anticoagulants

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RPh PharmD

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ANTICOAGULANTS
You'll start hearing lots more about the comparisons between warfarin, dabigatran (Pradaxa), and rivaroxaban (Xarelto).
Now that Xarelto is approved for atrial fib, people are asking if they should switch to it or Pradaxa as an alternative to warfarin.
Help keep their pros and cons in perspective.
Efficacy is where Pradaxa may have a slight edge. Pradaxa 150 mg BID prevents about 5 more strokes per 1000 patients/year than warfarin.
Xarelto 20 mg once a day doesn't seem to work better than warfarin.
Side effects such as overall bleeding are similar between Pradaxa and Xarelto compared to warfarin. Both seem to cause FEWER intracranial bleeds...and MORE GI bleeds than warfarin.
But dyspepsia is a problem with Pradaxa.
Cost is less with warfarin...totaling about $80/month with INR monitoring once/month. Pradaxa and Xarelto both cost about $260/month.
Continue to suggest warfarin for many atrial fib patients.
Suggest another oral anticoag if INR control is poor...warfarin interactions are a concern...or monitoring isn't feasible.
If a newer anticoagulant is needed, suggest Pradaxa first...it's more effective than warfarin in some patients. Tell patients that Pradaxa is now good for 4 MONTHS after opening...instead of just 60 days.
For now, suggest Xarelto for patients who can't tolerate Pradaxa due to dyspepsia...or have trouble with its BID dosing. Advise taking Xarelto with dinner to improve absorption.
Recommend monitoring renal function with the new anticoagulants...and lowering the dose if needed.
Discourage using aspirin for atrial fib. New evidence suggests that it's not much better than placebo...and it still increases bleeding.
Suggest saving aspirin for younger patients without additional stroke risk factors...or those who won't take an anticoagulant.
If you want to be the smartest person in your area about the new anticoags for atrial fib, go to our PL Detail-Document...and listen to our experts talking on PL Voices. Also see our PL Chart, Comparison of Oral Antithrombotics, for their indications, dosing, interactions, etc.

View Detail-Document #271201
 




Brilliant analysis until you realize "RPh Pharm D" that there are no direct head to head studies including warfarin, Xarelto and Pradaxa. What this means to you is you can't create "comparisons" by pulling data from different studies and integrating it all together to come to a single conclusion and make a valid Evidence Based Medicine decision on which anticoagulant "may have a slight advantage" in efficacy.
 




this is the way it is. real world. i wanted you all to see what healthcare professionals are reading from their journals. it is what it is. also , if you review canadian a fib guidelines they now recommend PRADAXA 1st line over warfarin
 




exactly so. a critical care drug like an anti-coagulant its all about efficacy first. Everything else is a secondary consideration. So unless you have shown superiority to the "gold standard" you are only going to change based on a tolerability issue, certainly not cost. You guys got a third line drug.
 




Anonymous said:
exactly so. a critical care drug like an anti-coagulant its all about efficacy first. Everything else is a secondary consideration. So unless you have shown superiority to the "gold standard" you are only going to change based on a tolerability issue, certainly not cost. You guys got a third line drug.
Click to expand...

Yes it sucks you guys couldn't design a trial to save your life, even when you tried to stack the deck in your favor (inclusion criteria, cherry picked research sites, unskillful use of comparator, and so forth) you still drew up a blank dud. That's the breaks, accept that your drug is useful in that it should be placed on the shelf closest to the floor and cede room for a top-shelf product. Efficacy shows utility and pradaxa' efficacy shows utility whereas riva's data-set makes it unclear how useful it would be. The great thing about evidenced based medicine now you guys can go replicate our study substitue yours and move on. But until then you get what you got and stop whining about it.
 




Anonymous said:
exactly so. a critical care drug like an anti-coagulant its all about efficacy first. Everything else is a secondary consideration. So unless you have shown superiority to the "gold standard" you are only going to change based on a tolerability issue, certainly not cost. You guys got a third line drug.
Click to expand...

you're wrong. anti-coaging is all about safety first.
 




What a fucking joke of a thread - don't you BI/Pfizer pricks have anything better to do?

YOU CANNOT FRIGGIN COMPARE DATA BETWEEN STUDIES.

Rivaroxaban works. Dabigitran works. Coumadin works. Apixaban might work. They all cause bleeds. Only one is QD and doesn't require monitoring. Only one of the new ones has multiple indications (soon to be three).
 




Let the parsing begin. Your PI states: "Non-inferiority to warfarin." Safety first? Seriously? Comparing studies? So what? You want to prevent stroke first and foremost right? Everthing else is secondary. So if your drug is not better than warfarin in PREVENTING stroke but it has its own safety issues and is WAY more expensive then sorry. You are not first line.
 








Anonymous said:
Let the parsing begin. Your PI states: "Non-inferiority to warfarin." Safety first? Seriously? Comparing studies? So what? You want to prevent stroke first and foremost right? Everthing else is secondary. So if your drug is not better than warfarin in PREVENTING stroke but it has its own safety issues and is WAY more expensive then sorry. You are not first line.
Click to expand...

So then why are you here with all your ranting and raving? You're awesome, Pradaxa is awesome, the market is dominated by warfarin so why get all wound up here? You're trying to sound superior but you're coming across as insecure, whiny and a douche. Take all your awesomeness and go make thousands in bonus dollars and be happy. Or, are you really here because you're that scared?
 




Anonymous said:
What a fucking joke of a thread - don't you BI/Pfizer pricks have anything better to do?

YOU CANNOT FRIGGIN COMPARE DATA BETWEEN STUDIES.

Rivaroxaban works. Dabigitran works. Coumadin works. Apixaban might work. They all cause bleeds. Only one is QD and doesn't require monitoring. Only one of the new ones has multiple indications (soon to be three).
Click to expand...

They don't all cause the same bleed rates you idiot. And none of the new ac require labs.
 




Anonymous said:
Let the parsing begin. Your PI states: "Non-inferiority to warfarin." Safety first? Seriously? Comparing studies? So what? You want to prevent stroke first and foremost right? Everthing else is secondary. So if your drug is not better than warfarin in PREVENTING stroke but it has its own safety issues and is WAY more expensive then sorry. You are not first line.
Click to expand...

It's clear that X was significantly superior to warfarin on treatment. It's clear that compliance is better on a QD drug. It's clear that many aren't in well-controlled INR range in the real world. It's clear that there are costs associated with monitoring and that many will pay $1 a day to not have to take coumadin. It's clear that there will soon be three inidcations for X. And it's fucking clear that the d-bags posting here from BI and Pfizer are worried.
 








Anonymous said:
What a fucking joke of a thread - don't you BI/Pfizer pricks have anything better to do?

YOU CANNOT FRIGGIN COMPARE DATA BETWEEN STUDIES.

Rivaroxaban works. Dabigitran works. Coumadin works. Apixaban might work. They all cause bleeds. Only one is QD and doesn't require monitoring. Only one of the new ones has multiple indications (soon to be three).
Click to expand...

Maybe you can't but the hell I can!
 




Anonymous said:
So then why are you here with all your ranting and raving? You're awesome, Pradaxa is awesome, the market is dominated by warfarin so why get all wound up here? You're trying to sound superior but you're coming across as insecure, whiny and a douche. Take all your awesomeness and go make thousands in bonus dollars and be happy. Or, are you really here because you're that scared?
Click to expand...

I am here becuase for the last year you rivarox douche's came over and bagged on my board and I don't like it. Bout time I mercilessly tossed your salad for the next year. (You have until Nov 2012).
 




Anonymous said:
It's clear that X was significantly superior to warfarin on treatment. It's clear that compliance is better on a QD drug. It's clear that many aren't in well-controlled INR range in the real world. It's clear that there are costs associated with monitoring and that many will pay $1 a day to not have to take coumadin. It's clear that there will soon be three inidcations for X. And it's fucking clear that the d-bags posting here from BI and Pfizer are worried.
Click to expand...

X was not superior to warfarin in the ITT (all else is statistical smoke and mirrors)

Compliance is always WORSE on a QD drug and ALWAYS worse when you can only take said drug at evening with a meal. NO OTHER DRUGS ARE TAKEN THIS WAY AND SO PEOPLE WILL FORGET!! Your half-life of 5 hours will NOT suffice for 48 hrs as well. Double whammy, sonny boy!!

In the real world, family practice offices get 55% TTR on warfarin. But anticoag clinics which make up the majority of patients get 62% and higher which is way better than yours.

In the real world you want to make sure the comparator is as good as you can get, so as not to bias the results. Learn essentials of clinical trials 101 before you even debate this. Whoever gets the highest utility out of their comparator wins because it means the results are more robust and better approximates the bell-curve.

Monitoring is a 10 buck copay on top of 5 dollar warfarin. So half the monthly price with NO DOUGHNUT Hole sliding.

Indications don't mean shit outside of a cost-constrained institution. Why would a family practice guy care that you use Zarelto after someone cuts on a knee or hip, especially since they ain't doing this themselves.
 




Anonymous said:
X was not superior to warfarin in the ITT (all else is statistical smoke and mirrors)

Compliance is always WORSE on a QD drug and ALWAYS worse when you can only take said drug at evening with a meal. NO OTHER DRUGS ARE TAKEN THIS WAY AND SO PEOPLE WILL FORGET!! Your half-life of 5 hours will NOT suffice for 48 hrs as well. Double whammy, sonny boy!!

In the real world, family practice offices get 55% TTR on warfarin. But anticoag clinics which make up the majority of patients get 62% and higher which is way better than yours.

In the real world you want to make sure the comparator is as good as you can get, so as not to bias the results. Learn essentials of clinical trials 101 before you even debate this. Whoever gets the highest utility out of their comparator wins because it means the results are more robust and better approximates the bell-curve.

Monitoring is a 10 buck copay on top of 5 dollar warfarin. So half the monthly price with NO DOUGHNUT Hole sliding.

Indications don't mean shit outside of a cost-constrained institution. Why would a family practice guy care that you use Zarelto after someone cuts on a knee or hip, especially since they ain't doing this themselves.
Click to expand...



Girlfriend, why all the anger? It's holidays, Merry Christmas!
 












alert

December 19, 2011 Heartwire
RECOVER II confirms benefit of dabigatran in treatment of VTE

San Diego, CA - Data from the RECOVER II study confirms the safety and efficacy of dabigatran (Pradaxa, Boehringer Ingelheim) when compared with warfarin for the treatment of patients with acute venous thromboembolism (VTE) [1]. The new study included significantly more Asian patients than the 2500-patient RECOVER trial, note investigators, and the rates of recurrent VTE and bleeding were similar in these patients and non-Asian patients.

RECOVER II, presented last week at the American Society of Hematology 2011 Annual Meeting, led by Dr Sam Schulman (McMaster University, Hamilton, ON), was designed to replicate the results of RECOVER, given the low rate of the primary outcome—a composite of recurrent VTE or fatal pulmonary embolism (PE)—in the original trial.
 




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