MARIKA SBOROS: Doctors take fight to antistatin trolls armed with study on benefits for elderly
But several local and international cardiologists say the recommendation is controversial and the study is flawed and based on too little data
Doctors should give statins — drugs that are often prescribed to lower cholesterol and help prevent heart attacks and strokes — to more people aged over 75, even if they have no symptoms of heart disease, say top UK and Australian cardiologists.
This will save 8,000 lives annually, they say in a meta-analysis — a statistical analysis that combines the results of a number of scientific studies — in the medical journal The Lancet. Editors of 24 major cardiovascular journals worldwide agreed in a timed editorial in the Journal of the American Heart Association.
They “sound the alarm that human lives are at stake”. The danger lies in “medical misinformation” about statins that “travels faster through social networks than truth”, they say, and “rogue” medical voices are “overhyping” statins risks.
Statins were first launched in the late 1980s and are the world’s most prescribed and the pharmaceutical industry’s most profitable drugs ever. They lower low-density lipoprotein (LDL), or “bad cholesterol”, in the blood.
Common side effects are muscle pain and weakness. Others include sleep disturbance, erectile dysfunction, increased type 2 diabetes risk, liver problems, haemorrhagic stroke and cognitive impairment.
Cardiologists agree with statins for secondary prevention (to prevent a second heart attack). Many say there is no evidence for primary prevention or that benefits outweigh risks in most cases, as claimed.
Many local and international cardiologists say that The Lancet recommendation is controversial and the study is flawed. They say that the authors, the international Cholesterol Treatment Trialists Collaboration, are conflicted with long-term drug-company links.
The collaboration is jointly co-ordinated by Oxford University’s clinical trial service unit, under co-director Sir Rory Collins, and Australia’s National Health and Medicine Research Council’s clinical trials unit at Sydney University.
Collins said via email that the Oxford unit has a rigorous approach to maintaining independence of research and managing potential conflicts of interest.
It is worth noting that statin therapy is now “generic and, hence, very affordable”, he said. That contrasts with newer, far more costly, less well-studied PCSK9 antibody-based inhibitors. He cited a 2017 British Medical Journal article on “potential commercial pressures to demonise statin therapy in order to create a market for these more expensive treatments”.
It is probably “as problematic to extrapolate too far and use a treatment in patients who do not benefit as it is not to extrapolate far enough and withhold a treatment from patients who would benefit”, Collins said.
His interpretation of research is in the context of “compelling overall evidence” of efficacy and safety of statin therapy. It is likely to produce “worthwhile benefits in elderly people who have not yet suffered heart attacks and strokes but are at high risk due to age and in whom the consequences can be catastrophic”, he said.
In 2012, Collins published research calling for doctors to give statins to anyone over 50, including people with no heart disease. In 2014, the UK National Institute for Clinical Excellence under its National Health Service (NHS) updated guidelines to recommend halving preventative treatment for cardiovascular disease (CVD) from a 20% risk of developing the disease over 10 years to a 10% risk. That made an additional 4.5-million people eligible for statins.
Under radical new NHS guidance, National Institute for Clinical Excellence guidelines later extended statin therapy to children aged 10 with familial hypercholesterolaemia, an inherited condition of abnormally high cholesterol levels. The condition is common among Jews and Afrikaners.
In the US in 2016, the preventive services task force recommended statin use to anyone over 40 — with or without cardiovascular disease history.
In 2018, a joint consensus statement by the SA Heart and Stroke Foundation and the Lipid and Atherosclerosis Society of Southern Africa said that statins are “remarkably safe drugs” and cardiovascular protection benefits “far outweigh” risks.
SA-born cardiologist Dennis Goodman, professor of medicine at New York University’s Langone Medical Centre, said that data for statins in the elderly “is sparse and unconvincing”. Accordingly, the American Cardiology College and American Heart Association do not even address patients over 75.
“We already know the major benefit of statin therapy is secondary prevention,” Goodman said. “The number needed to treat for primary prevention is over 100 and probably well over that in the elderly.”
For now, doctors should reserve statins for secondary prevention and in high-risk patients, including familial hypercholesterolaemia, for primary prevention, he said. “Until there’s a well-done, double-blind study in the elderly, we should practice good medicine assessing risk versus benefit in each patient. One size does not fit all."
Johannesburg cardiologist Dr Riaz Motara agreed that there is no clear evidence of benefit from chronic statin therapy for patients over 75.
“As we age, a decline in homeostatic capacity, polypharmacy (the concurrent use of multiple medications) and suboptimal nutrition contribute to greater risk of complications, drug-interactions and side-effects,” Motara said.
“Long-term statin therapy is shown to increase diabetes risk. Implications of life-long statin therapy and associated risks have not been fully understood. If doctors consider statin therapy in elderly patients, they must discuss risks versus benefits. In my experience, most patients in this age group opt not to take statins,” he said.