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Member Forum >> Heart Health Forum >> Novartis Lp(a) Drug Study
 Novartis Lp(a) Drug Study
Malcolm

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Posted: 1/31/2020 10:05:30 PM
 
I’m copying some older previous discussion about Lp(a) here and adding my update regarding the Novartis study that I got invited to join by my cardiologist.

LCL wrote: No studies out there about whether lowering Lp(a) decreases risk, yet so many companies out there trying to develop drugs and other treatments that lower it.

Malcolm responded:

My cardiologist’s office phoned to ask if I would be willing to participate in an Lp(a) study for the drug company Novartis. I said yes. My appointment is on Friday, Jan. 24th.

I’ll post a follow-up if anything interesting comes of it.

When I was contacted I mentioned that if they plan to do a blood draw to test my Lp(a) that I would make sure I’m fasted (12 hours).

The woman said the test subjects don’t necessarily have to fast. I told her if that’s the case they’ve already confounded the study.

 

 

Bob Niland’s Reply...


Malcolm: if I would be willing to participate in an Lp(a) study for the drug company Novartis.

Sounds like that might be Phase 3 of this: Novartis to pursue transformational therapy to reduce risk of cardiovascular disease in people living with elevated levels of inherited lipoprotein(a)

Novartis announced today that it is exercising its option to license the rights to develop and commercialize TQJ230, an investigational agent previously known as AKCEA-APO(a)-LRx, from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals

Here’s the trial: NCT04023552 (HORIZON)
Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON)

A couple of back forum hits:
LP(a) Article
AKCEA-APO(a)-LRx Clinical trial shows up to 99% Lp(a) reduction

re: I told her if that’s the case they’ve already confounded the study.

And if you’re doing the program here, plus the fish oil boost, you’re further confounding, if they’re minding outcomes, which over 4 years, they will be.

If it’s that RCT, you’re also in a random arm: untreated/placebo vs. treated. They may also want you on Standard High Intensity Therapy (statin), and may raise an eyebrow at either the carny diet, or any low-carb diet.

 

Malcolm’s  Response:

Bob:Thanks for the links. I’ll check ’em out.

I’m going to be curious to see whether they even accept me into the trial.

When the cardiologist’s office first contacted me, they said they are looking for people who have had a heart attack and doing a study of Lp(a).

I explained that although I had some angina and a CABG (bypass surgery), that I never actually had a heart attack. The lady said she would check into this and get back to me. 

Then it got turned over to another person who sent me the paperwork/consent form. So, it appears they want me to come in on Friday but we’ll see what happens when they speak to me in person.

If they include me in the trial, and they ask whether I’m willing to take a drug or placebo, or a statin, I would decline.

The other reason they might not want me in their trial is that I don’t have high Lp(a). I’ve had it tested 20 times over the past decade. The reference range (in my testing) goes from 0 - 30 mg/dL. 

Caution: the rest of this post is "tongue-in-cheek" humor.

My very first value was the highest one ever, in Aug/2010. It was 32, and it was BWB (which stand for "Before Wheat Belly"). Hey Bob, there’s a new abbreviation for your list!

Generally, my Lp(a) has tracked consistently around 15. A couple of times it was pushing 20, but those results came from a different lab, namely SpectraCell. Therefore, according to my N=1 study, where you get tested can affect your Lp(a).

One of my lowest values, 10 mg/dL, was in April 2016, one month prior to my heart bypass. Therefore, my N=1 study would say low Lp(a) results in bypass surgery.

Two of my other low values have come in March 2019 (Lp(a) = 11) and July 2019 (Lp(a) = 10), which I believe is a response to my heavier animal-based diet. Therefore, my N=1 study would come to the same conclusion as Siobhan Huggins who works with Dave Feldman. When he asked her what magical cure she used to lower her Lp(a) dramatically, she replied... "Eggs." Same for me. Now we’re up to N=2.

I actually got our doctor to test my father’s Lp(a). He was 95 at the time. His value was elevated. It was 36 mg/dL. I can only conclude that if you want to live a good, long life, keep your Lp(a) on the high side.

Wouldn’t it be something if the Novartis study came up with these same conclusions!

Bob’s Comment...

Malcolm:  I can only conclude that if you want to live a good, long life, keep your Lp(a) on the high side.

Depending on what’s keeping it elevated, that might be true. The program here has backed away from shoving the marker around per se, as it appears that outcome (ACM) isn’t shoved with it, using the strategies of yore, anyway.

re: Wouldn’t it be something if the Novartis study came up with these same conclusions!

That could happen, and it appears we’ll see the result either way … in 2024. The challenge might be de-confounding the results, due to the {likely} inflicted SoC in both arms, and {likely} lack of control or recording of macro and micro nutrients. Who knows what markers they’ll track and report. Even TG and A1c could provide some insight.

What Novartis would love to find, of course, is frank ACM benefit despite the SoC variable and random SAD context.

Watch out for MACE hand-waving in the 2024 paper.


Update from Malcolm - Jan 31, 2020


I got my Lp(a) test result of Jan 24, 2020 that was done for the Novartis study.

My Lp(a) value came in at 13 mg/dL (Reference range is 0 - 30 mg/dL). It was a very typical result for me.

They also did a full lipid panel. My cholesterol values are definitely on the rise as I continue eating a more animal-based diet. My numbers are looking more and more like a Dave Feldman "lean mass hyper-responder."

Here are my latest values (in mg/dL) from Jan 24, 2020, along with my last lipid panel of Nov 2019.

Nov 6, 2019 Jan 24, 2020

Total Cholesterol 328 360

HDL 62.5 69.9

LDL-C 253 276

Trigs 65.5 70.8

Total/HDL Ratio 5.2 5.1

Trig/HDL Ratio 1.05 1.01


My HDL is the highest it has ever been in my life.

Notice that despite all the cholesterol values increasing, the ratios of Total/HDL and Trig/HDL actually improved slightly.

The Trigs of 70.8 are higher than I would like. I did fast for 12 hours but ate popcorn the night before around 9:00 pm. The blood test was the next morning at 9:00 am.

I ate about 4 cups of popcorn, which according to the nutrient panel exposed me to 15 net grams of carbs.

By the way, I’m getting a bunch more blood work done on Feb. 11th and I’ll post those results later on in February. 

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