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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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.

Cycling and AF Blog

John’s Bike

I’d like to recommend that readers of this blog take some time to check out the Cycling and AF Blog , if you haven’t already done so.

In this easy to read blog, with generally short entries, you’ll read of the personal journey of a middle aged road cyclist /club rider from England.

His atrial fibrillation (AF) began with some vague  symptoms in 2015, eventually diagnosed as AF. Follow his personal journey dealing with alcohol, coffee, diminished cycling performance, beta blockers (and other AF drugs), two ablations (!) and an Atricip procedure.

I think readers of this blog will find his journey interesting. Based in England the healthcare system is different, as are some names – a TEE (trans-esophageal echocardiogram), for example, is a TOE (trans-oesophageal echocardiogram).

I would certainly like to learn about the Atriclip procedure – I’ll research that and post about it in the future.

Speaking of alcohol – I’m planning my next blog post to be about alcohol and AF.

I hope you enjoy the Cycling and AF Blog as much as I did.

This is me, in AF, riding around Crater Lake

Bicycling the Rim Drive Crater Lake National Park and Atrial Fibrillation

I haven’t blogged for a while because we’ve been on vacation in Croatia for two and a half weeks, and of course after being gone for that long I’ve been incredibly busy at work. I am working on along blog entry (actually it’ll be a separate blog) about Croatia, so stay tuned.

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Me During a Brief Rest Stop

In my opinion bicycling around Crater Lake is one of the finest bike rides in the entire United States, and Crater Lake National Park will, from time to time, close of twenty-four of the thirty-three miles of the Rim Drive to allow bicyclists, hikers, and runners to have a relatively car free day. This year they had vehicle free days on two Saturdays: September 20 and 27, and I made time to be there for both days.

Since I live near Crater Lake N. P. I’ve had the opportunity to ride the rim several times, but this year was my first time doing it in permanent atrial fibrillation (and while on a beta blocker). Always a challenging ride under any circumstances, adding a fib and a beta blocker to mix changes things a bit.

Most riders start at the Steel Visitors Center (Park Headquarters) and ride clockwise. The first thing on the agenda is a three mile climb with 650 feet of elevation gain up to the Rim Village. This is actually the steepest hill along the route, but not the most difficult, in my opinion, mostly because the legs are still fresh. It is quite odd to pedal up a climb like that and find a lake at the top. There are several climbs and descents along the thirty-three mile route, and rarely is there any flat road, and the two toughest climbs, in my experience, are in the second half of the ride – the long easy climb to Cloud Cap (where most people stop to sigh and eat their Clif Bar) and the last grind up to Dutton Ridge. I might even say that you only need two gears to ride the rim – whatever you use as your easiest climbing gear and a big gear for coasting downhill.

Elevation varies from 6700 to 7700 above sea level. Personally I don’t have an issue with the elevation at Crater Lake because I’m used to living at higher elevation, but people coming from sea level might feel it.

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Bicycling in Croatia with Margo

To be honest, none of the climbs (going clockwise) are particularly steep, and there is only a total of about 3500 feet of climbing, but the climbs are so long and persistent that it seems like more. The descents can be fast and one could easily go 50 mph down the descent from Cloud Cap, but don’t. The speed limit is 35 mph and there are often surprising potholes encountered once you get up above 40 mph. The vehicle free days are great because you don’t have to worry about cars behind you. One day I was descending at 45 mph, a speed at which the wind in my ears prevents hearing anything, riding right down the middle of the lane, and was passed by a van. I thought, “What’s your hurry, bro? I’m already going 10 mph over the speed limit!”

The scenery is world class and seeing it slowly, up close on a bike, complete with the sounds and the smells is unimaginably beautiful. Being there on a vehicle free day with hundreds of bicyclists from all over Oregon is even better – there is an amazing energy in the air on the vehicle free days.

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Snowshoeing with Libo April 2013

If you are going to ride the rim, especially on a vehicle free day, keep in mind that once you are past the Visitor Center and the Rim Village (basically once you are past the first three miles) there is no water. I’m a heavy sweater so I’ll take three liters on a hot day. Actually along the last big climb there are some little “waterfalls” right along the roadside and I have seen people filling their water bottles there and it is probably fine; but it is definitely not tested and designated as potable water. Also keep in mind that there will be no SAG wagon trailing you so make sure you have the proper gear and tools for changing flat tubes and minor repairs.

As far as riding the rim in a fib while on a beta blocker, well, it is much slower. I was able to ride it but it took me at least an extra hour. I had a triple chainring on my old road bike, and I used to be able to do the entire ride in the middle chainring (except for part of the first climb); but now I am using my easiest gear for most of the climbing (my new bike has compact double, but the gearing is similar). I think I need to be happy with being able to complete the ride without falling to pieces, and quit lamenting my slower speed.

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Photo by Margo

My personal preference, now that I am in a fib, is to keep going and minimize rest stops. It seems every time I stop it’s like starting over again. On the first Saturday I was riding with a group of friends, including my wife Margo (her first time doing the rim ride) and I told them I wouldn’t be stopping much and that they could catch up to me. The last I saw them was at the top of the first climb, and I actually completed the ride a half hour or so ahead of them – they had fun, stopped at the many overlooks, stopped for lunch. I was the tortoise to their hare; slogging up the hills and only stopping a few times.

Another difference is that now that I am on an anticoagulant I brake a lot on the descents. I’m usually the biggest rider in whatever group I’m riding in and consequently the slowest climber that makes up for that by being the fastest descender. No more. Now I think about how descending slowly will help me keep my blood inside my body and I was passed by dozens of riders on each hill. As a matter of fact I kept getting passed by the same groups over and over. They’d pass me on the climb, then I’d pass them at the top of each hill where they’d stop to look at the stunning view of the lake, then they’d pass me on the descent and I’d pass them again at the bottom of the hill where they’d evidently stop to chat. Over and over – sort of fun.

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Skiing with Jan (evidently I’m relying on old photos because I only took one photo for two days of riding around Crater Lake – like I said I don’t stop enough!)

I returned and rode the Rim Drive again the following weekend as well but my friends didn’t accompany me. It was a much cooler, windier day and looked like rain, and they had other plans. I ended up doing the first half and deciding to make it an out and back. I was thinking about the big descent down the other side of Cloud Cap in the heavy wind and thought that might not be the best idea on account of my being anti-coagulated. I learned that riding the rim counter-clockwise is not as safe as riding clockwise. When riding clockwise the lake is to your right; but when riding counterclockwise there was quite often a steep drop off and no shoulder and no guard rail. The drop offs weren’t a thousand feet or anything like that but they were certainly much further than I wanted to go over on my bike so I did the long descents towards the middle of the lane although I pissed off a few drivers I will live to ride again. There is no way I will ever ride the entire rim counterclockwise. Keep in mind that most drivers are looking toward the lake (why wouldn’t they) and if you are between the driver and the lake they are likely to see you. But when riding the other direction there is more risk of being unseen.


Carter Lake Century 2011 (not my video)

Another good time to ride around Crater Lake in the Crater Lake Century. I have never ridden with the organized century (I’ve always been training for something at that time – it’s held in August) but I have been told it is a blast. As far as I know the Rim Drive isn’t closed during the century but there are about 300 riders up there that day. The number of applicants is limited so register early if you want to get in. The century, obviously, involves more than the thirty-three mile Rim Drive and in addition to more climbing from Fort Klamath up to the Park Headquarters, there is some routing around the local farmlands near Fort Klamath to make it an even one hundred miles.

I would love to hear from other bicyclists, especially cyclists dealing with atrial fibrillation. Please feel free to comment below.

Joe’s Story: A Middle-aged Runner Deals with Atrial Fibrillation and Heart Failure – A Guest Post by Joe

This is Joe’s Story – a guest blog article based on Joe’s comment on this blog describing his fascinating experience with atrial fibrillation and subsequent heart failure. Joe has really demonstrated persistence and a positive attitude that, I think, a lot of athlete’s with atrial fibrillation possess. Joe is making a comeback from serious, life-threatening heart failure, and he has done a good job of accepting the new reality of his post a fib performance.

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Joe Triumphant

Hi Everyone – I’ve had A-Fib for about three years now.

I live in the tropics and cycle, run, do weights. I train five days a week but not hard or too easy. I believe I got into this mess when I cycled up our small mountain here on the island I live on three times a week back then. I would only drink reverse osmosis cleaned water consuming about four liters just going up the mountain. I’d do weights in the morning and cycle in the afternoon and believe me it gets hot and humid. It’d take me about two hours to cycle up to the top of this very very steep course. (approximately 5K to the top)

In hindsight now I guess I’d been over-training terribly and not putting back potassium and minerals into my body at all. I happened by luck (or fate) to be given a heart monitor and thought it was cool to use it on my cycle ride up the mountain. I set the max at 185 and started off – as soon as I started up the steep hill after a five kilometer preamble the damn thing started beeping – it was at 205 and I just started up the hill! Like an idiot (ha ha) I kept going and it would not shut up. Did it the whole way up and for the next month it was like that. Can’t believe it now I did that but as I’m in constant A-Fib now the reality speaks for itself.

Been put on beta blockers and have to take warfarin. I suffered a sever influenza sickness last year and it really took a toll on my ticker. My left ventricular ejection fraction (LVEF) was only 17% when I finally went to see the Cardiologist here as the echo showed.

Fast forward now to a month and a half and I’m back up to 35%. The goal is to get back to 55%! I love running and exercise and like some of you wrote would rather plonk on the trail then sit on the couch, so be it. I used to run with the goal of just finishing the run and was happy about it.

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This is Joe’s heart on heart failure

Then I got into times, was happy about that too. Before my illness last winter my times were at my all time best. Slow for a lot of runners but for me great. After all I run to please me so I accept what ever pace I come home at. Not a biggie. The doc was amazed at how fast my heart recovered and I even saw the difference on the screen of my heart’s movement. The echo I had before it looked like Jabba the Hutt sleeping. I think I attribute this to doing a LOT of research on the internet getting informed of what I was dealing with and trying it slowly with my Doctor always in the know. He was very skeptical of the supplements I was taking but has done an about face now. I also believe the coconut water I drink everyday now has helped in a big way. I noticed I don’t have an ammonia smell anymore when I sweat. I always had that smell when I drank the Osmosis water. I drink a mineral water now along with the Coconut water.

Anyways – I do prattle on. The thing is not to Panic and get informed!

I wear a Polar T-80 watch with GPS and follow the Zone rules. Yeah, I’m running about four minutes slower than normal but I feel great after a run now and do not dread the next one. Hoping my pace will kick up a notch as the info says it will as the body adapts.

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This forum is great may I add and it sure is reassuring to read of Peep’s in their 80′s who’s lived with A-Fib for 20 or so years and keep running. Hopefully one day soon someone will find a cure for this curiously annoying ailment.

When I had 17% ejection rate it happened really fast. The time line is like this: on a Friday I ran a very fast 5K run for me. One of my best times. Later that day flew to spend three days with a friend, and after returning home I got ill and by Wednesday was full blown into whatever ailment I had (Influenza?). I tried running a week later but could not even go further than 50 yards! Then I stopped and decided to rest a week, do nothing and fight this illness. Well, it got worse and worse – my lungs started filling up with fluid and at night I could hear bubbling in my lungs. Fast forward a week of no sleep, etc, etc, and went to a doctor was put on antibiotics. I didn’t get better, still the same symptoms. (Turns out the heart, because of it not beating properly causes the fluid to back up and then it seeps into the lungs so any of you with these symptoms see a doc. You can do a thumb press on your shin and if the indentation stays and is deep you’ve got fluid retention and need a diuretic).

After a couple more weeks of this I decided because of previous symptoms I felt there was something wrong with my heart again. Seemed to be doing the same old symptoms of A-Fib. I thought I was free of it for almost two years or else it was Silent A-Fib and I did not know it!

My cardiologist gave me an echo and all he said was “What did you do?” Man, you don’t want to hear that from your doctor!

Like I said before I even could see my heart wasn’t doing anything. Just sort of sitting there: legs up – arms crossed!

He put me on meds again and the dreaded warfarin. They worked almost right away! I was on Codarone (amiodarone) for only a month and everyone should know that this is a dangerous drug! Long half life and it’s like shaking hands with the devil. Used a lot as a last resort. But! – for short periods it works miracles. Using it over six months or more can have repercussions.

Well, that day I came home from the doc’s I tuned up my mountain bike and went for a very short ride. I was out of breath the whole time. Did this for a couple of weeks and got stronger. Started weights again, and just started using the bars with no weights. Did this very very slowly and now after two months I’m almost back to benching 200. (ha ha – good for me anyways) The last check up the doc said my heart (Left ventricular ejection fraction) was up to 35% and I saw the difference in the video as well! Made me feel very very happy.

So now I’m trying something I never thought I’d do. I bought a Polar T-80 Heart monitor with GPS and run and cycle in the Zone. I exercise according to my heart rate. I’m finding I’m no longer exhausted during the rest of the day and overall feel better, stronger. It’s taking time to lose that competitive spirit though – ha ha ha – I’ve got friends who are in their 70′s running faster than me. My slowest times in years but I’ll stick to it and see if my times automatically come back up as the research suggests. This has to be done. I love being active but I hate being dead more so I have to accept and live accordingly. Don’t Panic!

A heart pumping at 33% efficiency feels a lot better than 17% I can tell you. I do more things than most of my friends. It still amazed me though how I can do weights for a hour, run for an hour then eat, chill and later in the day walking up a flight of stairs takes my breath away. It’s like a reminder – oh yeah I’ve got heart problems. A friend wisely told me that it could be like losing weight: fast in the beginning; then slower. I hope my ejection fraction % will keep increasing till 55%. Considered normal. Then I’ve got to deal with the A-Fib.

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Joe still the life of the party – but no more beer for this guy!

A very important footnote: I used to drink beer everyday for years! Love the amber fluid. After my first A-Fib about five years ago I stopped for about three months. Then about two years ago I only drank on Friday and Saturday. For two years I did this. No exceptions. I’m 51 now and even this was taking it’s toll I believe. Now I’ve cut it out completely and will go the distance – sort of sucks but I’m close to the three month period now and will keep going. My next visit to the docs is in August so I’ll hopefully remember to post what transpires.

If anyone is interested in what I’ve been taking for supplements, eating, drinking, and exercising please leave a message on this blog and I’ll be most happy to share. One thing I’ve always found frustrating with most blogs is when I’ve read what someone has done and it worked there was no follow up. I’ll try and keep posting on this one. Great site! Peace out…………… don’t Panic : )

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Update (from Joe)

Hi everyone. Went for my one month checkup at the cardiologist today and the results were better and improving. The Doctor said my heart has shrunk by a noticeable margin which is a good sign. (had an echo) It’s getting stronger. The ejection fraction went up a bit as well to around 37%. Getting nearer to 40% then in a few months hopefully 50 or 55%!! I was also able to wean off one med by half. I felt it in my run today – a really great run. Will continue on meds and supplements plus exercise and diet as is for another month. See ya then!