

    First drug approved for diabetes prevention

    By Merlin Halliday on the 22 May 2017

    Glucophage SR (sustained-release metformin) has gained new approval for use in preventing diabetes.

    Glucophage SR can now be used alongside lifestyle measures to reduce the risk or delay the onset of overt type II diabetes in overweight people with non-diabetic hyperglycaemia (impaired glucose tolerance, impaired fasting glucose or increased HbA1c) who are at high risk of progression to diabetes.

    NICE defines impaired glucose tolerance as a fasting plasma glucose less than 7.0mmol/L and a 2-hour venous plasma glucose (after ingestion of 75g oral glucose load) of 7.8–11.1mmol/L. Impaired fasting glucose is a level of 6.1–6.9mmol/L and HbA1c is considered increased at a level of 42–47mmol/mol (6.0–6.4%).

    Glucophage SR can be used when intensive lifestyle changes for 3 to 6 months have failed to stop progression to type II diabetes. Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons.

    Treatment with Glucophage SR must be based on a risk score incorporating measures of glycaemic control and including evidence of high cardiovascular risk.

    Recommended by NICE

    NICE public health guidance recommends standard-release metformin as an option to support lifestyle change for people at high risk of type II diabetes whose HbA1c or fasting plasma glucose has deteriorated despite participation in an intensive lifestyle-change programme or who are unable to participate in such a programme.

    If the person is intolerant of standard-release metformin, NICE says that a modified-release preparation can be considered. The drug should be prescribed for 6–12 months initially and stopped if there is no effect on fasting plasma glucose or HbA1c levels at 3 months.

    Once-daily dosing

    As when used to treat diabetes, dosing of Glucophage SR for diabetes prevention should be initiated with one 500mg tablet once daily with the evening meal. After 10 to 15 days, the dose should be adjusted on the basis of blood glucose measurements. A slow increase in dose may improve gastrointestinal tolerability. The maximum recommended dose is 4 tablets (2g) once daily with the evening meal.

    Glycaemic status and risk factors should be regularly assessed to evaluate whether treatment needs to be continued, modified or discontinued.

    Approval rationale

    In the 2.8 years of the Diabetes Prevention Program (DPP) (n=3234), patients treated with metformin were 31% (95% CI 17–43%) less likely to develop type II diabetes than those receiving placebo, compared with a risk reduction of 58% (95% CI 48–66%) for lifestyle modification versus placebo. DPP participants who were followed for a mean of 15 years in the DPP Outcomes Study (n=2776) showed a reduction in diabetes incidence of 18% (p=0.001) with metformin treatment and 27% (p<0.0001) with lifestyle intervention, compared with placebo.

    As these results show, lifestyle modification is still the primary way of reliably reducing blood glucose levels. However, metformin represents a second intervention for instances where lifestyle modification is insufficient.

    Safety profile

    Metformin has been used in patients since 1957. Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite, are the most common adverse reactions. These generally occur during initiation of therapy and resolve spontaneously in most cases.

    Glucophage SR is available as 500mg, 750mg and 1g sustained-release tablets.
     
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  2. bulkbiker

    bulkbiker Type 2 · Master

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    Or alternatively modify your diet...
     
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  3. AM1874

    AM1874 Type 2 · Well-Known Member

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    Some simple questions ..
    1. If this should be "once daily dosing", how come I (and, I suspect, many others) was told to start with 1x 500g and then, after a few days, increase to 2x500g, one in the morning and one in the evening? .. and that's what is written on my prescription
    2. If the initial dose should be "adjusted after 10 to 15 days on the basis of blood glucose measurements", how come the doc told me not to test? How do they get the BG measurements on which to base their decision?
    3. The approval rationale shows clearly that "lifestyle modification is still the primary way of reliably reducing blood glucose levels" .. so why do they insist on refusing to accept LCHF and exercise as an effective and successful method for lifestyle modification, preferring instead to push the Eatwell plate and starchy carbs?

    Or, can we now expect changes in the current NHS treatment regime??
     
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  4. AndBreathe

    AndBreathe I reversed my Type 2 · Expert
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    AM1874 - The article refers to the SR variant, which is slow release. Most often that is routinely prescribed to those who can't get along with the more usual Metformin/Glucophage.

    NICE approval and funding are separate processes. That a drug is approved for use doesn't necessarily mean Doctors will be in any massive rush to prescribe it.
     
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  5. Polgara

    Polgara Type 2 · Well-Known Member

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    It says when lifestyle changes have failed to stop progression. It's not an either or.
     
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  6. kokhongw

    kokhongw I reversed my Type 2 · Well-Known Member

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    This opens up a massive/lucrative market for big pharma. They now have an even more captive market.

    The fate of many are sealed...only the very few who stumble here may somehow find the easier path...otherwise they will simply be overwhelmed with the low fat eat less move more mantra.
     
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  7. bulkbiker

    bulkbiker Type 2 · Master

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    Next they'll be telling you that pre diabetes starts at an HbA1c of 35 to get some extra customers...
     
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  8. Rustytypin

    Rustytypin Prediabetes · Well-Known Member

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    Personally drugs are only to be used as a last resort, they mask any symptoms one may have and could cause long term harm. The body is quite good at self healing, if given a chance. For example, yesterday I woke up with a stinking headache, I could have resorted to painkillers, but went out on my bike instead. Headache gone by midday.
     
  9. Alison Campbell

    Alison Campbell Prediabetes · Well-Known Member

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    Following the evidence base of this article, it is clear that lifestyle intevention is better for us than medication. But I fear that this fact will get lost in practice.

    My other concern is that it will further limit the options of those diagnosed with type 2 who want to try diet and exercise.

    http://www.nejm.org/doi/full/10.1056/NEJMoa012512#t=articleBackground%20
     
  10. Phoenix55

    Phoenix55 Prediabetes · Well-Known Member

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    Before where we are NICE will have approved metformin to be issued with statins to everyone over the age of 50. It would be funny if the NHS wasn't already going bust so people who need treatment are not getting it in a timely manner.
     
  11. seadragon

    seadragon Prediabetes · Well-Known Member

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    My doc was way ahead of NICE on this. When she diagnosed me as pre diabetic two years ago she immediately offered (more like pushed) metformin and statins and told me lifestyle changes never worked and it was progressive and I'd end up on insulin. Yeah right. I refused the drugs and went low carb high fat and have never felt better. The annoying thing is she is simply not interested in finding out how I did it.
     
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  12. Brunneria

    Brunneria Other · Moderator
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    Thanks AB. It may be worth me pushing for Metformin again then.
    I have been asking for it for years, but no one will give it to me because (they say) my HbA1c is too low to justify it.
    Last time I asked I was told 'this CCG doesn't approve Metformin for non diabetics'
    (for non-diabetics, read anyone who has an HbA1c under 53)

    The fact that I have massive insulin resistance, and can only achieve my 'too low for Met' blood glucose by a very low carb way of eating doesn't seem to factor into their thinking. I'd quite like to eat the odd apple, or glass of milk, or have dhal with my curry occasionally.

    I don't want it for blood glucose control, or for appetite suppression - I can do both of those myself.
    I want it for any reduction insulin resistance I can get.
    And I am already on B12 supplements, so I think I have that side of things covered...
    In fact, I only want it for a 3 month trial, to see what happens.

    Bet they won't give it to me though.
     
    #12 Brunneria, Jun 8, 2017 at 6:08 PM
    Last edited: Jun 8, 2017
  13. dbr10

    dbr10 Type 2 · Well-Known Member

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    Typical response.
     
  14. dbr10

    dbr10 Type 2 · Well-Known Member

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    They just don't seem to be interested in helping diabetics to at least try to normalise their BG levels. It's bizarre.
     
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