New oral potassium binder lowers potassium levels in patients with heart failure and heart failure with chronic kidney disease

Results from a recent phase 2b clinical trial may provide a new approach to managing excess potassium levels in patients with heart failure and heart failure with chronic kidney disease. The PEARL-HF study has shown that a newly developed potassium binder - known as RLY5016 - can help regulate hyperkalemia in such patients, even those receiving aldosterone antagonists.
Hyperkalemia is a serious condition, characterised by elevated potassium levels in the blood (serum potassium), which increases a patient’s risk of cardiac arrhythmia and sudden death. At particular risk are heart failure patients, especially those with an underlying chronic kidney disease being treated with aldosterone antagonists. Although these drugs have shown life-saving benefits in multiple large outcome studies, their use is limited by the occurrence or fear of hyperkalemia
Professor Bertram Pitt from the Division of Cardiovascular Medicine, University of Michigan School of Medicine, USA, who was steering committee chairman of the PEARL-HF (Parallel Evaluation of RLY5016 in Heart Failure), said: “The PEARL-HF trial demonstrates that RLY5016 effectively and safely lowers serum potassium and prevents hyperkalemia in patients with heart failure or heart failure with underlying renal impairment, even those using renin-angiotensin-aldosterone system antagonists. Currently, the risk of hyperkalemia has limited the use of these RAAS inhibitors, which exposes patients to further cardiac risk. These trial data are therefore very significant.”
PEARL-HF was a multicentre, randomised, double-blind, placebo-controlled trial, designed to evaluate the efficacy, safety and tolerability of RLY5016 in the prevention of hyperkalemia in heart failure patients. The study tested a total of 104 patients over four weeks; 55 with a therapeutic dose of RLY5016 and 49 with placebo. Patients with a serum potassium level of 4.3-5.1 mEq/L and chronic kidney disease currently taking one or more heart-failure therapies, or patients with a documented history of hyperkalemia that led to the discontinuation of a heart failure therapy, were also given a daily 25-50 mg dose of the aldosterone antagonist spironolactone.
The primary endpoint was the measured change from baseline in serum potassium. Efficacy was also evaluated by the proportion of patients with hyperkalemia and the proportion of patients whose spironolactone dose could be increased.
Results showed that RLY5016 significantly reduced the incidence of hyperkalemia compared to the placebo (7% vs. 25%, p=0.015). It also increased the proportion of patients whose spironolactone dose could be increased (91 percent vs. 74 percent, p=0.019). RLY5016 seemed well tolerated by patients, with a withdrawal rate from the study due to an adverse event of 7% (compared to 6% with the placebo), and there were no drug-related serious adverse events.

The STAR-heart study: The acute and long-term effect of intracoronary stem cell transplantation in chronic heart failure

Bone marrow stem cell therapy improves ventricular performance, quality of life and survival in patients with chronic heart failure, according to results from the STAR-heart study. Professor Bodo-Eckehard Strauer, from the Cardiology Department, University of Duesseldorf, Germany, said that, although stem cells from bone marrow had been used in several thousand patients as regenerative therapy, there were still many unresolved questions, notably the quantitative amount of improvement in ventricular function, and the long-term effects in chronic heart failure. Both these questions were addressed by the STAR-heart study.
The study comprised 391 patients with chronic heart failure as a result of ischaemic heart disease (following myocardial infarction), with diagnosis defined by a left ventricular ejection fraction (LVEF) of 35% or less. Of these, 191 patients (with a mean NYHA class 3.22) agreed to have intracoronary bone marrow stem cell therapy, which was offered them between 2003 and 2005. The control group (mean NYHA class 3.06) consisted of 200 patients with comparable LVEF who did not have stem cell therapy.
The bone marrow was taken from the patient's iliac crest (at the top of the pelvic bone) and mononuclear cells isolated and identified. The cells were directly infused into the infarct-related artery via an angioplasty balloon catheter. Inflation of the balloon was important to prevent black-flow of the cells and extend the time for the cells to migrate into the infarct area. (Intravenous administration of stem cells allows only a small proportion of cells to reach the infarct region.)
With haemodynamic assessments taking place between three months and five years after the bone marrow cell therapy, there was a significant improvement in LVEF, cardiac index, exercise capacity, oxygen uptake, and LV contractility. Moreover, the beneficial effects of the bone marrow cell therapy seen at the first three-month evaluation were continued at 12 and 60 months - while in controls there was deterioration in LV performance.
Importantly, there was a significant decrease in long-term mortality in the stem-cell treated patients compared with the control group. Within a median follow-up time of 4.6 years, seven patients died in the bone marrow cell-treated group, equivalent to an average mortality rate of 0.75% per year. In the control group the average mortality rate was 3.68% per year (32 patients died within a median follow-up time of 4.87 years).
Commenting on the outcome, Professor Strauer said: "Despite progress in its medical treatment, heart failure is still a growing public health problem, with a high rate of cardiovascular complications and mortality. First-line treatment of chronic heart failure mainly aims to prevent the deterioration of heart function, which has often started following myocardial infarction. "Nevertheless, these conventional treatments for heart failure resulting from MI do not attempt to correct the underlying cause, which is usually the loss of functional myocardial tissue - and prognosis remains poor. That's why in these particular cases there is a need for strategies aimed at regeneration and tissue repair.
"Our study suggests that, when administered as an alternative or in addition to conventional therapy, bone marrow cell therapy can improve quality of life, increase ventricular performance, and increase survival. Intracoronary therapy has been shown to be effective in acute myocardial infarction, and the STAR-heart study now indicates its efficacy in chronic heart failure."

El tabaquismo aumenta el riesgo de depresión en la juventud

El tabaquismo incrementa los síntomas de depresión en los adolescentes, sobre todo en los que fuman para combatir la tristeza, según ha descubierto un grupo de investigadores de la Universidad de Toronto y la de Montreal, en Canadá, a través de un estudio publicado en 'Addictive Behaviors', cuyos resultados son parte del trabajo titulado 'Dependencia de la Nicotina en Adolescentes' (NDIT, por sus siglas en inglés), que desarrolla a largo plazo el Centro de Investigaciones del Hospital Universitario de Montreal.
Según el investigador principal de este estudio, Michael Chaiton, profesor de la Unidad Ontario de Investigación en Tabaco de la Universidad de Toronto, "este estudio observacional es uno de los pocos que examina los beneficios emocionales percibidos de fumar en los adolescentes".
"Aunque los cigarrillos parecen tener efectos similares a una 'automedicación' o mejorar el humor, a largo plazo hemos visto adolescentes que emperezaron a fumar que registran mayores síntomas de depresión", añade.
Como parte de un estudio mayor, unos 662 adolescentes de instituto rellenaron un cuestionario de unas 20 preguntas sobre su consumo de cigarrillos y cómo les afecta al humor. Los institutos fueron seleccionados para conseguir una mezcla de participantes franceses e ingleses, procedentes de centros rurales y urbanos y situados en barrios con niveles socioeconómicos bajo, medio y alto.
Los adolescentes fueron divididos en tres grupos: el de los que nunca habían fumado, los fumadores que aseguraron no usar el tabaco para 'automedicación' y mejorar su estado físico o anímico, y aquellos fumadores que reconocieron que fumaban para sentirse mejor.
Los síntomas de depresión fueron medidos utilizando una escala en la que se preguntaba con qué frecuencia los participantes se sentían demasiado cansados para hacer cosas; tenían problemas para irse a dormir o para permanecer despiertos; se sentían infelices, tristes o deprimidos; se sentían desesperanzados sobre su futuro; nerviosos o tensos, y demasiado preocupados por algún motivo.

"Los fumadores que utilizaban los cigarrillos como método para mejorar su humor tenían un mayor riesgo de sufrir más síntomas depresivos que aquellos adolescentes que nunca habían fumado", explicó la coautora del estudio Jennifer O'Loughlin, profesor del Departamento de Medicina Social y Preventiva de la Universidad de Montreal y del Centro de Investigaciones del Hospital Universitario de Montreal. "Nuestro estudio descubrió que los adolescentes fumadores que aseguraron conseguir beneficios emocionales de fumar corrían un mayor riesgo de desarrollar síntomas depresivos", señala.

La asociación entre depresión y tabaquismo se daba sobre todo entre los adolescentes que fumaban para sentirse mejor. "Es importante destacar que los síntomas depresivos eran mayores entre los adolescentes que reconocieron conseguir beneficios emocionales de fumar después de iniciarse en el hábito", recalca Chaiton.

La Agencia Europea del Medicamento analizará si una vacuna para la Gripe A causa narcolepsia

La Agencia Europea del Medicamento (EMA, por sus siglas en inglés) ha emitido este viernes un comunicado en el que anuncia que revisará los datos de eficacia y los efectos secundarios de la vacuna 'Pandemrix', desarrollada por la farmacéutica británica GlaxoSmithKline (GSK) frente a la gripe A, tras detectarse varios casos de narcolepsia en pacientes inmunizados.
Según informa esta autoridad europea, un limitado número de casos de narcolepsia han sido registrados en diferentes países de Europa después de que un total de 30,8 millones de ciudadanos recibieran la vacuna frente a la gripe pandémica, aunque la mayoría se han detectado en Finlandia, Suecia y Francia.
No obstante, la alerta la ha dado Finlandia, cuyo Instituto Nacional para la Salud y el Bieniestar recomendó este martes que se paralizara la vacunación con 'Pandemrix' después de la aparición de un total de veinte casos de narcolepsia en personas que habían recibido la vacuna de GSK.
La narcolepsia es un trastorno de origen genético desconocido que se caracteriza por la presencia de accesos de somnolencia irresistibles durante el día. En este sentido, el Comité para Productos Médicos de Uso Humano (CHMP, siglas en inglés) será el encargado de investigar los casos registrados para determinar si la relación entre la vacuna y el trastorno es directa o se trata sólo de una casualidad.
Una vez completados y analizados los datos necesarios para emitir un juicio sobre la seguridad de 'Pandemrix', el CHMP decidirá en su reunión del próximo mes de septiembre las acciones a tomar en Europa con este fármaco por parte de la EMA.
España adquirió un total de 13 millones de vacunas frente a la gripe A de tres laboratorios: 'Focetria' de Novartis, 'Panenza' de Sanofi Pasteur y 'Pandemrix' de GSK. Finalmente, sólo se han utilizado unos tres millones de dosis; cuatro millones se donaron a la Organización Panamericana de la Salud (OPS) y otros dos se han almacenado como medida prevenitva.

Un estudio da al arroz negro chino un poder muy antioxidante

El arroz negro, una variedad de grano conocida en la antigua China como 'el arroz prohibido' porque sus cosechas eran requisadas por los nobles y no estaba permitido su uso entre la gente más pobre, podría ser una alternativa más barata para conseguir las propiedades antioxidantes que se atribuyen a frutas, como los arándanos o las moras, según un grupo de investigadores de la Universidad Estatal de Louisiana, en Baton Rouge (Estados Unidos).
Este descubrimiento, presentado en el 240 Encuentro Nacional de la Sociedad Química Americana (ACS, por sus siglas en inglés), que se celebra en Boston, revela que el arroz negro es rico en antocianinas antioxidantes, sustancias que se han mostrado como promesas en la lucha contra las enfermedades cardíacas o el cáncer, entre otras patologías.
El arroz negro se utiliza sobre todo en Asia, para decorar la comida, en 'noodles', en el 'sushi' y en 'pudding'. Tras este hallazgo, los empresarios podrían comenzar a utilizar salvado de esta variedad de arroz, o su extracto, para disparar el valor en salud de los cereales de desayuno, las bebidas, los pasteles, las galletas y otros tipos de alimentos, según los autores.
En la actualidad, el arroz marrón es la variedad que más se produce en el mundo. Los molineros eliminan sólo la cáscara más externa de cada grano de arroz para conseguir este arroz. Si se procesa más el grano, quitando el salvado rico en nutrientes que está por debajo, se obtiene arroz blanco.
Muchos consumidores creen que el arroz marrón es más nutritivo que el blanco, aseguran estos investigadores, porque el salvado del arroz marrón contienen mayores niveles de tocotrienol-gamma, uno de los compuestos de vitamina E, y del antioxidante gamma-oryzanol.

--PARA COMBATIR LAS ENFERMEDADES CARDÍACAS

Diversos estudios han demostrado que estos antioxidantes pueden reducir los niveles en sangre del denominado colesterol malo, ayudando así a combatir las enfermedades cardíacas. El equipo de investigadores dirigido por Zhimin Xu, profesor del Departamento de Ciencia Alimentaria del Centro de Agricultura de la Universidad Estatal de Louisiana, analizó muestras de salvado de arroz negro de una plantación del sur de Estados Unidos.

Descubrió que los antioxidantes lípido solubles del salvado de arroz negro poseían mayores niveles de antocianinas antioxidantes, que son antioxidantes solubles en agua. Así, el arroz negro podría ser incluso más saludable que el marrón, sugiere Xu.

Asimismo, demostraron que los pigmentos del extracto de salvado de arroz negro podían producir una variedad de colores diferentes, que iban desde el rosa al negro, y proporcionar una alternativa más saludable que los colorantes artificiales que se añaden a los alimentos y las bebidas y que, según diversos estudios, podrían estar vinculados a problemas de salud como el cáncer o las conductas problemáticas en la infancia, entre otros.

Según Xu, "sólo una cucharada de salvado de arroz negro contiene más antocianinas antioxidantes de las que hay en una cucharada de arándanos, pero con menos azúcar y más fibra y antioxidantes de la vitamina E". "Si las bayas se utilizan para mejorar la salud, por qué no utilizar también el salvado de arroz negro y el de arroz blanco. En especial, el de arroz negro puede ser un producto único y barato para aumentar el consumo de saludables antioxidantes", concluyó

Deaf woman to receive first implant

The electronic device will make it possible for the woman, from the Isle of Wight, to hear sound in both ears by running two stimulator wires from the single implant.
One will go into one inner ear and the other under her scalp from the single implant into her other ear - giving the 44-year-old woman much improved bilateral hearing.
Usually adults only have one implant fitted in one ear which leads to problems in noisy situations or finding where the sound is coming from.
A cochlear implant is an electronic device that can help both adults and children who have a severe to profound hearing loss.
It has two parts: an internal receiver/stimulator package and electrode array, and an external speech processor that looks like a hearing aid.
The device uses small electrical currents to directly stimulate the hearing nerve, which then sends signals to the brain where they are interpreted as sound.
The procedure has been developed at the South of England Cochlear Implant Centre (SOECIC), based at the University of Southampton.
Joint head of the centre Julie Brinton said: “Some adults and children have already received two implants, with one in each ear. The difference with the device being used today is that, although information is delivered to each ear, there is only one implant.”
Although around 40 of these devices have been implanted in patients in Europe, this is the first of its kind in the UK, the centre said.

**Published in Nursing times.net

Brazil: cancer patients to be offered nine new treatments

Under a massive expansion of its oncology services, Brazil’s national health care system (SUS) will offer cancer patients access to nine new treatments and expand coverage for 66 already-covered procedures, including 46 chemotherapy treatments.
The nine treatments which are to be made available for the first time through the SUS include three for liver cancer plus five for breast cancer, leukemia and lymphoma and one new radiotherapy treatment.
Investments in the SUS oncology services, which provide treatment for around 300,000 cancer patients, will increase 25% to 412.7 million reals this year, rising to 2 billion reals in 2011. The widening of value coverage for already-provided treatments will see investments in chemotherapy services increasing from 1.25 billion reals last year to 1.5 billion in 2011, with particularly large increases in spending on treatments for conditions such as chronic lymphocytic leukemia, set to rise 765%.
For 24 chemotherapy treatments, value coverage is to be reduced but this will reflect purely reductions in costs of these treatments, say analysts at IHS Global Insight, who also point out that SUS funding for radiotherapy treatments will be increased 94% over 2009 levels to reach 318 million reals in 2011.
The analysts forecast that the SUS oncology services will continue to give priority to the introduction of new technologies, and that the government will maintain its support for local production facilities, such as the development, in partnership with Argentina, of two reactors for the production of oncology drugs, announced in June.
Cancer is Brazil’s second-biggest killer after cardiovascular disease, and the fact that the SUS guarantees virtually all diagnosed patients have access to treatment makes it an attractive market for drugmakers. For example, last year the country’s breast cancer drug market was worth $424 million, rivaling some major markets such as the UK and Japan and greatly exceeding the other BRIC (Russia, India and China) nations, says market research firm Decision Resources, which forecasts that breast cancer drug sales in Brazil will rise to $611 million by 2014.
Decision Resources is also forecasting good growth for Brazil’s non-small-cell lung (NSCL) cancer drug market, driven by increased uptake of higher-priced brands of chemotherapy, around 21% annual growth for targeted regimens and maintenance treatment (all in the advanced setting) and modest uptake of novel targeted agents. Drugs produced by western manufacturers will increase their share of the market from around 60% last year to 70% in 2014, when the total NSCL cancer drug market will be worth $240 million, it says.
- With annual drug sales of just over $17 billion, Brazil is the world’s 11th-largest pharmaceutical market and is once again the biggest in Latin America. Having fallen behind Mexico in the earlier part of the decade, it has produced consistent double-digit growth in the last five years, reaching a peak of 33% in 2005 and rising 13% in 2009, reports IMS Health.

http://www.ihsglobalinsight.com/

http://www.decisionresources.com/

http://www.imshealth.com/

**Published in Pharma Times