Hundreds of thousands of patients may have stopped taking statins because of widespread media coverage of controversy over the drugs’ risks and benefits, a study in the BMJ has claimed.
The UK researchers estimated that an extra 200,000 stopped statin therapy in the six months after a period of intense media coverage on the topic, which coincided with NICE plans to widen statin use for primary prevention in low-risk people.
They said that this could lead to around 2,000 more heart attacks and strokes within 10 years than would have been expected if the usual statin discontinuation rates had been maintained.
The team also claimed that GPs stopped giving patients a cardiovascular risk score during this period – something they said could be down to both GPs and patients being less willing to discuss risk scores and statins, because of worries about the potential side effects of statin treatment.
The authors said that, although they could not prove that the additional discontinuations were down to statins reporting, the study suggested that the debate had dented public confidence and they urged better balanced reporting.
Using data from UK GP practice records, the researchers calculated the number of people starting and stopping statins each month, over the period from January 2011 to March 2015.
They found a 19% relative increase in the proportion of people stopping statins for primary prevention – up from a rate of 0.08 to 0.09 per month – in the six months from April to October 2014, following a period of intense media reporting of statin controversies.
During that period – at the end of 2013 through to 2014 – there was widespread media coverage of research papers in the BMJ claiming statin side effects are worse than has been reported from randomised trials, as well as opposition to NICE plans to advise that millions more low-risk people should be on statins.
After the six-month post-exposure period, from October 2014 onwards, discontinuation rates went back to normal.
Similarly, there was a transient 25% relative increase in the proportion who stopped statins among those taking them for secondary prevention – up from about 0.06 a month to 0.07.
The researchers said the increase in patients stopping statins for both primary and secondary prevention would equate to an excess of 218,971 patients stopping statins across the whole of the UK. Assuming two-thirds of people would have restarted therapy, this could mean 2,173 excess cardiovascular events within 10 years, the team said.
Co-author Professor Liam Smeeth, a part-time GP in North London who also heads up the department of non-communicable diseases epidemiology at the London School of Hygiene and Tropical Medicine, said the study raised concern that reporting of the debate on statins ‘may have given disproportionate weight to a minority view about possible side effects, denting public confidence in a drug which most scientists and health professionals believe to be a safe and effective option against heart disease for the vast majority of patients’.
But Dr Bill Beeby, deputy chair of the GPC clinical prescribing subcommittee, said that the controversy over the risk and benefit ‘is far from resolved, with large numbers of clinical trials remaining unpublished concealing much of the negative data surrounding their use’ and that ‘doctors who offer the benefits still lack all of the data to quantify the risks to individual patients’.
He said: ‘We need to ask patients for their opinion about the information they need to come to a reasonable judgement not influenced by tabloid journalism. Then we may be able to present it in a way that doctors can consistently explain and patients can properly assess what it means for them.’
BMJ 2016; available online 28 June
The statins controversy
Controversy around statins reached fever pitch at the end of 2013 when NICE announced plans to expand statin use in people at relatively low risk for cardiovascular disease – meaning potentially millions more people taking the drugs.
At the time many GP experts vociferously opposed the NICE proposal, with dissent among doctors picked up in the national press. The GPC and RCGP warned that the plans were unjustified by the evidence and would create unsustainable workload for GPs. The LMC conference in 2014 called on NICE to postpone their decision until they had full access to trials data, following concerns raised about the true extent of side effects.
Professor Clare Gerada, then chair of the RCGP, along with other leading doctors including Professor Richard Thompson, former president of the Royal College of Physicians, warned NICE that they risked ‘splitting the profession’ over the decision.
NICE has pushed ahead with the move, but data uncovered by Pulse has since suggested that GPs are reluctant to follow the guidance.
And controversy over the true benefits and harms of statins has not gone away, with experts continuing to call for drugs companies to disclose all their trials data to the public – not just a single research team – so that an independent study can be carried out.
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