Already 1994 the 4 S Study, the first study was published, a Scandinavian study with 4444 patients for 5 years showing effects of simvastatin on hard end points, heart infarctions – and in diabetic patients there was a 55% drop of heart attacks. The lipid hypothesis is accepted, and lowering LDL is important.
Powerrful new cholesterol-lowering treatment hold hope for millions of people around the world for patients with heart attacks or diabetes- but they are real expensive as a new drug. FDA is schedulled to make its decision of the launch in the end of the summer for the US market. In Europe the EMA has accepted the new class of drug and several companies, among Amgen and Sanofi, are working with the antibody treatment of high LDL
Like statins, the new drugs, called PCSK9 inhibitors, lower LDL cholesterol, the so called bad-cholesterol, although the two type of drugs work in different ways and could be used together to get an even lower LDL level.
About a third of Americans have too high LDL cholesterol, a major cause of heart attacks.
Statins can reduce LDL by 30-50% and PCSK9 inhibitors may be slightly more potent, reducing LDL by 40 to 60%. Doctors could prescribe both drugs in tandem to dramatacially lower chokesterol in high risk patients.
The new drug could be used to help people who can not tolerate statins because of side effects, such as muscle pain, or can not lower their choelsterol enough with statins alone.
The injectable medication would be the first major new class of choelsterol-lowering drugs since simvatstain were released in 1987, said Steven Nissen, chairman of cardiovascular medicine at Cleveland Clinic, US
There is a discussion about what kind of patients should be prescribed the drug with reimbursement, and it will in the beginning be limited because of the high cost for the health system, for the high-risk patients – and later on perhaps on a more broaded scale. We also need hard endpoint study showing its potential effects.
The future could now be even more positive for even many more patients with high LDL in order to prevent future unavoidable cardiovascular diesease
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