Internal Medicine, Lipid & Wellness of Fort Myers
Internal Medicine, Lipid & Wellness of Fort Myers Newsletter
In This Issue
PKS9 Inhibitors
A Super Shot
A Device For Atrial Fibrillation?
Quick Links
 Philosophy
 
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Medicare In Peril?
Three new (and somewhat unsettling) blog posts on The Doctors Report
 
Issue: # 2June/2015


There has been a lot happening in the health care field.  While I love going deep into a subject I am convinced most of us don't want to work that hard for our information. This newsletter I am going to take the approach of something I have done in the past which is "what is the doctor reading".  I will provide a synopsis and perhaps a "bottom line" comment as to why I felt the item was worth bringing to your attention.  I will link you to actual articles or other relevant information so you may dig deeper into the details if you wish.  So- here goes!
 
New Cholesterol Medication Class On The Horizon
Proprotein convertase subtilisin-kexin type 9
PSK9 Inhibitors
As a cholesterol expert I am aware that there is a significant number of people who report side effects to the standard (and proven) therapy for abnormally high LDL cholesterol, namely the drug class called statins. There are many statins available and all of them have been shown to reduce the risk and certainly reduce the recurrence of heart attack in people who have survived an acute myocardial infarction. The clinical evidence and experience is that any medication or behavioral change that reduces the number of non HDL cholesterol particles translates to lower risk of a first or subsequent vascular event. 

We haven't had any new/novel medication offerings for people who can't tolerate or can't get adequate response to statin therapy.  The class of medications known in the industry as PSK9 inhibitors are showing terrific promise.Two recent published studies demonstrate tolerance and effectiveness for lowering LDL cholesterol. 

The first study involved a medication that involves two pharmaceutical companies, Sanofi and Regeneron.  The drug name (all drugs start as generic named compounds) is Alirocumab.  It is an antibody that inhibits the PSK9 enzyme. It is injected under the skin of the patient. When this enzyme is inhibited the body is allowed to clear LDL cholesterol from the serum/blood stream and this then lowers measured cholesterol dramatically.  At 24 weeks (6 months) it dropped LDL cholesterol 62%!  This change persisted to 78 weeks/19 months.  In a subsequent analysis there were significantly lower cardiovascular events as well. After this publication the FDA announced they are recommending allowing approval of this medication to be used in a restricted setting of familial hypercholesterolemia.  This condition affects between 1:10,000 to 1:100,000,000 people.  These patients get premature heart attacks starting in their 30-40's.  The speculation is this injectable medication will cost $1200 a month to provide. 


LDL cholesterol levels, blue line represents Alirocumab treatment group



The next product reported to be equally as impressive in terms of results is made by Amgen pharmaceutical. This medication works on the same mechanism, again an antibody to the enzyme (the antibody diminishes the enzymes activity which translates to more LDL clearance from the serum).  The name of this molecule is Evolocumab.  It lowered LDL cholesterol 61%.  The rate of heart attack events went from 2.8% absolute incidence in the standard treatment (which included statins) to 0.95 in the treatment group. That is a very significant drop.  If 100 people were treated there would be 2 less heart attacks. Treatment was for one year. 
 

Cumulative Incidence of Cardiovascular Events 
 
Promising Vaccine For Shingles
A Better Mousetrap Is On the Way

Anyone in the middle to older age group either has personally had or knows someone who has experienced shingles. This is a very painful "resurfacing" of the chickenpox virus. For the past several years we have been vaccinating older adults (50 and above have been eligible) with a vaccine called Zostavax.  This product has been a major breakthrough as it lowered the actually incidence of an acute shingles episode by about 55-58% and the severity of pain from an outbreak by about 65%. 

A recent short followup duration but powerfully positive outcomes trial was recently reported in the New England Journal Of Medicine.  The product studied is a subunit vaccine containing a chickenpox virus glycoprotein combined with a "adjuvant" system called HZ/su. Adjuvant means "serving to help".  Boy did it!  This involved over 15000 people in over 18 countries. They followed these subjects 3.2 years and a clinical outbreak occurred in 6 vaccinated subjects versus 210 people in the control group.  That translates to an effective "take rate" of 97 %! People studied were age 50 and up.  I assume they will follow this group further into time and if this efficacy holds up, expect a new and far improved vaccine to come to the market. 
Look Ma- No Medication For Stroke Prevention!
A Device To Prevent Atrial Fibrillation Related Stroke?

This is not the first time I have read about this novel approach to stroke prevention but this is the most recent report I have seen. So far this option is reserved for persons who have been determined unsafe to take the present "gold standard" treatment of anti-coagulation.  This recent study from the Cleveland Clinic Journal Of Medicine showed "noninferiority" when the Watchman percutaneous device was compared to warfarin (Coumadin). 

Atrial fibrillation independently increases the risk of stroke by a factor of 4-5.  It accounts for 15% of all stroke and 30% of strokes in the 80 plus age range. Untreated folks run a 2-5% risk of a stroke in any given year.  

If the results found in this report can be replicated and if we can follow people out several years and find the same success rate this could well become the treatment of choice.  

As the diagram to the right shows,. the left atrial appendage has a rough surface. Roughness in the presence of blood flow will propagate a clot.  This device basically is deployed through the venous system in the groin and eliminates the rough surface of the appendage from the circulation. It apparently works well, as well as traditional therapy in this reported analysis. 
I hope you enjoyed this newsletter.  It was fun putting it together for you. I appreciate your patronage.
 
Sincerely,

Raymond W. Kordonowy MD
 
I appreciate the opportunity to be of service.

Raymond Kordonowy MD
Internal Medicine, Lipid & Wellness of Fort Myers
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