Statin drugs

[gu99]

I have battled high cholesterol for most of my adult life and am now at 170 (total) with the aid of a statin drug.  I have seen some reports that say that even though statins reduce cholesterol numbers there isn't the expected correlation with reduced incidence of heart disease. Is that true?  And if so, why should I continue taking a statins and risk liver damage?

[gymdandee]

Cholesterol comes not only in the good (or HDL) and the bad (LDL), but also in large and small particles.

"Large cholesterol particle size … seems to protect them from a variety of age-related diseases such as heart diseases, hypertension and diabetes," said Dr. Nir Barzalai of the Albert Einstein College of Medicine in New York, author of a recent study on particle size published in the Journal of the American Medical Association.

Researchers suspect that inside blood vessels, the larger, so-called fluffier cholesterol particles are able to pass more easily. Smaller, denser particles tend to cling to artery walls, which leads to the buildup of plaque and an increased risk of a heart attack or stroke.

An Increasingly Important Distinction

Normally, people focus on their total cholesterol level. But studies show that even among people with the same cholesterol level, those who have lots of large cholesterol particles have only about a third the risk of having a heart attack as those who have mostly small particles.

A handful of labs in the United States now measure blood for particle size. And some doctors are now recommending the test to patients who have a strong family history of heart disease and other risk factors but have only borderline cholesterol levels.

"It's extremely helpful to show them these abnormalities in particle size so they understand why they are at higher risk and why they should be treated," said Dr. Ronald Krauss of the University of California-Berkeley and a researcher in cholesterol particle size.

Doctors say you can make your cholesterol particles larger through a low-carbohydrate diet, exercise and medications, including niacin. Researchers are already working on a drug that would both lower cholesterol levels and increase particle size.

It's yet another way to improve the odds of living a longer life.

[erijon]

I thought small was good for HDL, the larger more fluffy HDL particles are not good at binding with LDL, did I read that wrong?

[erijon]

How do you know it's the statins? Muscle pain only occurs in 5.3% of patients, your issue could something else. One thing that is known, an LDL over 70 for an individual with known heart disease is a risk. If you can do it with diet and exercise and some lifestyle changes, even better, but I would not stop the statin without discussing it with your cardiologist.

[gymdandee]

When you get your blood test for cholesterol do they do a particle size test? large is OK small isn't good!

[maydaykay]

All I can say is, I have known several people who had very high cholesterol who lived into their 90's -- or in the case of my father-in-law's bride of 10 years -- STILL living at age 103(!), whose cholesterol has always been close to 300, and she has never taken ANY drugs! Then, there's my own history, which never included high cholesterol (has always measured below 155-160), but I had triple bypass surgery 10 years ago at age 51! I have been taking statin drugs ever since, my cholesterol hasn't changed. Recently, my doctor increased my dosage dramatically (trying to get my LDL under 70 - the highest it's ever been at in all these years), and I have definitely suffered from increased muscle pain, peripheral neuropathy, joint pain, and memory loss since the change. For years, I've been saying, "If it hurts this much to be 59...60...61, then I don't want to live to be 80 or 90!" With this most recent (3months) change, I realize that I have been suffering from the statins for a long time, and although I have a history of heart disease, I would rather take my chances with changes in diet, exercise, stress elimination, and NO STATINS!!

[erijon]

I understand your concern over studies funded by the drug manufactuers, however please remember that the study is not controlled by the manufactuer. The FDA places an Independent Data Monitoring Board in control of all data resulting from studies for the sole purpose of keeping it out of the hands of the manufactuer. The decision to stop the study was ultimately made by the FDA based on the recommendation of the IDMB for JUPITER, not the manufactuer.

If you want to look at true ARR and NNT numbers, you only need to look at studies for other statins. The one most commonly used is the 4S study for Simvastatin which showed a NNT of 11.7.

[twopack]

It looks to me like that last study erjon cited reported a decrease in RELATIVE RISK but no significant decrease in cardiovascular DEATHS with statin use.  Yet it reports a reduction in deaths WAS found for other diseases.  

This IS interesting!  There’s finally a study that makes sense to me.  The anti-inflammatory effect of statins (natural OR synthetic) is well known.  It makes sense they would be beneficial to many body systems, including the CV system.  After all, it is also widely accepted today that inflammation is a leading factor in the development of heart disease and sudden adverse cardiac events.  

Inflammation causes the body to lay plaque down to 'repair' vessels that aren't actually damaged.  The plaque can sit there or it can collapse/break off in the future.  We all know what happens then.  If we can reduce the inflammation that triggers this process we can reduce the amount of useless plaque lining our blood vessels.  Less plaque means more patent blood vessels (little matter the cholesterol level) and reduces the risk of sudden cardiac events from plaque collapse/emboli at the same time.

It has actually been proposed by some that the anti-inflammatory nature of statins may be more important in improving CV health than their ability to lower cholesterol levels.  In addition, the anti-inflammatory benefits of statins are achieved with low dose administration.  Higher doses have not been shown to further decreases inflammation.  For me, it’s important to know I can choose a low dose statin therapy and receive important benefits while avoiding the side effects higher doses are likely to cause.  (I’ve been there.  Can’t go again.)  

IMO, Gymdandee gave some excellent direction about lifestyle changes that absolutely work.  Anyone who can’t take statins, or prefers not to, should go back to his remarks and take notes.  I’ve seen those very things make a huge difference as I’m able to work them into my changing lifestyle.

The other stats in this thread seemed meaningless to me.  How can anyone assume results on a study that was never finished?  Initial results looked terrific?  That’s wonderful!  But it doesn't mean anyone can project initial findings into results that MIGHT have resulted further into the study.  It seems to me when you abandon your own study protocol you have abandoned the study.   Studies should be, and are, stopped immediately if it becomes clear participants are being significantly harmed.  Otherwise, I say take them to the intended conclusion.  To do otherwise raises suspicion.  After all, this wasn’t a drug targeted for a disease that had no present treatment or for patients who were desperate for it to come to market.  Clearly, the motives came from elsewhere.  Perhaps someday drug trials will be performed by people other than the manufacturers.  Those trials might be a bit easier for me to trust.  But that’s me.

[erijon]

Interesting story on the long term effects of statin use on all cause mortality numbers. An excerpt from the link below;

“The long-term benefit unexpectedly is not protection against heart disease and stroke, but against other illnesses that appear to be linked to infection,” said the lead author, Dr. Peter S. Sever, a professor of therapeutics at Imperial College London."

http://www.goupstate.com/article/20110905/znyt04/109053011

Also;

"The benefits of statins for preventing heart attacks and strokes are well-established, but after long-term follow-up the most significant effects seem to be on deaths from other causes. It's quite remarkable that there is still this difference between the two groups, eight years after the trial finished.

"Some studies have suggested that statins protect people against death from infectious diseases such as pneumonia. More research is needed to explain how these drugs might have unforeseen actions that prevent deaths from other illnesses."

http://www.sciencedaily.com/releases/2011/08/110828101912.htm

Very interesting!

Jon

[erijon]

"It looks like the in the years after four more people would be dying from Crestor then if they take nothing. And that why the study was stopped."

That is not correct and as you know if you read studies, All Cause Death Rates are not always linked back to the trial and they are not considered statistically significant unless they are tied to a direct cause which was not the case in JUPITER.

The statement approved by the FDA;

"A press statement on the company's website said that the trial's Steering Committee and also the Independent Data Monitoring Board recommended that JUPITER be stopped early because there was "unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients" who took Crestor compared to patients who took placebo."

This decision was approved by the FDA based on the opinion of the Independent Data Monitoring Board overseeing JUPITER.

Here is the statement from the National Institute of Health (NIH);

"AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo."

[Occupant]

"You are quoting the NNT from JUPITER which was stopped early due to positive results and because of that, the NNT is grossly understated .."

My interpretation as to why the JUPITER Study was stopped early is a bit different. There is a graph as part of the study that shows "Death from any cause" Rosuvastatin versus Placebo. It looks like the in the years after four more people would be dying from Crestor then if they take nothing. And that why the study was stopped.

[erijon]

Your analysis of the NNT is a bit misleading. You are quoting the NNT from JUPITER which was stopped early due to positive results and because of that, the NNT is grossly understated. Had the Jupiter study run it's intended length, the NNT would have been 25. Also, every statin has a different NNT, they are not all the same. Here is one example from the AHA;

>>>Some LDL-C–lowering clinical end-point studies achieved a low NNT per year such as the Scandinavian Simvastatin Survival Study (SSSS), which achieved an NNT of 11.7 and an NNT per year of 2.2.<<>>However, the 6 clinical end-point LDL-C–lowering statin studies (Table 2) achieved an average NNT of 41.0 and an average NNT per year of 8.5, reflecting an overall less efficient therapeutic approach. Three recent trials have compared 1 statin brand or dose against another.18,24,25 In these “statin versus statin” trials, the average NNT was 64.6, and the average NNT per year was 19.1. Arteriographic LDL-C–lowering statin studies achieved an average NNT of 64.3 and an average NNT per year of 28.7. <<<


Here's the link, it has all the NNT's listed;

http://circ.ahajournals.org/content/117/4/560.full

Also, these are the actual numbers from JUPITER;

http://circoutcomes.ahajournals.org/content/2/3/279.full

[gymdandee]

Ubiquinol should be taken!

[Red_Star]

Serum cholesterol is elevated by the body to protect itself from various acids and toxins. Heavy metals, fungal mycotoxins and trans fatty acids (trans fats) are toxins which will cause a rise in the serum cholesterol. Thyroid hormone is necessary for the healthy metabolism of cholesterol so hypothyroidism (most common cause is Hashimoto's Thyroiditis) is also a common cause.

High cholesterol is caused by the following:

Poor diet (eg: inflammatory transfats/too much inflammatory omega 6)
Genetic - but this is VERY rare (< 1% of cases)
Untreated/poorly treated hypothyroidism
Toxins and acids (eg: mercury/metabolic acidosis)
Chronic systemic fungal infections

Studies on statin drugs show:

No reductions in death in people over the age of 65
No reduction in death in people with no existing heart disease
No benefit at all in women of any age
Men under the age of 65 with pre existing heart disease: 100 have to take a statin for 3 years to prevent 1 heart attack. *

* "It is very important to understand statistics here and the difference between relative risk and absolute risk reduction. Much of the advertising with statins describe a 36% risk reduction in heart attacks. This is a relative risk reduction.

The absolute risk reduction is a decrease from a 3% risk to a 2% risk. In practical terms, this means that in men under the age of 65 with pre-existing heart disease, 100 (the NNT- Number Needed to Treat) have to take a statin for 3 years to prevent 1 heart attack. The other 99 men receive no benefit.

Professor James Wright from the University of British Columbia states that “most people taking statins are taking something with no chance of benefit and a risk of harm.”

Interestingly, the small reductions in death in men under 65 with pre-existing heart disease was independent of cholesterol reduction and was almost certainly due to their anti-inflammatory effects (there are safer ways to get this effect)."

Statin drugs deplete Coenzyme Q10 levels. Low levels of CoQ10 are implicated in virtually all cardiovascular diseases including angina, hypertension, cardiomyopathy and congestive heart failure. Other side effects including nausea, headaches, dizziness, sleep disturbances, sexual dysfunction, fatigue, shortness of breath, memory loss, liver problems, muscle weakness, muscle pain, peripheral neuropathy (nerve damage).

[Flycaster305]

Nice post, rsarah99, you really summed up what a lot of us feel who battled heart disease.  I rejected statins early on, deciding to control it with diet and 'natural' products.  That bit of ignorance on my part led to eight stents, two heart attacks and a pacemaker, finally bypass surgery.  I'm healthier than most of my contemporaries, and we are all old men, thanks to great drugs, procedures, diet and exercise.  
gu99, I'd shop at the wonderful Saturday Market in your city regularly, exercise, take the good pharmas.  We celebrated an important anniversary (50) at the Governor Hotel in Portland last weekend with several dozen friends and family.

[rsarah99]

I'm one of the statistics, I have heart disease after having a long battle in trying to manage my cholesterol.  I didn't take statins regularly and their you have it, honestly although I am just one data point, the risk of liver damage is low in comparison to putting your loved ones at worry...

[gymdandee]

Two studies on RA and Perio Dental

http://www.perio.org/consumer/mbc.heart.htm

http://www.arthritis.org/ra-heart-disease.php

[gymdandee]

Poor dental health has been linked to body-wide inflammation and to an increased risk of heart attack, stroke or diabetes. Plaque build-up along the gum lines causes gingivitis, creating a home for bacteria to thrive in. This will cause gum-tissue breakdown, allowing bacteria to pass into the bloodstream where they cause inflammation. I suggest a mandatory daily flossing, a full two-minute brushing with a soft toothbrush, a 30-second gargle with a plaque rinse, and a thorough cleaning performed by a dental hygienist at least two times per year. a homemade helper: Work a paste of baking soda and hydrogen peroxide into your gum lines with a rubber-tipped gum stimulator. Rinse with warm salt water from a Water-Pik. Do this daily, or at least three times per week. And if your gums are bleeding, take 100 to 200 mg of coenzyme Q10 daily, which will speed the healing.

[remar]

Yes, please do keep up this discussion. It's all very interesting.
As a heart patient, I'm trying to learn everything I can. My mother and sister are also heart patients. Kind of strange that my cholesterol was more than good, but my mom and sister had very high cholesterol when we had our heart attacks. It makes me wonder what the numbers should be.
I've heard about dental problems and heart disease. What studies have been done on that subject?
My sister also has RA. We all know that causes inflammation of the joints. What studies have been done on that and heart disease?

[gu99]

This is good information.  Thank you all.  I think I have much to discuss with my my GP and Cardiologist at my next appointments.

I was especially interest to see that statins have been linked to hormonal imbalances.  At my last annual physical my GP found that I had low testosterone levels and wanted to immediately start HRT. Knowing that it was a huge step, I've been resisting. Now I have some additional information and maybe HRT is not the answer.

Thanks again to all.  Please keep up the discussion.  It never hurts to have more information and viewpoints.

[gymdandee]

inflammation sometimes starts as early as childhood. And they always run their course slowly, silently, and steadily with inflammation as the key.
In fact, name just about any disease, and you can bet that inflammation is a part of the
picture. Heart disease, arthritis, Alzheimer’s, asthma, or osteoporosis—all of these
conditions can be traced back to inflammation.
The pill pushers behind Big Pharma know this well their entire business is built on it.
If we learned one thing from the Vioxx scandal, it’s that prescription anti-inflammatories kill and a whole lot faster than the diseases I just mentioned, too.
Your immune system is a complex array of cells that work to protect your body
from invaders viruses, bacteria, allergens, and toxins, to name a few. Inflammation is
what happens when this system springs into action.
inflammation doesn’t ravage your body without leaving a few clues. And knowing your levels of C-reactive protein (CRP) can give you a fair warning as to what kind of trouble it could be causing.
Your body makes CRP in response to many different kinds of inflammation—and
elevated CRPs are associated with increased risk of a variety of serious conditions
including heart disease, diabetes, and dementia.
there’s an excellent blood test called the highly sensitive CReactive
protein test (hcCRP).your level should be less than 1.0. Levels
between 1.0 and 3.0 are termed borderline But anything above this range can mean trouble, and should always be followed by a recheck in one to three months.
to prevent inflammation start with diet. And the Mediterranean standard is the best one to keep. anti-inflammatory supplements, adding some omega-3 fatty acids especially in the form of (EPA), a key anti-inflammatory fat. I suggest 2,000 mg of EPA per day. Probiotics (healthy gut bacteria found in fermented foods like yogurt, kefir, and sauerkraut) can also help. tumeric (which is found in curry), ginger, and rosemary. Resveratrol (found in grape skins and red wine) is also a powerful anti-inflammatory and one that is especially helpful in protecting against cancer.
anti-inflammatory vitamins , vitamin D (at least 1,000 to 2,000 units a day)
may be the most important although you clearly need adequate amounts of vitamins A,
C, and E along with the minerals zinc, magnesium, potassium, and selenium.
Exercise is another proven in-flammation-reducer, partly as a result of its fat-burning
effect, fat cells increase inflammation. You should get 30 to 45 minutes of
vigorous exercise (the kind where you really work up a sweat) at least five days a week—
with some strength training also fit in for at least two of those days. And make sure you
get a professional to help you devise a routine and to show you good exercise form just
slopping around on your own is a surefire way to get injured!
physical and emotional stress is a large, essential piece of the antiinflammation
puzzle which means not only cutting down the stress in your
environment, but also learning how to cope with it better . Good nutrition
and exercise can both help this, as can a wide variety of mind-body techniques, including
meditation, deep-breathing exercises,

[erijon]

Actually, the statement;

"That explains why hardening of the arteries has become an epidemic only in the last 100 years"

Is not completely accurate. The reason that heart disease is so prevalent in the past 100 years is because it was not an accepted cause of death until 1920 and was rarely used until the 1930s. The reason for such a dramatic increase over the past 100 years has been proven to be more of a result of accurate reporting. The rules for reporting and  ranking  causes of death were developed by the NCHS (National Center for Health Statistics) around 1950. These standards were revised in 1967 and again in 1979 to the standards being used today. Prior to that, causes of death were reported based on each physician's discretion and heart disease was rarely used until well into the 1930s. It was not until the introduction of the above listed standards that causes of death were correctly reported and ranked based on one singular set of rules. This is when heart disease saw it's largest increases year over year. It is most likely true that heart disease was just as prevalent in 1900 as it is today, it just was not reported as it is today.

Just another thought on the increase over the past 100 years. Also, have you considered airborne irritants as a cause for inflammation in the body? We are all affected by the quality of the air we breathe. Just a thought.

[gymdandee]

I would rather not mention the Co.  I will tell you he has worked with the FDA on various
investigations with products.
One study showed that people who had higher levels of bacteria in their mouth were
more likely to have plaque buildup (atherosclerosis) in the carotid artery.
This bacteria is thought to enter the bloodstream through the gums and adhere to the plaques in the arteries, contributing to the narrowing of the arteries.
Another theory is that the presence of the bacteria triggers inflammation, which is the body’s response to foreign substances, that can cause illness.
This inflammation and swelling could also contribute to the narrowing of vessels and possibly cause blood clots to form in the arteries.
The No. 1 source of inflammation in the body is a bad diet. That explains why hardening of the arteries has become an epidemic only in the last 100 years:
Exercise helps keep arteries elastic Like I mentioned in an earlier try the peak 8 routine
I f you give me a list of vitamins and or supplements i will let you know the ones that are approved and the ones that failed and why they failed.

[Flycaster305]

I credit statins for keeping me alive the last twelve years, but I've mixed in exercise, diet, weight loss and lifestyle changes at the same time.  My blood tests have been perfect, and I pay extra to outside my insurance coverage to test for vitamins, etc. A balance seems prudent.

What pharma does your son work for?  

[erijon]

As I recall, we have discussed the FDA and your son's experiences before, it was very interesting. I'm only going by what I've read and the discussion with the doctors I volunteer with. I also have read the FDA warning concerning supplements, not all things are equal.

Consumer Labs may run tests on some supplements, but there is a vast difference between a Consumer Labs test and a multi-year NIH managed drug trial with tens of thousands of participants tracked for years after the trial is over to validate the findings.

However, I can understand that some things may slip through the loop holes in the system, but I think the odds are better when they are controlled by the FDA.

Jon