Lipitor (atorvastatin), the cholesterol reducing statin medication sold by the Pfizer Corporation, is the number one best-selling prescription drug of all time. In fact, two of the top five best-selling prescription drugs of all time are statin medications (Crestor being the other one). Rounding out the top five are a blood thinning medication, an asthma medication, and an arthritis medication.
Cholesterol and Q10 — the same biological pathway
For some time now, we have known that Lipitor and the other statin medications inhibit not only the body’s production of cholesterol but also the body’s synthesis of Coenzyme Q10, a substance that is very important for cellular energy production and for antioxidant protection (2). This inhibition of the body’s generation of Coenzyme Q10 is not a good thing for our heart health.
Finnish study of statins and risk of type-2 diabetes
More recently, we have learned that Lipitor and other statin medications are suspected of increasing the risk of developing type-2 diabetes (1). The results of a Finnish epidemiological study published in the journal Diabetologia in March of 2015 show a 46% increase in diabetes among 8,749 Caucasian men aged 45 to 73 years old whom the researchers followed for nearly six years in the Metabolic Syndrome in Men (METSIM) study based in Kuopio, Finland. The Finnish researchers have attributed the increase in the onset of diabetes in men taking statin medications to increased problems with insulin sensitivity and with insulin secretion.
Meta-analysis of statin medications and diabetes in The Lancet
In 2010, Sattar and a team of researchers conducted a meta-analysis of 13 randomized controlled endpoint studies of statin use (4). Each of the 13 studies enrolled more than 1000 patients. Altogether, the 13 studies enrolled 91,140 participants. 4278 participants (2226 assigned statin treatment and 2052 assigned to placebo treatment) developed diabetes during an average period of four years.
There was, therefore, a 9 percent increased risk of developing diabetes while receiving the statin treatment. The risk was highest in older participants. Body-mass index and LDL-cholesterol levels were not seen to be related to the increased risk of developing diabetes.
The researchers concluded that the increased risk of developing diabetes while on statin therapy is slight both in absolute terms and in relation to the reduction in coronary events. The researchers concluded that the clinical practice of using statin therapy in cases of moderate or high cardiovascular risk should not be changed.
Heart attacks down, heart failure up?
Okay, the Sattar meta-analysis was published in the The Lancet in 2010. Since then, various researchers have noticed that, at the same time that the incidence of heart attacks has been declining somewhat, the incidence and mortality of chronic heart failure has been increasing.
Theoretical explanation for the increase in heart failure
Heart failure is defined, simply, as the failure of the heart muscle to pump blood as well as it should. In its most advanced stage, patients are tired and lethargic even at rest, and, in slightly less severe stages, the heart failure patients are unable to exert themselves without becoming fatigued and out of breath.
The American cardiologist Dr. Peter H. Langsjoen of Tyler, Texas, and a group of Japanese researchers have developed a theoretical explanation for the increases in the incidence and mortality of chronic heart failure that are occurring at the same time that the incidence of heart attacks has fallen somewhat (3).
Dr. Langsjoen and his colleagues speculate that pervasive use of statin medications may be contributing to the increased incidence of congestive heart failure in three ways (2):
- Through an impairment of heart muscle function because the statin medications inhibit the body’s synthesis of Coenzyme Q10, which, in turn inhibits the body’s production of ATP for energy
- Through the statin medications’ inhibition of the body’s synthesis of vitamin K2, which is a co-factor for the activation of matrix Gla-proteins, which protect the arteries from calcification
- Through the statin medications’ inhibition of the body’s biosynthesis of seleno-proteins such as glutathione peroxidase (which suppresses peroxidative stress)
One noticeable difference between the United States and Europe is the placement of the burden of proof in matters concerning environmental protection and public health. Generally, the United States seems to place the burden of proof on the consumers. Producers in the United States – think: tobacco industry – are mostly free to put the environment or public health at risk until there is definitive proof that the producers’ actions are harmful. Since many harmful outcomes such as cancer are slow to reveal themselves, producers can continue to make big profits for long periods.
In Europe, on the other hand, the burden of proof is frequently placed on the producer. Producers should not take actions that might cause harm to the environment or public health until there is proof that such actions will not be harmful. This European approach, which can be seen, for example, in the cautious European attitude towards genetically modified organisms, is known as the precautionary principle.
The problem with the American cost-benefit approach – used in place of the precautionary principle – is that the potential benefits to the society are often over-estimated, and the potential costs to society are consistently under-estimated, not least because it is very difficult to put a monetary value on disabling injuries and deaths caused by a producer’s action. Moreover, the costs to future generations are almost always undervalued, and the benefits to future generations of not taking an action are usually impossible to calculate.
What the Food and Drug Administration is saying about statins
The FDA is advising health care professionals and consumers that people who are being treated with statin medications may be exposed to the following adverse effects:
- An increased risk of developing type-2 diabetes
- An increased risk of suffering from memory loss and confusion
- An increased risk of muscle damage
A reasonable person might well ask why there was not more extensive testing to ascertain the adverse effects of statin medications before the big drug corporations got permission to make scads of money selling statins.
The FDA is now advising patients taking statin medications to contact their healthcare professional if they have any questions or concerns about their statin medications and to report adverse side effects from using statin medications to the FDA MedWatch program.
- Cederberg H, Stančáková A, Yaluri N, Modi S, Kuusisto J, Laakso M.(2015, Mar 10). Increased risk of diabetes with statin treatment is associated with impaired insulin sensitivity and insulin secretion: a 6 year follow-up study of the METSIM cohort.Diabetologia. [Epub ahead of print]
- Littarru, GP, Langsjoen, PH. (2007, Jun). Coenzyme Q10 and statins: biochemical and clinical implications.Mitochondrion, 7 Suppl:S168-74. Epub 2007 Mar 27.
- Okuyama H, Langsjoen PH, Hamazaki T, Ogushi Y, Hama R, Kobayashi T, Uchino H. (2015, Mar). Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms. Expert Rev Clin Pharmacol, 8(2):189-99. doi: 10.1586/17512433.2015.1011125.
- Sattar, N., Preiss, D., Murray, H. M., Welsh, P., Buckley, B. M., de Craen, A. M., & … Ford, I. (2010). Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet, 375(9716), 735-742. doi:10.1016/S0140-6736(09)61965-6