Opiniones: La controversia por los resultados del ENHANCE: simvastatina sola o con ezetimiba


El Supositorio: La controversia por los resultados del ENHANCE: simvastatina sola o con ezetimibe

El estudio ENHANCE era un ensayo clínico en paciente con Hipercolesterolemia Familiar Heterocigota con cifras muy elevadas de LDL-colesterol basales. Comparaba la utilización de 80mg de simvastatina sola versus 80mg de simvastatina + 10mg de ezetimiba en una población de alto riesgo cardiovascular donde no se suelen conseguir reducciones importantes de LDL-colesterol a pesar de usar dosis máximas de estatinas. El objetivo primario no era clínico, era la medición mediante ECO del grosor de la capa intíma-media de la carótida, utilizando esta medición con objetivo subrogado de la progresión de la placa arterioesclerótica. Los resultados, hechos públicos mediante noticias de prensa, refieren a la ausencia de diferencias en ambos grupos. La controversia ha surgido por el retraso sobre la fecha prevista de anuncio de los resultados de casi 1 año.
Una opinión sobre este tema interesante es la del Dr. Nissen (cardiólogo de la Cleveland Clinic) que destapó el tema del incremento del riesgo cardiovascular de los COX2.

Fuente: El Supositorio (Vicente Baos)

Statement from the American Heart Association on ENHANCE Study Results


DALLAS, TX — January 16, 2008 — Merck/Schering-Plough Pharmaceuticals released results from the ENHANCE trial, which found that the ezetimibe/simvastatin (Zetia/Zocor) combination drug known as Vytorin was no more effective in reducing artery plaque build-up than simvastatin (Zocor) alone. There were no statistically significant differences in the safety of the drugs, which are used to lower cholesterol. The combination drug did lower low-density lipoprotein (LDL — “bad” cholesterol) significantly more than the single agent, but it did not reduce the amount of arterial plaque build-up in the carotid (neck) arteries. However, the LDL levels in both groups remained well above target level.

Plaque build-up (atherosclerosis) in the arteries can lead to coronary heart disease or stroke. However, the study was not large enough or long enough to determine whether the combination drug is more or less effective than the single drug in reducing heart attacks or deaths.

“It will be very important for those larger studies, directed at assessing cardiac outcomes, to be completed, so we can fairly assess the potential of ezetimibe,” said American Heart President Daniel W. Jones, M.D.

Because high cholesterol levels are a very important risk factor for coronary heart disease, the American Heart Association urges patients to consult with their physician before changing or stopping any medication treatment.

“Because Vytorin does not appear to be unsafe, lipid-lowering therapy with simvastatin is of proven benefit, and some patients have been prescribed Vytorin because a statin alone may not have been sufficiently effective in lowering their LDL or was not appropriate for them because of other medical conditions, we do not believe patients should stop taking the drug on their own,” said Dr. Jones. “However, patients on this combination drug should check with their doctor to see if they should stay on the drug, be switched to a statin alone, or take another combination of drugs for their cholesterol.”

Statins are the only drug class for lowering cholesterol that currently has evidence that heart attacks are prevented and life extended with their use. Until other drug classes have mortality data available, to lower cholesterol in patients with continued above-goal LDL cholesterol, who are already taking the maximum tolerated doses of a statin, physicians will need to choose among drugs known to lower LDL cholesterol, but with uncertain benefit in regard to preventing events.

American Heart Association guidelines have long recommended statin treatment for lowering cholesterol. It is important that patients who need to lower their cholesterol take the medications prescribed to them because stopping those medications can increase their health risks.

SOURCE: American Heart Association