Ezetimibe no ha mostrado efectividad clinica en un ensayo clinico


Fuente: New York Times. MSD y Schering-Plough parece que van a perder mucho dinero vendiendo -enfermedad- ezetimibe.

Al final va la version en castellano, gracias a Martin Cañas 🙂 .

A clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people a week, failed to show that the drug has any medical benefits, Merck and Schering-Plough said on Monday.
The results will add to the growing concern over Zetia and Vytorin, a drug that combines Zetia with another cholesterol medicine in a single pill. About 70 percent of patients who take Zetia do so in the form of Vytorin, which combines Zetia with the cholesterol drug Zocor.
While Zetia lowers cholesterol by 15 to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes — or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems.
This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew somewhat faster in patients taking Zetia along with Zocor than in those taking Zocor alone. Patients in the trial who took the combination of Zetia and Zocor were receiving it in the form of Vytorin pills.
Dr. Steven Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.” Patients should not be prescribed Zetia unless all other cholesterol drugs have failed, he said.
“This is as bad a result for the drug as anybody could have feared,” Dr. Nissen said. Millions of patients may be taking a drug that has no benefits for them, raising their risk of heart attacks and exposing them to potential side effects, he said.
Both companies’ stocks were down in mid-day trading in New York on Monday, with Merck’s share price off by 2.4 percent and Schering-Plough’s down nearly 6 percent.
The results will also add to the controversy surrounding a long delay in releasing the results of the trial, which was known as Enhance. Merck and Schering-Plough completed the trial in April 2006 and had initially planned to release the findings no later than March 2007. But the companies then missed several self-imposed deadlines, blaming the complexity of the data analysis from the study and saying they did not know when or if the data would be ready for publication.
Last month, after several news articles highlighted the delay, they finally agreed to release the results soon.
For Merck and Schering-Plough, which jointly market Zetia and Vytorin and share profits from the drugs, the trial’s results are a serious setback. Zetia and Vytorin are important contributors to both companies’ profits, especially to Schering, which is smaller and less profitable than Merck.
Analysts estimate that about 70 percent of Schering’s earnings depend on the drugs. The controversy over the trial is also a problem for Merck, which is trying to repair its reputation after withdrawing the painkiller Vioxx from the market in September 2004.
Zetia (Ezetimibe), droga reductora del colesterol, no muestra  beneficio médico alguno en prueba diario El Tiempo/15 de Enero de 2008

Un ensayo clínico demostró que este fármaco no produce en los pacientes los efectos que pregona.  El anuncio, divulgado por The New York Times, fue hecho en Estados Unidos por representantes de los laboratorios Merck y Schering-Plough, quienes comercializan esta molécula bajo los nombres Zetia y Vytorin (en forma combinada).
Aunque Ezetimibe reduce el colesterol entre un 15 y un 20 por ciento, en la mayoría de los pacientes ninguna prueba ha mostrado que reduzca los ataques cardiacos, los accidentes cerebrovasculares o el crecimiento de las placas de colesterol en las arterias, que pueden causar infartos.
La prueba fue diseñada para mostrar que Ezetimibe podía reducir el crecimiento de esas placas. En lugar de eso, las placas crecieron más rápido en pacientes que la tomaban combinada con Simvastatina que en aquellos que tomaban solo Simvastatina.
Steven Nissen, jefe de cardiología de la Clínica de Cleveland, dijo que los resultados eran “chocantes”. Aseguró que a los pacientes no se les puede prescribir este medicamento, a menos que todos los demás hayan fracasado. “Es la peor consecuencia en el análisis de un fármaco; millones de personas pueden estar tomando uno que no tiene ningún beneficio para ellos. Es un gran riesgo para pacientes que necesitan medicarse por sus problemas cardíacos, además de estar expuestos a posibles efectos secundarios”, dijo Nissen a The New York Times. Se estima que en Estados Unidos más de un millón de personas consumen este producto a la semana. En Colombia, Ezetimibe se comercializa con los nombres Zetia y Ezetrol. Combinado con otros medicamentos se encuentra bajo los nombres Vytorin, Zintrepid, Ezator y Vasotenal.
En E. U. estos resultados se suman a la controversia generada por el retraso en la entrega de los resultados de la prueba, conocida como ‘Mejorar’. Merck y Schering-Plough concluyeron en análisis en el 2006 y había planeado dar a conocer las conclusiones en marzo del año pasado. Sin embargo, las empresas fueron ampliando sus plazos excusándose en la complejidad del análisis de los datos.

Sesgo de publicacion o sesgo de financiamiento? * Sign In to E-Mail or Save This * Print * Reprints * Share o Del.icio.us o Digg o Facebook o Newsvine o Permalink Article Tools Sponsored By By ERIC NAGOURNEY Published: November 13, 2007 Sesgo de publicacion o sesgo de financiamiento?


By ERIC NAGOURNEY

Published: November 13, 2007

Inhalers are an effective treatment for asthma and other respiratory diseases, but they can have adverse side effects. The conclusions of studies on these effects apparently depend in part on who pays for the study.

A review of more than 500 studies has found that independently backed studies of the inhalers, formally known as inhaled corticosteroids, are up to four times as likely to find adverse effects as studies paid for by drug companies. The paper appears in the Oct. 22 issue of The Archives of Internal Medicine.

Even randomized clinical trials — the “gold standard” for clinical research — were two and a half times as likely to find adverse effects if a drug company did not pay for the work. Moreover, when authors of studies with drug company financing did report adverse events, they were less likely than authors of independently backed studies to interpret them as clinically significant. But when the researchers did a statistical analysis that eliminated the effect of study design, the disparities were no longer apparent. This suggests that design features chosen before the study begins might lead to a certain kind of finding about adverse effects.

Reviews of drug-company backed studies of other drugs have found similar results.

Many medical journals now require authors to disclose their financial relationships. The senior author of the review, Dr. F. Javier Nieto, professor of population and health studies at the University of Wisconsin, recommended requiring “that the disclosure is made in the abstract, right up front.”

Resto del articulo en el NYT. Sin desperdicios.

Sesgo de publicacion o sesgo de financiamiento? * Sign In to E-Mail or Save This * Print * Reprints * Share o Del.icio.us o Digg o Facebook o Newsvine o Permalink Article Tools Sponsored By By ERIC NAGOURNEY Published: November 13, 2007 Sesgo de publicacion o sesgo de financiamiento?


By ERIC NAGOURNEY

Published: November 13, 2007

Inhalers are an effective treatment for asthma and other respiratory diseases, but they can have adverse side effects. The conclusions of studies on these effects apparently depend in part on who pays for the study.

A review of more than 500 studies has found that independently backed studies of the inhalers, formally known as inhaled corticosteroids, are up to four times as likely to find adverse effects as studies paid for by drug companies. The paper appears in the Oct. 22 issue of The Archives of Internal Medicine.

Even randomized clinical trials — the “gold standard” for clinical research — were two and a half times as likely to find adverse effects if a drug company did not pay for the work. Moreover, when authors of studies with drug company financing did report adverse events, they were less likely than authors of independently backed studies to interpret them as clinically significant. But when the researchers did a statistical analysis that eliminated the effect of study design, the disparities were no longer apparent. This suggests that design features chosen before the study begins might lead to a certain kind of finding about adverse effects.

Reviews of drug-company backed studies of other drugs have found similar results.

Many medical journals now require authors to disclose their financial relationships. The senior author of the review, Dr. F. Javier Nieto, professor of population and health studies at the University of Wisconsin, recommended requiring “that the disclosure is made in the abstract, right up front.”

Resto del articulo en el NYT. Sin desperdicios.