Ignoring a recent trial that suggested the cholesterol-lowering drug ezetimibe has no effect on atherosclerosis, authors of a study in the Journal of the American College of Cardiology are suggesting using ezetimibe in kids who are genetically predisposed to high cholesterol. The authors state that adding ezetimibe to a statin would help more of these kids meet the strict LDL (“bad”) cholesterol targets suggested in recent guidelines issued by the American Heart Association and the American Academy of Pediatrics.
The study compared ezetimibe combined with a generic statin with the generic statin alone in kids with heterozygous familial hypercholesterolemia (heFH), a genetic disorder that causes very high levels of LDL (“bad”) cholesterol. The study, funded by Merck/Schering-Plough, showed that ezetimibe lowered LDL by an additional 15% when added to simvastatin, and appeared to be safe over a period of one year. The authors conclude that “coadministration of ezetimibe may be considered an important treatment strategy for adolescent patients 10 to 17 years of age with heFH who require a statin plus adjunctive therapy to reach recommended LDL-C goals.” The AHA and AAP guidelines recommend a “minimum” LDL goal of 130 or “ideal” goal of 110 even for kids whose LDL cholesterol is well over 200 to start with (the average baseline LDL in this study was 225 in the ezetimibe/simvastatin group and 218 in the simvastatin group, with a range from 148 to 351).
Curiously, the authors do not mention the ENHANCE trial, in which adding ezetimibe to a statin did not slow the growth of thickness of the carotid arteries in adults with the same genetic disorder. However, the authors admit that achievement of these aggressive LDL goals in kids with heFH “has not been demonstrated to provide long-term reduction in cardiovascular risk” but rather is based on “expert opinion.” To translate that into plain English, the LDL goals in the AHA and AAP guidelines are arbitrary rather than being based on any evidence that achieving these goals lowers the risk that these children will have heart attacks as adults.
I continue to believe that ezetimibe should not be prescribed except in clinical trials until it has been shown to prevent heart attacks and strokes and until the question of whether it increases cancer risk is resolved. This position seems even more prudent in the case of children whose lifetime cardiovascular risk is high, but whose risk in the near future is very low.
Editor’s Note: Six months ago, when Marilyn first started blogging on Gooznews, she used a pseudonym, “PM.” As an employee of the Securities and Exchange Commission, she is not permitted to publish anything related to the SEC’s mission without going through a preclearance process. Her fear was that comments on pharmaceutical companies and their products could be construed as a comment on their SEC filings. She has since concluded that this connection is too attenuated to be a real concern. Accordingly, she will now be an occasional blogger on GoozNews under her real name. Welcome aboard. — Merrill