La American Heart Association emite la primera declaración para el tratamiento de los triglicéridos

La American Heart Association (AHA) ha emitido recientemente su primera declaración sobre el tratamiento de los triglicéridos, en el que se incluyen las recomendaciones para la ingesta de Omega-3 EPA/DHA. Los elevados niveles de triglicéridos llevan mucho tiempo asociados a la enfermedad cardiovascular (CVD). Según la AHA, más del 31% de la población de Estados Unidos ha superado unos niveles elevados de triglicéridos. Además, los datos estadísticos para 2006 de la AHA estiman que 81.100.000 personas de Estados Unidos padecían una o más formas de enfermedad cardiovascular, cobrándose en ese mismo año las vidas de 831.272 personas.

Junto a otros importantes cambios en el estilo de vida, la AHA recomienda una ingesta de 0,5 - 1 g de Omega-3 EPA y DHA para personas con unos niveles de triglicéridos en ayunas en la frontera (150-199 mg/dL), 1 - 2g para personas con elevados niveles de triglicéridos en ayunas (200-499 mg/dL) y 2 - 4g para personas con niveles de triglicéridos muy elevados en ayunas (mayores o iguales que 500 mg/dL). La AHA ha recomendado anteriormente que las personas sanas normales consuman una variedad de pescado (preferiblemente azul) y una toma diaria de 1g de Omega-3 EPA y DHA para pacientes con enfermedad arterial coronaria documentada.
La reciente declaración emitida por la AHA supone un paso muy positivo para mejorar el conocimiento del papel de los triglicéridos en los consumidores de cara al tratamiento de la CVD. A pesar de que la concienciación de los beneficios de Omega-3 es muy elevada entre los consumidores, muchos siguen sin conocer las diversas formas de Omega-3 (EPA, DHA y ALA) o los beneficios de salud de cada una.
Es importante para los consumidores comprender que el pescado proporciona EPA y DHA, mientras que la mayor parte de fuentes de algas solo proporcionan DHA. Además, aunque ALA es un ácido graso esencial, muchos de los beneficios de salud indicados asociados a Omega-3 han sido el resultado de la suplementación con EPA y DHA. A pesar de que el organismo podría en teoría convertir ALA en EPA y DHA, la actual tasa de conversión en muy baja. De hecho, muchos estudios indican que la tasa de conversión podría ser tan baja como del 1% o menor. De este modo, los suplementos de pescado azul y los productos de alimentación enriquecidos con pescado azul son las mejores fuentes de Omega-3 para los consumidores.

Se lanza en España Livazo(R) (pitavastatina), una nueva y potente estatina

Kowa Pharmaceutical Europe da la bienvenida al primer lanzamiento en Europa de su estatina, pitavastatina en España, donde se comercializará y distribuirá como Livazo(R) a través de Recordati, y como Alipzadegrees por medio del socio de distribución de Recordati, Esteve.
España es el primer mercado de Europa para Livazo, que está indicado para pacientes con hipercolesterolemia primaria y/o dislipidemia mixta. Kowa Pharmaceutical Europe Co. Ltd., con Recordati, pretende lanzar al mercado Livazo en más mercados europeos a finales de este año y en 2012.
Livazo es una potente estatina que combina el control efectivo de la lipoproteína-colesterol (LDL-C) de baja densidad y los triglicéridos (TG) con el incremento a largo plazo del aumento de lipoproteína-colesterol (HDL-C) de alta densidad, y gracias a su nueva estructura, es menos propensa a disponer de interacciones relacionadas entre fármaco para fármaco. Su eficacia se ha demostrado en varios ensayos clínicos en Fase III :
-- La seguridad y eficacia de Livazo reduce LDL-C y ha conseguido los objetivos de las directrices de la European Atherosclerosis Society (EAS) en la mayoría de los pacientes con hipercolesterolemia primaria o dislipidemia mixta, similar a las reducciones experimentadas con atorvastatina y simvastatina
-- Livazo 2 mg y4 mg ha demostrado una eficacia comparable a las estatinas prescritas de forma común, con 2 mg Livazo demostrando una eficacia estadísticamente superior en comparación con simvastatina 20 mg en la reducción de LDL-C, lipoproteína colesterol (non-HDL-C) no de alta densidad y colesterol total (TC) (4)
-- Livazo reduce de forma eficaz LDL-C en las personas mayores , mejorando a su vez LDL-C y otros parámetros de metabolismo de lípidos en pacientes con un riesgo cardiovascular superior
-- Livazo fue superior a pravastatina en la mejora de LDL-C en pacientes mayores (de 65 años y mayores)
-- Livazo demostró un aumento gradual y sostenido de HDL-C a largo plazo, con el apoyo de los datos en un estudio de ampliación de 52 semanas
"La pitavastatina es una opción de tratamiento atractiva para los pacientes complejos clínicamente en Europa con medicamentos múltiples debido a sus características farmacológicas distintas, entre las que la interacción baja de fármaco-fármaco vista en los ensayos clínicos es particularmente relevante. También ha demostrado una eficacia destacada en los pacientes con síndrome metabólico sin el efecto de los niveles HbA1C, además de en pacientes mayores", afirmó el profesor John Chapman, director de la Unidad de Investigación de Dislipidemia y Ateroesclerosis del National Institute of Health and Medical Research, del Hôpital de la Pitié-Salpêtrière Université Pierre et Marie Curie Paris, Francia.
"Los tratamientos innovadores, como Livazo, son claves para el avance en el tratamiento de la enfermedad, tal y como ha demostrado esta innovadora estatina, no solo al reducir LDL-C de forma eficaz, sino también al hacer frente a los bajos riesgos residuales, lo que significa su asociación con una cifra baja de HDL-C, indicando claramente que cuenta con el potencial para aumentar la proporción de pacientes que consigue los objetivos de tratamiento", añadió el profesor Chapman.
Los elevados niveles de colesterol son un importante factor de riesgo para las enfermedades cardíacas (enfermedad cardiovascular), la causa número uno de fallecimiento en el mundo, contabilizando el 33% de todos los fallecimientos en España.
La seguridad y tolerabilidad generales de la pitavastatina son consistentes con las de otras estatinas prescritas de forma común. En los ensayos de Fase III en los que se compara la pitavastatina con atorvastatina, simvastatina y pravastatina, se ha demostrado el perfil de seguridad general de la pitavastatina, con una incidencia baja de efectos secundarios. Las tres dosis de pitavastatina (1, 2 y 4 mg) han demostrado un perfil de seguridad comparable con los 10, 20 y 40 mg de pravastatina, considerada como la estatina que es menos probable que cause reacciones adversas para los fármacos o interacciones entre fármaco-fármaco. Además, la pitavastatina ha demostrado un perfil de seguridad a largo plazo (hasta 52 semanas) comparable al de la simvastatina o atorvastatin.
Drummond Paris, director general de Kowa Research Europe, comentó: "El lanzamiento de Livazo en España representa un gran logro para Kowa como nuestro primer lanzamiento en Europa. Será el primero de los numerosos lanzamientos que se llevarán a cabo en Europa, Oriente Medio y el norte de África durante el año 2011. Estamos ansiosos de poder ofrecer a los pacientes de todos el mundo la elección de tratamiento mejorada y acceso a Livazo".

El estudio OSAKA muestra que ADVAGRAF(R) y PROGRAF(TM) generan resultados similares en el trasplante renal

Astellas Pharma Europe Ltd ha anunciado hoy que los resultados del estudio OSAKA de 6 meses demuestran que la terapia basada en la liberación prolongada de tacrolimus (QD; ADVAGRAF(R), Graceptor(R) en Japón) no es inferior a la misma dosis diaria de la terapia de liberación inmediata de tacrolimus (BID; PROGRAF(TM)) (0,2 mg/kg/día) para eficacia en trasplante renal. Estos datos se presentaron por primera vez esta semana en el 2011 American Transplant Congress en Philadelphia.
En una era donde hay pocos inmunosupresores nuevos en la línea para el trasplante renal, el estudio OSAKA investigó cómo optimizar la exposición a tacrolimus QD en comparación con el actual estándar clínico, tacrolimus BID.
El estudio se realizó en 110 centros de 22 países e incluyó más de 1.200 pacientes. Los pacientes y donantes reflejaron la situación clínica de la vida real, con una descendente calidad de los órganos y una población de pacientes envejecida. Aproximadamente dos tercios de pacientes en el estudio eran hombres y la edad media estaba en torno a los 50 años. La edad media de los donantes de órganos en el estudio fue de 51,5 años y aproximadamente el 50% se definió como donantes de criterios expandidos.
A los 6 meses, la comparación de eficacia no reveló diferencia entre los brazos de tratamiento en la conclusión primaria de fallo de eficacia. La disfunción de injerto (medida al final del estudio) fue la principal causa de fallo de eficacia en todos los brazos de tratamiento. El nivel de la tasa de filtración glomerular estimada (eGFR) establecido para la disfunción de injerto (<40 mL/min/1,73 m2) y el alto número de donantes de criterios expandidos son propensos a responder por la alta incidencia de la disfunción de injerto como razón para el fallo de eficacia.
La incidencia del rechazo agudo confirmado por biopsia (BCAR), el tiempo para la primera incidencia de BCAR y la gravedad de BCAR fueron bajas, y comparables en los brazos de tratamiento. La función renal fue similar a las terapias de liberación prolongada e inmediata de tacrolimus. Curiosamente, el estudio también mostró que una dosis de inicio más alta de tacrolimus QD (0,3 mg/kg/día) no se asocia con una mayor eficacia. La terapia libre de esteroides se asoció con menos diabetes mellitus reportada y un menor colesterol comparado con otros brazos de tratamiento, pero una menor función renal, y no hubo diferencias importantes en los efectos adversos entre los brazos.
La doctora Laetitia Albano del Centre Hospitalier Universitaire de Niza, Francia, que presentó los resultados del estudio en el American Transplant Congress, comentó: 'El estudio OSAKA complementa los hallazgos previos de una reciente comparación de doble ciego y doble simulación de tacrolimus QD y BID, y demuestra la similitud en el uso de tacrolimus QD y BID en un entorno de etiqueta abierta que representa más estrechamente la práctica clínica'.

Colorectal cancer screening rates on rise among Medicare beneficiaries due to expansion of coverage

Colorectal cancer screening rates increased for Medicare beneficiaries when coverage was expanded to average-risk individuals, but racial disparities still exist, according to researchers at The University of Texas Health Science Center at Houston (UTHealth). "Despite the expansion of Medicare coverage for colorectal cancer screening, disparities persisted among the ethnic groups we examined," said Arica White, Ph.D., M.P.H., former doctoral student at The University of Texas School of Public Health, part of UTHealth. In 1998, Medicare began covering fecal occult blood test (FOBT) annually and sigmoidoscopy coverage every 4 years for average-risk beneficiaries and in July 2001 coverage was expanded to include colonoscopy for average-risk beneficiaries every 10 years.
The research is published in the May issue of Cancer Epidemiology, Biomarkers and Prevention.
"Screening rates are significantly lower among racial/ethnic minorities and this study tells us expansion in screening coverage does not necessarily lead to reduction or elimination of disparities among ethnic populations," said White. Researchers found Hispanics were less likely to receive screening after colonoscopy coverage was expanded, and blacks were less likely than whites to get screened during the periods prior to FOBT coverage, during FOBT coverage-only and after colonoscopy coverage, according to the study. White believes this is the first study to use Medicare claims data to examine the impact of the change in Medicare policy on disparities in guideline-specific colorectal cancer screening from prior to FOBT coverage to after colonoscopy coverage.
Differences in screening rates may be attributed to differences in socioeconomic status, health beliefs and health education as well as healthcare access. "These differences should not exist within a population that is universally insured," said White. "We need to identify and address the barriers which are causing these disparities in screening rates among the Medicare population."
In 2005, only 50 percent of U.S. adults age 50 years or older reported having a fecal occult blood test within the past year and/or an endoscopy within the past 10 years, according to the Centers for Disease Control and Prevention's National Health Interview Survey. "Many people age 65 years and older who are at risk of developing the disease are not getting screened even though they have access to screening services through Medicare," said White.
Colorectal cancer is the third most frequently diagnosed non-skin cancer in men and women in the United States, according to the American Cancer Society (ACS). The risk of developing colorectal cancer is slightly higher in men than in women and it is estimated that more than 50,000 Americans will die from the disease this year. Regular colorectal cancer screening or testing is recommended by the ACS as the most important way to prevent the disease. However, despite these national recommendations, prevention and early detection, screening rates remain low.
"There needs to be more emphasis on evidence-based strategies to continue to increase colorectal cancer screening rates among all Medicare beneficiaries," said White. She believes if there continues to be an increase in screening rates it is possible to attain the Healthy People 2020 goals and objectives of increasing colorectal cancer screening and eliminating racial disparities for some racial/ethnic groups.
White is currently an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention.

**Source: University of Texas Health Science Center at Houston

Rutgers offers hope in new treatment for spinal cord injuries

Rutgers researchers have developed an innovative new treatment that could help minimize nerve damage in spinal cord injuries, promote tissue healing and minimize pain. After a spinal cord injury there is an increased production of a protein (RhoA) that blocks regeneration of nerve cells that carry signals along the spinal cord and prevents the injured tissue from healing.
Scientists at the W.M. Keck Center for Collaborative Neuroscience and Quark Pharmaceuticals Inc. have developed a chemically synthesized siRNA molecule that decreases the production of the RhoA protein when administered to the spine and allows regeneration of the nerve cells.
"It is exciting because this minimally-invasive treatment can selectively target the injured tissue and thereby promote healing and reduce pain," says Martin Grumet, associate director of the Keck Center and senior author of a recent study published in the Journal of Neurotrauma.
The neuropathic pain, also known as phantom pain that occurs as a result of a spinal cord injury is often associated with an increased production of RhoA. When researchers injected the chemically synthesized molecular substance into the spinal cords of laboratory rats with spinal cord injury using a procedure similar to a spinal tap, there was an overall improvement in tissue healing and recovery.
More than 250,000 people in the United States are living with a spinal cord injury and currently there is no way to reverse the damage. No drugs for early treatment of spinal cord injury have been approved in over a decade. Based on this joint research, Quark Pharmaceuticals, Inc now has a drug development program for the treatment of spinal cord injury and neuropathic pain. This new research is supported by grants from the New Jersey Commission for Spinal Cord Research and Quark.

*Source: Rutgers University

Public confused about ingredients in pain relievers

People take billions of doses of over-the-counter pain relievers like Tylenol every year, but many do not pay attention to the active ingredients they contain, such as acetaminophen, according to a new Northwestern Medicine study. That lack of knowledge about popular pain relievers plus particular ignorance of acetaminophen's presence in more than 600 over-the-counter and prescription medicines could be a key reason acetaminophen overdose has become the leading cause of acute liver failure in the U.S. The study reported only 31 percent of participants knew Tylenol contained acetaminophen. In addition, 75 percent of participants knew Bayer contained aspirin; 47 percent knew Motrin contained ibuprofen; 19 percent knew Aleve contained naproxen sodium; and 19 percent knew Advil contained ibuprofen.
The solution proposed by the researchers is to develop a universal icon for acetaminophen that would appear on all medicine labels.
"It's incredibly alarming," said Michael Wolf, an associate professor of medicine at Northwestern University Feinberg School of Medicine and senior author of the study that will be published May 3 in the American Journal of Preventive Medicine.
"People may unintentionally misuse these medicines to a point where they cause severe liver damage," Wolf said. "It's easy to exceed the safe limit if people don't realize how much acetaminophen they are taking. Unlike prescription products, there is no gatekeeper, no one monitoring how you take it."
Individuals don't understand they may be taking the drug simultaneously in multiple medications, said Jennifer King, lead author of the paper and project leader for medication safety research in Feinberg's Health Literacy and Learning Program.
The study found only 41 percent of participants read the ingredients on drug labels.
"When you have pain, you aren't paying attention to what's in a medicine, you just want relief," King said. "People think 'if I can buy it without a prescription, it can't be harmful'. They don't realize exceeding the maximum dose can cause liver damage."
It may also be difficult to identify the drugs in some medicine. Acetaminophen is called APAP on prescription medications. "It's confusing, so even if a person is looking for acetaminophen on the label, she wouldn't know APAP is the same ingredient in her Tylenol," King said.
In addition to proposing a universal icon for acetaminophen on all medications, consumer focus groups suggested manufacturers place an icon on Tylenol that resembles a red stop sign indicating the maximum dose in 24 hours. Consumers also said they would like to see a more clear warning about potential liver damage on the package.
Wolf and King launched the study after a Food and Drug Administration panel in 2009 determined there was little concrete evidence showing how consumers misuse over-the-counter products. The Feinberg School team focused on acetaminophen because its misuse was of particular interest to the FDA.
Researchers interviewed 45 individuals in six focus groups during 2010 in Chicago and Atlanta. The interviews evaluated knowledge of over-the-counter pain relievers, attention to product label information and literacy level. Forty-four percent of participants, all English speakers, read at or below the sixth-grade level -- a low-literacy group at highest risk for drug misuse.

**Source: Northwestern University

HIV drug could prevent cervical cancer

A widely used HIV drug could be used to prevent cervical cancer caused by infection with the human papilloma virus (HPV), say scientists. University of Manchester researchers, working with colleagues in Canada, have discovered how the antiviral drug lopinavir attacks HPV by switching on a natural viral defence system in infected cells.
The study, published in the journal Antiviral Therapy, builds on the team's previous work in 2006 that first identified lopinavir as a potential therapeutic for HPV-related cervical cancer following laboratory tests on cell cultures.
"Since publishing our earlier work, we have now found that lopinavir selectively kills HPV-infected, non-cancerous cells, while leaving healthy cells relatively unaffected," said Dr Ian Hampson, from Manchester's School of Cancer and Enabling Sciences.
"This is a very significant finding as these cells are not cancer cells but are the closest thing to being like the cells found in a pre-cancerous HPV infection of the cervix. In addition we were also able to show that lopinavir kills these HPV-infected cells by re-activating a well-known antiviral system that is suppressed by HPV."
In many developing countries, HPV-related cervical cancer is still one of the most common women's cancers accounting for approximately 290,000 deaths per year worldwide. The same virus also causes a significant proportion of cancers of the mouth and throat in both men and women and this disease is showing an alarming increase in developed countries, such as the UK, where it is now more than twice as common as cervical cancer.
Although in the developed world vaccination programmes against HPV are well underway, these are not effective in women already infected with HPV. Furthermore, the current vaccines do not protect against all types of HPV and they are expensive, which will limit their use in countries with limited resources. A cheap and preferably self-administered treatment that could eliminate early-stage HPV infections before these have developed into cancers would therefore have distinct health advantages.
Dr Hampson said: "Our results suggest that for this drug to work against HPV it would be necessary to treat virus-infected cells of the cervix with roughly 10-15 times the concentration that is normally found in HIV-infected patients taking lopinavir as tablets. This implies that, for this treatment to work, it would need to be locally applied as a cream or pessary."
Co-author on the paper, Dr Lynne Hampson, added: "These results are very exciting since they show that the drug not only preferentially kills HPV-infected non-cancerous cells by re-activating known antiviral defence systems, it is also much less toxic to normal non-HPV infected cells.
"Lopinavir is obviously safe for people to take as tablets or liquid but our latest findings provide very strong evidence to support a clinical trial using topical application of this drug to treat HPV infections of the cervix."

**Source: University of Manchester