BMJ hits back at the Lancet's statins review, demanding an independent analysis of the data
The controversy over statins shows no signs of abating, with the editor of the BMJ strongly disputing the conclusions on a major Lancet review into their safety and efficacy.
The 30-page review declared the debate over, and even drew claims from some observers that critics of statins were akin to anti-vaxxers.
The authors, Professor Rory Collins and colleagues, said the benefits of statins had been underappreciated and the harms exaggerated, largely because critics had ignored RCTs and given inappropriate weight to observational studies.
But BMJ editor-in-chief Dr Fiona Godlee has called for an independent review of statins, saying a third-party analysis of the data was essential to resolve this “increasingly bitter and unproductive dispute”.
While the benefits of statins for secondary prevention were undisputed, the controversy largely centred around offering them to large numbers of people at low risk, she said.
According to the review, the benefits of statin therapy depended on an individual’s absolute risk of occlusive vascular events and reduction in LDL cholesterol. But modelling showed that lowering cholesterol by 2 mmol/L in 10,000 patients for five years could prevent major events in 1000 people with pre-existing vascular disease, and in 500 individuals at high risk of an event.
In terms of side-effects, this approach would result in five extra cases of myopathy, one of which might result in rhabdomyolysis if treatment was not stopped, five to 10 haemorrhagic strokes and 50 to 100 cases of diabetes.
While the same duration of statin therapy had been said to cause 50 to 100 cases of muscle pain and weakness, RCTs have shown almost all these cases were not actually caused by the drugs, they said.
Professor Garry Jennings, chief medical advisor of the Heart Foundation, said while statins clearly had side-effects, the Lancet review showed the numbers affected were very small – little more than placebo when head-to-head comparisons were examined.
Detractors usually ignored the fact that statin therapy was often given to older people, who often suffered musculoskeletal pain, he said. “Who doesn’t get muscle aches and pains at some time in their life, whether they are taking statins or not?”
Melbourne cardiologist Professor Peter Barlis told The Medical Republic there had been an unfortunate scare in his own practice last year following the ABC’s controversial Catalyst television program, which led to a number of patients discontinuing their medication.
The show claimed that the link between cholesterol and heart disease was the “biggest myth in medical history”, and subsequent reports showed 60,000 fewer Australians took their statins in the eight months following the program.
The benefits of statins in secondary prevention were absolutely clear, Professor Barlis said, and for primary prevention, individual cardiovascular risk should be calculated before prescribing.
Meanwhile, he looked forward to a further analysis on adverse events by Professor Collins, expected in 2017.
Professor Jennings said the Lancet’s analysis of 30 years of research should mark the end of the fears and conspiracy theories in the community that had been stoked by “ill-informed people quoting fallacious or poorly designed studies”.
“If anything, the benefits of statins have been underestimated in the mainstream scientific literature,” he said. Furthermore, no opposing argument held anywhere near the weight of this review’s distinguished group of international experts, he said.
US cardiologist Dr Rita Redberg, editor of JAMA Internal Medicine, said many studies included in the review had run-in periods during which subjects who complained of side-effects from statins were excluded from the trial.
“For example, 35% of the statin users were excluded during the open-label run-in in [one study]. Thus, the actual adverse events rate is certainly higher than in the trials,” she told CardioBrief.
Lancet; online 8 September
