Private practice with Dr Seth Bilazarian

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Simvastatin: Now what?

Jul 5, 2011 08:50 EDT


Finding the right path for patients on simvastatin in light of the recent FDA recommendation is a dilemma as we wade through the recommendation itself, manufacturer information, pharmacy letters, and media coverage. How do we manage the simvastatin/calcium-channel-blocker interaction? What is the best method to review patients' records? How will (soon to be) generic atorvastatin fit into the equation? What is your approach?

See also:

FDA restricts use of simvastatin 80 mg








Your comments
Simvastatin: Now what?
# 1 of 7
July 6, 2011 05:29 (EDT)
KobayashiMaru

Well, just because nobody in the group has "seen" a case of rhabdo doesn't mean they weren't out there.  Maybe they were "lost to follow-up", which are often the ones with adverse events.  The data is the data and there are understandable physiological mechanisms behind the interactions. 

We are running EMR screens for all patients and advising them to come in for additional consulation, probably to be switched to Crestor, if affordable, and otherwise Lipitor, with the generic version upcoming. 

Of course, confusion and adherence problems are a consideration but this is actually a sound recommendation, in my view. 

# 2 of 7
July 6, 2011 08:52 (EDT)
Dan
Gosh, I didn't realize people were still prescribing simvastatin, particularly in the aftermath of studies like ASAP, A-to-Z and IDEAL.  Milligram for milligram you are going to get better LDL lowering and event reduction for atorvastatin or rosuvastatin, without the interaction through CYP3A4 and without the risk of myotoxicity at higher doses used alone (without the long list of CYP3A4 interactors on board).  Atorvastatin has been generic here for a while so I see this as a non-issue.
# 3 of 7
July 7, 2011 12:28 (EDT)
Blythe

Our formulary statin is Simvastatin.  We limited the dose to 40mg in March 2010, as well as the drug interaction dosing limitations.

We maintained Lipitor 80mg for post ACS patients, as well as Crestor 40mg on our formulary.

Some cardiologists are frustrated with the simvastatin labeling changes because in practice we very rarely see rhabdomyolysis cases, but from a legal standpoint, are we sitting ducks?

The recommendation on the table is to switch to pravastatin as statin workhorse at our hospital, as well as maintain Lipitor 80mg and Crestor 40mg.

# 4 of 7
July 15, 2011 11:02 (EDT)
John Lonergan
I'm not surprised that most of your cardiologists don't see rhabdo or similar problems.  They are neither trained nor do they exhibit a predilection to find it.  Rhabdo is much more common than you think, as are similar EM nerve troubles.  Recent NEJM and BMJ studies have demonstrated much higher numbers than previous literature, and opined that the risks of high-dose statins outweigh the benefits, particularly as patients approach the age of 75.  Above the age of 75, statins in general are not recommended.
# 5 of 7
July 15, 2011 11:59 (EDT)
Lyn

Thank you John.  I see patients with significant muscle pain and weakness to the point of distraction!  I also perform acupuncture and see a significant number of elder elders (80yrs+) on high dose statins and this has concerned me for awhile.  Thanks for the direction for the literaterature to show their physicians!

 

# 6 of 7
August 17, 2011 02:28 (EDT)
David
I was on 20mg simvistatin and 240mg Cardizem for a short time before the FDA warnings came out. I developed severe rash, malaise and just plain sick feeling until I was taken off of the simvistatin after the warning notes came out. It looks like the problem might be more than just muscle related as well.
# 7 of 7
August 26, 2011 09:57 (EDT)
Leslie

I'm a pharmacist with Walmart and I have been absolutely shocked to see the number of patients on Simvastatin 80 mg.  I think when you work in areas serving the middle to upper class you tend to see the more expensive statins being utilized, but with the turning economy, more and more people are being placed on Simvastatin, quite often at the highest doses.  

I've worked as a clinical pharmacist in hospitals for years and  volunteer at a local clinic for the poor.  In these settings, I have seen documented cases of rhabdo.  It is rare, but important and quite frightening to the patient.  

My approach to this new information has been to review rhabdo with every patient on Simvastatin 80 mg coming in for a refill/new Rx.  I call/fax the doctor to give them a heads up about the new information from the FDA in case they've missed it and as a gentle reminder that they have a patient on this high dose.  I also provide the patient with that information.  Additionally, I'm making a TON of recommendations on dose adjustments in light of the FDA alert for CCBs, gemfibrozil, etc. 

You specifically mentioned concern about switching to alternative statins and I want to share with you that I am working with people highly concerned about their wallets.  They come to Walmart to save money, often because they are unemployed, etc.  

During this time, I have had private conversations with the customers, reviewed the information, explained that it is extremely rare, but potentially very serious and reviewed options with them.  I explain that Lipitor will likely be off patient within a few months and show them the FDA chart comparing doses of equivalent statins.  I find that customers really appreciate knowing that there ARE options, understanding the risks/benefits of those options and most of my patients have been willing to pay more money for a brand name drug for a few months for better safety.  I do agree that switching several times between drugs is not a good idea, so I've been pushing more for Lipitor.

Hope that helps.  I really enjoy your blog!  Thanks. 

 

 


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About Dr Seth Bilazarian
Seth Bilazarian MD has been a Clinical and Interventional Cardiologist at Pentucket Medical Associates in Massachusetts since 1993. He is board certified in Internal Medicine, Cardiovascular Medicine, Nuclear Cardiology, Vascular Ultrasound, Interventional Cardiology, and Vascular and Endovascular Medicine.

Dr Bilazarian performs coronary and peripheral interventions at Lahey Clinic and Massachusetts General Hospital. He has been an investigator in the interventional laboratory for new devices including drug-eluting stents, distal protection devices, imaging devices (OCT and InfraRed), and anticoagulant pharmacotherapy.

Dr Bilazarian is an active participant in clinical trials in congestive heart failure, hypertension, coronary disease prevention, prediabetes management, anemia, atrial fibrillation, and anticoagulation/antiplatelet therapies in the outpatient setting. He has authored numerous papers and book chapters in clinical cardiology. He was appointed as a physician advisor to the circulatory device panel of the FDA in 2008.
About this blog
My intent is to create a forum for dialogue on issues pertinent to private practice cardiology around topics such as:

  • Integration of new data and guidelines on inpatient and outpatient practice in clinical and interventional cardiology
  • Practice approaches to the extra clinical issues in dealing with managed care insurers
  • Strategies for navigating the restrictions of pharmacy benefits managers (PBMs) on pharmacologic therapies for our patients
  • Experiences with restrictions on testing and imaging
The video blog (VLOG) will provide an opportunity to share broadly different approaches to the common conundrums we face in caring for patients. My hope is that this forum will provide useful data points for practice outside of tertiary and academic centers and a look inside community hospitals and physician?s practice patterns in the office, starting with mine.