New study suggests benefit-harm balance of statins for healthy adults “generally favorable”

Statins are associated with a small increased risk of side effects in patients with no history of heart disease, but these effects are mild compared to the potential benefits of treatment in preventing major cardiovascular events, researchers say. . The BMJ today.

They say their results suggest that the benefit-harm balance of statins in adults without heart disease is generally favorable.

Statins are widely used to prevent heart disease and serious side effects they are rare, but many people are reluctant to take them because of the potential for milder effects such as muscle weakness and rigidity.

For people with existing heart disease, the benefits of statins far outweigh the risk of these effects, but when statins are used by people with no history of heart disease (known as primary prevention) the benefit-harm balance of treatment may be less favorable.

However, recent guidelines have recommended a wider use of statins for primary prevention.

Therefore, a team of researchers from the United Kingdom and the United States set out to examine the associations between statins and adverse events in adults without a history. heart disease, and how they vary according to the type and dose of statins.

They analyzed the results of 62 randomized controlled trials with 120,456 participants (mean age 61; 40% women) followed for an average of 3.9 years. The trials were designed differently and were of variable quality, but the researchers were able to allow this in their analysis.

Statins were associated with a slightly increased risk of self-reported muscle pain, liver and kidney problems, and certain eye conditions, such as cataracts, but were not associated with clinically confirmed muscle disorders or diabetes.

These risks amounted to 15 more cases of muscle symptoms, eight more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for one year.

However, these risks did not compensate for the reduced risk of major cardiovascular events. For example, statins are estimated to avoid 19 color attacks, nine strokes and eight deaths from cardiovascular disease per 10,000 patients treated for one year.

This suggests that the benefit-harm balance of statins for the primary prevention of cardiovascular disease is favorable, according to the researchers.

Analysis by type of statin showed that atorvastatin, lovastatin, and rosuvastatin were associated with some adverse events, but few significant differences were observed between statins.

A possible modest dose-response relationship for the effect of atorvastatin on liver dysfunction was identified, but the dose-response relationships for other types of statins and adverse effects were inconclusive.

This suggests that it is currently not necessary to adjust statin doses to address safety issues when treatment is initiated, the researchers add.

This is an extensive study that was able to accurately assess the adverse effects of statin treatment. But researchers point to some limitations in trial design that may have led to the underestimation of events or the loss of more serious long-term events.

However, they say the low risk of adverse events caused by statins reported in this review “should reassure patients and physicians that the potential damage from statins is small and should not deter their use for statins. to primary prevention disease. “

They agree that routine control of liver function during treatment is likely to be justified in primary prevention and argue that additional studies are needed to help improve treatment adherence and achieve more efficient control.