KISS Guide to the NOACS

A Keep it Simple Summary guide to the NOACS 

You wait 50 years for a new anticoagulant to come along, and then 3 come along at once...with a fourth (Edoxaban) just round the corner.

For the last 5 years evidence has been emerging for the novel oral anticoagulants (NOACS) dabigatran, rivaroxaban and apixaban as an alternative to warfarin for the prevention of stroke and systemic embolism. All have been approved by NICE and the SMC as alternative options to warfarin. 

This month NICE are to publish their updated guideline on Atrial Fibrillation and it is expected (in line with NICE draft AF Guideline 2014) that GPs will be able to prescribe all 3 on the NHS. It is also anticipated that for patients who are already taking warfarin that we will be encouraged to assess their TTR (time in the therapeutic range) and if this is <65% to consider switching warfarin to a NOAC.

We would argue that for the majority of patients warfarin should remain the first-line option. It has 50 years of clinical experience behind it, it is cheap, it is effective, we can tell if patients are actually taking it, it is safe if properly monitored and there is an antidote in case of haemorrhage.

However, many patients are likely to choose to have a NOAC for understandable reasons of convenience and there is a strong argument (improved efficacy) for switching to a NOAC if patients INR is not well controlled. So, we shall all be prescribing these drugs much more over the next few years. There are some important differences between them which will influence which is the most appropriate for your patient. We present our KISS NOAC guide to help you - this is a general guide, all doses should be checked & prescribing should be guided by an appropriate national formulary such as The BNF

Note that all 3 of these NOACs share the following:

·     They are licensed for the prevention of stroke and systemic embolism in patients with non-valvular AF with one or more of the following risk factors

o   Prior CVA or TIA

o   Age over 75

o   Symptomatic heart failure

o   Hypertension

o   DM 

·      

Contraindications

o   Active clinically significant bleeding or significant risk of major bleeding

o   Pregnancy and breast feeding

o   Additional anticoagulant therapy (extreme care and specialist advice with antiplatelet therapy)

o   Concomitant therapy with ketoconazole, itraconazole and HIV protease inhibitors

All patients need to be warned re bleeding risk and to get medical advice ASAP if bleeding occurs. They also need to be reminded on the crucial importance of compliance, as efficacy will quickly drop if tablets are missed. They all share a very high cost, which is likely to be subject to some regional variation but is approximately £800 per annum.

Differences between the NOACs

	Dabigatran SPC	Rivaroxaban SPC	Apixaban SPC
Mechanism	Direct thrombin inhibitor	Factor Xa inhibitor	Factor Xa inhibitor
Time to peak levels	3 hours	3 hours	3 hours
Half-life, h	12-17	5-13	9-14
Excretion	80% renal (avoid then if renal problems)	66% liver, 33% renal (avoid then with liver disease)	75% faecal, 25% renal  (NB Apixaban is the preferred choice in CKD NICE 2014)
Dose	150mg bd (110mg bd if aged over 80)	20mg od (same dose in elderly)	5mg bd (2.5mg bd if age over 80 and under 60kg)
Dose in renal impairment	110mg bd if egfr 30-50, contraindicated if eGFR <30	15mg od if eGFR 15 to 50, not recommended if eGFR <15	2.5mg bd if eGFR 15-29, not recommended if eGFR <15
Interactions	PPIs may impair absorption Avoid enzyme inducers & ciclosporin/tacrolimus Increased bleeding risk with verapamil, amiodarone, quinidine, ketoconazole, SSRI, SNRI & clarithromycin	Enzyme inducers (e.g. rifampicin, phenytoin, carbamazepine etc) reduce efficacy Avoid dronaderone & voriconazole	Enzyme inducers (e.g. rifampicin, phenytoin, carbamazepine etc) reduce efficacy Avoid voriconazole
Administration	Swallow whole , opening capsules may increase bleeding risk Dyspepsia more commonly reported than with warfarin & the other NOACs	Take with food	No special directions

Helping patients to decide

NICE have produced a decision aid to help patients choose between the different anticoagulant options

NICE NOAC decision aid for patients

The MHRA also produced updated safety advice in Oct 2013



Simon Curtis

References:
NICE AF Guidance 2014

NICE draft AF Guideline 2014 

The BNF

ESC 2012 Guidelines on Atrial Fibrillation

NICE Apixaban TA

NICE Dabigatran TA

NICE Rivaroxaban TA

NB Medical Hot Topics Out of Hours Course

We did our first ever Hot Topics Out of Hours course yesterday here in beautiful Northern Ireland. The course, for Dalriada Urgent Care, was full with over 200 delegates & the feedback was great. We covered:

• conditions commonly seen in OOH (with evidence-based Keep it Simple Summaries) e.g. RTIs incl croup & bronchiolitis, pre-school wheeze, exacerbations of asthma, COPD, pneumonia, vertigo & dizziness, red eye, gastroenteritis, chest pain, diagnosis of VTE, common MSK problems, acute kidney injury etc etc
• challenging problems such as optimising end of life care
• update on emergencies e.g. anaphylaxis
• telephone triage & consulting (including a new model for delivering safe, effective & efficient telephone consults)
• risk management. Unfortunately the nature and context of OOH means that OOH docs are more likely to be subject to complaints and litigation, we covered what we can learn from the evidence to reduce this risk

OOH is such an important part of GP & OOH docs do such an amazing job, we've thought for a long time there is a need for this course & all the delegates yesterday definitely agreed. As ever, we think GPs do an amazing job and OOH GPs do the most amazing job of all. It was a real feel-good day about OOH care and had a great energy and positive vibe to it.

We'll be rolling the course out across the UK later this year. Contact us at www.nbmedical.com if you're interested.

If you've never been to N Ireland, do come & visit it's beautiful - especially Game of Thrones fans!

Simon

The 5:2 Fast Diet

GP Tips: The 5:2 Fast Diet

Dr Kevin Fernando

“Doctor, what do you think of the Fast diet?”

 The phenomenally popular Fast Diet (www.thefastdiet.co.uk) was devised by Dr. Michael Moseley and Mimi Spencer and gained notoriety after the broadcast of a BBC Horizon documentary “East, Fast and Live Longer” during August 2012 (you can watch it here http://vimeo.com/54089463) Moseley subsequently published a best-selling book “The Fast Diet: The Secret of Intermittent Fasting - Lose Weight, Stay Healthy, Live Longer” (http://www.amazon.co.uk/dp/1780721676)

This diet dictates that you eat normally 5 days weekly, and “fast” the remaining 2 days.  On fasting days, women eat 500kcal daily, and men 600kcal.

In addition to weight loss, Moseley claims increased lifespan and cognitive function, protection against Alzheimer’s dementia and “general protection from disease” – bold claims indeed!

So What is the Evidence Base for the Fast Diet?

The Fast diet is based on the work of Dr. Krista Varady, a pioneer of alternate day fasting (ADF) so immediately there is a departure from the original literature where there were 3 or 4 fasting days weekly.  A further discrepancy was that Varady’s subjects took their food allowance in one sitting (to promote a fasting state) whereas Moseley spreads it over 2 meals. 

As you can imagine, there are very few human studies and many animal studies.  Furthermore, the published studies are mostly short-term.

Weight Loss

Varady published a reasonably robust study in the American Journal of Clinical Nutrition during 2009 however involving just 16 obese subjects.  Varady demonstrated a significant reduction in weight, lipid profile and BP with ADF.  Average weight loss after 8 weeks was 5kg. 

Cognitive Function & Dementia

These claims are based on 2 poor quality studies.  The first (Johnson et al (2006) Medical Hypotheses), was an extrapolation from an ethically dubious study undertaken in Spain during the 1950s, which involved fasting nursing home residents and following them up to see who died first, compared with non-fasted residents (I kid you not!). The second study involved intermittently fasting genetically engineered mice and observing how they performed in a water maze test (Halagappa et al (2006) Neurobiological Disease)

 General Protection Against Disease

This claim is based on a study by Harvie et al published in the International Journal of Obesity during 2010.  This is a higher quality randomised study involving 107 overweight women and did actually use a protocol involving 2 fasting days weekly.  Harvie et al demonstrated a mean weight loss of 6.4kg over 6 months, and also significant improvements in insulin sensitivity, and reductions in BP and lipid profiles.

Probably most telling of all was a systematic review of ADF authored by Varady herself in 2007, which stated that ADF may protect against heart disease, type 2 diabetes and cancer, however much more research is required.

Should We Recommend the Fast Diet to Patients?

Despite a somewhat shaky (albeit promising) evidence base, that both departs and extrapolates from original literature, there is plenty anecdotal evidence for significant weight loss with the Fast diet in both patients and medical colleagues!

And actually the Fast diet is sustainable in the short to medium term unlike many other fad diets (the Paleo diet! anecdotally, patients, friends and colleagues certainly say they find the 5:2 diet easier to comply with than they would have expected to, and whilst we lack comparative evidence of sustainability and weight loss with other diets this alone may make it a reasonable choice to advise to patients)

Ultimately, it’s not rocket science – it’s simply about total calorie reduction – if our (male) patients regularly consume 3800kcal less per week, which can only be a good thing.

If supporting type 2 diabetes patients to undertake the Fast diet, it is important to either down-titrate or cease any hypoglycaemic medication on fast days. 

Finally, the main theory of Moseley is that humans evolved during times of severe dietary restriction, and that fasting was the norm and conferred health benefits.  Surely then, we should be completely abstaining from food during the fast days?  Some food for thought…Boom Boom…

 References

Harvie MN et al (2011) “The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women” Int J Obes (Lond) 35(5): 714-727

Varady KA & Hellerstein MK (2007) “Alternate-day fasting and chronic disease prevention: a review of human and animal trials” Am J Clin Nutr 86: 7-13

Varady KA et al (2009) “Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults” Am J Clin Nutr 90: 1138-43

 

Preview for the Spring 2014 Hot Topics GP Update Courses

We are all very excited about our upcoming Spring series of the Hot Topics GP Update course which starts in Sheffield on March 14^th. We have been working very hard trawling through all the guidelines, research and papers for you finding the evidence which is recent, reliable and above all relevant to primary care. We will be covering some of the most challenging Hot Topics facing GPs today: the evidence around reducing unplanned hospital admissions, how to safely and effectively manage polypharmacy, medically unexplained symptoms and chronic pain as well as a wide range of other problems we commonly face from dyspepsia to overactive bladder.

·       All the presented Hot Topics will be new compared to Spring 2013  so if you came a year ago, do come back. You can be confident it will all be new presented material with lots of new CPD ideas to help you prepare for appraisal and revalidation

·        We have streamlined the paper book, and included more of our ever popular KISS (keep it simple) summaries. Less text, more KISS

·      The electronic version of the book has been developed to become an invaluable resource to use during your working day. It is a PDF you can download onto all of your devices (computer, phone, tablet etc). It is instantly searchable. Original sources are hyperlinked, and the KISS summaries contain direct links to resources for you and your patients to make life easier for you and to encourage self-management and help in your patient.

·       You will be emailed pre and post course MCQs so that you can test your knowledge and demonstrate your learning

·        We have developed some of our own patient information sources to reflect current evidence for you to give your patients e.g. for patients requesting a PSA test, on low salt/high potassium diets in hypertension, low FODMAP diet in IBS etc.

·        We focus on the things which are most likely to have an impact on your practice. A survey from our Spring 13 courses showed that 97% of our delegates changed practice as a result of the course, and over 70% use the course material at least weekly to find an evidence-based answer to a clinical pro

 

As ever, a broad range of topics will be discussed which reflect the incredible diversity of things we have to deal with in primary care….highlights will include new research, evidence reviews and guidelines on:

·         Reducing unplanned hospital admissions

 

• Polypharmacy, how to manage safely and effectively

·         Malnutrition, impact, diagnosis and management

·         Medically unexplained symptoms

·         End of life care

·         Hypertension, lipids and statins

·         Stroke and TIA

·         MI secondary prevention

 

• Acute kidney Injury

 

• Chronic non-cancer pain

·         IBS

·         Dyspepsia

·         Anal fissures

·         Overactive bladder syndrome

·         Cow’s milk protein allergy and lactose intolerance

 

• Pre-school viral wheeze

·         Common sports injuries & MSK problems e.g. shin splints, plantar fasciitis etc

·         Gout

·         Detection of melanoma

·         Common infections

·         Obesity, alcohol and smoking

·         Common infections

 

As ever we want you to have a relaxing and fun day out of the practice, so we will keep the atmosphere light, with some good new funny clips and we really hope you have an enjoyable day. With GPs being so busy, we are convinced that this model provides us the best way of practising patient-centred evidence based medicine. So, do come along and we look forward to seeing you next month!

Simon, Zoe, Neal and Gail

Helping GPs promote exercise: Motivate to Move

Guest Blog from Dr Brian Johnson MRCGP

Honorary Medical Advisor for Public Health Wales

 “The potential benefits of physical activity to health are huge. If a medication existed which had a similar effect, it would be regarded as a ‘wonder drug’ or ‘miracle cure’ ” Professor Sir Liam Donaldson, 2010.

·         Physical inactivity kills more than smoking, diabetes and obesity combined.

·         Exercise as prevention or treatment now features in 39 UK national guidelines.

 So what can we as GPs do?

The vast majority of GP’s acknowledge that promoting increased activity is important in primary care, but sadly the evidence shows that the giving of physical activity guidelines and exercise advice are inconsistent. Many GP’s cite lack of time and resources as barriers to routinely giving advice on physical activity and a recent review¹ of primary care perceptions of physical activity cited lack of training and lack of knowledge as a primary barrier to counselling efforts.

In response to this the Motivate 2 Move website has been developed and endorsed by RCGP Wales as a comprehensive educational package designed to tackle the barriers identified above. It aims to increase the health professional’s ability to incorporate exercise advice routinely within patient consultations.

Designed as brief bites of information but with links to more detailed material for those who need it, the site comprises five main sections: 

ü  UK physical activity guidelines

ü  Health benefits - for 33 different medical conditions

ü  Motivation – using two different methods

ü  Starting to exercise

ü  Resource section of further information and

     practical tools.

With downloadable and printable resources for both professionals and patients, short instructional videos and case studies the website covers all aspects of exercise and health from general recommendations to disease specific information.

If ever there was a time that called for urgent change in how we promote increased physical activity and a healthy lifestyle it is NOW. This package gives GPs the tools to overcome many of the barriers and spending time on it would be a very valuable use of your CPD time.

Brian Johnson MBCHB, MRCGP, MFSEM,

Honorary Medical Advisor for Public Health Wales

 

Reference

1. Hebert ET, O Caughy M, Shuval; BJSM 2012;46:625-631

 other references available on request and on the Motivate 2 Move  site

 

 

Impact of the NB Medical ‘Hot Topics’ GP Update Course

It is often quoted in the medical literature that traditional medical CME is ineffective in achieving ‘knowledge translation’ i.e. translating clinical research findings into changes in practice. Implementation Science2012;7:50

We challenge that view with our Hot Topics GP Update course. Having received many emails over the years from delegates telling us how the course had changed their practice, in 2013 we surveyed our delegates to assess the impact of their learning.

We sent a ‘Survey Monkey’ questionnaire to 3,854 delegates 6 weeks after attending the course in April 2013. 844 answered (22% response rate)

·         97% of delegates have changed practice as a result of new knowledge gained on the course

·         72% of delegates use the material at least weekly to find evidence-based answers to clinical problems

·         70% had already used the material for their own in-house training and teaching

·         24% had already completed a personal audit based on an idea from the course

 
We repeated the survey 6 months after attending the course, 200 delegates responded (5% of all delegates).

·         93% of respondents had maintained a change in practice at 6 months

 

How have GPs changed practice following the course?

We have over 800 examples on file of how practice has changed as a result of the course.  See below for some examples.

 

Conclusion: our data confirms our view that a high quality, independent 'traditional' medical course enthusiastically delivered to GPs with quality supporting materials can change practice and leads to meaningful quality improvements for patients, which are maintained at 6 months.

 

Simon Curtis FRCGP

Medical Director NB Medical Education

scurtis@nbmedical.com

Some example responses from delegates (over 800 on file, available on request) as to how they have changed practice include:

·         Prompted the formation of a register and the start of health checks for patients with a learning disability in the practice.

·         I now usually check urine samples in children with a fever before saying the cause is viral.

·         Cancer diagnosis - have researched RAT/Qcancer and has improved my management of suspicious cases especially those not fulfilling 2WW criteria

·         Lifestyle questionnaire for mental health QOF, elderly and poly pharmacy, multiple disease registers looking at managing better

·         I developed a template in the practice for management of paediatric constipation

·         Our prevalence of AF is lower that it should be and we have tried to look at a simple way to pick up more patients. We are going to check pulse rhythm and rate in every patient coming in for influenza vaccine this autumn.

·         checking urine in everyone with anaemia

·         reduced my prescription of antibiotics

·         Oh there are so many. I found the section on GCA and PMR v useful and has changed the way I managed 2 patients.

·         I did an audit to see how many patients were co-prescribed tamoxifen and paroxetine/ fluoxetine. I changed their antidepressents. It would be terrible after a woman’s fight with breast cancer for me to give something that would make her tamoxifen work less. There were 3 patients in my Practice. I educated the rest of the team and have re-audited recently. Now there are no patients being co-prescribed these medications

·         We are trying to bring patients with multiple morbidity to one clinic rather than separate clinics

·         Development of diagnosis support tool for vertigo and recommending the booklet balance retraining which hopefully will reduce some of our ENT referrals

Reasons to be cheerful for 2014

Happy New Year! 

Best to put 2013 behind us.  It was a hard year for the profession.  There was a constant barrage of negativity laid down by politicians and the media – paid too much, working too little and responsible for many of the ailments eroding the NHS. 

Of course none of these is true.  But negativity sells papers and allows politicians to undermine and further their own murky agendas.

But 2014 is upon us and it is time for a change.  So turn off the TV, throw that newspaper on the fire and, for the love of God, don’t go on any internet forums because there are reasons to be positive!

Patients actually still like us and value what we do.

Did you get a card or a present from a patient this Christmas?  I bet you did.  Is this the action of people that despise the profession?  Of course not.  Regardless of the rubbish you may read in the paper, the vast majority of people appreciate the work we do and believe we are good at it.

The latest GP Patient Survey shows exactly that.  Published in December 2013, 92% of patients had confidence and trust in their GP.  Despite a year of overwhelming negativity, when you ask the people that we help day in day out, the people that really matter, you get a positive reply.

Less bureaucracy

With around a third of QOF dropped for the 2013/14 contract (in England at least, with the rest of the UK likely to follow in time) and many onerous tasks such as QP shelved, there is a swing back to patient contact rather than computer contact.  While getting a feel for what will be necessary is going to take time, this feels like a step in the right direction.

Our skills are more vital than ever.

Over the past decade we have seen the rise of the guideline.  Evidence-based medicine has become, quite rightly, the benchmark of good clinical practice, but has been often misappropriated by the establishment, particularly through QOF.  Too long have we been shackled to guidelines.

We should never forget that evidence-based medicine is about using the best available evidence together with our own experience and that of our patient to address a problem.  Nothing in primary care is ever black and white.  No guideline should be blindly followed.

The growing recognition of multimorbidity and polypharmacy (which we will cover on the Spring Hot Topics course) herald the emancipation of our profession.  Patients with multiple chronic diseases are the norm and a growing body of research explains that a one-size-fits-all approach will not work.

But more research cannot give us all the answers.  As one delegate pointed out last year: “I feel sad that this even needs to be researched.  This is our job.”  No study will ever be able to usefully address the endless permutations of patients with different conditions, different medications, different lives – which is why our experience and skill is vital to work out what is best for that person and can never be replaced.

Thinking positively
Anyone who has ever done Mindfulness will know that by simply smiling we feel better.  It’s a cheap trick but it works.   So, let’s not focus on the negatives – focus on the good bits.  Once we are positive about ourselves then we, our staff and our patients will start to feel good about what remains a great profession.  I for one am glad to be a GP.

Neal