Reversal Agent for Eliquis and Xarelto Receives FDA “Fast-track” Approval

 

This is great news for people with atrial fibrillation (AF) who take the newer anticoagulants Eliquis or Xarelto. According to a recent article in Cardiology News the FDA, in early May 2018, approved Andexxa (Portola Pharmaceuticals), the first reversal agent for the popular newer anticoagulants Eliquis and Xarelto.

I think runners and mountain bikers, correctly, worry about problems with excessive bleeding while on anticoagulants because we are certainly at increased risk of falls or of being hit by a car, and many have hesitated to transition from warfarin (Coumadin) because of the lack of a reliable reversal agent.

Pradaxa (dabigatran) and warfarin both already have reversal available reversal agents.

Andexxa acts as a decoy molecule and essentially binds to the drug preventing it from interacting with clotting factors.

Terrific news, right?

According to drugs.com “In the U.S. alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month.” 

But wait – there’s catch!

Andexxa has been approved but as the writing of this blog post (May 23, 2018) it is not yet available. It exists, but you can’t get it!

I called one of the pharmacists at our hospital (Sky Lakes Medical Center) and asked if it was going to be readily available at our hospital – that’s when I discovered that it wasn’t yet being distributed – but she told me that our hospital plans to have it in stock and available for use.

She also said that once Andexxa is actually available our hospital would then develop guidelines for usage of the new drug. These have not yet been declared but she expects that it will be similar for guidelines pertaining to the reversal agents for Pradaxa and warfarin which are 1.) Patients with serious, life threatening bleeding and 2.) Patients who need emergency surgery.

I think that means that people having elective surgery (like a knee replacement) will not be eligible and will have to taper off their anticoagulant and bridge with Lovenox, just like they do now. I imagine that emergency surgery refers to surgery that is necessary to save your life, not necessarily surgeries like fracture repair, where it would be possible to wait a few days.

As far as my personal experience – I take warfarin and don’t intend to change. I had taken Pradaxa for several years and was very happy with it until I had a mini-stroke and a trans-esophageal echocardiogram revealed that I had a blood clot in my left atrium.

The next big question, of course, is how much will Andexxa cost? I have no idea and I can’t find any information about cost – but I’m guessing it will be really expensive. But then again – people who are anti coagulated and have life threatening bleeding or need emergency life-saving surgery can just go ahead and get Andexxa and worry about how to pay for it later.

 

Any comments are appreciated! Thanks for reading.

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Atrial Fibrillation Podcasts?

 

For many years I’ve been running with an iPod and truly enjoy listening to music while running – I wrote about it in a previous entry about Runner’s High – nothing like some nice stoner music to listen to while you’re high on life, right?

I realize that listening to music while running is controversial for many people; but I am an unabashed YES when it comes to running and music. Because I live in rural, mountainous Southern Oregon I do 95% of my running on trails of one sort or another – and yeah, yeah – bears, mountain lions, dogs – I get it – but I’m not changing anything. I’ve been running with music ever since my first Walkman cassette player in 1984!

Even worse – I’m Mr Bad Example and ride my bike with an iPod going, and again 95% trails but still not really a good idea.

Lately, with my atrial fibrillation requiring more and more medication to control (the high dose of the beta blocker carvedilol really takes the wind out of my sails), I am doing more hiking and less running – but still with an iPod.

Since “runner’s high” is a rare event with hiking compared to running I’ve been listening to more podcasts than music playlists. Podcasts are sort of like radio shows, either professional or homemade, that can be downloaded from the iTunes store and elsewhere, in MP3 format to be listened to using an iPod, smartphone, or even on your computer. They are mostly free, but many have commercials, and there are a few podcasts that cost money.

There are millions of them. Over the past couple of years here are the ones I’ve found most entertaining:

All of these recommendations are unrelated to atrial fibrillation

Dirtbag Diaries – a “dirtbag” is something along the lines of a Yosemite rock climber who lives in his or her car and lives for climbing. The term has a broader application and this excellent podcasts primarily deals with outdoor adventure, mostly done econo!

Outside Podcast – if you like Outside magazine you’ll like the podcast – the Science of Survival episodes are particularly great.

My Dad Wrote a Porno – The funniest podcast I’ve ever encountered – but truly dirty and probably offensive to most people – you’ve been warned. A young British man discovers his dad wrote a clueless porno novel so he reads it with his two friends and they basically give it a sort of Mystery Science Theater 3000 treatment.

Dan Carlin’s Hardcore History – probably my favorite podcast ever – fascinating and detailed episodes about various historic eras like World War I, Genghis Khan, the Roman Empire, etc. The episodes are long – like four or five hours long – and never boring. The narrator reminds me of Steve Dahl (only other Chicago natives will know who that is) merged with a historian who loves guy movies. Okay – if that doesn’t make sense just try an episode or two – it’s a great show.

Revisionist History – a Malcolm Gladwell podcast – very thoughtful and as with all his work always an amazing twist near the end.

The various NPR podcasts (Snap Judgement, TED Radio Hour, Radiolab, Invisibila, etc.) are consistently excellent, maybe a little too slick.

I think most people who listen to podcasts have already listened to Serial, Dirty John, and S Town. If not, what are you waiting for? They are among the best ones out there.

Others I’ve found interesting include Rich Roll Podcast, Beautiful Stories from Anonymous People, Judge John Hodegman, WTF, and the Nerdist.

Actual running podcasts include Trail Runner Nation and Ten Junk Miles.

But what about podcasts specifically about atrial fibrillation? It seems like any topic, no matter how esoteric, has a number of podcasts. If you don’t believe me do an iTunes store podcast search for your hobby, your favorite TV show, favorite band – and you’ll see what I mean.

I was surprised when I did an iTunes store podcast search on “atrial fibrillation” I found zero podcasts that were anything like this blog – that is to say produced by somebody with atrial fibrillation for non-clinicians who deal with their own AF. All I found were atrial fibrillation episodes for technical medical podcasts directed toward clinicians. Just have a look at the screenshot at the top of this post. It amazes me that with all the people dealing with atrial fibrillation none of them seem to be podcasting about it, although, as you know, several people blog about it.

Rich Roll Podcasting

If you know of any atrial fibrillation podcasts, or if you just want to discuss podcasts in general, please comment. Thanks for reading.

A Casualty of My Atrial Fibrillation: My Single Speed Cross Bike

I miss my Bianchi San Jose.

It’s true that a person could easily get by with one bike – most people in the world do just that. If I only was going to have one bike it’d be a nice mountain bike – because it could be ridden in all conditions, four seasons, on or off road, and it’s usually a comfortable ride.

But I’m a typical middle aged (employed) male cyclist – I have three bikes – a mountain bike, a road bike, and a cross bike.

Okay – I‘ll admit it – I actually have four bikes. My fourth bike is my “legacy” bike – the first fine bike I ever owned that I had to  save up for about a year as a poor graduate student – my 1981 Trek 930 Sport Touring road bike with the Columbus tubing and the mix of Campy and Sun-tour components. I haven’t ridden it in nearly twenty years but I just can’t part with it – we had so many incredible road rides back in the eighties! My old bike is actually featured on the Vintage Trek website.

Alright – full disclosure – I still have the frame and (non-suspension) fork from my 1990 Fischer Supercaliber – still my favorite mountain bike of the several I’ve owned for the past thirty years.

But out of the three bikes I actually ride the most frequently ridden is my full suspension cross country 29er mountain bike – a real beast built for the clydesdale that I am.

I also have a carbon Giant Defy (their knock off of the Specialized Roubaix) that I bought as a retired rental fleet bike from the local bike shop. Yes – I know that you’re never supposed to buy a used, god forbid a former rental fleet carbon framed bike – but the extra large sizes are so infrequently rented that it had very few miles on it.

But my Bianchi San Jose is the one that was a casualty of my atrial fibrillation (AF). A single speed cross bike – perfect for cruising on our local Rails to Trails (OC&E and Woods Line State Trail) geared perfectly for the relatively flat trail (Trains can only handle so much steepness – no more that a 2% grade) and because it was a cross bike it was ideal for the nine miles that are paved as well as the ninety unpaved miles. Although it’s a single speed it had brakes – it wasn’t quite a hipster messenger fixy. I think those things are nuts – especially now that I’m anti-coagulated.

If you’ve never ridden a single speed – give one a try – a very smooth and quiet ride. My San Jose was a little tricked out. I upgraded the tires to a more aggressive set, and I had a beautiful Brooks Saddle (which I kept) and some matching but really over-priced Brooks leather handle bar tape. That bike just had a terrific look and feel – the most comfortable bike I’ve ever had. I could ride in the drop position for a long time without getting sore.

But regrettably as my AF got worse and the medications were going up to higher dosages (Thanks, Carvedilol!) I could no longer ride it up to the hill to our house. It isn’t the biggest or steepest hill in the neighborhood (we live in the mountains, after all) but it is about a 250 foot climb in about three quarters of a mile (75 meters in 1.2 kilometers). It never was an easy climb on the single speed, but currently it is impossible for me.

To be honest I never was a good single speed cyclist. I’ve always had a fast cadence and used a lower gear, and I tend to shift constantly maintaining an even power output. I’ve ridden with guys who just stay in the higher gears and grind – not my style. It was always a challenge getting up that hill in the single 42/17 gear.

I considered getting an after market three speed hub for the back but that would be too dorky. I  still rode it on the bike trail but I’d have to drive to the trailhead schlepping the bike on my truck’s bike rack. Eventually I traded it in at the bike shop when I bought my most recent bike – a Specialized AWOL – sort of a gravel grinder meets full touring bike.

I like the AWOL well enough, and ride it frequently; but compared to the light, sporty, cool looking San Jose the big, clunky, awkward looking AWOL seems more like riding around in a UPS delivery truck. Oh well – life changes as you go – I’m grateful to  still be riding.

Please feel free to share your comments.

Is Digoxin a Good Choice for Treatment of Atrial Fibrillation?

Is Digoxin a Good Choice for Treatment of Atrial Fibrillation? I want to make it clear, once again, that I am writing this blog as an endurance athlete dealing with atrial fibrillation (AF) – not as a clinician. I’m not a cardiologist or a primary care physician. I’m simply posing a question and not answering it. It is important for you to be in agreement with your cardiologist and primary care provider about your treatment plan Whatever you do – DON’T STOP TAKING ANY MEDICATION YOU HAVE BEEN PRESCRIBED BECAUSE YOU READ ABOUT SIDE EFFECTS ON SOME GUY’S BLOG!

Also – full disclosure – I take a low dose of digoxin.

Digoxin is the generic name for Lanoxin which has been actually been used for hundreds of years as an herbal preparation (Digitalis) from the foxglove plant, seen above, which is a lovely plant, don’t you think?

Digoxin is used to treat atrial fibrillation, atrial flutter, and heart failure. My cardiologist told me that many of the younger cardiologists don’t generally even prescribe it any longer.

Digoxin has a narrow therapeutic index, which means that at too low of a dose it isn’t very effective and at higher doses it is toxic. Because of this it has many side effects. It is unknown whether digoxin is safe during pregnancy. Digoxin works by improving heart function by strengthening the contractions and slowing the heart rate.

A 2018 paper published Journal of the American College of Cardiology concluded that digoxin increased mortality in patients with atrial fibrillation regardless of heart failure.

Conclusions In patients with AF taking digoxin, the risk of death was independently related to serum digoxin concentration and was highest in patients with concentrations ≥1.2 ng/ml. Initiating digoxin was independently associated with higher mortality in patients with AF, regardless of heart failure.

Yikes!

Also consider that several of the authors of the study disclosed that they had financial ties to pharma and medical device companies, including pharmaceutical giants Bristol-Meyers Squibb and Pfizer who funded the study.

But look! Runners and other endurance athletes need to ask their cardiologists about digoxin toxicity because both dehydration and low magnesium increase the chance of toxicity. Who among us hasn’t been dehydrated?

I’m going to be asking my cardiologist more questions about digoxin next time I see her. As I mentioned I take a small dose and when we did lab work my digoxin level was low, below the therapeutic window, which she said was fine – she just wanted to make sire it wasn’t too high. Me too!

I’d love to see your comments!

Dehydrated Trail Runner – me!