OTC simvastatin 10 mg gets go ahead in UK

May 12, 2004

London, UK - The UK has approved a 10-mg dose of simvastatin for over-the-counter sale. The product, to be known as Zocor Heart Pro, will be available through pharmacies in July for the reduction in risk of a first major coronary event in people likely to be at a moderate risk of coronary heart disease. The price has not yet been announced, but there are suggestions that it could be around 15 a month. This is the first country to make a statin available OTC.

Following a 10-week public-consultation exercise on a proposal to make simvastatin 10 mg available over the counter in pharmacies, no new issues were raised, and the UK Committee on Safety of Medicines (CSM) advised the government that the switch would be safe.

Chair of the CSM Prof Gordon Duff said: "Patient safety is the prime consideration in the decision to make a medicine available over the counter. The safety of carrying out this switch has been debated thoroughly, and the case made convincingly that the balance of potential health benefits and any possible risks is overwhelmingly positive."

The idea behind the OTC switch is to make simvastatin available for primary prevention of heart disease to a broader population without costing the government any extra money. The drug will still be available on prescription at higher doses for higher-risk patients.

About 1.8 million people in England are currently taking statins. It is the most widely prescribed class of drugs, and the most expensive item on the National Health Service drugs bill, costing the health service more than 700 million a year.

Who will be eligible?

Pharmacists will be trained to ask the right questions to ensure that they sell statins only to those at moderate risk of heart disease. The government-supplied information on the switch says those likely to be at moderate risk are men aged 55 years or older or men between the ages of 45 to 54 years and women over the age of 55 years with one or more of the following risk factors: family history of CHD, cigarette smoking, being overweight, and South Asian ethnicity (Indian subcontinent). If it is thought any individuals are at a higher-than-moderate risk of CHD, the pharmacist will refer them to their GP.

The information also notes that no mandatory tests need to be performed to buy the OTC simvastatin, but customers can monitor their cholesterol through in-store or home testing. No liver-function tests will be required, as the risk of hepatotoxicity with a 10-mg dose of simvastatin is said to be "extremely low."

UK Health Minister John Reid said: "CHD is the nation's biggest killer. Giving people the chance to buy a preventive medicine that they would not otherwise be able to get must be right. Just as people have the choice to give up smoking and improve their diet, we want them to be able to choose a medicine that will reduce the risk of CHD."

Most organizations have welcomed the move. The British Heart Foundation noted: "The evidence is that in people at risk of heart attack and stroke, taking 10 mg of simvastatin each night can reduce their risk by about 27%. However, to ensure that these drugs reach the right people, patients should be encouraged to accept the offer of reliable cholesterol checks as well as take appropriate lifestyle measures. These include stopping smoking, controlling their weight, eating a balanced diet, and taking more exercise."

Some concerns voiced

But some groups are concerned about the switch, saying the dose may be too low to have any effect and that it may be difficult to monitor patients. The Royal College of General Practitioners issued a statement saying: "Unless the system is rigorously managed, simvastatin could be made available to those who do not need it, and the risk of the drug may then outweigh the benefits. With lower socioeconomic groups being at greater risk of cardiovascular disease and least able to afford this preventive measure, we have to urgently consider how access to these useful drugs can be equitable."

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