Heart and Vascular Health

Sharing a rare moment of person-to-person time during the scientific sessions in San Francisco, Dr Seth Bilazarian asks Dr. Samuel Goldhaber how he goes about bridging with "Novel oral anticoagulants" (NOACs) #dabigatran, #rivaroxaban, and #apixaban.

My comment: We have new options for patients with atrial fibrillation.  These new drugs Pradaxa and Xarelto are under scrutiny because they are new nadn bleeding hazard has been reprted.  This study helps us understand that warfarin (coumadin) also has significcant risk and the risk is high in the first week of starting thsi medicine.  This early hazard but be an advatage for the newer options.

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Rates of serious bleeding among patients taking warfarin are much higher than those found in clinical trials of the drug and are even greater during the first month of use, according to a five-year study of 125,195 seniors with atrial fibrillation.

The findings complicate an already difficult decision-making process for patients with atrial fibrillation (AF) and highlight the importance of careful management of warfarin, especially during the first month of use, experts said. Warfarin is a generic anticoagulant that is marketed under brand names such as Coumadin and Jantoven.

Compared with clinical trials for warfarin that found serious hemorrhaging rates of between 1% and 3% per year, bleeding problems are more common in real-life clinical practice, said the study, published Nov. 26 in the Canadian Medical Assn. Journal. In the study, the overall rate of hemorrhaging — bleeds serious enough to send patients to the hospital — was 3.8% per person, per year.

However, during the first month of treatment, the annualized hemorrhage rates were 11.8% in all patients and 16.7% among patients with higher risk of stroke. 

My comment: Do you want your drug approvals too fast or too slow? As a practioner I would like access to new therapies for my patients so we can make best decisions based on our assessment of the risks & benefts from the avaialble data.  Making drugs available does not require them to be used.  Not approving drugs absolutely prevents us from using them.

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An FDA effort to speed approval of new medicines allowed drugs onto the market without proper safety analysis, according to two drug-safety experts.

" the FDA could strike a better balance of safety versus innovation by insisting that companies produce more safety and effectiveness data soon after the drug is approved—and by insisting on automatic withdrawal of a drug if the data don't materialize. "Once a drug is approved, it is often very difficult to put the genie back in the bottle,"

The FDA's recent decisions on novel anticoagulants in atrial fibrillation have stirred debate and generated some consternation. For the clinical practitioner, how can we efficiently and effectively communicate the issues related to anticoagulation choice to the patient?  Dr Bilazarian proposes -CRABI:

C - Prescription coverage?
R - Normal renal function?
A - Early adopter?
B - GI bleeding?
I - Instability on warfarin?

Download the powerpoint presentation and the comparative Excel sheet.

An in-depth conversation between Pentucket Medical cardiologists Seth Bilazarian and Sunny Srivastava, focusing on a newly released medicine to reduce the risks of atrial fibrillation. The latest among recently approved blood thinners, Eliquis joins Pradaxa and Xarelto as an alternative to Coumadin, a drug that has been in use since the 1950s. Like Pradaxa and Xarelto, Eliquis has been shown to reduce risk of stroke and bleeding, as well as mortality. All the new drugs eliminate the need for regular blood testing that Coumadin necessitates.

As Pradaxa (dabigatran) celebrates its second anniversary since FDA approval, the clock is ticking to 2018, when its first patent is set to expire.  What are the impediments to new blood thinners despite a strong set of data from the development of this first in class new blood thinner. My thoughts in theheart.org Vlog.