The Safety of Lipid Therapy: Statins
A question I am always asked is "Are statins safe?" In the next series of posts, I will cover this topic and also discuss the safety of all the different classes of drugs used in lipid management.
Many patients and physicians have questioned the safety of statins. These concerns have arisen from information in the news and print media, on the internet, and from direct-to-consumer advertising. Unfortunately, much of the factual evidence is either overlooked or unknown. Because of this 'misinformation', many patients refuse to initiate statin therapy and others stop long term treatment out of fear for their safety.
To address these concerns about the safety of lipid modulating drugs, The National Lipid Association appointed a Safety Assessment Task Force to evaluate statin safety and in a second report, the safety of nonstatin lipid altering drugs. The charge given to this task force was to conduct a "rigorous, scholarly, up-to-date, and unbiased assessment."
Four panels were assembled which focused on the muscle, liver, renal, and neurological effects of statins. To assure a rigorous comprehensive assessment of statin safety, the Task Force further commissioned reviews of special literature on adverse reactions and drug interactions. Reports of the work included an "up-to-the-minute" systematic review of published cohort and clinical trial data on statin safety, the most recent data from the FDA's AERS, an inspection of the data contained in the new drug applications, and the FDA's summary basis of approvals for marketed statins and associated adverse health events in a 22 million person managed health care data base.
The Task Force report on statin safety was published in April 2006 in The American Journal of Cardiology; the report on nonstatin safety was published in the same journal in March 2007. To me, this is the most comprehensive, evidence-based, unbiased assessment of all these drugs, and the guidelines should be followed by all physicians and their patients.
Now a little background. Cardiovascular disease continues to be an epidemic and is responsible for more than half of all deaths in the United States. Each day more than 2600 Americans die from cardiovascular disease. Approximately 80 million American are affected by CVD and more than 125 million lipid panels are performed annually. Despite the increase in cholesterol testing, the number of Americans affected with CVD continues to rise. Why is that? (In subsequent posts I will cover the reason why I believe this is happening.)
Abnormal lipids (Dyslipidemia) is well established as one of the strongest independent predictors of CV morbidity and mortality. There have been large outcome trials that have consistently shown that lowering LDL cholesterol reduces morbidity and mortality associated with coronary heart disease. As the data continues to accumulate, the notion that "lower is better" has uniformly been supported.
As a result of 5 large clinical trials, the National Cholesterol Education Panel (NCEP) Adult Treatment Panel (ATP) III has recognized this and new guidelines recommend further reducing the goal for the LDL cholesterol to less than 70mg/dl in the most high risk patients. You can read the NCEP guidelines on lipid management as well as the newer NCEP guidelines on treatment of the metabolic syndrome on my website.
But despite this new recommendation, the American Heart Association's 2007 statistical update shows that fewer than 20% of patients with CHD have achieved recommended goal levels of LDL cholesterol. In my next post, we will begin to look at the safety of each class of drugs starting with statins.
Related Topics: Technorati Tags: cholesterol, statins, heart disease, health and wellness
Many patients and physicians have questioned the safety of statins. These concerns have arisen from information in the news and print media, on the internet, and from direct-to-consumer advertising. Unfortunately, much of the factual evidence is either overlooked or unknown. Because of this 'misinformation', many patients refuse to initiate statin therapy and others stop long term treatment out of fear for their safety.
To address these concerns about the safety of lipid modulating drugs, The National Lipid Association appointed a Safety Assessment Task Force to evaluate statin safety and in a second report, the safety of nonstatin lipid altering drugs. The charge given to this task force was to conduct a "rigorous, scholarly, up-to-date, and unbiased assessment."
Four panels were assembled which focused on the muscle, liver, renal, and neurological effects of statins. To assure a rigorous comprehensive assessment of statin safety, the Task Force further commissioned reviews of special literature on adverse reactions and drug interactions. Reports of the work included an "up-to-the-minute" systematic review of published cohort and clinical trial data on statin safety, the most recent data from the FDA's AERS, an inspection of the data contained in the new drug applications, and the FDA's summary basis of approvals for marketed statins and associated adverse health events in a 22 million person managed health care data base.
The Task Force report on statin safety was published in April 2006 in The American Journal of Cardiology; the report on nonstatin safety was published in the same journal in March 2007. To me, this is the most comprehensive, evidence-based, unbiased assessment of all these drugs, and the guidelines should be followed by all physicians and their patients.
Now a little background. Cardiovascular disease continues to be an epidemic and is responsible for more than half of all deaths in the United States. Each day more than 2600 Americans die from cardiovascular disease. Approximately 80 million American are affected by CVD and more than 125 million lipid panels are performed annually. Despite the increase in cholesterol testing, the number of Americans affected with CVD continues to rise. Why is that? (In subsequent posts I will cover the reason why I believe this is happening.)
Abnormal lipids (Dyslipidemia) is well established as one of the strongest independent predictors of CV morbidity and mortality. There have been large outcome trials that have consistently shown that lowering LDL cholesterol reduces morbidity and mortality associated with coronary heart disease. As the data continues to accumulate, the notion that "lower is better" has uniformly been supported.
As a result of 5 large clinical trials, the National Cholesterol Education Panel (NCEP) Adult Treatment Panel (ATP) III has recognized this and new guidelines recommend further reducing the goal for the LDL cholesterol to less than 70mg/dl in the most high risk patients. You can read the NCEP guidelines on lipid management as well as the newer NCEP guidelines on treatment of the metabolic syndrome on my website.
But despite this new recommendation, the American Heart Association's 2007 statistical update shows that fewer than 20% of patients with CHD have achieved recommended goal levels of LDL cholesterol. In my next post, we will begin to look at the safety of each class of drugs starting with statins.
Related Topics: Technorati Tags: cholesterol, statins, heart disease, health and wellness
20 Comments:
I'd just like to thank you, Dr. Richman. Your presentation of the often times confusing and misunderstood topics of cholesterol management and lipid therapy is quite informative and enlightening. Perhaps the most impressive component of your blog is that you draw your conclusions from evidence based research consisting of sound theory and relevant evidence. Thank you for your expertise and for sharing!
I see a lot of positive information about statins in your article, but, I see no comments about the negative side of statins. Wish you had addressed that issue.
I was on statins for approx l month
but began to feel unwell and experienced soreness in the muscles in my arms.Although they did reduce my cholestrol level.I came off them.
Untreated, my cholesterol total is in the 460 range. I have taken various statin drugs for years. Although they have reduced my cholesterol to the 150 range, especially with Vytorin, muscle soreness and high CK readings have caused great concern and I have been ordered to stop its use. The commercials say it is a "rare but serious" side effect, yet in my talks with family, friends and associates, I hear this compalint frequently. Just how rare is it?
I have used several of the statins and each time have had the muscle aches in my legs and hips. They have worked at getting the cholesterol down, I usually run at 240 to 170...but when this happens I call my Dr who then has me call my pharmisist who says "off" now. Too dangerous. So what is the answer.
I certainly appreciate the comments. I will be addressing the effect of statins on the kidneys in my next post and after that will talk about the effect on muscles. I will hopefully be able to tackle all these questions. In the mean time, there have been numerous responses to similar questions by me on my message board so you may want to scroll through to locate them. Have a great day!
Statins are life savers for those who can take them but I almost died from one of them because of severe muscle damage . It took two years to recover . People on statins should talk to their Doctor about taking CoEnzyme Q10 .
I was on a statin and did not realize the pain and fatigue was from medicine because I was working in a very physical job and thought that was causing it. I had been in the hospital a month or so earler and a mistake was made in dose of lipitor from 10 to 40. When I saw my gp 2 months later he quickly lowered it to 10. The symptoms had already started of: severe muscle/joint pain, fatigue, gait problems. It has been over a year, I still use a walker and have trouble with fatigue. Please address these problems in one of your letters. I know the frequency of these problems are low, but I seem to match the symptoms. A psychologist I just started seeing thinks I have a conversion disorder, but I have no recent trauma. Physicians have not been able to find abolute cause. Docs Isee no do not think conversion, but hesitant on statins. I have high cholesterol but am scared to death, live a shorter life with a disability I have now learned to cope with, or live longer and my disability possibly get worse.
I agree with Mrs B i'm sure its the statins which have caused her problems.As i have written before after only being on symvastin for l month how unwell they made me feel and my G.P was reluctant for me to come off them.I am sure if i had remained on them i would have irevirsable muscle damage. I feel completely well now but colestrol still high even with exercise and good diet.My G.P did say it could be genetic so what is the answer?
I think that it is very important that your Doctor make you very aware of the side effects of these drugs. Some people have no problems taking statins but others as myself had very bad side effects and just thought it was my artritis worsening but after getting worse and worse my husband starting doing research and had me call my Doctor immediate response stop taking the drug. Bur i have been off these for over 30 days and my condition has had no improvement as fall as being in pain constantly and muscle problems. I have a diease that runs in my family known as Lou Gherigs alias ALS and I have to wonder if any of the people who have problems have this diease may run in their family's? As far as I'm concerned there have not been enough studies on these drugs and they are ver dangerous.
70mg is a bit too hard to achieve.
I have been in dibilitating and excruciating pain for months now. I have had arthritis for years so I know what constant pain is like and am use to dealing with it. However, never in my life have I experienced such severe and constant pain. Today I ate late so I did not take my medications till about 11:30. I usually eat by 5:00 a.m. Suddenly I realized how wonderful I felt for the first time in months. I realized it had been about as long as I had been taking Vytorin. I took all my meds except Vytorin. I still feel great this evening. I will not take it again. It must be the sorce or my pain.
To the person with ALS. The Dec 2007 International Symposium on ALS had a paper which found that Statins greatly accerlerated the progression of ALS. Another paper found that ALS patients with low cholesterol had a one year less survival time than ALS patients with normal cholesterol. Pfizer is currently running a trial to determine if the anti-inflammatory properties of Lipitor will help ALS patients. The study is described as "counter intuitive because of Lipitors known nerve and muscle damaging properties. The study appears to be a publicity stunt to defend against charges that Lipitor causes ALS. If the Toronto study is correct, then the patients in the trial may be in grave danger.
I was prescribed 40 mg Lipitor and took only 2 doses when I started experiencing aching in my spine, a slight nausea feeling, and then a spike in temperature to 104. I thought I had the flu, so I stopped taking the Lipitor and then over five days felt better so I took a 40 mg Lipitor and the same thing happened. My liver enzymes were elevated and are now coming down.
this seems pretty well spread, to me. I was on Statins about 6 yrs, 40 mg about the last 2 years. the pain is so severe in my legs. they wake me up at night, and can't walk more then 20 ft without stopping. because of the pain. My feet burn they wake me up at night, muscle loss in one leg. I have taken vascular tests, (MRA) & MRI, no one can find any problems. I keep telling every one it is the statin, but the Doctors do not listen to me. I have been off statins about a year now and the pain is still there. Symptoms include confusion, muscle pain in legs back hips and butt, is this a life time thing?
year later still have them. someone please help.
Dr. Richman,
Your comments would have been better if you had expounded on the adverse effects. I started taking Zocor in 2003, by 2006 I was unable to go up and down stairs, I could not get off the floor when I stooped down. I finally went off the drug and it took 6 months for all the pain in my joints to go away(shoulder,elbow,knees,feet, hands). Then my cholesterlo went to 200 and I went on Zetia and Crestor. 6 months later when my cholesterol was 142 and LDL was 65 I again developed pain(from a forearm that woke me up from sleep as if it were on "fire" to"knots" in the instep of my feet, to heels that seemed on fire. Then the areas around my joints would swell with edema and pain and then disappear in 2 days and show up at other joints(toes, knuckles, ankles). I had negative testing at a Rheumatogist after the Zocor and recently had screening done at my family doctor. Nothing shows up! However now the pain shifts around, edema continues and I believe an Autoimmune disease has been set off. I would appreciate your comments.
Have just been taking Lipitor 10mg 2 months now and thought the pain in my upper arm muscles and joints might be arthritis (family heredity and already have some in my back)but I will be addressing this with my Dr. ASAP after reading the posted comments...
Pat said...
It is time for physicians to listen to their patients re: side effects of statins and to present the patients adverse effects to the FDA. I think there is a "head in the sand" approach toward what is happening to many people who take statins and suffer awful side effects. It is too bad that these patients are not believed but the pharmaceutical companies are given full trust.
A recently completed study by UC San Diego has shown that 40% of all statin takers have some level of myopathy. I took Zocor last year for about six months. My muscle pain started a few days after beginning Zocor - I didn't even think about it being a dangerous drug. I have improved some but not completely. The RN in our cardiologist's offce said she can take statins because of memory problems.
There is starting to be some talk that perhaps the whole cholesterol is bad theory is starting to melt.
I would never take those drugs again. I can barely get around by myself and just recently retired and expected to do lots of walking and exploring.
I HAVE BEEN TAKING STATINS ABOUT 10 YEARS, LIPITOR, CRESTOR,VYTORIN, AND I HAVE BEEN HAVINF MUSCLE PAIN FOR TWO YEARS NOW, IS THIS BECAUSE OF THE STATINS? THE DOCTORS KEEP CHANGING THE STATINS. THE PAIN IS WORSE IN THE SPRING OF THE YEAR AND SUMMER. I AM 59. SOME DOCTOR THAT READS THIS PLEASE TELL ME WHAT TO DO!
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