Why are the incidence of side effects from statins very low in clinical trials while they appear to be very high in the real world?
“There is overwhelming evidence to support the reduction of LDL-C (low-density lipoprotein cholesterol)” – so-called cholesterol – the number one murderer in men and women. 40% of patients, and up to 80%, did not fully comply with statin treatment recommendations. “Three-quarters of patients can stop taking the medication, and almost 90% can stop treatment completely.
When asked why they stopped taking tablets, most “previous statin users or discontinued… cited side effects as the main reason…” “Samus” – statin-related muscle symptoms – are “the most common and important adverse events, with up to 72% of statin adverse events being related to muscles.” Taking coenzyme Q10 supplements as a treatment for statin-related muscle symptoms was a good idea in theory, but they don’t seem to help. Symptoms of side effects usually go away when you stop the medication, but sometimes last for more than a year. “There is growing evidence that statin intolerance is primarily psychosocial and not pharmacological.” Really? Maybe it’s mostly in people’s minds?
“Statins have generally had a bad reputation among the public, a phenomenon driven primarily by the Internet’s proliferation of persuasive criticism of these drugs, although odd and unscientific, on the Internet.” “Does Google lead to statin intolerance?” However, people stopped taking statins for decades before the internet existed. What data does the doctor suggest when the patient mistakenly “incorrectly (ing) (incorrectly (ing)” that “normal pain and pain are side effects of statins”?
If you take people who claim to have statin-related muscle pain and randomize them back and forth between the statin-identical placebo in a three-week block, they won’t know if they are taking actual drugs and sugar pills. But the problem with the study is that not only does it develop statin-induced muscle pain, it may take several months before it disappears. So you won’t be surprised for three weeks.
However, these data are more convincing: 10,000 people were randomised to statins or sugar tablets for several years, but the study had to be stopped prematurely as more people were dying in the sugar tablet group. So everyone was given statins, and the researchers noted that patients assigned to statins have “not excessive reporting of muscle-related AEs” (side effects) (side effects) (side effects). However, when the placebo phase ended and people knew they were taking statins, they continued to report more muscle side effects than people who knew they were not taking statins. “These analyses show the so-called nosebo effect.” This is similar to the opposite of the placebo effect.
The effect of placebo is a positive outcome caused by mistake in treatment, whereas the effect of nosebo is a negative outcome caused by mistake in treatment, as clearly seen here. There was an excess of muscle-related side effects reported only when the patient and his physician were aware that statin therapy was being used, not when its use was hidden. The researchers said, “These results help to ensure that most statin-related AEs are not causally related to drug use and to counter exaggerated claims about statin-related side effects.”
These show that “placebo-controlled randomized trials (That) clearly show that almost all symptomatic adverse events caused by statin therapy in routine practice are not actually caused by it (i.e., representing a false contribution.” In fact, “Discontinuation of statin therapy may be a life-threatening mistake.”
At 4:46 below my video, how common is muscle side effects from statins? This translates to “about one excess death for every 83 patients who discontinue treatment” within four years. So, if there is media coverage of side effects of statins and people stop taking them, this could “result in thousands of fatal and injuring heart attacks and strokes. This would otherwise have been avoided. In the history of modern treatments, there is rarely a substantial benefit of treatment due to serious misrepresentation of its safety.” However, “is it a misrepresentation to suggest that statin therapy causes side effects in up to a fifth of patients? That’s what we see in clinical practice. 10-25% of patients placed on statins complain of muscle problems. However, controlled trials accused of patients as confused because they are not visible near these types of numbers. Why is the incidence of side effects from statins very low in clinical trials while they appear to be very high in real life?
Take this meta-analysis of clinical trials. For example, we found that not one in five patients, and not just one in 2,000 patients. Should everyone be in statins at a certain age? Naturally, all of these trials were funded by the statin makers themselves. So, for example, “How do statin RCTs (randomized controlled trials) miss the detection of mild statin-related adverse side effects such as muscle pain (muscular pain)? So, are the majority of side effects only missed in all these trials, or are the majority of side effects seen in clinical practice just numbers in the patient’s imagination? The bottom line is something we don’t know, but there is certainly an urgent need to understand it.
