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Have you heard about the REDUCE-IT study?

For those attending the American Heart Association meeting in Chicago By James Joseph Rybacki, Pharm.D. 1/8/19

On November 10-14 2018, you could have heard a pin drop in the large conference room when Dr. Deepak Bhatt presented the results. The results showed a relative risk reduction of 25% in Major Cardiac Adverse Events (MACE). This study looked at more than 8,000 people who were already taking statins, had heart disease and may also have been diabetic.

It’s not my first rodeo and even I was impressed by these results. Interestingly, many of you know I have a history of heart disease and suffered an early heart attack in 2005. Despite this, and despite the new REDUCE-IT data, my insurance carrier REFUSED to pay for Vascepa, although my doctor sent in two requests saying that the medicine was warranted.

The problem stems from the product labeling (although huge numbers of prescriptions are written off-label in the US). Who will pay for the drug? For now, me. I have been absorbing the two hundred dollar expense because I think that the data are simply that good. Will the label for Vascepa change? This remains a decision for the FDA. In the interim, I think US insurance companies who attempt to deny heart patients this valuable medicine are short sighted and are WRONG. We have a new video on Vascepa on

What on earth is the controversy over PCSK9 medicines for cholesterol.??

By James Joseph Rybacki, Pharm.D. 1/8/19

Hmmmm, it comes down to money, or it used to, or, it still does. Let’s take a closer look. The challenge for the two novel cholesterol medicines in the PCSK9 family (evolocumab Repatha and Alirocumab or Praluent) has NOT been lack of use because they don’t work, it has been a failure of insurance companies to pay the roughly $12,000 dollars per year that they cost. Let me repeat that. COST, NOT results have been the key reason that these extremely effective and safe medicines have not been widely used.

A study released at the Heart Association meeting in Chicago Nov 11, 2018, showed that the ODYSSEY Outcomes trial found Praulent is cost-effective when the price is $6,319 a year when the willingness-to-pay threshold is at a usually accepted $100,000 per QALY (Quality Adjusted Life-year). The author, Deepak Bhatt from the Brigham and Women’s hospital expressed his hope that this analysis might provide evidence for what the price should be, versus market pricing that uses expense that might be tolerated.

Interestingly, the Repatha manufacturer (Amgen) lowered the price of Repatha to $5,850 per year last October. It will be interesting to see how Repatha sales are impacted by this novel pricing.

Did you think that Twitter would become mainstream medicine?

By James Joseph Rybacki, Pharm.D. 1/8/19

I wasn’t so sure when I decided to call myself Rybacki knows. Sounded pompous at first, then had a certain ring to it. Thousands of tweets later, I think of it in the same light at LinkedIn.

I remember reading “Medicine in the age of Twitter in the NY Times in 2009. At that time Pauline Chen, MD was reflective and it was noted that more than 60% of Americans went on line for medical information. Yikes.

If we jump to 2017, we find Vinay Prasad challenging his medical colleagues via Twitter and doing a righteous job of it as well. I’ve found myself roundly criticized at times, but then, if you are saying something worthwhile, this is bound to happen from time to time. Is Twitter the appropriate place for patient discussions or consultations, definitely no, but Twitter does have a place in mainstream medicine IF you manage by data and accurately quote the facts.

By James Joseph Rybacki, Pharm.D. 1/8/19

Even when patients are treated to blood pressure and cholesterol goals, they still have heart attacks and some of them die. This sobering fact has led to an emerging residual cardiovascular risk, residual inflammatory burden and a number of other explanations.

The CANTOS or the Canakinumab Anti-Inflammatory Thrombosis Outcomes Study took a look at the idea that inflammation had a role in cardiac events. The results did indeed show that 150 mg of canakinumab worked better than a sugar pill at preventing bad (adverse) heart (cardiac) events.

You may not have heard about canakinumab unless you’ve been ready nerdy research or have recently attended a heart meeting. This experimental medicine is a MAB (monoclonal antibody) that works against an inflammatory molecule called interleukin-Beta. The goal of CANTOS was to see how placebo stacked up against canakinumab in people with a history of heart attack (MI) and an elevated high sensitivity C-reactive protein levels (HsCRP).

It appears that the evidence is growing (swelling) for some kind of role of inflammation, but the exact cause of the swelling and the ideal way to lower the swelling and heart attack risk have yet to be clearly decided.

Greeting new Guidelines or should we embrace them and quickly integrate them into practice?

By James Joseph Rybacki, Pharm.D. 1/8/19

You may have noticed that guidelines are updated about every 2-3 years. This gives time for new research to be published, new conferences to reveal the research and of course the busy clinicians who sit on and lead the guideline panels to meet and hash out the facts, levels of evidence and try to anticipate some aspects of what has happened balanced with good clinical approaches.

There are new cholesterol guidelines which were revealed at the November American Heart Association meeting in Chicago. There are a lot of changes. Thresholds where we should take some action, new nomenclature to be sure, yet the changes in the context of the ever-changing studies this make sense.

I plan to try to interview Roger Blumenthal from John’s Hopkins, one of the leaders of the new cholesterol guidelines at the upcoming American College of Cardiology (ACC) meeting in NOLA in March. If it becomes a reality, we will post the video on in late March.