Dabigatran approved by NICE

Hi All

No doubt lots of you will be seeing information in the media about a new oral anticoagulant called Dabigatran which has been approved by NICE:

pulsetoday.co.uk/newsarticl...

These new drugs have not been trialled for Hughes syndrome/APS so are not available to us yet. There is a multicentre trial being set up called RAPS which is looking at Rivoraxaban and APS (Rivaroxaban is similar to Dabigatran just a different trade name and manufacturer). However, this study is hampered by a lack of funding at the moment but it should go through - fingers crossed! This still means that it will be years until the new drugs have been proved safe so I'm afraid it's the warfarin for a while still ...

15 Replies

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  • Well, a step in the right direction at least. M x

  • Yes definitely but one of the interesting things is that not many patients are keen to take part in the trial. I'm on the steering committee for RAPS and one thing the profs hadn't taken into consideration was the human factor - they couldn't understand why people were reluctant but who wants to go from the known (but annoying) warfarin to the unknown and un-monitored new drugs?

    They are now building in a monitoring system into the RAPS trial but, as with all the new anticoagulants, there is no reversal (unlike with warfarin) so there is still much trepidation. I'm sure they will be able to enlist enough people in the end though :)

  • I would be up for it, unless people are prepared to be guinnea pigs, there will never be imoprovement or cure.

  • Thanks Sue but the recruiting is left to the doctors involved and I'm sure they will be asking their pool of patients. There should be a good selection as it's not just Tommies, but Imperial and UCL involved too :)

  • NICE may have approved it - no doubt for AF patients, but it will be interesting to see how many PCT's will fund it!

  • Yes - they're already up in arms about it! The argument for is that it will cut down on the costs involved with monitoring INR but the immediate layout for Dabigatran is going to be a huge difference from warfarin. I think a lot of AF patients will have a battle on their hands ...

  • Hello Kate

    This will be one of the most watched bits of news for us all.

    Keep watching!

    Cheers

    Garry

  • Interesting stuff - shame it all has to take so long.

    Thanks for the update though

    Tx

  • I still don't think they have a antidote (reversal) for it though???

  • Hello Kate

    My understanding, from trials in the USA, is that certain people do not metabolise nor excrete the new drug so, as there is no antidote, it can just build up in their system, rapidly, and become fatal. It seems that there is no way of knowing which patients will be affected by this problem, so it's a potential death sentence!

    I'll stick with Warfarin, myself, supplemented with fragmin as necessary.

    Best regards.

    Dave

  • Yes, the no reversal is becoming quite an issue although I guess with any drugs there are potential dangers - bleeding being the obvious one with warfarin. As my old GP used to say 'you pays your money and takes your chance''! But I do understand the reluctance to move from warfarin if you're quite stable on it - another old saying 'if it ain't broke, don't fix it'.

    Sorry, seem to be full of cliches this afternoon - must be Friday ...

  • Hi my Consultant asked me if I was willing to take part in the trial as I am on Clexane as allergic to Warfarin.

    I was initially positive about the opportunity but am having second thoughts due to the reversal issues. Especially as I would not accept a blood transfusion.

    I took an accidental overdose (due to bonkersness caused by TIA) fortunately I was able to have an antidote to the Heparin but I still got an upper GI bleed five days later.

    If I made the same mistake with Dabigitran it could have been fatal for me.

    Will have to take all this into consideration but I am sure it would be discussed in detail.

  • The panic over the higher cost of Dabigatran over warfarin begins ...

    pulsetoday.co.uk/main-conte...

  • oh Joy the spin machine starts

    Paddy

  • Breaking news that the price of Dabigatran is to be reduced:

    pulsetoday.co.uk/newsarticl...

    However, when you look at the cost comparison of Dabigatran at £2.20 and Rivaroxaban at £2.10 (no mention of Apixaban) to warfarin at 3p - you can see the problems facing the health economists!

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