Some real-world challenges faced by Dabigatran (Pradaxa)

Doctors that treat atrial fibrillation (AF) are getting close to celebrating the one-year anniversary of having a substitute for warfarin. As an early adopter of the novel new blood-thinner, I would like to share some (almost) one year-old observations on dabigatran (Pradaxa).

First, the science behind dabigatran is stellar. The landmark RE-LY trial studied 18,000 patients with moderate to high risk AF. Dabigatran was clearly superior to warfarin in both stroke prevention and lessening of intracranial hemorrhage. This is old news.

Second, dabigatran offers far more convenience (Americans do like convenience) than warfarin. Not only does dabigatran not require monitoring of the blood, but it also has no dietary and drug interactions. No longer does one risk bleeding because a urinary tract infection requires taking antibiotics. This is a significant benefit.

Third, dabigatran offers near immediate blood thinning. The rapid onset (and offset) of action further adds to the convenience of AF patients. No longer do patients have to stay in the hospital getting IV (heparin) and oral blood-thinners together, or endure expensive twice-daily subcutaneous injections in the belly (lovenox).

Theses are all clearly positives.

But let me tell you about some of the problems with dabigatran that have come to light over the past year.

Cost: Dabigatran is still expensive, though I will give Boehringer-Ingelheim some credit here; they have been generous with starter samples and done well in convincing third party insurers that dabigatran is probably cost effective in the long run. Still, many patients have yet to consider better health something that should cost as much as cable Internet or an Apple product.

Compliance: I want to tell you that even non-motherly doctors like myself are struggling with the personal responsibility aspects of this drug. Remember, unlike warfarin and its frequent INRs, the doctor that prescribes dabigatran has no way to confirm that their patients are protected from stroke. In other words, we cannot know if patients forget the second dose of dabigatran or miss days at a time to lower the cost. This “trust” comes squarely into play when an AF patient requires a shock or ablation.  Has there been adequate blood thinning in the previous weeks? Only the patient knows, not the doctor. That’s a new paradigm.

Side effects: There is no doubt that the acidic capsule that dabigatran comes in (to foster better absorption in the gut), creates GI discomfort in many. The RE-LY investigators reported just 11.8%, but to a private practitioner that is used to zero side effects with warfarin, it seems like way more than 11.8%. My experience suggests that many patients get some manner of reflux, stomach pain, esophageal pain, diarrhea or bloating from dabigatran. Some tolerate the side effects, some mitigate them by taking the drug with food, and some have to switch back to warfarin. Though not life-threatening, these nuisance effects have created extra work for both stressed out AF patients, and busy non-foundation-supported AF doctors. For AF patients, it’s another reminder of their disease, and for AF doctors, it’s another unreimbursed phone call and concern over a period of time of disordered blood thinning. Think: barriers to widespread-use.

Loss of interaction with healthcare professionals: Many want to complain, bitterly in some cases, about warfarin’s requirement to have frequent blood checks. These three-minute encounters where a finger yields a drop of blood for INR testing require driving to a health care center. But no one talks about one of the positives of this inconvenience: warfarin patients get to interact with an INR nurse and other AF patients while they are there. This human-to-human interaction offers a chance to learn something about AF, which I have written is one of the best tools in treating the disease. Warfarin patients can have the nurse check their blood pressure, which on more than one occasion has discovered an arrhythmia which required attention. Dabigatran patients, on the other hand, don’t get this fringe benefit.

It was ironic last week–as right after I told our dabigatran representative about these concerns over the Boerhinger-sponsored lunch, the very next patient was a high-risk AF patient having trouble getting regulated on warfarin. The patient asked me, “Do you think I would be a good candidate for that new blood thinner?”

“Yes, you sure are.”

JMM

Comments

  1. Michelle Johnston says

    And perhaps to add to the list of drawbacks, what happens when a patient on dabigatran comes into ER bleeding – following blunt trauma, or intracerebral bleed? Lack of reversibility seems like a potentially highly risky scenario, compared to warfarin.

  2. says

    I’ve been on Pradax almost six months and in ER three times for heartburn and stabbing pains in the stomach. Each time I was sent home on medication for a proton pump inhibitor…prevacid, nexium and now tecta since nexium isn’t covered by my medical plan. My question is-how much longer dare I take this medication which weakens bones that are already at the osteopenia stage? Yet the advantages of Pradax bear serious consideration, although I was well controlled on warfarin. As a patient I don’t know what I should do and I don’t think my doctor knows either though he is one of the best I’ve ever had.

  3. frank says

    glad pradaxa is front burner again on this blog. it was very well covered at first at the same time i started it. this blog was a great hand holding assist. thanks again.

  4. Peter Hunter says

    I have been on Pradaxa for about 40 days. I had one very bad episode of low-esophagus high GI pain. Then no problem for five weeks. Now it has returned with a vengeance after a very fatty meal with garlic last night. My recommendation is take Pradaxa on a full stomach, zero alcohol, zero garlic, and cut way way down on fats and spices. Stick mostly with fish, fruits, and veggies. Avoid nuts, which are hard for the upper GI and lower esophageal sphincter to handle. I believe it is the lower esophageal sphincter and the smooth muscle just above it that are the most intolerant of the acid. Omeprazole an hour before eating and Pradaxa seems to help.

  5. frank says

    thanks. so far ( since june ) i’ve had a charmed life with pradaxa. hope i’m not jinxing myself. if i do have a reaction that i’ve been fortunate enough to avoid so far. drs. info. and the comments give me some real life experience from folks like you that may help me through. must be thousands if not 10s of thousands new to pradaxa. one would think that this blog would have more experience comments. suppose i need to be thankful for what we have. suppose quality is more important then quantity.

  6. Sally Kellis says

    I have been on Pradaxa since Spring 2011. I have been gifted with IBS for decades and have just assumed that is what causes any digestive disturbances. Don’t know.

    Not very definitive or exciting, I realize!

  7. frank says

    sally & all others. every grain of info. re pradaxa is appreciated. every posting by dr. is welcome. i look forward to this blog every am and several check ins during the day & early evening. may sound corny, but we do need each other thoughts and experience.

  8. Jim Piercy says

    Thanks for another excellent article on Pradaxa. I’ve been on Pradaxa for six months with no recognized side effects. I just had a significant skin cancer operation on my nose and the doctor said that the Pradaxa appeared to be doing its’ intended job. I was his first Pradaxa patient and there were no surprises. Keep the excellent Pradaxa write-ups coming.

  9. Fred Ehlers says

    Frank, in April I said I only had heart burn twice in the ten weeks I took pradaxa. Well things have changed, the past couple of months the heart burn has been two or three times a week. It only occurs when I take it after supper, never in the morning. I can’t associate it with any particular food I ‘m eating, I am going to try changing the time I take it and see what happens.

  10. says

    My doctor added Zantac twice a day to my diet and that seems to help with the gastric problems. Now I’m considering going off the proton inhibito to see if Zantac alone will keep the esophagus-upper stomach pain from returning. I really want to stay on Pradax because the side effects I had with warfarin (itchyness, fog brain and pulsating in my head have disappeared).

  11. Verted says

    I’ve been having a tough time with the Pradaxa GI effects. For me, it’s been mostly abdominal pain and very bad bloating with some GERD. The irony is, my afib started out as a GI/Vagal thing, so I’m praying the Pradaxa doesn’t bother me enough to make it return.

    This was to be a temporary pre and post cardioversion drug, but for various reasons, I’ve been on it now for 8 months – long story.

    Coumadin is not for me for several reasons, so I’m hoping I can tolerate this as long as necessary.

    What has helped somewhat is taking it in the middle of meals, and taking a daily PPI, as well as taking the low dose aspirin at the mid day meal instead of at the same time as the Pradaxa. Other meds mess with my stomach as well, so it’s hard to do the juggling act.

    • says

      I know exactly what you mean about the juggling act in an attempt to minimize gastric symptoms. Dr. Oz said most heart attacks occur in the early morning so I’ve been taking my aspirin with my supper meal. I never thought how it, along with Pradax, might exacerbate the GI tract problems. Hmm.

  12. Verted says

    Yes Carol. I don’t know if that’s helping or not, but I figured splitting them up might help. Also, after each out-procedure this year, my gout has flared up the following week, and I’ve had to take anti-inflammatories for that, so I needed to juggle those in the mix as well, as they cream my stomach too. I take my Prilosec before bed, and use some sodium bicarbonate and simethecone during the day something else I’m finding helpful, is to take some papaya extract digestive enzymes after meals. I don’t think they are counterindicated with any of my meds. I don’t know what other meds you have to take, but I’m also finding that Multaq has some GI effects as well.

    Good luck!.