HEALTH

Research: Vitamin D may slow progression of low-grade prostate cancer

BY Michael Johnsen

 

DENVER — Taking vitamin D supplements could slow or even reverse the progression of less aggressive, or low-grade, prostate tumors without the need for surgery or radiation, Bruce Hollis, a researcher at the Medical University of South Carolina, reported Sunday at the 249th National Meeting & Exposition of the American Chemical Society here.
 
If a tumor is present in a prostate biopsy, a pathologist grades its aggressiveness on a scale known as the Gleason Grading System. Tumors with Gleason scores of 7 and above are considered aggressive and likely to spread, requiring surgical removal of the prostate gland (prostatectomy) or radiation therapy. In contrast, prostate tumors with Gleason scores of 6 and below are less aggressive, and in some cases may cause no symptoms or health problems for the duration of the man’s life.
 
In cases of low-grade prostate cancer, many urologists do not treat the disease, but instead do what’s called “active surveillance,” Hollis noted. “The cure — meaning surgery or radiation — is probably worse than the disease, so they wait a year and then do another biopsy to see where the patient stands.”
 
However, knowing that they have even low-grade prostate cancer can cause patients and their families excessive anxiety, which prompts some of the men to undergo an elective prostatectomy, despite the risk of complications such as infection, urinary incontinence and erectile dysfunction. But a man must wait 60 days from the time of his biopsy before he can undergo a prostatectomy, so that inflammation from the biopsy can subside.
 
Hollis wondered if giving these men vitamin D supplements during the 60-day waiting period would affect their prostate cancer. His previous research had shown that when men with low-grade prostate cancer took vitamin D supplements for a year, 55% of them showed decreased Gleason scores or even complete disappearance of their tumors compared to their biopsies a year before.
 
In a new randomized, controlled clinical trial, his team assigned 37 men undergoing elective prostatectomies either to a group that received 4,000 U of vitamin D per day, or to a placebo group that didn’t receive vitamin D. The men’s prostate glands were removed and examined 60 days later.
 
Preliminary results from this study indicate that many of the men who received vitamin D showed improvements in their prostate tumors, whereas the tumors in the placebo group either stayed the same or got worse. Also, vitamin D caused dramatic changes in the expression levels of many cell lipids and proteins, particularly those involved in inflammation. “Cancer is associated with inflammation, especially in the prostate gland,” Hollis said. “Vitamin D is really fighting this inflammation within the gland.”
 
The protein most strongly induced by vitamin D was one called growth differentiation factor 15. Previous studies by other groups showed that GDF15 dials down inflammation, and many aggressive prostate cancers make little or no GDF15.
 
The new research suggests that vitamin D supplementation may improve low-grade prostate cancers by reducing inflammation, perhaps lessening the need for eventual surgery or radiation treatment. “We don’t know yet whether vitamin D treats or prevents prostate cancer,” says Hollis. “At the minimum, what it may do is keep lower-grade prostate cancers from going ballistic.”
 
Hollis notes that the dosage of vitamin D administered in the study — 4,000 U — is well below the 10,000–20,000 U that the human body can make from daily sun exposure. “We’re treating these guys with normal body levels of vitamin D,” he said. “We haven’t even moved into the pharmacological levels yet.”
 
The researchers acknowledge funding from Gateway for Cancer Research, the Department of Veterans Affairs, National Institutes of Health and South Carolina Clinical and Translational Research Institute.
 
The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. 

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Nexafed extended release found bioequivalent to Sudafed 12-hour tablets

BY Michael Johnsen

PALATINE, Ill. — Acura Pharmaceuticals on Monday announced preliminary results from a pilot clinical study which demonstrated bioequivalence of one formulation of Nexafed extended-release tablets to Sudafed 12-hour tablets. Nexafed extended-release tablets utilize Acura's Impede 2.0 enhanced methamphetamine-resistant technology. Acura intends to request a pre-investigational new drug meeting with the Food and Drug Administration to review this data and discuss a complete development program.
 
"These study results validate our ability to move our Impede technology into extended-release formulations," stated Al Brzeczko, Acura's VP technical affairs. "Demonstrating bioequivalence with one formulation this early in our development process allows us to more rapidly advance to discussions with FDA to determine our full development program for this product."
 
The study was conducted in 12 fasted, healthy subjects and measured the systemic absorption of the active ingredient, pseudoephedrine, from a single dose each of two experimental Nexafed extended-release formulations compared to Sudafed 12-Hour tablets. Nexafed formulation B met FDA's standards for bioequivalence for maximum plasma concentration and extent of absorption. Nexafed formulation A met the bioequivalence criteria for extent of absorption but was low for maximum plasma concentration.
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Walgreens Boots Alliance, WebMD to speak at 2015 Lions Health Conference

BY Michael Johnsen

LONDON — Experts from international retail pharmacy organization Walgreens Boots Alliance and multinational health, hygiene and home products company Reckitt Benckiser have been confirmed as speakers for the upcoming Lions Health conference in Cannes, France in June.
 
During the WebMD session at the Festival, Alex Gourlay, EVP Walgreens Boots Alliance, and president of Walgreens, will join WebMD CEO David Schlanger to examine what it will take for consumers to incorporate the necessary behavior changes they need to make to improve their health, Lion's Health announced. And Ukonwa Ojo, the global brand director and head of global brand equity for Durex and KY at Reckitt Benckiser, will take to the stage to explore how leveraging popular culture has transformed Durex from the world's No. 1 condom brand to the world's top sexual wellbeing brand.
 
"It's a privilege to be able to bring world-class talent like this to the stage at Lions Health," said Louise Benson, festival director for Lions Health. "After our launch year, we've been working closely with the industry to create an exciting new festival programme that truly delivers on both learning and inspiration."
 
Launching a new format, Lions Health will offer four streams of content focusing on "Creative Inspiration," "The Big Issues," "Creative Tools and Innovation," as well as interactive "Knowledge Huddles," focusing on some of healthcare's most pressing topics and exciting developments.
 
In exploring changing health care and "The Big Issues," one of the key themes under discussion will be the realm of digital and specific areas within this.
 
David Blair, head of industry for health at Google, will address innovation and behavior change. "The velocity of connected life continues at a torrid pace and nowhere is this being felt more than in healthcare," Blair said. "I'll be using the seminar to dive deep into behavior-changing digital experiences and technological innovations, which are now a fundamental part of the industry."
 
Lions Health is a global annual awards for creative excellence in pharma and healthcare and wellness communications, judged by international industry professionals. The awards form part of a two-day Festival of content, learning and debate that will explore the essential and unique issues relating to the world of healthcare communications, present exhibitions and screenings of the work being judged and offer networking opportunities. Lions Health 2015 will be held June 19 and 20, Palais des Festivals, Cannes, France. 
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