FDA approves drug that lowers cholesterol in a new way

[Omaha Steve]

Source: AP

By LINDA A. JOHNSON

TRENTON, N.J. (AP) — U.S. regulators on Friday approved a new type of cholesterol-lowering drug aimed at millions of people who can’t tolerate — or don’t get enough help from — widely used statin pills like Lipitor and Crestor.

The Food and Drug Administration approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and people who have heart disease and need to further lower their bad cholesterol. The daily pill is to be taken in conjunction with a healthy diet and the highest statin dose patients can handle, the FDA said.

High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems. Studies showed that Nexletol could lower LDL by about 25% when taken alone and by an additional 18% when combined with a statin.

“This is a nice alternative” to statins, but those medicines will still be the first choice, said Dr. Christie Ballantyne, Baylor College of Medicine’s cardiology chief. He consults for Esperion and helped test the drug.



This undated photo provided by Esperion Inc. shows the cholesterol-lowering drug Nexletol made by Esperion Therapeutics Inc. The Food and Drug Administration on Friday, Feb. 21, 2020 approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and others who have heart disease and need to further lower their bad cholesterol.(Esperion Inc. via AP)


Read more: https://apnews.com/528e7e964a18429240638fcf2308bd1d

[dawg day]

1. Thanks-- will talk to my doctor

I'm not all that sure about statins-- side effects.
But they do definitely lower cholesterol for me. Would love something without the other problems.

[in2herbs]

11. You might try Red Yeast Rice for lowering cholesterol. Even though it is a natural

(and effective) alternative it's biggest drawback to be aware of is that it can put a load on the liver while the bad cholesterol is being cleared out since the liver is clearing channel. Some get even better results using Red Yeast Rice and CoQ10 together.

[lagomorph777]

35. Red Yeast Rice is the original source of statins.

The real solution to clogged arteries is more complex than any pill.

Statins nearly killed my wife. Look up "statin rhabdomyolosis."

Cholesterol is absolutely essential to human survival. Among many other functions, it is a precursor every hormone. Suppressing the cholesterol production system is dangerous.

And get over the misconception that eating cholesterol or fat causes cholesterol. Carbs cause imbalances including fatty liver and clogged arteries.

[area51]

17. Have you tried oatmeal?

I eat instant oatmeal and it helps with my cholesterol levels. Hope it helps.

[lagomorph777]

36. Only eat organic oats. "Conventional" oats are soaked with Glyphosate.

And they tend to absorb more of it than other crops.

[Drahthaardogs]

31. Statins are life savers. They do so much MORE

Than just lower cholesterol.

Red Yeast Rice used to contain the statin mevacor. It cannot by law any longer. Some brangs may have a little, but dosing is inaccurate.

5 or 10 mg of statins could save your life. If you taken them for 5 years, the benefits can last a decade or more.

[Grasswire2]

42. where do you get that info?

Because the top integrative cardiologists only recommend statins for a certain population. Not for everyone.

And if you are taking a statin, you better be also taking CoQ10, because statins deplete CoQ10 (a natural substance made in the body but depleted in most people and critical for heart health.)

[denem]

2. "and by an additional 18% when combined with a statin"

Statins don't lower LDL. This is a combination therepy breakthrough.

"Esperion is betting an old-school approach will win out with this the Nexletol pill. The company plans to price it at around $10 per day before discounts and rebates."

https://www.businessinsider.com/esperion-heart-drug-nexletol-approved-fda-cost-sales-strategy-2020-2

[sakabatou]

3. So, how long until the price is changed to something sky-high?

[denem]

4. Who knows ?

Lipitor did not become the most widely prescribed drug in history by price gouging.

[discntnt_irny_srcsm]

12. It's already sky high

$300 a month isn't really affordable. Folks with high deductibles will have to skip it.

[Grasswire2]

43. $10 a day for one pill is sky high. Crazy. nt

[C Moon]

5. I remember when some "doctors" and politicians were pushing to add statins to US water supplies.

Gee, do you think these doctors/politicians may have had some connection to the drug industry?
(2012ish)

[Scarsdale]

6. Not too long ago,

drug companies wanted every school child tested for cholesterol problems. They wanted to put the ones with high cholesterol on statin drugs! That could have made a fortune for "someone". What if the child was too young to even notice side effects? What about becoming immune to the drug? I have bad side effects from statin drugs, so can not tolerate them. How long before many people start on this new drug, then find out the side effects are worse than the high cholesterol is?

[Drahthaardogs]

32. No. I suggest you read the JUPITER and PROVEIT

Studies. Statins SAVE lives!

[Grasswire2]

44. How about you put a link here?

What the hell is the JUPITER?

[Drahthaardogs]

45. A statin study on effects of statins on people with

High CRP but otherwise normal cholesterol levels. Spanned 26 countries and about 1500 people.

Overall reduction in cardiac events were so significant, they stopped the study early because they felt it was unethical to keep the control group on a placebo.

https://www.ahajournals.org/doi/full/10.1161/circoutcomes.109.868299

[Grasswire2]

46. what does that have to do with statins?

We all should know by now (but most don't) that INFLAMMATION is the enemy, not CHOLESTEROL.

It is inflammation of the arteries that allows particles of cholesterol to stick and cause plaque.

That is the cause of coronary artery disease.

Getting your CRP down is important, but statins are not necessary to do so.

[Drahthaardogs]

47. We're fucking done...

I don't entertain bullshit. Look up homozygous familial hypercholesterolemia and tell me it doesn't matter.

You didn't even read the article. Go get a vial of your memory water or Kabuki doll or whatever fucking stupid homeopathic bullshit people are spending stupidly on now.

[Grasswire2]

48. Jupiter study was flawed.

From Dr. Stephen Sinatra, the pre-eminent board-certified integrative cardiologist considered authoritative on issues of cholesterol (who only prescribes statins for a limited population of patients.

Some particularly persuasive papers have also been written by cardiologist Michel de Lorgeril, M.D., from the French National Center of Scientific Research in Grenoble. He challenged the results of the highly publicized JUPITER study. The particular statin being studied in this trial was Crestor (rosuvastatin) and the results hailed Crestor’s ability to decrease the risk of developing cardiovascular disease.

De Lorgeril’s report pointed out that nine of the authors in the study had financial relationships with AstraZeneca, the manufacturer of Crestor and sponsor of the study, and that such conflicts of interest are a common denominator in statin-related studies. His critique also noted that most published cholesterol-lowering drug trials since 2005 have been negative or ambiguous. He argued that the recent studies “strongly suggest” that the results of previous, highly positive statin trials between 1994 and 2004 “should be carefully re-examined by experts independent from the pharmaceutical industry.” “The next question,” he wrote, “would be whether it is not time for a full reappraisal of the theory according to which cholesterol-lowering results in a significant protection against cardiovascular morbidity and mortality.” I couldn’t agree more.

Here's Dr. Sinatra's comprehensive article on statins:

]https://heartmdinstitute.com/heart-health/cholesterol/rethinking-statins/

[Drahthaardogs]

49. I told you, I'm not fucking playing this game

Statins SAVE lives, and Sinatra is about selling his "Natural Cures Books".

For anyone reading this, don't believe the hype! Sinatra sells the same shitty science as the guy from Oprah, Dr. Oz. Fucking Woo!

These drugs do have side effects, but if you are at risk of CHD, they can help prolong your life and have actual SCIENCE behind it.

[Grasswire2]

51. the data doesn't support you. But nobody's making you reject what you believe.

I'm just pointing out to OTHERS here that the study you cite was flawed, and it supported the growth of Crestor (the sponsor of the study).

You can think whatever you wish. But when someone posts flawed studies, they should not be surprised to be called out.

Statins do have value for certain populations of patients. But not universal. And with horrid, damaging side effects for many.

[Grasswire2]

52. Plenty of literature on google calling JUPITER a flawed study.

Was JUPITER trial data influenced by AstraZeneca to favor Crestor?

Reanalysis of a landmark cholesterol-lowering trial of people typically considered at low risk for heart attacks indicated that the results are flawed — and do not support the primary-prevention benefits that made headlines, authors of the review asserted.

The reanalysis of the massive JUPITER trial involving almost 18,000 people with low or normal cholesterol but elevated levels of the inflammatory biomarker C-reactive protein (CRP) — turned up no evidence of the “striking decrease in coronary heart disease complications” reported by the trial investigators. Instead, the reanalysis has called into question the involvement of drug companies in such clinical trials, according to an article in the June 28 issue of the Archives of Internal Medicine.

Moreover, Michel de Lorgeril, MD, of Joseph Fourier University and the National Center of Scientific Research in Grenoble, France, and co-authors argue that a major discrepancy exists between the JUPITER trial’s report of significant reductions in nonfatal stroke and myocardial infarction (MI) but a lack of effects on fatal stroke or MI. Moreover, cardiovascular mortality and the case-fatality rate for MI fell far below predicted rates.

etc. etc.

[Drahthaardogs]

50. Dr. Sinatra recommends "Earth Bathing" to help Coronary Disease

I fucking kid you not! Anyone reading, this is BULLSHIT!

[abqtommy]

7. Thanks, I bookmarked this.

[Vinca]

8. Coming to a pharmacy near you for a mere $100 a tablet.

[VarryOn]

16. My experience with new drugs...

Last edited Sun Feb 23, 2020, 02:32 PM - Edit history (1)

Are never added to formularies because of cost. I bet this one will be expensive as hell. The manufacturer will want to recover its R&D .

I am a migraine. New drugs come on the market frequently for migraines. I usually have to wait 4-5 years before insurance will cover anything new. The exception is a new injection I'm on. Out of the pocket, it would cost me $754/month. My insurance graciously would knock $150, after my doctor jumped through administrative hoops. Fortunately, the manufacturer has program to cover me for 6 months for $5/month. After 6 months, I'll have to go with the pittance from insurance. I'll end up paying the $600 myself. The drug works remarkably! So, I'll just buckle up and pay.

[Vinca]

18. I had wicked migraines when I was in my 30's. A neurologist put me on amitriptyline which I took

for several years and it greatly reduced the attacks. Fortunately, they're known to go away for women when we hit menopause and that's what happened. Last year I unexpectedly had one that was a doozy and reminded me of how miserable I was when I had them regularly. I'm glad you found something that works. You might look into buying it from a Canadian pharmacy. It might be cheaper even taking the part your insurance covers into account.

[VarryOn]

20. Amitriptyline was one of the first preventative I took....

It didnt work. It also made me crave sugar, so weight gain was an issue.

Over the last 30 years I've tried probably 30 or so preventative, including verapamil, Topomax, propranolol, depakote, neurontin, nortriptyline, Inderal, Zonegran, atenolol, various antidepressants, and several NSAIDs. I also took several Botox rounds. Those were very painful and didnt work. I did get a smooth forehead, though!!

I've been to a handful of neurologists. I've learned most don't like dealing with migraine patients.i kin od don't blame them. Migraine patients are a tad whiney and high maintence.

I finally talked my GP into prescribing the Aimovig injections. So far, I've been very pleased! The cost, though, is the biggest issue. I will take your suggestion to look into Canadian pharmacists. I got up there about once a quarter for my job. It would be pretty easy for me.

[lagomorph777]

37. My migraines went away when I gave up meat.

It was a freaking miracle.

I also lost 40 lbs, joint problems, and allergies. My blood used to have a lot of bacteria and parasites; they went away too. I wonder where all that crap was coming from? Nothing to do with those hideous filthy feedlots, right?

[VarryOn]

40. That's awesome! It's amazing how diet...

Can affect headaches. Alcohol is my greatest known food trigger. And I still drink some even knowing it may cause a migraine.

But I dont know that I could give up meat. The tomahawk chop at Ruth’’s Chris is worth the risk!! Lol

[gab13by13]

9. The article says the new pill works

along with a healthy diet, maybe it's the healthy diet and exercise that is the trick?

[LittleGirl]

10. Yup

I lowered, by half, my cholesterol by going gluten, dairy and sugar free.
Triglycerides dropped so fast my doctor was amazed. I take fish oil everyday.

[Nay]

13. I went vegetarian for a while and had a similar result. Unfortunately, I am diabetic and

cutting out meat AND dairy pretty much whacks the list of foods diabetics can eat, since carby veggies are a big no-no. I don't like meat anyway, but have been eating chicken. I really need to stop the chicken and go back to just veggies and, perhaps, fat-free or lowfat dairy.

Do you eat eat meat, but not dairy?

[LittleGirl]

19. Yes I do

Probably too much. I eat dinner for breakfast and dinner for dinner since I’m also allergic to eggs.
I eat mostly meat and veggies and very few fruit. I tried vegetarian before I realized I was allergic to gluten and there was just too much I couldn’t eat so am mostly Paleo. I was pre-diabetic back then too. I’m getting checked in April and will double check all of these things.

I follow the auto immune protocol which eliminates most allergens.

[Nay]

22. I shouldn't eat soy because I've had estrogen-related breast cancer, I can't eat

beans because they impact my blood sugar WAAAY too much, and I limit bread to a couple of small slices of lower-carb whole wheat bread because of the blood sugar. So, like you, I wonder what the hell to eat. I end up eating yogurt & berries & walnuts for breakfast, salad and cottage cheese for lunch, and then your kind of dinner for dinner. I do replace breakfast once in a while with a vegan drink that has none of the common allergens. It only has 10 carbs, which is perfect.

I'd love to hear how well you do on your April appointment!

[LittleGirl]

23. Ahhh, thanks.

Dairy is like poison to me. I don’t touch soy either because I am naturally estrogen dominant. The auto immune protocol is called AIP for short. There are substitutes for those watching carbs . I think it might help you. Some great books are out there with recipes.

I take a lot of vitamins because of genetics and deficiencies. Doctor said I would need to take Vit D and Bs for the rest of my life because I don’t store those. Being a meat eater is how I get most of my Bs but I still have to supplement. I monitor those closely.

As an Italian, I miss pasta, pizza, bread and Parmesan cheese! Ice cream! Toast.

[lagomorph777]

38. Chicken is meat. Carbs wrapped in whole vegetables won't mess with your blood sugar.

It's a myth that doctors use, so they can sell you Metoformin and other crap.

[Nay]

39. Uh, I know chicken is meat. When I gave up being vegetarian, I really only ate chicken or

fish, and not every day.

As any diabetic knows, you have to test foods in your own body. I can eat bananas, but not grapes. Corn and peas, but not a baked potato. Beans are good for me, but shoot my blood sugar into the stratosphere.

[lagomorph777]

41. That's a careful approach.

[Grasswire2]

29. uh.....maybe it was the omega 3 that dropped your triglycerides

Mine dropped by half when I started high quality omega 3 fish oil capsules.

[LittleGirl]

33. could be

as I started this protocol all at the same time. I still take the fish oil and have kept my cholesterol under 200 since.

[Farmer-Rick]

14. High Cholesterol levels have not been proven to cause heart attacks or death due to heart disease.

"About 75% of heart attack sufferers do not have dangerously high LDL (bad) cholesterol levels." https://www.health.harvard.edu/topics/cholesterol

"This evidence seems to point towards there being a causal connection between cholesterol in heart disease. However, a closer examination of the issue may make us skeptical of this conclusion.

Firstly, the evidence about the association between high LDL levels and heart disease is more complicated than it first appears. A follow-up from the initial Framingham study suggested that there was only an increase in mortality, by heart disease or other causes, in people with higher cholesterol levels under the age of 50 [6]. This is significant if we want to offer medication or lifestyle advice about preventing heart disease to those over 50 years old. A recent systematic review even suggests that patients over the age of 60 actually lived longer if they had higher LDL levels, directly contradicting the hypothesis that you are more likely to die of heart disease the higher your cholesterol levels are. [7]

Moreover, despite statins showing a correlation between lowered cholesterol levels and a reduced risk of heart disease, some other medications do not show this connection. Niacin, for example, is a cholesterol lowering drug which is known to decrease LDL levels, but has been shown to cause no significant reduction in risk of heart attack, stroke or mortality by heart disease [8] . Even more worrying is the case of Torcetrapib. This experimental drug was designed to reduce rates of heart disease by lowering patients’ LDL levels, but the research was discontinued early because it was linked to an increased risk of mortality and heart disease [9]."
https://www.students4bestevidence.net/blog/2018/07/02/cholesterol-and-heart-disease-whats-the-evidence/

I don't know what the answer is, but I don't think all the evidence is in that high cholesterol causes heart disease.

But we do know that high cholesterol foods Do Not cause high cholesterol in our bodies and smoking can cause heart disease.

[Nay]

21. That's interesting, because when I ditched all meats (except fish once in a while) but kept eating

dairy, my cholesterol numbers plunged, so I had to assume that diet did contribute to my higher numbers. I started to eat meat again only because others in the family eat it and I hate cooking so much that I did not want to prepare multiple meals every night. I'm about to ditch meat again because I never liked it much anyway, and my cholesterol numbers have gone in the wrong direction again!

Another statin finding was that only men, not women, get the protection from heart attacks that statins provide.

[Grasswire2]

28. Yes, you are right.

I have been following the work of the top metabolic/integrative cardiologist, Dr. Stephen Sinatra, for some years now. His findings are that delivering energy directly to the heart muscle with targeted natural supplements is now widely accepted in forward-thinking cardiology. It is infuriating that the general medical world won't catch up on this matter. But $$$$ rules.

He advocates for the "awesome foursome" and says he could not practice cardiology without these, having proved their value through his own practice.

1. CoQ10 (and anyone taking a statin is depleted of CoQ10)

2. Broad spectrum magnesium (meaning from more than one source, combined in tablet)

3. Acetyl L-Carnitine

4. D-Ribose powder.

All four of those contribute to the delivery of energy directly to the heart muscle.

[Grasswire2]

30. the answer is that it is inflammation of the arteries that causes coronary artery disease.

That's the finding of integrative cardiologists.

[Faux pas]

15. Niacin

works for me.

[Mendocino]

24. LDL

[link:

&t=126s

[MRDAWG]

25. What does it cost?

?

[Mersky]

26. "for people genetically predisposed to have sky-high cholesterol"

Would like to emphasize this by relating how I had a friend that truly fits this description. She was an athletically fit vegan in her mid twenties who literally rode her bike everywhere. I was shocked that her cholesterol numbers were so high, that I thought the lab had made a mistake and swapped out samples from an older heart patient. It was nuts trying to square her lab reports with the person standing in front of me. Those numbers were subsequently confirmed, btw.

[Grasswire2]

27. this is bad info. Old info.

The major cause of heart disease is NOT cholesterol, but inflammation of the artery walls allowing particles to stick.

Geez.

Catch up, AP!!!!

Top integrative cardiologists have known this, and the literature has begun to reflect the truth.

Cholesterol is not the villain, and statins are definitely not the answer except for a certain segment of the population.

And so now they are going to try to push a new drug class?? For $$$$$

Infuriating and tragic.

The remedy is an anti-inflammatory diet and targeted natural supplements. Statins have horrible side effects for many people.


Anti-inflammatory diet includes green tea, walnuts, pomegranate juice, ginger, turmeric, garlic, extra virgin olive oil, and so on. A lab test called C-Reactive Protein will tell you your level of inflammation in the body.

Supplements and diet recommended by the top board-certified integrative/metabolic cardiologist are at this link:

[link:https://www.drsinatra.com/statin-drugs-and-natural-solutions-for-healthy-cholesterol|



This is not woo. It's a better way than side effects of meds.

[LittleGirl]

34. Thanks for the link but there's an error on that link

I was put on statins for my cholesterol before I was diagnosed with Hashimoto's and the leg pain was severe. I woke up with leg cramps so bad after only 2 weeks on them that I quit taking them. Hashimoto's is known to cause high cholesterol too. I agree that anti-inflammatory diets work.