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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!
- 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.
- 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.
- 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.
- 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.
- 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.
The American Heart Association (AHA) Scientific Sessions November 10-12th in Chicago will have great science as always, but may stand out as having the most significant impact on cholesterol management, exercise as a drug with specific guidelines, results from novel medicines and important practice implications of any AHA meeting in the last decade.
In AHA meetings, Late Breaking Scientific Sessions stand out as having crucial results, potential practice changing results and often see new treatments come of age in a single presentation. One such session will happen November 10, 2018 at about 2:16 PM. THis editor will be there to get the information and is excited at the potential value of icosapent ethyl (EPA), also known as Vascepa, more commonly known as fish oil and reported in lay press as "prescription fish oil".
Fish oil containing DHA and EPA had negative results in some recent studies, however the REDUCT-IT study (NCT 01492361) revealed a 25 % relative risk reduction in Major Cardiac Events. This study evaluated Vacepa, an EPA only fish oil in a dose of 4 grams a day in a large number of people (8,175) who had high triglycerides (150-499 mg/dl) despite taking statins. This study was important for many reasons:
1) The study was large, well designed and multinational.
2) The drug was well-tolerated in the study which started in 2011.
3) The results are remarkable in that a 25 % lowering of heart and blood vessel (cardiovascular) events was seen.
4) The study of Vascepa (EPA) will be fully discussed at a major conference in a late breaking clinical session.
5) The results of REDUCE-IT certainly have the probability of changing FDA approved labeling for Vascepa and probably will significantly help a large number of patients avoid serious heart-related problems.
Vascepa has had a limited treatment approval for addressing high triglycerides, but now appears to have a much much more significant effect. Will prescription fish oil come of age November 10th. It appears most probably so and an unmet medical need for a large number of heart patients may be filled by Vascepa in combination with other evidence-based treatments.