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 “trustâ€ comes squarely into play when an AF patient requires a shock or ablation.Â Has there been adequate blood thinning in the previous weeks? Only the patient knows, not the doctor. Thatâ€™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, itâ€™s another reminder of their disease, and for AF doctors, itâ€™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 warfarinâ€™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, donâ€™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, â€œDo you think I would be a good candidate for that new blood thinner?â€
â€œYes, you sure are.â€