Dabigatran (Pradaxa) is an oral direct thrombin inhibitor (first in class) that is FDA approved ONLY for systemic embolism prevention in non-valvular atrial fibrillation. When compared to warfarin in the RE-LY trial , Pradaxa decreased strokes with comparable major bleeds. However, there were 50% higher GI bleeds.

Dosage: Renally eliminated

-CrCl > 30 ml/minute = 150 mg PO BID
-CrCl 15-30 ml/minute = 75 mg PO BID
-No recommended dosage in CrCl < 15 ml/minute or hemodialysis.

Therapeutic level is achieved in ~ 2 hours

No coagulation monitoring is required or recommended by the FDA.

The INR is relatively insensitive and may or may not be elevated. APTT can be useful in determining an excess of anticoagulation activity ALTHOUGH changes in aPTT during monitoring treatment should be interpreted with caution. The median peak aPTT was approximately 2-times the control with a dose of 150mg PO BID in the RELY trial.

Thrombin time (TT) is sensitive, but there are no standardized reference ranges for therapeutic monitoring. TT will be available at Sharp Grossmont July 1, 2011.

No antidote is available. However, Pradaxa has a shorter half-life (12-17 hrs) than warfarin. It is important to maintain adequate diuresis because Pradaxa is primarily excreted in the urine. Pradaxa can be dialyzed.

There is possible reversal with prothrombin complex concentrate (PCC) based upon extremely limited anecdotal experience at UC Davis Medical Center.

Offset after discontinuation is two days with normal renal function; four days with renal impairment.

Adverse reactions: bleeding and GI effects (dyspepsia is most significant).

When converting patients from warfarin therapy to Pradaxa, discontinue warfarin and start Pradaxa when the INR is below 2.0.

When converting patients currently receiving a parenteral anticoagulants, start Pradaxa 0 to 2 hrs before the next dose of the parenteral anticoagulant.

PATIENT INFORMATION:

o ALWAYS store Pradaxa in it's original container.
o Once opened the product MUST be used within 30 days.
o Do NOT chew, break, or open capsules as it can result in increased exposure.
o No food- drug interactions reported.
o Drug interactions: Rifampin may decrease Pradaxa peak serum levels by 67%

FOR FULL PRESCRIBING INFORMATION REFER TO THE PACKAGE INSERT

Dancing with the Doctors
Friday, July 15
5:30 pm Hors d'oeuvres and 6 pm Dancing Lesson
Professional Instructors
$10 per person
SPOUSES WELCOME

Upcoming events: (details to follow)

• Monday, September 12 - General Medical Staff Meeting with Dr. Neil Farber, author of "The Blame Game"
• Wednesday, September 14 - SGH Medical Staff Happiness Committee "Afternoon of Tennis"

ONLY 10 DAYS LEFT IN THIS PROJECT!

It's time for the 2011 Medical Staff Community Service Project sponsored by the Happiness Committee! This is your chance to make a difference by helping some special kids right here in La Mesa!

Here's how to help:

Either:

• Decide how many kids you'd like to help and pledge $50 for each - we'll do the shopping! (Email lesley.bradley@sharp.com and then make your check payable to SGH Medical Staff and send it to Medical Staff Services at SGH.)

As of 6-20-11
92 backpacks have been purchased!

Are you interested in seeing a recently published issue of the E-Bulletin?