The study in Lancet

Cholesterol, statins are better than portrayed: few real side effects

Many potential users do not follow the doctor's advice because of what they read on the package leaflet

by Agnese Codignola

FARMACIA FARMACISTA FARMACI MEDICINE CASSETTIERA CASSETTO

2' min read

Translated by AI
Versione italiana

2' min read

Translated by AI
Versione italiana

Statins, the drugs against so-called bad cholesterol (LDL) that have been in use for over thirty years, are not always taken by those who need them. Despite the fact that they are estimated to have saved millions of lives, preventing serious cardiovascular diseases, many potential users do not follow the doctor's advice because of what they read on the package leaflet: a list of some sixty-odd possible troubles that end up frightening them away from treatment. But what is true about what in Italy is often called the bugiardino, and which often errs on the side of over-zealousness, even pointing out possible events that are actually very rare? Not much, according to one of the most important studies carried out on the subject, c

Under the lens 23 clinical studies

The study was conducted by the Cholesterol Treatment Trialists' (CTT) Collaboration, a co-operative group at the University of Oxford in the UK, founded in 1994 with the aim of investigating the results of clinical studies on statins, as too often research was published on small samples, or with single objectives (e.g. blood pressure measurement), which were not placed in a broad cardiovascular context and therefore had little significance. In order to obtain a broader view of statin toxicity, the team carried out a meta-analysis of 23 clinical trials, all large (i.e. with no less than 1,000 participants, all followed for at least five years), all double-blinded, i.e. conducted without either the investigators or the patients knowing what they were taking, involving just under 124,000 people, with 190 comparisons between one or more statins and a placebo and four between standard or intensive treatment.

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The Lancet reports on side effects

The result, illustrated in the Lancet, was quite resounding: of the 66 possible side effects listed in the leaflets - including memory loss, dementia, sleep disorders, depression, erectile dysfunction, weight gain, headache, nausea, fatigue and many others - only four turned out to be realistic, and in any case never very serious or so common. In a percentage of patients not exceeding 0.1%, there may be an elevation of liver enzyme values, which, however, never gives rise to serious hepatitis; in 1% of cases, and only in the first year, there may be muscular disorders such as non-disabling cramps; in 0.2%, there may be some changes in the urine, a small increase in blood sugar and a slight accumulation of liquids or oedema: nothing else. The picture should therefore reassure anyone who has to take - always under medical supervision - a statin because, as the authors pointed out, the benefits outweigh, and by far, the possible risks. Statins are not, however, sufficient on their own to eliminate cardiovascular risk: as they reiterated, they must be included in a context that includes appropriate lifestyle modifications with an adequate diet and regular physical activity.

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