Frequency of side effects
According to a study published in July 2017 in the Annals of Internal Medicine , about 20% of people who took a statin reported experiencing a side effect, mainly muscle disorders. Of those who reported these effects, about a third stopped taking statins, and the risk of dying, having a stroke, or having a heart attack increased by 13% in the 4 years following discontinuation of treatment compared to those taking statins. . The study involved analyzing 28,266 patients who reported statin-induced side effects. The patients came from 2 hospitals in Boston (USA) and it was carried out between 2000 and 2011.
Here are the main side effects of statins:
muscular type
The use of statins can lead to muscle side effects (muscle pain , etc). A study of 20 million people showed that 10-20% of this population had side effects and in particular muscle type problems. Most of the time, these muscle changes are not serious, but they can disrupt the patient’s life.
Few people actually experience muscle-type side effects from statin use alone (studies)
– In the United States, scientists estimate that up to 10% of Americans taking statins could experience muscle-type side effects, the equivalent of between 3 and 4 million Americans.
– In an article published in April 2019, the journal Wellness at the University of California at Berkeley goes even further and estimates that less than 1 in 100 statin users develop muscle pain (myalgia) of any degree, compared to a placebo. According to this American university, the reference to muscle pain is common, especially in middle-aged and elderly people, and can have numerous causes. In fact, most clinical trials have found that nearly as many people reported muscle problems in both the placebo group and the statin group. However, as noted in the 2019 Wellness journal article, some researchers believe that participants in these statin trials or studies were not representative of the general population, therefore,
– It should be noted that these numbers are based on large population studies and not controlled clinical trials. When looking at evidence from controlled clinical trials, where patients are randomly given a statin or placebo and carefully studied, the risk of muscle symptoms as a side effect appears to be much lower: 5% or less, according to the University article. from Berkeley.
– According to an article by the University of Berkeley , in the United States, dated October 2018, which refers to the scientific literature, the prevalence of adverse effects at the muscular level varies between 7 and 29%, according to different studies. This wide variation comes from the fact that describing muscle pain or symptoms is often quite subjective.
These muscle diseases or disorders can be symptomatic (myalgia, cramps) myopathy, asymptomatic (with elevated creatinine levels) or rhabdomyolysis. The latter disease is characterized by the destruction of muscles with consequences on other organs (for example, the kidneys. It is a very serious disease, but it is a very rare side effect of statins in the order of 1 in 1 million people. Note that there are small variations between each statin, with some statins causing 0.3 cases per 1 million while others causing 1 case in 1 million It is important to read the package insert and consult your doctor or pharmacist.
Risk factors for muscle-type adverse effects
The appearance of muscle-related side effects depends on factors such as patient characteristics, with women being more affected than men and the elderly more than young people, low weight, people with certain diseases such as kidney dysfunction and Liver dysfunction, grapefruit juice consumption, excessive alcohol consumption, dehydration, a family history of intolerance to statins, taking other medications, and hypothyroidism all carry a higher risk of developing side effects that affect the muscles.
There are also differences between statins, some statins have more or less side effects that affect the muscles. The dose of the prescribed statin can also be an influence, the higher the dose, the greater the risk of muscle-related side effects. Another risk factor is the “nocebo effect” , which is the opposite of the placebo effect. This occurs when patients experience certain side effects due to negative expectations, perhaps because they are aware of the potential risks.
Rhabdomyolysis and statins
Rhabdomyolysis is characterized by the destruction of muscles, with consequences for other organs (kidney, for example). It is a very serious disease with a sometimes fatal outcome, which is a rare side effect of statins, on the order of 1.5 cases in 100,000 people taking statins according to the Mayo Clinic . Dark urine (in English dark urine) can be a sign of rhabdomyolysis. If you notice dark urine, stop taking the statin and call a doctor right away.
In cases of muscle complications from taking statins, the doctor can determine the amount of CPK (muscle enzymes). The amount of transaminases can also be determined to monitor the state of the liver.
The STOMP study (Effect of Statins on Skeletta Muscular Function and Performance) is one of the main studies on the link between myalgia (muscle pain) and statin intake. In this research, scientists recruited 420 participants, one part took a placebo and the other atorvastatin. In the placebo group, 4.6% of participants reported muscle problems versus 9.4% in the atorvastatin group. Thus, this study showed a doubled risk of muscle-type side effects when statins are taken, at least in the case of atorvastatin.
In April 2019, an article in the journal Wellness at the University of California at Berkeley estimated that about 1 person in 10,000 who take statins will develop rhabdomyolysis.
Location of these muscle disorders
In the case of muscle-type side effects, symptoms are usually manifested in the large muscles of the legs (upper legs), chest, arms, shoulders, and lower back, but may occur elsewhere. In the legs, pain is usually located in both legs and not just one, that is, symmetrically.
Time of occurrence of these side effects
Symptoms of myalgias usually appear one to several weeks after starting treatment and not one day after taking statins, as some patients sometimes report (probable evidence of a placebo effect). In fact, one study showed that a significant portion of patients who received a placebo, while believing they were on statins, reported myalgia, proof of the placebo effect for a portion of the population.
hemorrhagic stroke
The use of statins reduces the number of cases of stroke, especially non-fatal cases. However, a large clinical study has shown that statins may slightly increase the risk of hemorrhagic stroke, a very serious form of stroke. The risk of hemorrhagic stroke appeared to be particularly greater among men, older patients and those taking a high dose of statins. In postmenopausal women, the association of statins and antiplatelet drugs also increases the risk of hemorrhagic stroke, as shown by another study published in 2015.
Study of 2019
Statins are effective in preventing cerebral hemorrhage, according to a large Danish study. This study refutes the idea suggested by other studies published in the past, which show a possible increased risk of suffering brain hemorrhage after taking statins. For Danish researchers, this opposite effect is true for cases of people who have never suffered a cerebral hemorrhage in the past, in which statins precisely prevent the risk of cerebral hemorrhage. This is the largest study to date on this topic. More than 500,000 people have been followed since they started taking statins between 2004 and 2014. Scientists noted in data analyses, that people taking statins (statin group) had a lower risk of brain hemorrhage than those not taking statins (control group). The risk of developing brain hemorrhage in the statin group was 22% to 35% lower than in the control group after taking statins for at least 6 months. None of the participants had suffered a brain hemorrhage or blood clots in the past. A 2006 clinical study showed an increased risk of bleeding in people taking statins who had already had a brain bleed in the past. This new Danish study shows that in people who have not had brain bleeding, statins can work effectively to prevent bleeding in the brain. The University of Aarhus, Denmark,EclinicalMedicine (DOI: 10.1016 / j.eclinm.2019.02.007).
Cognitive disorders (mainly memory loss)
In February 2012, the FDA (American Medicines Regulatory Authority) issued a statement regarding the possible risk of cognitive impairment, including memory, with the use of statins. These disorders seem to be reversible, that is, after stopping the use of statins, memory returns. Cholesterol is involved in brain growth and it is known that 25% of total cholesterol is found in the brain, particularly in the myelin sheaths. Statins can theoretically interfere with cholesterol synthesis in the brain. However, it is not possible to measure the protein that transports cholesterol in the brain with a conventional blood test such as LDL or HDL. Statins can theoretically cross the blood-brain barrier, particularly very lipophilic statins such as simvastatin, which is not the case with pravastatin, a more hydrophilic statin. However, clinical studies are conflicting on this matter.
Thus, despite the theoretical elements, in clinical practice it is estimated that currently (2015) few studies have demonstrated the negative effect of statins on memory. Citing the PROSPER study, a research paper involving 5804 participants, with one group taking 40 mg of pravastatin and another group taking a placebo. In these individuals between 70 and 82 years old, the researchers did not find a deterioration in cognitive impairment, comparing the placebo group with pravastatin.
gastrointestinal disorders
Gastrointestinal disorders or liver problems can also occur with statin use.
Type 2 diabetes
– A large Finnish study published in March 2015 in the specialized European journal Diabetologia, showed that the risk of type 2 diabetes, at least among white men (the study involved more than 8,700 Finnish white men aged 45 to 73 years), was about twice as high in people taking statins as in those who did not, and 46% higher after accounting for correction factors, such as obesity, so as not to skew the results. According to investigators, statins increase insulin resistance by around 24% and reduce insulin secretion by 12%.
– According to an Australian study published in 2017 in the specialized journal Drugs and Aging, women over the age of 75 had a 33% increased risk of developing diabetes when they took statins. This study conducted by the University of Queensland in Western Australia performed data analysis on over 8,000 Australian women.
Other studies have shown an association between taking statins and diabetes in postmenopausal women, as reported by the American journal Prevention in its December 2017 issue.
Other side effects
Other side effects can be back pain and liver problems. Liver damage from statins occurs very rarely, about 1 person in 100,000 who use statins, according to the American Heart Association (AHA).
For a complete list of side effects, please read the medication leaflet.
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