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We share this report from Agencia SINC about an international analysis with data from more than 150.000 patients that questions the relationship between cholesterol drugs and common symptoms cited in the package inserts.
Statins do not cause most of the conditions listed in their package inserts, such as memory loss, depression, sleep disturbances, or erectile and sexual dysfunction, according to the a more thorough review of possible side effects. The work has been led by researchers from Oxford Population Health and it has been published in the magazine The Lancet.
Cardiovascular disease causes approximately 20 million deaths worldwide. Statins are highly effective drugs that lower levels of LDL cholesterol, known as "bad" cholesterol, and have been repeatedly shown to reduce cardiovascular risk and mortality in both men and women. However, in recent years, concerns have arisen about their potential adverse effects.
To address this issue, researchers compiled data from 23 large randomized studies of the Cholesterol Treatment Trialists' CollaborationIn total, they analyzed 123,940 participants from 19 clinical trials comparing statins versus placebo and 30,724 participants from four studies evaluating more intensive versus less intensive statin treatments.
The results show similar rates of reported side effects for those taking statins and those receiving a placebo for almost all the conditions listed in the package inserts. For example, the annual frequency of reported cognitive or memory impairment was 0,2% in both the statin and placebo groups. This suggests that, although some people may experience these problems while taking the medication, there is no strong evidence that they are caused by the statins.
The analysis concludes that there is no statistically significant excess risk associated with statin treatment for almost all of the conditions listed as possible side effects.
Taking statins does not significantly increase the risk of memory loss or dementia, depression, sleep disturbances, erectile dysfunction, weight gain, nausea, fatigue, headaches, or many other conditions. Only a small increased risk, of about 0,1%, was observed in abnormalities in liver blood testsHowever, no increase in liver diseases such as hepatitis or liver failure was detected, suggesting that these changes do not usually lead to serious problems.
Christina Reith, associate professor at Oxford Population Health and lead author of the study, stated that “statins are life-saving drugs and have been used by hundreds of millions of people over the past 30 years.” He noted that “concerns about their safety have deterred many people at risk of serious disability or death from a heart attack or stroke,” adding that “our study provides reassurance, as for most people the risk of side effects is far outweighed by the benefits of statins.”
Previous work by the same group of researchers had already established that most muscle symptoms are not caused by statins. Therapy with these drugs only produced muscle symptoms in 1% of people, mainly during the first year of treatment, without subsequent excess. It had also been shown that statins can cause a slight increase in blood sugar levels, so some high-risk individuals may develop diabetes earlier.
Evidence from large randomized trials
For its part, Anthony Keech, co-author of the work and cardiologist at the Royal Prince Alfred Hospital and professor of Medicine, Cardiology and Epidemiology at the University of Sydney, explained that all the trials included in the analysis were large in size, with at least 1.000 participants, and followed the results for a median of close to five years. The studies were double-blindSo, neither the participants nor the researchers knew who was receiving which treatment, in order to avoid bias. The list of possible side effects was compiled from those collected for the five most prescribed statins.
The study was conducted by the Cholesterol Treatment Trialists' Collaboration, a joint initiative coordinated by the Clinical Trial Service Unit & Epidemiological Studies Unit of Oxford Population Health and the National Health and Medical Research Council Clinical Trials Centre of the University of Sydney, on behalf of academic researchers from leading statin trials worldwide.
The research has been funded by the British Heart Foundation, the UKRI Medical Research Council and the National Health and Medical Research Council of Australia, and the work of the CTT group is supervised by a independent panel.
Source: SINC Agency
