Friday, May 19, 2017

The campaign to sell PCSK9

Expensive PCSK9 inhibitors should be used to treat LDLc greater than 189 mg/dl before trying inexpensive low dose triple therapy treatment.

In my book, The Tubby Theory from Topeka, I documented my success with triple therapy for high LDLc for about 200 patients.

I advised starting with lowest dose of a generic statin.  I have updated my advice from using generic simvastatin (Zocor) to lipitor (Atorvastatin) and now generic rosuvastatin (Crestor).
Zetia is now generic but there is a 6 month window where the company is allowed to sell the generic for $1.00 less than brand Zetia.
Endur-acin is an over the counter niacin which has a proprietary matrix that causes very little flushing and side effects.  1,000 tablets can be purchased on line for $90.  I advise 2 tablets (1,000 mg) a day.

I am Diabetic type 2 and have gotten my LDLp down to 333 with this triple therapy.  That is the lowest number/value Liposcience lab will give for LDL particles measured with NMR.  I have lost 80 pounds since 2006 but I gained back 50 lbs despite intensive exercise after 5 years.  I then went on Atkins since 2011 with 60% fat and less exercise.  No false hope for diet and exercise.

I am very skeptical of the usual recommendation of diet and exercise as the  10 year long LOOK AHEAD trial resulted in a negative study to prevent cardiovascular events more that the control.

I take:
 Lipitor 10 mg/d
Endur-acin (Niacin) 1,000 mg a day.
Cost about $100 a year.
This gets me to the lowest LDLp possible while eating 60% fat and walking 1-2 miles a day at a 20 minute per mile pace.

I gave my patients a third drug if they could not get to goal.
 Zetia 10 mg (ezetimide).
Presently, ezetimide is sold as generic and hopefully with go down in price.
At high price start with one half tablet.
(Note: there are hyperabsorbers of cholesterol that have great benefit with this drug)

I am at the NLA meeting in Philadelphia.  Last night I went to a dinner sponsored by Amgen.  I have great regard for the panel that participated in the discussion of Optimizing Patient Outcomes in the Era of PCSK9 Inhibitor Therapeutics. 

Doctor Harold E. Bays presented 3 case studies to treat a high LDLc.  
The problem for me with his questions is low dose triple treatment was never offered as a choice in the answers. 
Niacin was rarely mentioned and when it was it was diminished. 
To Dr. Bays credit he did say he didn't think there was a wrong answer in the quiz but the audience had been guided by the speakers to vote 90% as PCSK9 inhibitor use as the correct answer.
This is a manipulation of the Fourier trail 2 year data as being more important than 50 years of positive outcomes with Niacin. 
Niacin has a better long term decreased mortality 6.2%(CDP increased from end of trial) result than any statin (3.2% from 4S decreased from end of trial. )
"We therefore conclude that treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued survival benefit."
"Statin treatment for 5 years was associated with a legacy benefit, with improved survival and a substantial reduction in cardiovascular disease outcomes over a 20-year period, supporting the wider adoption of primary prevention strategies"

4-No long term outcomes for PCSK9. Fourier trial was stopped early after 2 years because it reached a 15% reduction in events. 

Niacin low dose is extremely safe after decades of use. 
We have no idea what the effect of decades of PCSK9  will be. 

Please place triple therapy with Niacin on the list of choices for treatment. 


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