Autor/es reacciones

Héctor Bueno

Cardiologist at the 12 de Octubre Hospital in Madrid and principal investigator of the Multidisciplinary Translational Cardiovascular Research Group of the National Center for Cardiovascular Research (CNIC)

I find this to be a high-quality study with a very robust methodology, using exclusively data from each participant in all large randomized clinical trials comparing different statins, at varying doses, against placebo or other controlled comparators (such as another statin or a different dose). This type of design represents the methodological gold standard for understanding the causal effects of treatments. Furthermore, the study was conducted by a broad academic consortium of experts whose analyses are not directly influenced by the pharmaceutical industry, which strengthens its credibility.

The results, in fact, confirm much of what we already knew. Essentially, they corroborate the risk of liver toxicity and muscle discomfort, as well as the increased risk of developing diabetes in predisposed individuals when using high doses of statins, referring the evidence of direct muscle damage (myopathy or rhabdomyolysis) to previous studies.

However, the study rules out other risks that had been subsequently attributed in observational or pharmacovigilance studies, such as tendon or joint damage, or neuropsychiatric effects like cognitive impairment, depression, or insomnia.

[Regarding potential limitations] The very advantages of the design, based exclusively on randomized clinical trials, also constitute a significant limitation. These studies typically exclude higher-risk individuals—such as elderly patients with multiple comorbidities—as well as women and minorities. Therefore, it cannot be ruled out that these groups may experience additional risks associated with statin use that could be detected in pharmacovigilance studies. However, as the authors themselves point out, establishing causality is more problematic in this context.

Furthermore, this type of trial limits the analysis of drug interactions, which are more frequent in real-world clinical practice and in patients who are not usually represented in clinical trials. Therefore, it cannot be entirely ruled out that they may produce more side effects than those reported. In any case, I believe the overall assessment of the study reaffirms the safety of statin use despite certain scientific or media noise.

Finally, the article does not delve into the evidence of direct muscle damage, which the same group has already demonstrated in the past and which attracted considerable media attention and has been used as an argument to promote the use of other lipid-lowering drugs or to recommend lower doses of statins.

 
EN