Statin News

[Paw]

I hadn't fully realized that statin intolerance was still considered "controversial" by some in the medical community, but apparently it provides yet another opportunity to write off severe symptoms as merely psychological. When my latest attempt to go back to statins crippled me for months I started reading some alternative practitioners who said they'd never met anyone with FM who could tolerate statins at all. Still, my cardiologist did everything she could to cajole me into continuing them -- as if their effects on my muscular system were merely an annoyance.

Now comes news that statin intolerance is a very real thing! And, apparently, there's an alternative that effectively raises HDL and lowers LDL without the adverse effects. It's a PCSK9 inhibitor that is already available (yet not FDA approved for cholesterol) for about $10,000 per monthly injection.

But there are still doubts about whether the HDL/LDL ratio is truly the key to lowering stroke and heart-attack risk. There's another, long-term, study (cited in the same link above) about a different class of drugs that clearly lowers LDL and raises HDL, but shows absolutely no life-saving benefits.

Yet here's some new research that shows statins are proven to have a life-saving cardiovascular impact even in populations without heart disease or high cholesterol.

All of which confirms, for me, that there are still way too many unknowns about statins and cholesterol. It seems clear that statins may be helpful to those who can tolerate them. But maybe that's not directly because of their impact on LDL and HDL? I am glad they're looking into alternatives, but it might be premature to spend $10,000 a month on them.

 

[GG]

I only take compounded Cholestryamine, does that count? I have been diagnosed with CFS and Fibro.

https://en.wikipedia.org/wiki/Cholestyramine

GG

 

[Who Me?]

Statin intolerance objectively identified in patients

PUBLIC RELEASE: 3-APR-2016

Cleveland Clinic research also shows that evolocumab is superior to ezetimibe for lowering cholesterol in statin-intolerant patients
CLEVELAND CLINIC

Sunday, April 3, 2016, Chicago: In the first major trial of its kind, Cleveland Clinic researchers used a blinded rechallenge with atorvastatin or placebo to objectively confirm the presence of muscle-related symptoms in patients with a history of intolerance to multiple statins and found that evolocumab (a PCSK9 inhibitor) was a more effective option to lower cholesterol than ezetimibe in these patients.
The double-blinded, placebo-controlled clinical trial was designed with two stages:

• In Phase A, patients were assigned to two groups. Each group was treated for 10 weeks with atorvastatin or placebo in a blinded fashion, then crossed over to the alternate therapy for another 10 weeks. Patients were asked to report any muscle pain or weakness.
  
  
• Patients who reported intolerable muscle symptoms on atorvastatin, but not placebo, moved to Phase B. In this 24-week phase, patients with confirmed statin intolerance were administered two alternative non-statin therapies, ezetimibe vs. evolocumab.

The research is being presented at the American College of Cardiology's 65th Annual Scientific Session and simultaneously published online in the Journal of the American Medical Association.
"Statin intolerance has been a very challenging clinical problem," said Steven Nissen, M.D., chairman of Cardiovascular Medicine at Cleveland Clinic. "The study showed that PCSK9 inhibitors can significantly lower cholesterol in patients with documented statin intolerance, providing an effective treatment for these difficult to manage patients."

The GAUSS-3 trial enrolled 511 patients with very high levels of LDL cholesterol - averaging more than 210 mg/dL ¬¬- and with a history of muscle-related statin intolerance. More than 80% of participants had previously reported intolerance to three or more statins. The study showed that 42.6 percent of these patients reported muscle pain or weakness on atorvastatin, but not placebo, and 26.5 percent on the placebo, but not atorvastatin.

Those who demonstrated statin intolerance only on atorvastatin were randomized to two alternative treatments to lower LDL cholesterol - evolocumab or ezetimibe. On average, patients showed a 52.8 percent reduction on evolocumab compared with 16.7 percent reduction with ezetimibe. The PCSK9 inhibitor evolocumab was more effective, but had a similar incidence of muscle-related adverse effects compared with ezetimibe.

Left untreated, patients with high levels of LDL cholesterol are at an increased risk of heart disease. Statins are the most effective drug currently available to lower LDL, but 5-105 of patients report they are unable to tolerate statins, due to muscle pain or weakness. Statin intolerance was previously diagnosed primarily by patient complaints since there exist no blood tests to document muscle-related stain intolerance.
Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is an injectable non-statin cholesterol-lowering drug self-administered by the patients once per month. Ezetimibe, used as the control in the trial, lowers LDL by decreasing the absorption of cholesterol in the small intestine. In the trial, both drugs rarely induced muscle symptoms, leading to discontinuation, which occurred in one patient given evolocumab and five patients given ezetimibe.

###​

The study was funded by Amgen. Dr. Nissen has served as a consultant for many pharmaceutical companies and has overseen clinical trials for Amgen, AstraZeneca, Cerenis, Eli Lilly, Novartis, Novo Nordisk, The Medicines Company, Orexigen, Takeda and Pfizer. However, he does not accept honoraria, consulting fees or other compensation from commercial entities.

About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. More than 3,000 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a main campus near downtown Cleveland, eight community hospitals, more than 90 northern Ohio outpatient locations, including 18 full-service family health centers, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and Cleveland Clinic Abu Dhabi. In 2014, there were 5.9 million outpatient visits throughout the Cleveland Clinic health system and 152,500 hospital admissions. Patients came for treatment from every state and 147 countries. Visit us at http://www.clevelandclinic.org. Follow us at http://www.twitter.com/ClevelandClinic.
Editor's Note: Cleveland Clinic News Service is available to provide broadcast-quality interviews and B-roll upon request.
Contact:
Tora Vinci, 216.339.4277, vinciv@ccf.org
Andrea Pacetti, 216.316.3040, pacetta@ccf.org

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to

http://www.eurekalert.org/pub_releases/2016-04/cc-sio033116.php

 

[RuthAnn]

Many people have adverse reactions to statins.

I have met people who have developed polymyositis from taking statins.

Why don't doctors recommend berberine HCl instead?

http://www.ncbi.nlm.nih.gov/pubmed/15926873

 

[GracieJ]

I do not think statins were ever a good idea in the first place, and have stayed as far away from them as possible! They may lower numbers but do not really prevent anything, just cause new issues that are not being tracked well. Relatively young people needing to go in for an ablation? Suspicious to me.

So our population does not tolerate them well, huh? Very interesting!

My poll choice is not included - have never taken statins.

 

[Wayne]

I recently read a book on the history of Vitamin C, and learned most NDs believe about 85% of heart disease and related blood circulation problems like strokes, aneurysms, blood clots, etc., have very little to do with cholesterol levels that are supposedly too high. They're instead caused by blood vessels that have become too weak (with cholesterol often trying to come to the rescue to "patch"). The primary underlying cause of most of these circulation problems is actually a form of scurvy, caused by lack of Vitamin C intake.

I watched a video by Mark Hyman recently who described a large study done in which thousands of people consumed 1 quart of olive oil -- per WEEK. That's a LOT of saturated fat (20%), supposedly a real bugaboo for cholesterol levels. Instead of cholesterol levels going up however, they came down on average of 30%, which is about the same results as occurs on statin drugs. As Paw said, there's way too much we don't know about cholesterol and its effects on the body to believe we understand everything about it.

I've also read that when patients with Alzheimer's and dementia have their cholesterol levels tested, they routinely come in at levels well beneath the average. I wonder how many of these people were part of the 35-40 million people who take statins, and perhaps gave themselves dementia in the process. The brain needs PLENTY of high quality cholesterol. Saturated fats provide this good HDL cholesterol, whereas sugar is what creates the bad LDL cholesterol.

The following 1-minute YouTube video about wraps up my own conclusions on statins. And he doesn't even mention how statins deplete the body of CoQ10. As I recall, CoQ10 is more concentrated in the heart than any other area of the body and is critical for heart health. This fact has been well-known to the makers of statins, and they even considered adding CoQ10 to their statin drugs. They decided against it however. Probably because they don't want the public to suspect their drugs are not quite as "safe and effective" as they would like us to believe.

Will This Go Down as History's 'Greatest Medical Hoax'?