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Stendra jubila al Viagra: Doble del efecto, Doble de rapida

Por muchos años el Viagra, la pastillita azul, ha sido la solucion de la disfuncion erectil para muchos, pero la ciencia avanza y acaba de aprobarse la nueva pastilla que se supone sea la sustituta del Viagra tan pronto salga al mercado. Stedra es el doble de potente que el Viagra y actua en solo casi 15 minutos. Su potencia y rapidez, además de ser mejor tolerada por las personas son las nuevas caracteristicas que se anuncian. En Estados Unidos luego de aprobarse el medicamento por parte de la temida FDA su venta no tardará, esperemos que a otros paises no demore. En este reporte la información sobre el nuevo farmaco que se ha difundido y las contraindicaciones que si tiene para determinadas inteacciones con otros medicamentos. Hemos añadido tambien los estudios Clínicos realizados y el reporte completo de la firma VIVUS con lo cual sus acciones han subido y la guerra por la erección vuelve a comenzar….
Ramiro Peres para cubaout

La Administración de Alimentos y Medicamentos (FDA) acaba de aprobar Stendra, de la compañía Vivus, de California (EEUU). Se suma a la lista de otros tratamientos de la misma clase contra la disfunción eréctil.

La aprobación del medicamento por parte del organismo federal se basa en tres estudios clínicos que involucraron a 1,267 pacientes durante 12 semanas.

Además, un subgrupo de los pacientes fue seguido durante 40 semanas, donde se chequearon los potenciales problemas de seguridad del fármaco.

El medicamento debe tomarse 30 minutos antes del incio de la actividad sexual. Y según el reporte presentado del producto, éste empieza a actuar a los 15 minutos de su ingesta, aunque en algunos pacientes los efectos pueden ser más rápidos.

Como otros productos de este tipo, no puede ser utilizado por aquellos hombres que estén tomando nitratos, los vasodilatadores que se emplean para tratar el dolor de pecho relacionado con la angina y para aliviar los síntomas de la insuficiencia cardíaca congestiva.

La FDA también advirtió que el producto puede causar cambios en la visión de los colores. Otros posibles efectos en algunos hombres es una pérdida repentina de la visión en uno o ambos ojos, o una pérdida o disminución repentina de la audición.Estos efectos seundarios solo apareceran en menos del 2% de las personas que la tomen y en las pruebas solo ha sido de forma leve. Se reporta que los efectos de una ereccion prolongada demas de 4 horas es poco comun.

También se advierte que entre los probables efectos de Stendra se incluyen el dolor de cabeza, enrojecimiento de la cara y otras áreas, congestión nasal y dolor de espalda.

Clinical studies

Stendra’s safety and efficacy were established in three double-blind, placebo-controlled clinical studies. A total of 1,267 patients were randomly assigned to take Stendra for up to 12 weeks at doses of 50 milligrams (mg), 100 mg or 200 mg, or a placebo as needed about 30 minutes before sexual activity.

At the start of the studies and every four weeks thereafter, patients completed questionnaires to evaluate erectile function, vaginal penetration and successful intercourse. Results showed patients taking Stendra experienced statistically significant improvement in all three endpoints for all three doses of Stendra studied.

To further evaluate Stendra’s safety, a subset of patients from two of the studies were enrolled in another trial to receive up to an additional 40 weeks of treatment.

Patients were initially given Stendra at the 100 mg dose, but could have their dose increased to 200 mg or decreased to 50 mg based on their individual response to treatment. Results showed that the side effects commonly reported in patients using Stendra did not worsen over time.

Stendra is marketed by Mountain View, Calif.-based VIVUS Inc.

Estudios Clínicos [traducción]

La seguridad y la eficacia clínica del Stendra se establecieron en tres estudios clínicos doble ciego y controles con placebo. Un total de 1.267 pacientes fueron escogidos al azar para tomar Stendra por hasta 12 semanas con una dosis de 50 miligramos (mg), 100 mg, 200 mg o placebo según necesidad unos 30 minutos antes de la actividad sexual.

Al comienzo de los estudios y cada cuatro semanas a partir de entonces, los pacientes han completado cuestionarios para evaluar la función eréctil, penetración vaginal y las relaciones sexuales exitosas. Los resultados mostraron que los pacientes que tomaron Stendra tuvieron estadisticamente una mejoría significativa para los tres tipos de dosis con que se estudió el Stedra.
Además se valoró la seguridad de Stendra en un subconjunto de pacientes de dos de los estudios que fueron sometidos a otro análisis con un tratamiento adicional de hasta 40 semanas.
Los pacientes recibieron inicialmente Stendra a la dosis de 100 mg, pero podrían aumentar la dosis hasta 200 mg o disminuirla hasta 50 mg segun su respuesta individual al tratamiento. Los resultados mostraron que los efectos secundarios comúnmente reportados en pacientes con Stendra no empeorar con el tiempo.
Stendra es comercializado por basado en Mountain View, Calif. VIVUS Inc.

Vivus Announces FDA Approval Of STENDRA™ (avanafil) Tablets For The Treatment Of Erectile Dysfunction
First New ED Agent Approved in Nearly a Decade
MOUNTAIN VIEW, Calif., April 27, 2012 /PRNewswire/ — VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.

“Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED,” said Peter Tam, president, VIVUS. “We believe that the PDE5 selectivity and absorption profile of STENDRA make it an important new treatment option for many men with erectile dysfunction.”

More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of STENDRA. STENDRA at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile function was observed for all doses in STENDRA-treated patients compared to placebo.

It is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit http://www.Stendra.com.

“STENDRA is the first of a new generation of PDE5 inhibitors, and the approval marks an exciting new milestone for the millions of men suffering from erectile dysfunction who are in need of a new treatment option,” said Dr. Wayne Hellstrom, Professor of Urology and Chief of Andrology (male infertility and sexual dysfunction) at Tulane University School of Medicine in New Orleans.

ED affects an estimated 52 percent of men between the ages of 40 and 70. Prevalence increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular conditions, prostate cancer); and spinal cord injuries. Left untreated, ED can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt. However, about half of men being treated with currently available PDE5 inhibitors are dissatisfied with treatment. The market opportunity for ED medical treatments continues to grow, with worldwide sales of PDE5 inhibitors exceeding $5 billion in 2011.

VIVUS is currently in discussion with potential partners to commercialize STENDRA in the United States and in its territories in the rest of the world.

STENDRA (avanafil) is licensed from Mitsubishi Tanabe Pharma Corporation. VIVUS has development and commercial rights to STENDRA for the treatment of sexual dysfunction worldwide with the exception of certain Asian Pacific Rim countries. In South Korea, STENDRA is approved and is marketed by JW Pharma under the brand name Zepeed.

IMPORTANT SAFETY INFORMATION

STENDRA™ (avanafil) is prescribed to treat erectile dysfunction (ED).

Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.

Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.

STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir (Crixivan), saquinavir (Fortavase or Invirase) or atazanir (Reyataz); some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (Sporonox); or some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin.

In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.

Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA.

Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.

STENDRA in combination with other treatments for ED is not recommended.

STENDRA does not protect against sexually transmitted diseases, including HIV.

The most common side effects of STENDRA are headache, flushing, runny nose and congestion.

Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

About VIVUS

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. Vivus resubmitted the Qnexa NDA in October 2011, which has a FDA action date of July 17, 2012. On February 22, 2012 , in a 20-to-2 vote, the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended that Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. For more information about the company, please visit http://www.Vivus.com.

Comentarios

2 comentarios en “Stendra jubila al Viagra: Doble del efecto, Doble de rapida

  1. Soy diabetico.
    Y quisiera una nueva droga que me ayude con la disfuncion erectil,y la anciedad que me produce.el fallar

    Publicado por ignacio ramirez | 1 julio 2016, 03:48
  2. cuando puede estar disponible en Venezuela ymas comentarios sobre la edad limite para tomarla

    Publicado por Jaime Gomez | 26 mayo 2012, 03:18

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