To stimulate your clinical pharmacy paradigm

[ZpackSux]

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Who's read the blockbuster trial OASIS 5?

It is the largest ACS (acute coronary syndrome) trial to date. This trial will shake up the LMWH market and can potentially destroy Enoxaparin market share.

Don't worry guys. I've already presented my case and I'm not trying to get you guys to do my work. But I am curious to know who amongst you can identify opportunities which arise for clinical pharmacy and pharmacoeconomics from this simple trial?

What do you know about it and how will it change the future of anticoagulation?

 

[sdn1977]

Is this a test????? 😱

 

[imperial frog]

There will be blood on the walls. Or are we trying to stop that from happening...I always get confused.

 

[ZpackSux]

Is this a test????? 😱

kinda

 

[ZpackSux]

There will be blood on the walls. Or are we trying to stop that from happening...I always get confused.

we're gettin close..but not quite.

If you read the study, then you would know..

 

[WVUPharm2007]

Let me guess, they figured out Arixtra works better than Lovenox longterm. Haven't they been hinting at that for a while now or have I been hallucinating journal articles again? Less deaths, less stroke, something, something? How much more does Arixtra cost your pharmacy over Lovenox, anyway, there, Z? I've never dispensed the aesthetically pleasing blue Arixtra syringe since I started my retail stint, so I have no frame of reference.

 

[dgroulx]

I haven't read the trial. At my administration rotation, a change was discussed and LMWH won the battle because it's cheap. Medication management is all about using the least expensive drug at some hospitals.

 

[All4MyDaughter]

Our pharmacy manager threw some Oasis related stuff away yesterday without opening it, so I dunno.

 

[ZpackSux]

I haven't read the trial. At my administration rotation, a change was discussed and LMWH won the battle because it's cheap. Medication management is all about using the least expensive drug at some hospitals.

With all due respect, LMWH is not cheap. Througout the nation, it is one of the highest cost class of medication in top 5.

Lovenox 80mg q12h will cost $70. (hospital cost)
Fragmin 10,000u q12h will cost $60.

Arixtra 2.5mg once a day costs $22 without marketshare and $16 with.
Heparin will of course cost like nothing.

Not sure where you did the rotation but they are either highly mis-informed or they didn't read OASIS 5.

 

[ZpackSux]

Let me guess, they figured out Arixtra works better than Lovenox longterm. Haven't they been hinting at that for a while now or have I been hallucinating journal articles again? Less deaths, less stroke, something, something? How much more does Arixtra cost your pharmacy over Lovenox, anyway, there, Z? I've never dispensed the aesthetically pleasing blue Arixtra syringe since I started my retail stint, so I have no frame of reference.

Read the dang article will ya? I can email it to you if you want...

 

[sdn1977]

Zpack....are you referring to the dosing controversy of enoxaparin during the OASIS 5 trial? That was a big limitation of the study.

Altho Arixtra does not need as much dosing adjustment than Lovenox, Lovenox still must be dose adjusted for decreased renal clearance.

Since bleeding was one of the endpoints for safety which were evaluated, when the Lovenox was not adjusted, the bleeding appeared to be greater in that group.

That does not make the Lovenox better nor make Arixtra not a good drug to add....it just means that part of the study was poorly designed so the results must be taken with a grain of salt, IMO.

😳 Did I pass? 😉

 

[WVUPharm2007]

Here's the thingy-do from Medscape:
http://www.medscape.com/viewarticle/513986

It doesn't discuss the pharmacoeconomics, though. Do you have a cost-benefit type article, Z?

 

[Caverject]

With all due respect, LMWH is not cheap. Througout the nation, it is one of the mostly costly class of medication being in top 5.

Lovenox 80mg q12h will cost $70. (hospital cost)
Fragmin 10,000u q12h will cost $60.

Arixtra 2.5mg once a day costs $22 without marketshare and $16 with.
Heparin will of course cost like nothing.

Not sure where you did the rotation but they are either highly mis-informed or they didn't read OASIS 5.

I smell a Sanofi rat around here...

 

[dgroulx]

Not sure where you did the rotation but they are either highly mis-informed or they didn't read OASIS 5.

At one meeting that I went to, Arixtra was proposed. It actually cost more because they weren't getting a "special deal". I found that drug companies will sell certain products at a loss to make sure that another of their drugs is put on your formulary.

The rotation was in administration, so it dealt with all the business meetings and planning. Patient care was never part of the agenda. It was all about wheeling and dealing. There were free lunches almost every day.

Another thing we did on a regular basis was chart bio tech drug usage by physician. Then they went after the physicians for using these drugs because of the cost. I had to track down use of non-formulary medications, too.

I won't mention the hospital where I was at, but if I ever get really sick I'm going someplace else.

 

[ZpackSux]

At one meeting that I went to, Arixtra was proposed. It actually cost more because they weren't getting a "special deal". I found that drug companies will sell certain products at a loss to make sure that another of their drugs is put on your formulary.

The rotation was in administration, so it dealt with all the business meetings and planning. Patient care was never part of the agenda. It was all about wheeling and dealing. There were free lunches almost every day.

Another thing we did on a regular basis was chart bio tech drug usage by physician. Then they went after the physicians for using these drugs because of the cost. I had to track down use of non-formulary medications, too.

I won't mention the hospital where I was at, but if I ever get really sick I'm going someplace else.

They weren't looking at 2.5mg Arixtra vs Lovenox. The traditional Arixtra ACS dosing is 10mg..which is comparable cost to Lovenox. Oasis 5 showed 2.5mg is just effective with 50% less bleeding. And nowhere will you pay more than $25 for 2.5mg of Arixtra.

 

[ZpackSux]

Zpack....are you referring to the dosing controversy of enoxaparin during the OASIS 5 trial? That was a big limitation of the study.

Altho Arixtra does not need as much dosing adjustment than Lovenox, Lovenox still must be dose adjusted for decreased renal clearance.

Since bleeding was one of the endpoints for safety which were evaluated, when the Lovenox was not adjusted, the bleeding appeared to be greater in that group.

That does not make the Lovenox better nor make Arixtra not a good drug to add....it just means that part of the study was poorly designed so the results must be taken with a grain of salt, IMO.

😳 Did I pass? 😉

What did you do..read an editorial?? I'll give you a B.

Granted, Lovenox was dosed 1mg/kg q12h.. which is how it's dosed.. unless of course crcl < 30. That's right, Arixtra saw 50% reduction in bleeding. That's huge!!!.. Would renal dosing allow Lovenox to have less bleeding? maybe... but 50 percent reduction? I doubt it.

Then how about efficacy? It showed that a low dose of Arixtra 2.5 mg was just as effective as Lovenox..overdosed or not.

So we have a drug that costs 20% of Lovenox but has 50% less bleeding but just as effective in ACS.. Think about that. Sanofi never ever gave us a deal in Lovenox pricing..until recently.. That why I've been a big proponent of Fragmin which used to cost 40 percent less than Lovenox... and I took Lovenox off the formulary at 3 different hospitals..

This time, it will be easy.. Arixtra is making Lovenox reps nervous. Gotta love it. 👍

 

[Wildwilly]

With all due respect, the clearance of fondaparinux is a concern. If you look carefully, patients were not admitted in trial with Sr Cr above 2. Look further to see that bleeding in patients with creatine clearanance less than 30 is CONTRAINDICATED. Furthermore, the trial results are not a true head to head trial of fondaparinux vs Lovenox. Over 75% of the patients in Lovenox arm had UFH added, therefore more bleeding in this arm. However, the fondaparinux arm had the advantage with only 18% of patients having UFH added. Moreover, the 2.5mg dose of fondaparinux dose is a prophylaxis dose, where the 1mg/kd dose of enox is a full anticoagulation dose. This is why the bleeding profile favored fondaparinux. The overall clinical outcomes was a composite endpoint including Bleeding indexes. If the bleeding index is not included in final endpoints, fondaparinux did NOT do better than enoxaparin. Therefore, the design of trial is flawed in that one can not make a conclusion that fondaparinux is better with regards to safety or efficacy. Take a closer look.

 

[npage148]

is this the correct reference?
N Engl J Med. 2006 Apr 6;354(14):1464-76. Epub 2006 Mar 14

Ill read it right now

 

[ZpackSux]

With all due respect, the clearance of fondaparinux is a concern. If you look carefully, patients were not admitted in trial with Sr Cr above 2. Look further to see that bleeding in patients with creatine clearanance less than 30 is CONTRAINDICATED.

Low CrCl requires dosing modification for Enoxaparin also. Hence Clearance of Enoxaparin in these patients is also a conern.

Furthermore, the trial results are not a true head to head trial of fondaparinux vs Lovenox. Over 75% of the patients in Lovenox arm had UFH added, therefore more bleeding in this arm. However, the fondaparinux arm had the advantage with only 18% of patients having UFH added.

Wrong. 17.8% vs 17.7% at the randomization for E vs F and 31.2% vs 22% in the hospital after randomization.

Moreover, the 2.5mg dose of fondaparinux dose is a prophylaxis dose, where the 1mg/kd dose of enox is a full anticoagulation dose. This is why the bleeding profile favored fondaparinux.

Woah.. isn't that amazing? A prophylaxis dose at 2.5mg had a ACS anticoagulation efficacy equivalent to Enoxaparin full dose!!!!!

The overall clinical outcomes was a composite endpoint including Bleeding indexes. If the bleeding index is not included in final endpoints, fondaparinux did NOT do better than enoxaparin.

Wrong. Even in the Enoxaparin group who didn't get UFH had a higher rate of bleeding. You don't read the fine prints..do you?

Therefore, the design of trial is flawed in that one can not make a conclusion that fondaparinux is better with regards to safety or efficacy. Take a closer look.

Actually we can make a fairly clear conclusion on the safety and efficacy. Only flaw is that they didn't list the bleeding data on the table on patients who didn't receive UHF. Because of the reduction of ischemic event in both arms were similar...despite the added UFH in the Enoxaparin. Then could we consider what would've happened if UFH wasn't added?


Welcome to the forum.

 

[ZpackSux]

is this the correct reference?
N Engl J Med. 2006 Apr 6;354(14):1464-76. Epub 2006 Mar 14

Ill read it right now

Yes

 

[ZpackSux]

With all due respect, the clearance of fondaparinux is a concern. If you look carefully, patients were not admitted in trial with Sr Cr above 2. Look further to see that bleeding in patients with creatine clearanance less than 30 is CONTRAINDICATED. Furthermore, the trial results are not a true head to head trial of fondaparinux vs Lovenox. Over 75% of the patients in Lovenox arm had UFH added, therefore more bleeding in this arm. However, the fondaparinux arm had the advantage with only 18% of patients having UFH added. Moreover, the 2.5mg dose of fondaparinux dose is a prophylaxis dose, where the 1mg/kd dose of enox is a full anticoagulation dose. This is why the bleeding profile favored fondaparinux. The overall clinical outcomes was a composite endpoint including Bleeding indexes. If the bleeding index is not included in final endpoints, fondaparinux did NOT do better than enoxaparin. Therefore, the design of trial is flawed in that one can not make a conclusion that fondaparinux is better with regards to safety or efficacy. Take a closer look.

This is what our Lovenox rep tried to tell me.... 😎

 

[OHMAN0125]

This is what our Lovenox rep tried to tell me.... 😎

Although this large study clearly favors Arixtra, have there been other studies that have also came up w/ similar data? I always like to see more data before deciding on which one to favor concretely.
Also, one more thing, did they mention the primary therapy for ACS? Were they the same in all patients? I'd think that those that received stents should be placed in a different group than those that received tpa,streptokinase(etc.) since this may have affected bleeding profile.

 

[ZpackSux]

Although this large study clearly favors Arixtra, have there been other studies that have also came up w/ similar data? I always like to see more data before deciding on which one to favor concretely.
Also, one more thing, did they mention the primary therapy for ACS? Were they the same in all patients? I'd think that those that received stents should be placed in a different group than those that received tpa,streptokinase(etc.) since this may have affected bleeding profile.

The answers to your questions are addressed in OASIS-5.

 

[GravyRPH]

So Zman, have you done anything policy wise since June? Has usage changed at all and if so, how did you go about getting them to change? We still use about 20 Lovenox to 1 Arixtra....

 

[ZpackSux]

So Zman, have you done anything policy wise since June? Has usage changed at all and if so, how did you go about getting them to change? We still use about 20 Lovenox to 1 Arixtra....

Groovey..

Can't do anything with Arixtra until FDA says it's Kosher for ACS. It's on the fast track..should be coming out with the indication pretty soon. But when we implement this, it'll have to be all or none deal or it won't work. When we went from Lovenox to Fragmin at a different hospital, we made it an automatic sub... we immediately went 95% marketshare.