Fibromyalgia and Epilepsy Drug Lyrica Helps Restless Leg Sufferers, Researchers Say

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of attorneyatlaw.com Legal Briefs

Lyrica, the Pfizer drug for treatment of the chronic pain disorder fibromyalgia and preventing epileptic seizures, also appears to benefit people who cannot get to sleep because of restless legs syndrome, new findings suggest.

A recently completed clinical trial found that pregabalin, the active ingredient in Lyrica, is “a promising alternative to current treatments” in terms of helping people with restless legs syndrome get more quality sleep, according to research unveiled this week at a meeting of the American Academy of Neurology.

Lyrica for Fibromyalgia Pain

In 2007, Lyrica became the first FDA-approved treatment for fibromyalgia, a debilitating condition which affects as many as six million Americans, mostly adult women. Fibromyalgia victims tend to experience chronic or long-lasting pain as well as muscle stiffness and tenderness, the FDA said.

Restless legs syndrome is a neurological disorder which causes burning or tugging sensation in the legs, sometimes called parethesias or dysethesias, particularly when the person is lying down at rest. The sensations can range from uncomfortable to extremely painful.

Study of Restless Legs Sufferers

Researchers from the Sleep Research Institute in Madrid, Spain studied 58 patients who suffered from restless legs syndrome. The patients were given placebo pills for two weeks then half were given 150 to 600 milligrams daily doses of Lyrica, while half continued to receive placebos for another 12 weeks.

The researchers monitored the severity of restless legs syndrome and sleeping habits of both groups and found that those taking Lyrica experienced less severe symptoms of the syndrome.

Less Symptoms, More Sleep

Using the International Restless Legs Syndrome Rating Scale, people on Lyrica saw their scores on the disease severity index decline from 19.8 to 6.8, while scores for participants on placebo treatments declined from 21.5 to 11.2, the researchers said.

Also, people in the study who were taking Lyrica spent significantly more time sound asleep in what is called deep slow wave Stage 3 sleep and less time in light sleep, called state 1 or 2 sleep, compared to people not taking the drug, the researchers said.

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(http://www.attorneyatlaw.com/2009/04/fibromyalgia-and-epilepsy-drug-lyrica-helps-restless-leg-sufferers-researchers-say/)

From the FMS Global News Desk of Jeanne Hambleton (UK)

Low Doses of Drug for Alcoholics Helps Reduce Fibromyalgia Pain, New Research Finds

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Taking low doses of a drug commonly given to alcoholics and drug addicts reduces pain and fatigue in some people battling the chronic-pain condition fibromyalgia, Stanford University researchers say.

In preliminary research, the drug, naltrexone, reduced the pain and fatigue in fibromyalgia patients by an average of 30 percent, researchers said. The findings are an encouraging development for millions of Americans who suffer from fibromyalgia, a somewhat mysterious disorder for which there is no reliable cure or treatment.

However, larger and more detailed studies are needed before naltrexone can be recommended for treating fibromyalgia, researchers said.

Study Finds Benefits for Fibromyalgia Sufferers

The Stanford University study focused on 10 fibromyalgia patients. Some of the patients received low doses of the drug at bedtime while some were given placebos. Those taking naltrexone reported significant drops in daily pain, highest pain, stress, fatigue, and improved pain thresholds, according to the study.

On average, patients given naltrexone had their fibromyalgia symptoms reduced by 32.5 percent, compared to improvement of 2.3 percent in patients given placebo treatments.

Few Side Effects, Relatively Inexpensive

Naltrexone treatments resulted in few side effects, although some participants reported experiencing vivid dreams after taking the drug. Researchers are excited about the prospects of naltrexone as a fibromyalgia treatment because there currently are few treatment options for such patients and the drug is relatively inexpensive, costing about $40 a month.

A second, longer-term study of the effects of naltrexone on fibromyalgia symptoms and including 30 patients tested over a period of four months is set to begin soon, Stanford researchers said.

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(http://www.attorneyatlaw.com/2009/04/low-doses-of-drug-for-alcoholics-helps-reduce-fibromyalgia-pain-new-research-finds/)

From the FMS Global News Desk of Jeanne Hambleton (UK)

Fibromyalgia: Millions Are Spent To Educate the Public About a Mysterious Condition

Courtesy of attorneyatlaw.com Legal Briefs

Two of the world’s biggest drug companies have paid millions of dollars to promote a chronic pain syndrome about which little is known, prompting some critics to accuse the companies of hyping a mysterious condition hoping to sell more drugs.

In the first nine months of 2008, drug makers Pfizer and Eli Lilly gave more than $6 million in grants to nonprofit groups to sponsor medical conferences and educational campaigns focused on fibromyalgia.

That sum tops the amount spent by the companies to raise awareness of more established diseases, such as diabetes and Alzheimer’s, and trails only AIDS, cancer, and depression in terms of educational spending from drug companies, officials said.

The problem, critics say, is that no one is exactly sure what fibromyalgia is. There is no known cause of the disease, critics note, and there are no tests for confirming its presence. Fibromyalgia patients most often may also be diagnosed with more widely understood conditions, including chronic fatigue syndrome.

Therefore, drug companies may simply be trying to drum up more patients for a disease that is treated by Lyrica, Cymbalta, and other popular drug brands, critics allege.

WHY THE FOCUS ON FIBROMYALGIA?

Why are drug companies paying millions of dollars to educate the public about a condition that even medical experts tend to agree may or may not even exist?

Are the drug companies engaging in the common practice of trying to influence the medical community into accepting and promoting a disease whose treatment might include the companies’ drugs, as critics allege?

Or, as the drug companies contend, are they simply exposing a newly developing disease which affects millions of Americans, just like depression, which went widely misunderstood and untreated for decades?

By convincing doctors to diagnose patients with fibromyalgia, Pfizer, Lilly and other drug companies figure to pocket billions in sales of drugs designed to treat the disorder. In fact, sales of Cymbalta, an antidepressant approved in June 2008 as a fibromyalgia treatment, and Lyrica, an anti-epileptic seizure drug also approved for fibromyalgia, have spiked amid the public-awareness campaigns.

In 2007 and 2008, sales of Pfizer’s Lyrica increased from $395 million to $702 million, while sales of Cymbalta, made by Lilly, were boosted from $442 million to $721 million, officials said. The drugs can help reduce pain in fibromyalgia patients, although researchers are not exactly sure how they work.

At the same time, the drug companies also poured millions of dollars into advertising the fibromyalgia drugs. Lilly spent about $128.4 million in the first half of 2008 to promote Cymbalta, while Pfizer shelled out more than $125 million on advertising for Lyrica, according to some estimates.

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

According to the American College of Rheumatology, between six million and 12 million people in the U.S. currently have fibromyalgia. Women are more likely to have the condition, accounting for more than 80 percent of all cases.

Symptoms of fibromyalgia include widespread muscle pain, fatigue, headache and depression. However, despite more than 30 years of studying the condition, researchers say the understanding of fibromyalgia remains “murky.”

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

The policy of drug companies issuing grants to nonprofit groups to conduct educational campaigns about diseases and conditions is fraught with potential abuses. It is not hard to see why companies like Pfizer and Lilly want to get the word out about fibromyalgia, since the companies make two of the drugs most commonly prescribed to treat the disorder.

By convincing physicians to diagnose cases of fibromyalgia and prompting patients to ask their doctors if fibromyalgia might be the reason for their unexplained pain, the companies have already earned millions of dollars in sales of the drugs.

The FDA must keep closer tabs on this practice to ensure that drug companies are not acting improperly in funding work to promote diseases or conditions. In the end, such practices may prove harmful to patients and drug users who are grasping at straws and desperate to find answers to their nagging pain.

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The Dream Diet: Losing Weight While You Sleep

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of WebMD.com

By Colette Bouchez -Reviewed by Leonard J. Sonne, MD – WebMD Weight Loss Clinic-Feature

Can more sleep really help us control our weight? Three top experts explore the possibilities.

Lose weight while you sleep. It sounds like something you would hear on a late night infomercial — just around the time you are reaching for that bag of cookies because, well, you cannot sleep.

But as wild as the idea sounds, substantial medical evidence suggests some fascinating links between sleep and weight. Researchers say that how much you sleep and quite possibility the quality of your sleep may silently orchestrate a symphony of hormonal activity tied to your appetite.

“One of the more interesting ideas that has been smoldering and is now gaining momentum is the appreciation of the fact that sleep and sleep disruption do remarkable things to the body — including possibly influencing our weight,” says David Rapoport, MD, associate professor and director of the Sleep Medicine Program at the New York University School of Medicine in New York City.

While doctors have long known that many hormones are affected by sleep, Rapoport says it was not until recently that appetite entered the picture. What brought it into focus, he says, was research on the hormones leptin and ghrelin. First, doctors say that both can influence our appetite. And studies show that production of both may be influenced by how much or how little we sleep.

In fact, have you ever experienced a sleepless night followed by a day when no matter what you ate you never felt full or satisfied? If so, then you have experienced the workings of leptin and ghrelin.

How Hormones Affect Your Sleep

Leptin and ghrelin work in a kind of “checks and balances” system to control feelings of hunger and fullness, explains Michael Breus, PhD, a faculty member of the Atlanta School of Sleep Medicine and director of The Sleep Disorders Centers of Southeastern Lung Care in Atlanta. Ghrelin, which is produced in the gastrointestinal tract, stimulates appetite, while leptin, produced in fat cells, sends a signal to the brain when you are full.

So what is the connection to sleep? “When you do not get enough sleep, it drives leptin levels down, which means you do not feel as satisfied after you eat. Lack of sleep also causes ghrelin levels to rise, which means your appetite is stimulated, so you want more food,” Breus tells WebMD.

The two combined, he says, can set the stage for overeating, which in turn may lead to weight gain.

Studies: Those Who Sleep Less Often Weigh More

How the hormones leptin and ghrelin set the stage for overeating was recently explored in two studies conducted at the University of Chicago in Illinois and at Stanford University in California.

In the Chicago study, doctors measured levels of leptin and ghrelin in 12 healthy men. They also noted their hunger and appetite levels. Soon after, the men were subjected to two days of sleep deprivation followed by two days of extended sleep. During this time doctors continued to monitor hormone levels, appetite, and activity.

The end result: When sleep was restricted, leptin levels went down and ghrelin levels went up. Not surprisingly, the men’s appetite also increased proportionally. Their desire for high carbohydrate, calorie-dense foods increased by a whopping 45%.

It was in the Stanford study, however, that the more provocative meaning of the leptin-ghrelin effect came to light. In this research — a joint project between Stanford and the University of Wisconsin — about 1,000 volunteers reported the number of hours they slept each night. Doctors then measured their levels of ghrelin and leptin, as well as charted their weight.

The result: Those who slept less than eight hours a night not only had lower levels of leptin and higher levels of ghrelin, but they also had a higher level of body fat. What is more, that level of body fat seemed to correlate with their sleep patterns. Specifically, those who slept the fewest hours per night weighed the most.

Eating and Sleep Apnea: The New Connection

As a result of these and other studies, researchers began to theorize that getting more sleep just might be the answer to society’s burgeoning waistline. But before you trade the cost of your gym membership for a pricey new mattress, take note: Experts also say the relationship is not as obvious as it seems.

The reason: Enter the somewhat mysterious nocturnal ailment known as “obstructive sleep apnea.” People with sleep apnea may stop breathing for up to a minute, sometimes hundreds of times during the night while sleeping, says Dominic Roca, MD, director of the Connecticut Center for Sleep Medicine at Stamford Hospital.

Though the exact cause of the problem remains unknown, Roca and others believe that in most instances physical abnormalities inside the mouth and neck cause the soft tissue in the rear of the throat to collapse. This briefly closes off air passages many times during a night, causing disruption in breathing and a tendency to snore.

The end result: Although you may go to bed early and think you are getting a good night’s rest, the disruption in breathing prevents you from getting deep sleep. Eight hours of disrupted shut eye can leave you feeling like you had only four.

“You wake up feeling tired and continue to feel tired all day,” Roca tells WebMD.

The Link Between Sleep Apnea and Weight

So what does sleep apnea have to do with weight gain?

First, says Roca, patients who suffer from sleep apnea are more likely to be obese. However, studies show they do not have the usual low leptin levels associated with being overweight. In fact, Roca says that folks with sleep apnea have uncharacteristically high levels of leptin.

What is more, when their apnea is treated, leptin levels drop — and somehow that helps them to lose weight.

“I have had about thirty patients who, when successfully treated for their sleep apnea were able to lose weight — possibly because they had more energy, so they were more active and they just ate less,” says Breus.

So why does low leptin seem to cause weight gain in some folks while allowing others to lose weight? One theory says that it may not be the level of this hormone that matters so much as a person’s individual response to it. In much the same way that obese people can become resistant to insulin, folks with apnea may be resistant to the fullness signal that leptin sends to the brain.

“It is like the body is trying to tell them to stop eating, but their brain just is not getting the message,” says Breus.

Another theory: The overall response to leptin may be more individual than we think. Experts say our environment, dietary habits, exercise patterns, personal stress levels, and particularly our genetics may all influence the production of leptin and ghrelin, as well as our response to them.

The fact that we just do not know causes at least some experts to view all the research on sleep and weight with a cautious or skeptical eye.

“There is a serious challenge to the closing of the loop. That is not to say that what we know about leptin and ghrelin is not important, or that when we finally do understand it that it will not be crystal clear — but right now it just is not,” Rapoport tells WebMD.

Breus agrees: “I think we are likely to find that bad sleep matters but that it is likely to be bad sleep plus some other problems. I do not think we know what they are yet.”

Sleep: You Cannot Lose

Until doctors do know more, most experts agree that if you are dieting, logging in a few extra hours of sleep a week is not a bad idea, particularly if you get six hours of sleep or less a night. You may just discover that you are not as hungry, or that you have lessened your craving for sugary, calorie-dense foods.

“One thing I have seen is that once a person is not as tired, they do not need to rely on sweet foods and high carbohydrate snacks to keep them awake — and that automatically translates into eating fewer calories,” says Breus.

If, on the other hand, you already sleep a lot, or you increase your sleep and feel even more tired, you should talk to your doctor. Experts say you may be one of the thousands of people with undiagnosed sleep apnea.

Says Roca: “As research continues, more and more data comes to the forefront to suggest that you simply cannot cut back on sleep without paying some price.”

SOURCES: David Rapoport, MD, associate professor and director of the Sleep Medicine Program, NYU School of Medicine, New York City. Michael Breus, PhD, Atlanta School of Sleep Medicine; clinical director of The Sleep Disorder Centers of Southeastern Lung Care, Atlanta. Dominic Roca, MD, director of the Connecticut Center for Sleep Medicine, Stamford Hospital. Annals of Internal Medicine, 2004; vol 141: pp 846-850. PLOS Medicine, December 2004; vol 1. Journal of Clinical Endocrinology and Metabolism; vol 89: pp 5762-5771. American Journal of Physiology — Heart and Circulatory Physiology, July 2000; vol 279: pp H234-H237.

©2005-2009 WebMD, LLC. All rights reserved.
(http://www.webmd.com/sleep-disorders/guide/lose-weight-while-sleeping)

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Defend Yourself with a Good Night’s Sleep

From the FMS News Desk of Jeanne Hambleton

Courtesy FibromyalgiaNetwork.com

Persistent pain and disturbed sleep create a tremendous stress on the body that could potentially drag down a person’s immune system. Given that people with fibromyalgia battle sleep disruption, pain and a number of other stressful symptoms, you may be wondering what impact this is having on your immune system. In fact, this was a question asked by Ines Kaufmann, M.D., and co-workers in Munich, Germany.1

Comparing 22 fibromyalgia patients with 22 age- and gender-matched healthy control subjects, Kaufmann found a significant reduction in two immune system markers. The markers in question, CD62L and CD11b/CD18, are called adhesion molecules because they stick to the surface of the white blood cells that circulate as part of the immune system.

These adhesion molecules work as communication “flags” in the immune system to get white blood cells to travel to places in the body where they need them, such as tissue injury sites. They also are involved in recognizing and destroying infectious organisms, as well as removing toxic substances and debris from the body.

A reduced number of adhesion molecules on the surface of your white blood cells would likely lead to a compromised immune system, one that lags in its ability to get rid of infections and clear up inflammation in the tissues. As a consequence, you may have a more difficult time getting over colds or flu-bugs that commonly occur during the winter months. So if you find yourself trapped with a head-cold, flu, or other infection that lingers on and on, try increasing your sleep time to help power up your immune system.

Besides lowering your ability to fend off infections, a decline in adhesion molecules on your white blood cells may also compound your painful symptoms. These molecules also play a role in triggering your white blood cells to release powerful opioid-like pain relievers in the muscles and other tissues where local injury may easily occur.

While the reduction in adhesion molecules may explain why you have trouble getting rid of infections and why the slightest injury produces more pain than it should for you, these defects in immune function cannot use these immunological findings to identify people specifically with fibromyalgia.

Kaufmann’s team has reported similar findings in people with complex regional pain syndrome.2 This means that additional studies are needed to determine the relationship between the immune system changes and the development and persistence of painful conditions. For now, your best defense is a good night’s sleep, and anything else you can do to minimize the stress of your chronic illness.

(http://www.fmnetnews.com/basics-news.php#goodsleep)

Sleep Deprivation Linked to Prediabetes
Study Shows Increased Risk for People Who Get Less Than 6 Hours of Sleep a Night

Courtesy of WebMD.com

By Caroline Wilbert – WebMD Health News

March 12, 2009 – Here is one more reason to get a good night’s sleep.

People who sleep less than six hours per night are more likely to develop impaired fasting glucose, or prediabetes, a study shows.

The research was presented this week at the American Heart Association’s Annual Conference on Cardiovascular Disease Epidemiology and Prevention.

The study examined the health records of nearly 1,500 participants in the Western New York Health Study. Researchers identified 91 participants who had fasting blood glucose levels of less than 100 milligrams per deciliter (mg/dL) during baseline exams between 1996 and 2001; the participants had higher blood fasting glucose levels — between 100 mg/dL and 125 mg/dL — at follow-up exams in 2003-2004.

Those 91 participants were compared with 273 people who had blood glucose levels of less than 100 mg/dL both at baseline and follow-up. Researchers matched the groups according to gender, race/ethnicity, and year of study enrollment.

A normal fasting blood glucose level is less than 100 mg/dL. A fasting blood glucose result of 100mg/dL to 125 mg/dL is considered impaired fasting glucose. Having impaired fasting glucose is commonly referred to as prediabetes because many people with prediabetes go on to develop type 2 diabetes.

Participants reported how much they slept during the work week. Participants fell into three categories: short sleepers (less than six hours), mid-sleepers (six to eight hours), and long sleepers (more than eight hours).

During the six-year study period, participants who slept on average less than six hours a night during the work week were 4.56 times more likely than those getting six to eight hours of sleep to convert from normal blood sugar levels to impaired fasting glucose, researchers said. These findings took into account other factors such as age, obesity, and family history of diabetes.

No association was found in people who slept more than eight hours compared to those who slept six to eight hours.

“This study supports growing evidence of the association of inadequate sleep with adverse health issues,” study researcher Lisa Rafalson, PhD, a National Research Service Award fellow and research assistant professor at the University at Buffalo in New York, says in a news release.

(http://diabetes.webmd.com/news/20090312/sleep-deprivation-linked-to-prediabetes)

What a sleep study can reveal about fibromyalgia

From the FMS Global New Desk of Jeanne Hambleton
Courtesy Eurekalert.com

Michigan Tech, U. Michigan team up on sleep research

Research engineers and sleep medicine specialists from two Michigan universities have joined technical and clinical hands to put innovative quantitative analysis, signal-processing technology and computer algorithms to work in the sleep lab. One of their recent findings is that a new approach to analyzing sleep fragmentation appears to distinguish fibromyalgia patients from healthy controls.

Joseph W. Burns, a research scientist and engineer at the Michigan Tech Research Institute (MTRI); Ronald D. Chervin, director of the University of Michigan’s Michael S. Aldrich Sleep Disorders Laboratory; and Leslie Crofford, director of the Center for the Advancement of Women’s Health at the University of Kentucky, report the results of their study in the current issue of the journal Sleep Medicine.

MTRI, a freestanding research institute acquired by Michigan Technological University in 2006 and based in Ann Arbor, specializes in remote sensors that collect data, and in signal processing, using algorithms or computer programs to analyze and correlate the information the sensors gather. MTRI has developed an ongoing collaboration with the University of Michigan’s sleep laboratory, one of the nation’s leading clinical and research centers specializing in sleep medicine.

This several-year collaboration provided MTRI’s first opportunities to apply quantitative analysis, remote sensing technology and computer algorithms to clinical challenges, said Burns. “In this case, our analyses of sleep stage dynamics suggest potential clinical relevance,” he noted. Newly explored measures of sleep fragmentation seem to correlate—at least in this study—with levels of pain reported by fibromyalgia patients.

Burns, who has a PhD in electrical engineering, finds that more and more of his research is taking a biomedical turn. He and his team are working with Chervin to use signal-processing technology to record and analyze the brain waves and biophysical responses of children and adults with a variety of sleep disorders. They hope it will help them better understand conventional sleep patterns, as well as diagnose and treat sleep disorders.

They presented the results of research related to assessment of sleep-disordered breathing and sleep fragmentation at Sleep 2008, an international sleep research conference, in Baltimore in June.

Patients who may have sleep disorders often undergo complicated and expensive tests in sleep laboratories, Chervin explained. These studies collect an assortment of biophysical data that reflect brain, cardiovascular and muscle activity throughout the night. Up to now, these data had to be analyzed manually by highly trained technicians.

“We are collaborating to find new ways to analyze routinely collected data in a way that will be meaningful to the patient’s health and will help us understand how sleep disorders affect brain functions,” he said.

Automated analysis of data potentially can provide improved assessments and reduce the cost of sleep studies, Burns noted. For example, MTRI and UM have developed an automated technique for assessing the severity of sleep-disordered breathing, using just two signals—brain waves and respiration—instead of the dozen or more signals typically needed for standard visual scoring of a sleep study.

“It may even become possible for people to take sleep tests—simpler and more effective than some of those currently available—at home where they can sleep in their own familiar bedrooms,” he suggested.

Both partners are reaping the benefits of the collaboration, Burns said. Not only can automated technology improve clinical research; what the MTRI scientists have learned about biomedical techniques such as brain mapping is informing their more traditional work on radar and optical sensing technology.

Michigan Tech and UM have patented the new algorithm for assessing sleep-disordered breathing, which enables them to study what the extra work of breathing does to the brainwaves of patients with sleep apnea, a sleep disorder in which breathing stops briefly many times during sleep. Sleep apnea has been linked to excessive daytime sleepiness, cognitive changes and other health effects, and to hyperactive behavior in children.

The universities have filed an application for another patent for an algorithm that helps automate the assessment of patients with REM Sleep Behavior Disorder. People with this neurological condition act out their dreams during Rapid Eye Movement (REM) sleep, which can cause them to harm themselves or a bed partner while they are asleep.

Burns and Chervin published the results of that study in the December 2007 issue of the journal Sleep.

The team plans to investigate other sleep disorders and to continue to develop automated processing techniques to improve the performance and efficiency of sleep disorder diagnosis and assessment.

Michigan Technological University is a leading public research university, conducting research, developing new technologies and preparing students to create the future for a prosperous and sustainable world. Michigan Tech offers more than 120 undergraduate and graduate degree programs in engineering, forestry and environmental sciences, computing, technology, business and economics, natural and physical sciences, arts, humanities and social sciences.

Internationally renowned for patient care, research and education, the University of Michigan Health System has been a leader in American medicine for more than a century and a half. UMHS includes the U-M Medical School, three nationally ranked hospitals, 40 outpatient health centers, and a number of specialized programs for treatment and research in cancer, cardiovascular disease, geriatrics, depression, diabetes, vision, women’s health, organ transplant and other specialties. Its biomedical research community is one of the nation’s largest, winning more than $342 million in funding each year while generating more than 120 newly disclosed inventions annually.

Contact: Jennifer Donovan – jdonovan@mtu.edu – 906-487-4521 – Michigan Technological University