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What is CLEAR Wisdom?

It sounds like something from your doctor of philosophy and your brain, but it’s really about a potentially valuable new treatment for your heart. If you visit ClinicalTrials.gov (the major site for any US study), you will see that the unique number for this study is NCT 02991118. This is a long-term study of a new drug called bempedoic acid (no brand name as yet since it is investigational), which also goes by ETC 1002.

This study has several things going for it:

  • The drug works in a new way to lower cholesterol and is actually also being studied in a different study combined with an older medicine to see if this gets even stronger results.
  • It is a long-term study, meaning that it will most likely have continued for enough time to show TRUE BENEFITS as well as uncovering possible risks.
  • This isn’t a study of healthy people with minimal chance of having problems. CLEAR Wisdom is looking at people with increased levels of abnormal lipids (hyperlipidemia) at HIGH RISK of heart and blood vessel (cardiovascular) problems.
  • The study has a reasonable patient (sample) size of roughly 700 people.
  • It is a trial of bempedoic acid added to adults with high cholesterol.
  • You only have to take this medicine once a day.
  • It’s being presented at a major heart meeting (The American College of Cardiology) with a balanced and objective discussion.

Why could this study be important?

Many many patients have problems tolerating (Statin intolerance) the widely used family medicines known as HMG-CoA Reductase inhibitors (AKA statins). The names are familiar because they all end in statin (rosuvastatin-Crestor, atorvastatin-Lipitor, etc.).

There is a clear unmet medical need for a new agent that avoids statin mechanisms of action—bempedoic acid works on liver specific ATP-citrate lyase (trust me, this is a different way of working versus statins.

As always, we have to wait for the ACC meeting and for the FDA to approve the medicine, but this phase 3 study (the last phase before FDA approval) holds great promise!

For additional information, look at the study itself on clinicaltrials.gov. We will be attending the ACC meeting in March and will post and blog more as the news becomes available!

  1. Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PH, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
  2. Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
  3. Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.
  4. Robinson JG. Management of familial hypercholesterolemia: a review of the recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Manag Care Pharm. 2013 Mar;19(2):139-49. Review.
  5. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45   10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2015 Dec 22;132(25):e396. Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8.

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 www.EssentialGuideToPrescriptionDrugs.com.

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 failure of insurance companies to pay the roughly $12,000 dollars per year that they cost. Let me repeat that. COST, NOT results has 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 Rybackiknows. 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 molecoule 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.