Statins and other cholesterol-reducing drugs rarely have a positive impact on the risk of early death, a new study has found.
The findings, published in the British Medical Journal’s BMJ Evidence-Based Medicine magazine, suggest decades of research have failed to show a “consistent benefit” for taking the drugs to curb heart disease.
The study analysed the results of 35 clinical trials, comparing treatment with one of three types of cholesterol-lowering drugs (statins, ezetimibe and PCSK9) with usual care or placebo drugs, for a period of at least a year in at-risk patients.
The researchers then calculated the number of people who would need to be treated in order to prevent one cardiovascular event such as heart attack, stroke or death.
Their analysis shows that three-quarters of all the trials reported no positive impact on risk of early death and nearly half reported no positive impact on risk of future cardiovascular disease.
Study author Dr Robert DuBroff, of the University of New Mexico’s School of Medicine in the US, said targeting “bad” – known as LDL – cholesterol should prevent cardiovascular events in patients at highest risk.
But he explained: “Unfortunately, the risk-guided model performs poorly in achieving these goals.”
Cholesterol-lowering drugs are prescribed to millions of people around the world in line with clinical guidelines. And although lowering LDL cholesterol is an established preventive treatment and backed up by a substantial body of evidence, the researchers said the approach has never been properly validated.
“Considering that dozens of trials of LDL cholesterol reduction have failed to demonstrate a consistent benefit, we should question the validity of this theory,” Dr DuBroff added.
Thirteen of the clinical trials met the LDL cholesterol-reduction target, but only one reported a positive impact on risk of early death and five reported a reduction in the risk of heart events.
Among the 22 trials that did not meet the LDL lowering target, four reported a positive impact on risk of early death while 14 reported a reduction in the risk of cardiovascular events.
This level of inconsistency was evident for all three types of drugs, the researchers said. They added that clinicians have overlooked weak evidence supporting such drugs.
Responding to the analysis, Professor Robert Storey, of the University of Sheffield, said there was “no controversy” around the evidence that cholesterol treatment drugs are effective in lowering LDL cholesterol in patients with fatty buildups, known as furring in the arteries.