New Labeling on This Popular Class of Cholesterol Medication Sparks Hot debate in Medicine
By Sarah LoBisco, ND
In February, the FDA issued a change to the labels of various statin medications. These changes included:
1. A warning of increased Hemoglobin A1c levels (a lab measure of the average amount of glucose in your blood)
2. A warning of increased risk of cognitive impairment
3. The discontinuation of monitoring liver enzymes with treatment. Instead, measuring liver function enzymes is encouraged at the start of treatment
4. Lovastatin included additional warnings in that should not be used in combination with certain antiretrovirals, antifungals, and certain macrolide antibiotics and their derivatives.
An article in Medscape describes the reasons for the changes:
February 28, 2012 (Silver Spring, Maryland) — Taking a statin can raise blood sugar and glycosylated hemoglobin HbA1c levels, according to a new labeling change approved by the Food and Drug Administration (FDA) today for the entire drug class .
As reported by heartwire , recent studies of popular statins showed a significant increase in the risk of diabetes mellitus associated with high-dose statin therapy. The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial showed a 27% increase in diabetes mellitus in patients taking rosuvastatin compared to placebo. Also, the Pravastatin or Atorvastatin Evaluation and Infection Therapy: Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy showed that high-dose atorvastatin can worsen glycemic control.
The labeling changes approved by the FDA also include new information on the potential for usually minor and reversible cognitive side effects. Also, the label for lovastatin has been significantly updated to provide information on contraindications and dose limitations for the drug in patients taking other medicines that may increase the risk for muscle injury.
The FDA says it is also eliminating the recommendation that patients on statins undergo routine periodic monitoring of liver enzymes, because this approach is ineffective in detecting and preventing the “rare and unpredictable” serious liver injuries related to statins. Statin therapy should be interrupted if the patient shows signs of serious liver injury, hyperbilirubinemia, or jaundice. The statin therapy should not be restarted if the drugs cannot be ruled out as a cause of the problems, the labeling will now state.
This sounds very similar to me….oh, I know why. Remember, I wrote about it in 2009?….. on this very site:
In this article, Dr. Diva explains the biochemistry behind high blood sugar and cholesterol. While traveling in the blood stream, glucose interacts with proteins such as the collagen in arterial walls and the lipoproteins of cholesterol. This interaction creates a cross-linkage through a process called glycation resulting in protein and lipoprotein structural changes. The results are more rigid arteries and LDL cholesterol molecules with decreased efficiency in ridding the body of excess cholesterol- (2) major hits in causing damage to arterial walls. Furthermore, this issue is compounded in that it increases the risk for developing insulin resistance, a major factor in developing type 2 diabetes.(http://www.saratoga.com/living-well/2009/08/blood-sugar-and-cholesterol.html.)
Doctors are being informed of the changes and being encouraged that the benefits outweigh the warnings. Furthermore, some evidence dose exist that statins have prevented some cardiovascular deaths.I agree to a point, in relation to prevention of secondary heart attacks in men. However, do the risks outweigh the benefits? Hmmm.
In 2011, I spoke about the the cholesterol-heart link and the studies proving their effectiveness:
Recently, I was fortunate to hear a seminar with Dr. White, an integrative DC & Nutritionist. He concluded:
The original study of cholesterol done in the 1960s on approximately 240,000 subjects found that cholesterol levels above 300 directly associated itself with an increased risk of heart disease. What was also reported in the same study also was that cholesterol less than 130 directly associated itself with an increased risk of cancer.
Furthermore, we need to look at the individual and what is the best treatment for each individual. If inflammation and cholesterol is dangerously high, perhaps the short term use of statin medications could be helpful in preventing damage to the heart. However, what about the connection between a change in lifestyle that not only produces lowered cholesterol levels, from the body healing, but other positive benefits. As Mark Hyman, MD reports:
I recall reading a scientific paper in the Journal of the American Medical Association a number of years ago by Dr. David Jenkins from the University of Toronto. He showed that using a combination of soy, fiber, almonds, and plant sterols (cholesterol-lowering fats) could lower cholesterol levels as much as statin medications.(i) Diet can lower cholesterol as much as statins–a surprise to many but common in my practice. Using a comprehensive approach of diet and lifestyle change, I routinely see effects that are more powerful than any medication. That was not why the article struck me. It was a finding buried in the text of the paper.
What I found fascinating was that the patients who lowered their cholesterol with statins had higher levels of insulin, while those who lowered their cholesterol through diet had lower insulin levels.
In closing, I’d like to reverberate what I wrote in my above mentioned blog:
High cholesterol in itself is not necessary an issue. The problem lies in when the cholesterol gets oxidized or inflamed and sticks to artery walls. Correcting hormonal imbalances, high blood sugar, sources of infection and inflammation, and addressing stress all can prevent this unwanted effect.
As a Naturopathic and Functional Medical Doctor, I practice upstream medicine. This means, I am looking for the cause of the problem. Blaming cholesterol for heart disease is like blaming a witness at the scene of the crime. We need to look at why the body is producing the cholesterol.
Cholesterol is needed in the body for a variety functions, it forms a protective layer around every cell in your body. It is a pre-cursor to important sex hormones, fat-soluble vitamins (including Vitamin D!), and is needed to make bile salts for the breakdown and use of dietary fats. Cholesterol is found in large amounts in the brain, adrenal gland, and nervous system. It is estimated that the liver actually makes about 40-50% and that only 50% of cholesterol from food is absorbed.
Cholesterol is so vital for health of the body, if it is reduced to too low of an amount; the liver is put to work and produces more. Due to its variety of functions, cutting it down so low, below 200, could be causing negative side effects outside of the heart. (http://www.dr-lobisco.com/is-cholesterol-the-bad-guy/.)
You can find additional information on my website and this site.
Reed Miller. FDA Adds Warnings to Statin Label. Medscape Today. 2/28/12. http://www.medscape.com/viewarticle/759335?src=ptalk.
Howard S. Weintraub, MD. The Statin Labeling Changes: Don’t be Spooked. Medscape Today. 3/6/12. http://www.medscape.com/viewarticle/759735?src=ptalk.
Laurie Scudder. Statins: The Story Behind the Label Changes. An Expert Interview with FDA’s AMy G. Egan. 3/6/12. Medscape Today. http://www.medscape.com/viewarticle/759736?src=ptalk.
Michael Mogadam, MD .Statins and Risk for Diabetes: Deconstructing a Flawed Study. Medscape Today. 2/24/12.http://www.medscape.com/viewarticle/759041?src=ptalk.
Brenda Goodman.Stroke Risk Triples After a Decade with Diabetes. WebMD. 3/1/12. http://diabetes.webmd.com/news/20120301/stroke-risk-triples-after-decade-with-diabetes?ecd=wnl_hyp_030812.
Hyman. M. Do Statins Cause Diabetes and Heart Disease. Huffington Post. 9/10/10. http://www.huffingtonpost.com/dr-mark-hyman/do-statins-cause-diabetes_b_712929.html.