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Menopause Matters magazine ISSUE 76 out now. (Summer issue, June 2024)

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Author Topic: Vagifem  (Read 20110 times)

moonbeam121167

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Re: Vagifem
« Reply #15 on: November 05, 2013, 11:11:00 AM »

Thanks Suzi Q, it my 6th day so lets hope  things will get better, thanks for your time xx
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Dancinggirl

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Re: Vagifem
« Reply #16 on: November 05, 2013, 12:20:00 PM »

When I saw the practise nurse last night re: HRT, Vagifem etc I told her that many on this site were using extra doses of Vagifem because it had been reduced down from 25 - 10mcg per dose.
She said the reduced dosage was because there had been trials that showed no evidence that the 10mcg was less effective than 25!!!!!
She has given me some Ovestin cream to use externally on my urethra which is still pretty sour - I'm hoping this will help. I'm to continue with Vagifem 2x per week and use just a little Ovestin externally.
DG x
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scriv

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Re: Vagifem
« Reply #17 on: November 05, 2013, 12:29:52 PM »

Yes, she is right - there was a study done in the US on a very small sample of ladies and they came back with that verdict - a one for all recommendation!

That verdict does not take into account at all that we are all at different ages and stages of the oestrogen journey, that our own body's oestrogen stores are very different, that some people just use Vagifem whereas others use it as well as another HRT which can be systemic or local, that some ladies have very severe vaginal atrophy and much more oestrogen deficient than others etc. etc.

And,  they admit this as well, they have very little evidence in their study of women  aged 60 plus!!!

So they decided in their wisdom to ignore the fact that we all had different needs and to say that 10mcg works just as well as the 25mcg on all ladies in the world based on their very small limited sample which ignored all variables.

Hmmm.....
 
« Last Edit: November 05, 2013, 12:34:28 PM by scriv »
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Dancinggirl

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Re: Vagifem
« Reply #18 on: November 05, 2013, 03:34:36 PM »

Sorry to be cynical but do you think it is because 10mcg is possibly cheaper the 25? ???
I thought they dropped the dose because some women had a thickening of the uterus?
You don't hear all these scare stories about 'The Pill' these days as the NHS are terrified of unwanted pregnancies and abortions.
 
I'm hoping there will be a time, when HRT is more tailored, that there will be a trend towards HRT as a routine option and it is seen as a preventative. Of course, we are the generation(those of us between 50&60) that will tell the tale.  Those who have had, even a few years of HRT, against those who have had no HRT - it should be interesting as time goes on.

All this discussion about vaginal atrophy has made me wonder if it leads to a susceptibility to vulva cancer.  My mother's periods stopped aged 37 and she didn't have any HRT treatment.  She developed vulva cancer in her 70s.  She has done well following major surgery but suffered a prolapsed bladder as a consequence which also needed surgery. If her skin had been healthier around this region would she have developed cancer at all?
I'm going to use localised oestrogen for as long as possible just in case.
DG x
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Hurdity

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Re: Vagifem
« Reply #19 on: November 05, 2013, 05:05:33 PM »

I don't think they actually said that 10 mcg is as effective as 25 mcg. What they said was that trials showed that 10 mcg was effective - which is totally different.

Here is the company's response in their FAQs about the discontinuation of the 25 mcg dose:

Does Vagifem® 10μg work as well as Vagifem® 25μg?
Vagifem® 10μg has undergone rigorous approval procedures in North America and the EU, where clinical data demonstrated the efficacy of the product in treating symptoms of vaginal atrophy.8


The rationale was to use what they say was the lowest effective dose.

The paper that quotes all of this is called:

Efficacy and safety of ultra-low dose Vagifem (10 mcg) (Chollet 2011)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234898/

Regarding efficacy - this is what the conclusion of one study involving 230 women found:

Vaginal tablets with 25 mcg and 10 mcg improved VVA [vulvovaginal atrophy] by decreasing vaginal pH and increasing maturation of the vaginal epithelium. These improvements were greater with the 25 mcg than with the 10 mcg which was to be expected.

However another study goes on to just look at the effect of 10 mcg compared to placebo (309 women) and found significant differences from placebo for various measures such as cells and pH, but that is not to say this difference is going to be felt by nor equally by all women. Basically it's a fudge. If the same study had also included women using 25 mcg they would have found an increased effect similarly to the study above, but the study was designed to test whether 10 mcg was effective - and within the limitations of that trial - it was.

No doctor can possibly conclude from this, that the 10 mcg dosage is going to work for all women.

Hurdity x


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Suzi Q

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Re: Vagifem
« Reply #20 on: November 06, 2013, 06:53:54 AM »

Vagifem 15x25=375m
Vagifem 20x10m= 200m
Less 175 if theres 20 in a BOX so you get 175m less for your money
Vagifem 25m was roughly 15 pounds or so Vaifem 10s was only slightly cheaper
It was money I went deap in to the trials at the time there were so few people in the trial
It didnt say Vagifem 25 was dangerous other wise women whod taken 25m for over 12 years
Would be either dropping like flies or sueing and they werent to me sorry it was money
Why now because the BABY BOMERS@POST BOOMERS had hit and Vagifem was selling big time
PLus one wonders how long their PATENT IS before a Generic Vagifem can be made?
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Dancinggirl

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Re: Vagifem
« Reply #21 on: November 06, 2013, 10:07:40 AM »

Hurdity -  I read your post last night & went to bed thinking about it. The findings of these trails really leaves one with a terrible sense of frustration. Can we ever trust scientific trials when so many are run to produce the results that various interested parties want to hear.
I can understand the need to be on the cautious side with any drugs or treatment but when lay people can clearly see obvious flaws in the trails and professionals have not questioned this and taken them on face value, I find this extremely worrying.
Is there a trial to look at the benefits vs risks of long term use of both 10mcg and 25mcg Vagifem?  Even if one dismisses the reduction in the distressing symptoms of VA, there are clearly benefits for the bladder which very often gives many problems as we get older. AS our life expectancy grows and treatment of age related issues become ever more expensive for the NHS long term, this short term financial saving could cost dearly later.
Of course trials are very necessary and most are invaluable but they should always be questioned by all concerned - even patients.

These flawed trials, resulting in inadequate treatment, are reflected in so many other areas I have experienced e.g:
Dementia - when my poor, lovely, mum-in-law was deteriorating with dementia her GP was marvellous (older, experienced chap who was very kind) but he had to refer her to a specialist neurologist and a memory clinic both of which were truly awful. Drugs were tried  for her parkinsonism (just her legs were affected so it wasn't true Parkinsons) but her obvious problems with memory were not addressed - I won't go into the demeaning way she was treated.  I did my research on the net and asked about dementia drugs but was told they are only prescribed for moderate to severe Dementia - (my mum-in-law's GP agreed she was beyond moderate Dementia but could not prescribe them as they had to come from the Memory clinic).  I argued that to maintain her small amount of independence (we had her in sheltered accommodation so she had a good degree of independence) the drugs should be given sooner rather that later to enable her to stay where she was - not go into a nursing home. Eventually they relented and gave her the drugs.  Unfortunately they were given too late and she did have to go into a home shortly afterwards which was very distressing for all of us.  Very soon after she was put into the home, the guidelines were changed re. these drugs and they are now supposed to be given much earlier in the development if dementia to enable longer independent living.
I suspect there are many short term financial savings within NHS treatment that will cost very dear later. Sadly this is why so many have to go privately to get the treatment they really need. 
SuzQ - I think we are singing from the same hymn sheet here. Good point about generic vagifem DG X
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Hurdity

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Re: Vagifem
« Reply #22 on: November 06, 2013, 02:35:13 PM »

Dancinggirl - I wouldn't say that the trials were flawed - just inadequate. The findings are correctly stated, but the conclusions that are drawn from them are not. Trials are designed to answer specific questions (or test a hypothesis) and the question in that case was: "Is 10 mcg Vagifem effective in treaing vaginal atrophy?" The answer of course was yes, based on the study and the criteria used for "effective".

In terms of lay people - I am not such when it comes to looking at scientific data as I have a research degree in a scientific subject - and the time to look at the information presented. Most doctors would not have the time to go back to the original data nor questions the trials and so would read the recommendations and statements that follow. We can't blame them for that.

There is no information on the safety of long-term use of Vagifem at all as I understand. This is what the British Menopause Society says about it in their latest recommendations:

Low-dose vaginal estrogen preparations can be used long-term in symptomatic women as required, and all topical estrogen preparations have been shown to be effective in this context.

There is no requirement to combine this with systemic progestogen treatment for endometrial protection, as low-dose vaginal estrogen preparations do not result in significant systemic absorption.

However, there is little evidence to prove the safety of vaginal preparations beyond one year of use; clinicians should therefore aim to use the lowest effective dose for symptom control and counsel women regarding this.


http://min.sagepub.com/content/19/2/59

However in practice most gynaecologists will prescribe it long term because there us equally no evidence from the short term studies to show that it is likely to be unsafe long term.

Sorry to hear about your mother in law too and her poor treatment for dementia and especially that your experience of the memory clinic was also poor. I lead a twice monthly music group for people with dementia and their carers (through Alzheimer's Society), which alternates with a memory cafe (I'm not involved with that) but is immensely rewarding and I can't imagine any similar service being provided that would fall short in their care. I agree long term health costs are not taken into account - eg due to osteoporosis as we all live longer and our bones thin due to oestrogen deficiency.

Suzi - the cost of a prescription isn't based on the amount of hormone contained eg Elleste solo 2 mg tablets are £1.78 and those for 1 mg are £1.68 - almost the same. The hormones themselves are only a fraction of the total cost of the product. I am sure the company isn't expecting women to double up otherwise the dosage would be given as such. Also I would expect that the drive for the reduction came from the medical or legal side - in America, and because of the repeated mantra to use the lowest effective dose for the shortest possible time. In fact the company said as much in their FAQ:
 
The development of Vagifem® 10μg was part of our goal to provide our customers with products that are effective at the lowest possible dose. More recent recommendations have made it ‘best practice' to use low dose HRT products where possible. Therefore the trial was designed as I said above with this in mind. I am not defending it (the decision to reduce the dosage) whatsoever.

What is absurd as dancinggirl says is that the trial results are accepted just like that and that no more are being conucted ( maybe they are???)

In the meantime those of us who have read up on it continue to express our views and share our findings with everyone on here so that we can continue to press our doctors to prescribe the dose we need to alleviate our symptoms and to hell with the cost!!!

Hurdity x

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dianaswr

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Re: Vagifem
« Reply #23 on: November 06, 2013, 03:00:33 PM »

question - went on holiday and forgot to take the vagifem 10mg, so missed four doses - I came home and just started on the twice a week again - should I have gone back to scratch or just done as I have?
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Hurdity

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Re: Vagifem
« Reply #24 on: November 06, 2013, 05:26:20 PM »

It depends how your body responds dianaswr. I would be inclined to use 3 a week for a couple of weeks to make up for the missing 2 weeks, to build up the cells again, and see how you get on.

Hurdity x
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scriv

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Re: Vagifem
« Reply #25 on: November 06, 2013, 05:32:17 PM »

Yep, I would agree with Hurdity :) x
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Suzi Q

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Re: Vagifem
« Reply #26 on: November 07, 2013, 07:58:22 AM »

NO sorry what I meant was
You pay almost as much for a box of 15x25 as you do  for 20x10
So the company make more money by using less product get it?
They charge is almost the same so they use less   so they make more money
Now e have ladies doubling and trbling up they will be selling more
I could understand if they said 2000 women have developed somehting but nothing to
Just ts as efective well if that was the case why ddnt they do it years abgo
Easy ther wasnt the call for it 12/15 years ago its been in 5 /7 years the take off
As I said I WOnder how long the PATENT lasts befre a generic Vagifem comes out
If theyd have gone fro 25 to 20 or even 15 but a massive drop from 25 to 10? why?
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Dancinggirl

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Re: Vagifem
« Reply #27 on: November 08, 2013, 05:49:47 PM »

Hurdity - I'm not surprised you do this music group with a dementia group - you sound such a grounded, kind person. I so wish your music group had been around when my mum-in-law needed it - she loved music. I know this is of message a bit - sorry everyone - these discussions took me back to the struggles I had over my mum-in-law's care and I'm pleased to hear there are some good practises and help out there from people like Hurdity. DG x
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dianaswr

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Re: Vagifem
« Reply #28 on: November 11, 2013, 04:26:36 PM »

Thanks Ladies - I have done that and its ok but having very bad twinges and stinging in the breasts - mainly the left but now the right is joining in - breast clinic today - mammogram and examination - nothing to see so hormones they think so back to the high dose GLA in borage oil
 :) :)
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Hurdity

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Re: Vagifem
« Reply #29 on: November 12, 2013, 05:05:52 PM »

Hi dianaswr

I can't remember where you are in meno and whether you are also taking HRT pills or patches?

The fact that you are experiencing side effects after a break from Vagifem for two weeks implies that your vaginal tissues have thinned in that time, so you could be absorbing more systemically. My advice would be to do the two weeks loading again (ie every night for two weeks) to thicken up the vagninal lining, and after this time there will be minimal absorption and hopefully any side effects should settle.

Hope this helps

Hurdity x
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