TUCSON, Ariz., Dec. 14, 2015 (GLOBE NEWSWIRE) -- Newly approved cholesterol lowering agents, Repatha (evolocumab) and Praluent (alirocumab), are being heavily promoted as a new breakthrough in preventing heart attacks, but risks outweigh benefits, writes former astronaut and retired family physician Duane Graveline, M.D., M.P.H., in the winter issue of the Journal of American Physicians and Surgeons.
The drugs are more convenient than statin drugs. An injection every two to four weeks replaces daily pill-taking. And distressing side effects such as muscle pain, which cause a large number of patients to stop taking their pills, are less. The cost, however, is 280 times higher, Graveline notes.
Statin drugs block an enzyme early in the synthesis of cholesterol, and also block the production of steroid hormones, coenzyme Q10 (CoQ10), and numerous other compounds critical for cellular function, Graveline explains. “The potential for collateral damage is obvious.”
The injectable drugs are antibodies that inhibit a newly discovered protein known as proprotein convertase subtilisin kexin 9 (PCSK9) and thereby dramatically reduce the amount of circulating LDL-cholesterol, without affecting the compounds downstream from cholesterol production. The problem, Graveline states, is that “cholesterol is not our enemy, but rather one of our most important biochemicals, especially for brain function.”
Cholesterol is an essential component of all cell membranes, Graveline explains. And in 2001 it was found to be the elusive factor responsible for the development of synapses, the contacts between nerve cells. Nerve conduction is dependent on abundant cholesterol reserves. Neurocognitive problems, such as mental confusion or trouble paying attention, have already been seen in some of the study participants receiving PCSK9 inhibitors, Graveline warns.
The FDA approved alirocumab and evolocumab “solely on the basis of a surrogate endpoint, the lowering of LDL-cholesterol levels. There is as yet no evidence of efficacy for reducing cardiovascular events, nor is there information on long-term safety,” he writes.
“American medical authorities are still miscasting cholesterol as a villain rather than a compound essential for life. The drugs aimed at attacking cholesterol are in such widespread use that if the accepted theories about cholesterol are wrong, the drugs are a serious threat to the health of Americans,” the article concludes.
The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.