A new polypill designed to reduce the risk of heart attacks and strokes in healthy patients has gone on sale in the UK over the internet this week, despite not being specifically licensed for this use.
People aged over 50 with no history of heart disease can now buy the pill - a combination of four medicines designed to lower blood pressure and cholesterol - through the Polypill Prevention Programme website, following an online consultation with its doctors.
The pill's four component medicines - the cholesterol buster simvastatin and blood pressure lowerers bendroflumethiazide, losartan and amlodipine - have each been licensed for individual use in the UK for many years, but the combination has not been cleared by any regulatory processes.
This is because to obtain official approval through normal channels for the polypill as a preventative medicine is extremely complicated and "would take years and years", a spokesman for the programme told PharmaTimes UK News.
"You need randomised trials that demonstrate efficacy and safety for each component and in combination. It’s so difficult that for practical purposes it’s impossible,” Polypill patent owner Professor Sir Nicholas Wald, from the Wolfson Institute of Preventive Medicine at Queen Mary University of London, told the Financial Times.
However, the spokesperson confirmed to PharmaTimes that regulatory approval for the single pill is still being sought, "but we wanted to provide people with access to it in the meantime", he said.
It is perfectly legal to sell the polypill because doctors are allowed to prescribe unlicensed drugs "off-label" where appropriate.
The cost of the drug, which is being manufactured and dispensed by partner IPS, is £88 for a three months' supply.
According to the website, "taking the Polypill components can reduce your blood pressure and cholesterol levels close to those of a 20 year old when you are 60", which significantly reduces the risk of a heart attack or stroke.
And data from several years' research, including by Prof Sir Wald, indicate that the single pill "can reduce the risk of a heart attack and stroke by over two thirds", the website claims.
Indeed, a study published last year in PLoS One showed that systolic blood pressure was reduced by an average of 17.9 mmHg (12%) on the Polypill, diastolic blood pressure by 9.8 mmHg (11%), and LDL cholesterol by 1.4 mmol/L (39%).
The researchers noted that the results were nearly identical to those predicted from estimates of the effects of the individual drugs; 18.4 mmHg, 9.7 mmHg, and 1.4 mmol/L respectively, indicating that the single pill has the same efficacy with the bonus of being much more convenient for patients.