PCSK9 Inhibitors Not All They Are Cranked Up To Be

For months now physicians treating patients with elevated cholesterol have been looking forward to learning how to use the new monthly injectable PCSK9 inhibitor medicines that were touted to dramatically lower LDL cholesterol and cause far fewer side effects. They were designed to be used in patients with a hereditary form of elevated cholesterol traditionally very hard to control with oral statin medications and for statin intolerant patients with coronary artery disease.

The drawbacks to the new medication is its costly nature running more than $1,200 a month with many insurers, including Medicare, not yet covering it. There were additional concerns that the lowering of LDL cholesterol was so dramatic that it may cause problems in other organ systems that require cholesterol for certain functions.

The April 3rd edition of the University of Pennsylvania’s online Medical Review known as MedPage Today revealed data from Steven E Nissan, MD, of the Cleveland Clinic on the use of evolocumab (Repatha) in the phase III GAUSS -3 trial. This study looked at statin intolerant patients who had failed on two previous statin drugs or were unable to raise the statin dose from the minimal available level.  This study compared the effects of Repatha to oral Zetia (ezetimibe) at 22 and 24 weeks.  The study clearly showed that Repatha lowered LDL cholesterol levels by about 55% compared to ezetimibe at 17%.  The level of LDL cholesterol level was similar to results of the other cholesterol lowering PCSK9 inhibitor alirocumab (Praluent).

What I found most interesting is not that these expensive new injectables worked well but that 20% of the statin intolerant patients had similar muscular aches and pains and complaints with this new non statin injectable. Less than one percent of the patients on the new injectable in the study actually stopped the drug due to the muscular pains.

At this point my practice is still investigating the new injectables. Part of that investigation is determining which insurers will pay for the use of the drug and which will not.  In the past I have waited a good year for a new type of medication to be out on the US market to observe the true adverse risk profile before prescribing it. This promising injectable monoclonal antibody to reduce LDL cholesterol will be treated no differently.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: