Last Friday an FDA expert panel voted overwhelmingly against the over-the-counter sale of Merck's cholesterol lowering drug Mevacor (lovastatin). Mevacor is one of a number of drugs known as "statins" which are widely considered to be the most effective drugs for the treatment of high cholesterol. Statins work by inhibiting a liver enzyme used in the manufacture of cholesterol.
Other drugs classified as statins include, atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol) and simvastatin (Zocor). Statins are the most sold prescription drugs in the world.
A majority vote denied the request by Merck's request. The panel members expressed doubt that patients would be able to correctly evaluate their need for treatment.
Other concerns raised included
- People not taking the drug in the correct dose.
- The possibility of pregnant women using the drug.
- Negative side effects, such as muscle damage.
- No studies in pre-pubertal patients or patients younger than 10 years of age.
UK health authorities expect to increase the usage of statins in primary prevention, in order to reduce cholesterol levels in the UK population and ultimately reduce the country’s high incidence of heart disease, arguing that the move is in favour of improving patient choice and access to medicines.
Recently The European Society of Cardiology (ESC) stressed the importance of viewing statins appropriately within the global risk management environment.
Professor Bassand, ESC President, said May last year, “The ESC is a strong exponent of global risk management. Lifestyle factors and the promotion of healthy living are crucial to cardiovascular disease prevention. Whilst statins, such as simvastatin, are extremely effective in reducing the risk of heart disease, it is crucial that a global approach is taken and efforts are made to reduce risk factors on all levels. Patients must be adequately encouraged to improve their lifestyles to lower their heart disease risk and not misperceive the taking of a statin as a stand-alone risk reduction option”.
Professor Bassand continued, “It is important that pharmacists are fully briefed in order to ensure that individuals take the treatment as recommended, regularly and with an appreciation of the need to report side effects. Blood cholesterol and other risk factors, such as family history of heart disease, should be noted and taken into account not only before but also during treatment, and individuals should also be advised on how to improve their lifestyles to reduce their risk profile overall”.
“Statins should not be considered as a stand-alone wonder-drug in the fight against heart disease. Individuals should be encouraged to reduce their cholesterol and other risk factor levels through lifestyle improvements and actively supported to do so with on-going public health campaigns”.