If we look deep down at this study and several of Crestors previous studies...these are "Marketing" driven studies and not true "Scientifically" driven studies...screen 90000 patients so you can get exactly the type of patient that you can show benefit, then compare your statin to placebo...the 44% reduction in the Crestor arm was 142 patients versus 251 in the placebo arm...yes, a reduction of 44%...out of 17000 patients!!!...then end the study at 1.9 years before cancers and AE start showing up to tarnish the study...what about the higher incidence of diabets in the active arm versus the placebo arm...knowing full well Crestor's past with Proteinuria, Hematuria and kidney toxcity when using the higher doses of 40mg and the banned dose of 80mg?...once again...a "marketing" driven study...which the media beautifully picked up and most people are touting as extraordinary...but why?...why?...because Crestor has to create a bigger Cholesterol market pie in order to grow more market share...why?...when Lipitor goes generic in 2011...the Cholesterol pie will take a big hit...unless you are Crestor and you have prepared some clever marketing studies over the past years to show that you are different than Lipitor and you are worth the cost beyond generics!...once again..."Marketing" driven study taken right out of the Pfizer playbook!!!...what this study does support is the LDL Hypothesis...that using statins to lower LDL-C below 70, even for patients with no pre-existing cardio risks...it provides benefits......but the itch that can't be scratched is...what would the results be if they used another active comparator and let the trial run its course?

Dear Melissa

this issue was already raised in your site and it is very interesting that this study gives a boost to move forward and start applying this practice either at home or in the physician office.

I have major concerns about the point that you raised regarding the lack of infrastructure and facilities for INR monitoring concerning many physicians whose practice is not the same than privileged physicians in university hospitals or highly well organized.

my concern is that this issue would sometime push treating physicians to shy and avoid prescribing coumadin, by finding some week justification and obviously they are retained  by the secondary lethal effect of coumadin, namely bleeding.

LET'S not forget that DAM IF YOU DO IT AND DAM IF YOU DON'T...so better get organized , well equiped and do it the proper way with the less risk possible and the biggest benefit and accomodation for the patients.in my humble experience with the INR self-monitoring program,I can certify that it is doable since there is no reason why diabetic patient are able to do it and not PT-INR patients.

Dr. Walton-Shirley's comments are right on target, other than the reference to monthly testing: medical evidence points to weekly rather than monthly testing (warfarin metablolism is affected by too many things to leave it to monthly checks). 

Warfarin is recognized as a dangerous but necessary drug, yet, when combined with adequate monitoring to make sure the patient is in therapeutic range it is shown safe and effective!  It seems to be that infrequent monitoring is what causes the danger.  Monthly or every 6 weeks seems to be just hap-hazard; the most often they could expect patients to show up at clinic, perhaps?  Some studies show the best results are once every 4 days, but once-a-week seems to be ideal among many studies worldwide. Medicare adopted "up to once-a-week" in the home monitoring decision memorandum of 2001, based upon medical evidence. 

Medicare has been covering home testing (patient self-testing) for people with Mechanical Heart Valves since 2001, and this year added patients with a. fib. This decision was based upon medical evidence.  Many private insurance companies have covered it for years, albeit with many hurdles for patients.  Every patient with an Rx for Warfarin should have easy access to POC or have an Rx for PST if they are able & willing (or have a caregiver / spouse / relative who is able & willing) to perform the test, much as a diabetic routinely checks their blood sugar (fingerstick). 

Several years ago I was a fly on the wall in a meeting of doctors, and the discussion came to one of the most basic: if you, or "your mom", needed warfarin, would you want frequent testing via PST?  The resounding answer I recall was YES.  If insurance covers it, and it saves even one stroke, POC or PST should be made available to every patient taking warfarin.

Dr. Alan Jacobson once suggested “…We don’t need more effective therapies, we need more effective means of delivering currently available therapy to those patients who would benefit…”.  Medical evidence supports increasing the PT (INR) test frequency to reduce adverse events.  Technology, available since the late 1990’s and used routinely in offices at the point-of-care, is available and cleared for use by the FDA  for patients (or their caregivers) to use under prescription, is covered by many plans, yet is not yet widely prescribed. What is holding this back?

Dear S:

Couldn't agree more but the author of this study stated that the current reimbursement to  manage a patient with coumadin is 9.00$ per month.  We run a protime clinic and only break even.  Some offices cannot afford to supply a nurse or tech to run their clinic if there is not even enough payment to cover their hourly wage.  Plus, it takes time.  Most protime clinic patients come in with other issues, it boggs down the clinic because they don't want to have to come to the office twice. Once CMS wises up, hires an accountant, figures out that the cost of one stroke costs more than a gazillion patient months adequate testing, the US of A will have cash to spare on this issue.

Dr Kiwan:

A point of care testing device is only around 1800 dollars.  I really feel it's a moral issue for us  to provide this service if we  are going to prescribe it.  

Dear JD,

Appreciate your commentary on the pharmaceutical underworld, but I think you posted on the wrong blogg.  I don't believe it's all espionage, or else I or my other family members wouldn't take a statin. It's funny how there is no public outcry for the billions of dollars spent on vitamins with NO efficacy proven and such a backlash for statin therapy when there is so much data to support its use.  I think it's a prejudice against industry and/or physicians that also drives a lot of undeserved negativity .  That negativity dilutes the much deserved criticism that we all see a need for on occasion.

Melissa 

Dear Dr.: 

I was diagnosed with a DVT of the right leg 1 month ago (early Feb 2009) and was started on Lovenox and Coumadin.  I was able to stop Lovenox within a week of diagnosis.  I have remained in the 2-3 range for most visits; however, my PT/INR increased to 4.1 in the second week.  My doctor ordered a STAT PT/INR drawn from my arm and the result was 5.5.

Now, I am not scheduled to return to the office for testing until the first week of April.  My last visit was March 5, 2009 and my PT/INR was 2.3.

I asked my doctor for a prescription to get the Coag Home Monitor made by Roche and she denied my request.  Her concerns were cost, reliability and that I should be monitored at the office.  I responded that the cost would be paid by my insurance and or flexible spending account and that the clinic should not be concerned about that.  Also, I expressed my concerns about the reliabiliby of the clinic's monitor since my finger stick was 4.1 and when taken from my arm (10 mins. later) that result was 5.5.  My doctor's denial was backed by the Medical Director of the clinic - stating that I should be monitored at the clinic, per policy.

I am a registered nurse and my doctor is well aware of that.  I argued that my reasoning was a proactive approach about my health and if my results were high at home, I would contact the office for testing there and that I would not self treat.

I have been going to this primary care physician for almost 10 years and I am deeply hurt that she denied my request.

Should I not feel this way?  I am seriously thinking about changing my primary physician.  Please share your thoughts.

Thank you,

Angie

I read your posts for quite a long time and must tell that your posts always prove to be of a high value and quality for readers.

Dear six pack, thanks for your compliment.  I always hope what I write is helpful to someone!

Dear Angie,

Although this website cannot be utilized to advise patients individually, since you are a health care provider, I'll speak generally about the topic. 

Like all other new modalities or changes in technique, it takes a while before practitioners/physicians/nurses, etc. can adapt.  I remember when I first came to Glasgow, every cath got 2000 units of heparin.  It only took about 15-20 minutes to do a the average case and the nurses were having to hold our groins forever.  My director asked if I'd be willing to decrease my heparin bolus to 1000 units max.  I couldn't think of such a thing, but did unwillingly try it and 20 years later, there are many patients in which I don't use any heparin at all for a diagnostic cath.

The uptake will be slow for many.  It's scary for some.  However, education is the key to understanding so I'd ask if there is any way that your physician might allow someone from the supplier to arrange for a visit with your physician.  After that, you'll need to have another conversation with her and then go from there.

Good luck

Melissa

You have a good site all very tastefully done! I really liked. Sincerely Ritt.

The result is still on the fax machine at 8 am when the office closes.  It's Tuesday, the staff collects all the overnight faxes the next morning.  With about 65 lab slips in hand, it's handed to the filing person.

Melissa is absolutely right.  I have just discovered her blog and her writings are impressive.  I speak to cardiologists, nurses, and clinicians who consistently have no idea about the many studies that show more frequent testing is safer and that in-home testing once a week is not only adequate but has shown in over a decade of studies to reduce dramatically the risks of stroke and major and minot hemorrhage. 

The staggering number of doctors who do not offer POC testing is most likely a result of it being a substantial loss leader economically.  With all the hits cardiologists have been taking from Medicare this past decade, it is not surprising that they rely on outside labs that can take days to relay the INR data of a patient back to their physician.  

Obviously, I am a passionate advocate for self testing on a weekly basis.  Melissa's desciption of 'rolling the dice' inbetween monthly INR tests is spot on.  It seems like common sense to me.  More data, more frequently, equals appropriate dosing, increased time spent in therapeutic range, and dramatically reduced risk.  

Additionally, the tests are simple to perform for able bodied patients and result in a better quality of life and a sense of ownership and independence about their therapy.  

Though I think that managing one's own dosage on Coumadin is further away in the United States, monitoring at home is an issue whose time has clearly come.  Why should Melissa's hypothetical patient even have to drive 18 miles, or find a ride from a relative, only to test at an frequency that has been proven to be inferior.  This simply makes no sense.  

The big players in the home monitoring market have shown themselve to be impersonal and more about patient reimbursement revenue than patient outcomes, with very few companies even attempting to be a true extension of the physician's care.  But that said, if the greed of giants results in extended and improved quality of life for patients, I do not understand why so many practices still shy away from even learning about patient self testing.  Phillip, Alere (inverness diguised), and others are content to take 3 or 5 eligible patients from a coumadin clinic, but why not embrace all eligible, interested patients?  Why care for only the few that a clinic is willing to part with when we could be seeing improved outcomes clinic wide?  

Thank you Melissa for your insight into this issue and your passionate argument.  

Daniel McKeever

PHM

Daniel

Thanks so much for your post and I'm glad you enjoyed it.  After this year's ESC, I'm even more optimistic about patients who need Vit K dependant pathway anticoagulation.  With the direct thrombin inhibitors coming down the pike, we hope to soon close the book forever on the warfarin era. (though prosthetic valve folks will be the last to be tested I'm sure, if ever) Though I know the pharmaceutical companies will bring these compounds onto the American market that will make 3rd party payers squeal and self payers stare longingly through their drug store windows at this wonderful new drug class, Dabigatran, Rivaroxaban and Apixaban will be  Godsends for those who are lucky enough to afford them.  

Melissa

 

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