Have the benefits of statins been oversold?
Available over the counter and recommended for just about everyone over 50, statins more than any other drug symbolise the mass medicalisation of the modern world.
The debate that swirls around statins mirrors a wider argument within medicine – are we protecting people from illness, or turning healthy individuals into patients?
Although statins are widely credited for a spectacular 36 per cent fall in heart disease deaths over the past decade, the backlash has inevitably begun. Sceptics have opened up two fronts in their criticism – questioning the need for aggressive cholesterol targets and wondering whether the drugs can be justified for primary prevention.
How low to go
A key point of disagreement is the extent to which GPs should chase tough cholesterol targets.
Although the quality and outcomes framework advocates a target of 5mmol/l total cholesterol, many experts believe
the updated Joint British
Societies guidelines should
be used. These push tougher
targets of 4mmol/l total and 2mmol/l LDL – but are controversial with some doctors.
A study assessing the JBS2 guidelines against international 'guideline standards for guidelines' recently concluded they had 'serious deficiencies' and should not be recommended for clinical practice.
Dr Rubin Minhas, the author of that study and a GP in Gillingham, says his findings may discourage some GPs from following JBS2. 'It means the guidelines may not have the
credence they should have,' he contends.
Dr Justin Cooke, a consultant cardiologist at Chesterfield Royal Hospital, says there are some serious questions over the costings the guidelines use. 'I have no doubt lower is better, but going from 40mg of simvastatin to 40mg of atorvastatin adds £25 to the monthly drugs bill.'
He questions the 'small incremental gain' in this degree of cholesterol reduction and points out that although reductions have been demonstrated for myocardial infarctions, they have not conclusively for mortality as a whole.
The cost argument is key for many, and it boils down to how much the Government is willing to spend.
Dr Stewart Findlay, treasurer of the Primary Care Cardiovascular Society and a GP in Bishop Auckland, County Durham, says: 'It's absolutely clear the lower your LDL the lower your risk of an event. The argument is about cost. What can the country afford? That's a political decision.'
Professor Paul Durrington, professor of medicine at the University of Manchester and leader of the internationally recognised lipoprotein research group, defends the JBS2 guidance but admits money will always be a factor.
He says several trials show reducing LDL to 2mmol/l should be achieved in all patients with pre-existing cardiovascular disease and diabetes. 'For reasons of financial expediency, the audit target of 3mmol/l might be reasonable in other groups of patients as an interim measure before fully implementing JBS2, if achieving lower levels necessitates use of more effective, more expensive statins than simvastatin. That, however, is a matter for the Department of Health and PCTs.'
The area does become grey when secondary gives way to primary prevention.
Dr Ahmet Fuat, a GP in Darlington and an honorary research fellow at the Centre for Health Studies, Durham University, says: 'If someone has had an event we should be aiming for 4 and 2. I'm not certain about lipid targets for primary prevention. I think I'd aim for 5 and 3 for those.'
Who to treat
There is fierce debate over who should actually be initiated onto statins. Some are pushing for an 'in the drinking water' approach, with a recent economic analysis finding benefits for an 'industrial-level' use of statins in low-risk patients.
At the milder end of the pro-statin spectrum, Dr Mark Davis, a board member of the Primary Care Cardiovascular Society, supports current NICE guidance opening the door to use of statins for primary prevention.
Dr Davis, a GP in Leeds, says: 'People with a CV risk greater than 20 per cent should have their lipid profile treated.'
But not all doctors are convinced. Some suggest statins may be harmful for patients at low risk, perhaps by preventing some from exercising by causing mild muscle pain.
Professor James Wright, professor of medicine at the University of British Colombia in Canada, says: 'If you have minor pain or weakness with exercise it may not be enough to lead you to complain, but it may well be enough to prevent you getting the exercise you need.'
Dr Francesca Pezzetta, a cardiologist at the San Vito al Tagliamento hospital in Italy, who came up with the exercise theory, adds: 'Patients are told side-effects are low in statin trials. But there is reason to believe they are much more common in clinical practice.'
With the care of millions of patients at stake, the debate over statins looks unlikely to subside any time soon.
• For up-to-date evidence on statins, go to searchmedica.co.uk