Sunday, August 26, 2007

Gabapentin shown effective for fibromyalgia pain

National Institutes of Health
June 7, 2007

New research supported by the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) shows that the anticonvulsant medication gabapentin, which is used for certain types of seizures, can be an effective treatment for the pain and other symptoms associated with the common, often hard-to-treat chronic pain disorder, fibromyalgia.

In the NIAMS-sponsored, randomized, double-blind clinical trial of 150 women (90 percent) and men with the condition, Lesley M. Arnold, M.D., director of the Women’s Health Research Program at the University of Cincinnati College of Medicine, and her colleagues found that those taking gabapentin at dosages of 1,200 to 2,400 mg daily for 12 weeks displayed significantly less pain than those taking placebo. Patients taking gabapentin also reported significantly better sleep and less fatigue. For the majority of participants, the drug was well tolerated. The most common side effects included dizziness and sedation, which were mild to moderate in severity in most cases.

NIAMS Director Stephen I. Katz. M.D., Ph.D., remarked that “While gabapentin does not have Food and Drug Administration approval for fibromyalgia1, I believe this study offers additional insight to physicians considering the drug for their fibromyalgia patients. Fibromyalgia is a debilitating condition for which current treatments are only modestly effective, so a study such as this is potentially good news for people with this common, painful condition.”

Fibromyalgia is a chronic disorder characterized by chronic, widespread muscle pain and tenderness, and is frequently accompanied by fatigue, insomnia, depression, and anxiety. It affects three million to six million Americans, mostly women, and can be disabling.
The precise cause of fibromyalgia in not known, but research suggests it is related to a problem with the central nervous system’s processing of pain. As with some other chronic pain conditions, people with fibromyalgia often develop a heightened response to stimuli, experiencing pain that would not cause problems in other people. Yet, unlike many other pain syndromes, there is no physical evidence of inflammation or central nervous system damage.

Although gabapentin has little, if any, effect on acute pain, it has shown a robust effect on pain caused by a heightened response to stimuli related to inflammation or nerve injury in animal models of chronic pain syndromes. Researchers have suspected that it might have the same effect in people with fibromyalgia. The new research, published in the April 2007 edition of Arthritis & Rheumatism, indicates the suspicions were correct.

Although the researchers cannot say with certainty how gabapentin helps reduce pain, Dr. Arnold says one possible explanation involves the binding of gabapentin to a specific subunit of voltage-gated calcium channels on neurons. “This binding reduces calcium flow into the nerve cell, which reduces the release of some signaling molecules involved in pain processing,” she says.

How gabapentin improves sleep and other symptoms is less clear, and there are probably different mechanisms involved in fibromyalgia symptoms. “Gabapentin improved sleep, which is an added benefit to patients with fibromyalgia who often report unrefreshing or disrupted sleep,” Dr. Arnold says.

What is important is that people with fibromyalgia now have a potential new treatment option for a condition with few effective treatments. “Studies like this give clinicians evidence-based information to guide their treatment of patients,” says Dr. Arnold.

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services’ National Institutes of Health, is to support research into the causes, treatment and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about NIAMS, call the information clearinghouse at (301) 495-4484 or (877) 22-NIAMS (free call) or visit the NIAMS website at http://www.niams.nih.gov/.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

Tuesday, August 21, 2007

Lilly seeks approval for Cymbalta in fibromyalgia

Reuters
PR Newswire

BOSTON, Aug 21 - Eli Lilly and Co. said on Tuesday it has filed for U.S. approval to sell its antidepressant Cymbalta as a treatment for the pain condition fibromyalgia.

The company said data shows that patients with and without depression who took Cymbalta showed greater reduction in pain than those who took a placebo.

Fibromyalgia is estimated to affect 2 percent to 4 percent of the U.S. population. It is characterized by widespread pain and fatigue, sometimes to a disabling degree.

Cymbalta is approved in the United States for the treatment of major depression, nerve pain associated with diabetes, and generalized anxiety.

INDIANAPOLIS, Aug. 21 PRNewswire-FirstCall -- New data suggest that patients with fibromyalgia treated with 60mg or 120mg of Cymbalta(R) (duloxetine HCl) experienced greater reduction in pain severity beginning one week after starting duloxetine than those taking placebo (sugar pill), as measured by the Brief Pain Inventory Average Pain Score (BPI).

The study, which included patients with and without depression, also showed greater improvements in patients taking duloxetine than in those taking placebo in scores on the Patient's Global Impression of Improvement questionnaire (PGI- I), which measures how the patient has felt overall since beginning to take the medication. The data were presented today at the 2007 Congress of the International MYOPAIN Society in Washington, D.C.

At three months, patients treated with 60mg per day or 120mg per day of duloxetine showed significantly greater reduction in pain and improvement in PGI-I scores compared with patients taking placebo. At three months, more patients treated with either 60mg or 120mg of duloxetine showed significantly greater reduction in pain as measured by a 30 percent improvement in baseline BPI scores (50.7 percent and 52.1 percent, respectively) compared with patients taking placebo (36 percent).

"Fibromyalgia is a chronic illness, characterized by widespread pain, tenderness and fatigue. It can also affect the patient's overall emotional health and well-being," said I. Jon Russell, M.D., Ph.D., associate professor of medicine at the University of Texas Health Science Center in San Antonio. "Between 34 percent(1) and 62 percent(2) of those living with fibromyalgia will experience depression at some point in their lives. In this study, which included patients with and without depression, duloxetine reduced the pain associated with fibromyalgia."

More

Wednesday, August 15, 2007

Cedars-Sinai opens fibromyalgia rehab program

Immunesupport.com

Cedars-Sinai Medical Center in Los Angeles offers an interdisciplinary outpatient Chronic Pain and Fibromyalgia Rehab Program, of the sort that might benefit FM patients everywhere. Directed by internationally recognized Fibromyalgia specialist Dr. Stuart Silverman, the Cedars program, founded more than 11 years ago, is a pioneer in FM self-management.

It requires a physician’s referral and provides the referring physician with follow-up consultation. The program reflects a recognition that:

  • Medication is at best only partially effective in relieving the symptoms of chronic pain
  • Medications are too often prescribed piecemeal, by specialists dealing separately with the FM patient’s different symptoms
  • Likewise, supportive therapies are too often prescribed piecemeal over time, with no overall framework for improvement of the patient’s self-management skills.
The Cedars-Sinai program provides an individually-tailored, coordinated treatment plan centered around a self-help “wellness model.” It is designed to inform patients and help them change their behaviors via constructive attitude, understanding of proper nutrition, sleep “retraining,” and pain, exercise, and energy management techniques.

More information about the program is available at (310) 423-9722, and at http://www.cedars-sinai.edu/3937.html.. In addition to serving as Medical Director of the Cedars-Sinai Fibromyalgia Rehab Program, Dr. Silverman is a Clinical Professor of Medicine at UCLA.

Friday, August 10, 2007

Clinical trials update

Forbes.com

(HealthDay News) -- Here is the latest clinical trials, courtesy of Thomson CenterWatch:

If you have muscle pain, fatigue and trouble sleeping, you may have fibromyalgia syndrome. To qualify for this clinical study of people with these symptoms, you must be ages 18 to 65.
The research site is in Albuquerque, N.M.

For information, see http://www.centerwatch.com/patient/studies/cat532.html.

Wyeth halts testing on Pristiq

TheStreet.com

Wyeth has experienced another setback with the experimental drug Pristiq, revealing that it has halted clinical trials for treating a chronic condition that causes fatigue and pain in muscles and joints.

Wyeth said it was stopping work on testing the drug's effectiveness in treating fibromyalgia, which was one of several intended uses for Pristiq. However, the drug also has run into delays at the Food and Drug Administration on applications to treat menopausal symptoms and depression.

The study for fibromyalgia was halted during the enrollment of patients in the second of three clinical-trial phases required before a drug is submitted to regulators.

The company stopped enrollment "after reviewing a planned interim data analysis" and determining that Pristiq wouldn't outperform a placebo in pain relief, Wyeth said in a document filed with the Securities and Exchange Commission after markets had closed Tuesday. "This decision was not made because of safety reasons," the company said.

Fibromyalgia represents a solid but elusive market opportunity. The FDA says fibromyalgia affects about 3 million to 6 million Americans annually, primarily women. The cause isn't clear, and there is no diagnostic test.

Until recently, there hadn't been an FDA-approved drug. Instead, patients shuttled from pain medications to muscle relaxants and from antidepressants to sleep medications as they tried to find relief.

More

Wednesday, August 08, 2007

National Fibromyalgia Association launches education campaign

PR Newswire

ORANGE, Calif., Aug. 7 -- The National Fibromyalgia Association (NFA) today announced the launch of a new national educational campaign aimed at increasing understanding of fibromyalgia among patients, healthcare providers and the public. Fibromyalgia is the most common widespread, chronic pain condition in the United States, characterized by a
unique kind of persistent pain and usually accompanied by poor sleep, stiffness and fatigue. The campaign was driven in part by the results of two new fibromyalgia surveys -- one of the general public and one of physicians -- underscoring the need for greater awareness of the
debilitating condition.

The multi-faceted campaign includes patient education materials, resources and tools, answering the call from more than eight in 10 physicians surveyed (82%) who agree there is a need for more patient-oriented information on fibromyalgia. The campaign also features a
partnership with internationally renowned physician and author Dr. Pamela Peeke, who has treated people with fibromyalgia for more than 20 years. A nationally-broadcast public service announcement featuring patient stories and an interactive Web site -- http://www.fibrohope.org/ -- are also available. The campaign is supported through a sponsorship by Pfizer.

"Fibromyalgia is a major public health issue that deserves increased attention and understanding, yet it's very much a misunderstood and invisible illness," said Lynne Matallana, founder and president of the NFA, and fibromyalgia sufferer. "While the pain of fibromyalgia can be chronic, people with the condition usually don't look sick, so it can be difficult
for their families, friends, colleagues and healthcare providers to understand the serious impact of the condition."

"The chronic pain of fibromyalgia can be frustrating for patients and healthcare providers alike -- at times it's like grabbing fog -- and this can lead to a communication gap," said Pamela Peeke, M.D., MPH, assistant clinical professor of medicine at the University of Maryland School of
Medicine. "An empathetic and knowledgeable healthcare provider who will work in partnership with an educated patient is a critical component of managing fibromyalgia."

The new public awareness survey shows a significant lack of understanding about fibromyalgia: nearly half of the general public (45%) has never heard of fibromyalgia and many people who are knowledgeable about the disorder incorrectly believe that nothing can be done to manage it.
Approximately one in three survey respondents who are knowledgeable about fibromyalgia incorrectly classify the condition as an autoimmune disease (32%) or a type of arthritis (28%). In fact, fibromyalgia is a chronic pain condition thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli
that are not normally painful.

A persistent and debilitating disorder, fibromyalgia can have a devastating effect on all aspects of a person's life. Survey results show that respondents perceive fibromyalgia as having a strong or very strong impact on patients' ability to work (62%), ability to care for family (54%), and personal relationships (47%). In the survey of physicians, doctors rank the ability to work as the area of a patient's life most impacted by fibromyalgia, followed by personal relationships and ability to care for family.

According to the physician survey, many healthcare providers lack confidence in diagnosing fibromyalgia and are reluctant to diagnose patients with the condition. For most specialties surveyed, less than one-third of physicians were extremely/very confident in their ability to
diagnose the disorder (6% of OB/GYNs; 23% of psychiatrists; 27% of neurologists; 28% of primary care physicians). In contrast, rheumatologists are the most confident in their ability to diagnose (87% extremely to very confident).

In addition, more than half of physicians surveyed (60%) agree they worry about labeling patients as having fibromyalgia. Nearly half (48%) report they are reluctant to diagnose a patient with the condition.

This reluctance may lead to delayed diagnosis -- the general public survey reveals that more than two in five (42%) respondents diagnosed with fibromyalgia by a healthcare provider report waiting two or more years for the diagnosis, including 22 percent who waited five years or more.
"People with a diagnosis of fibromyalgia have struggled with their symptoms for many years," said Dr. I. Jon Russell, associate professor of medicine in the division of clinical immunology and rheumatology and director of the university clinical research center, University of Texas
Health Science Center. "What they're looking for is not only information about the disorder, but also an understanding of their struggle. This understanding should come in the form of tangible compassion, with a medical care plan that offers realistic hope for improvement."

Once patients are diagnosed with fibromyalgia, they can work in partnership with their physicians to manage the condition through individualized therapeutic strategies, which may include lifestyle measures (such as exercise, nutrition and relaxation techniques) and behavioral
support, as well as medication. There is a wealth of fibromyalgia research being conducted in the US and globally. For additional information on fibromyalgia, please visit http://www.fibrohope.org/.

The general public awareness survey was conducted by Schulman, Ronca and Bucuvalas, Inc. using a random-digit dial (RDD) sample of 1,606 adults over the age of 18, living in the U.S. The survey, which included some patients diagnosed with fibromyalgia by healthcare providers, took place from May 22 to June 4, 2007. The maximum expected sample error for a simple random sample of this size is plus or minus 2.5 percentage points. The survey was commissioned on behalf of the National Fibromyalgia Association.

The physician survey, designed to understand the perceptions and attitudes doctors have towards fibromyalgia, was conducted by Penn, Schoen, & Berland Associates, LLC. Interviews with 557 physicians (100 rheumatologists, 102 neurologists, 103 OB/GYNs, 100 psychiatrists, 101 primary care physicians, and 51 anesthesiologists with a pain management sub-specialty) were conducted on the Internet from March 30 to April 9, 2007. The survey was commissioned on behalf of the National Fibromyalgia Association.

The National Fibromyalgia Association is a non-profit 501(c)(3) organization whose mission is to develop and execute programs dedicated to improving the quality of life for people with fibromyalgia by increasing the awareness of the public, media, government and medical communities. The NFA publishes a quarterly magazine, Fibromyalgia AWARE, and hosts an
award-winning Web site at http://www.fmaware.org/.

Monday, August 06, 2007

Fibromyalgia drug wins approval

The Washington Post
July 10, 2007

The first drug approved to treat fibromyalgia was given the go-ahead for marketing by the Food and Drug Administration last month. Lyrica, made by Pfizer, was approved several years ago to treat epilepsy, shingles pain and nerve pain related to diabetes. The federal agency okayed the new use after clinical trials showed some fibromyalgia patients had improved as well.

Other drugs shown effective in treating fibromyalgia include the antidepressant Cymbalta. Doctors often suggest exercise and acupuncture in addition to drugs.

Without insurance, the drug could cost $4 or more per day, based on Drugstore.com prices. Side effects include dizziness, sleepiness, blurred vision, weight gain, dry mouth and swelling of the hands and feet. The FDA advises patients to ask their doctor about the safety of driving while taking Lyrica.

More

Fibromyalgia center receives major grant

The Orange County Register

FULLERTON, Calif. — The newly opened Fibromyalgia Research and Education Center at Cal State Fullerton has received a $298,102 grant from Unihealth Foundation. The two-year funding will provide support for the FAME Project, or Fibromyalgia Assessment, Management and Education.

The project will focus on developing and implementing a Web-based training program for health care providers on the diagnosis and management of fibromyalgia and overlapping conditions. Also, the grant will be used to increase the number of trained health care providers to treat and care for fibromyalgia patients and improve delivery of care to those people.

FAME is a partnership between CSF and the Anaheim-based National Fibromyalgia Association. This marks the first time UniHealth, a nonprofit philanthropy, has awarded a grant to CSF and the first grant from UniHealth involving fibromyalgia. Jessie Jones, professor and center director, will serve as the principle investigator for the project.

Mindfulness Meditation: A New Treatment For Fibromyalgia?

Science Daily

Fibromyalgia has emerged as a common, yet difficult to treat disorder. A group of investigators of the University of Basel has proposed a new modality of treatment in the July 2007 issue of Psychotherapy and Psychosomatics. Mindfulness-based stress reduction (MBSR) proposes a systematic program for reduction of suffering associated with a wide range of medical conditions.
Studies suggest improvements in general aspects of well-being, including quality of life, coping and positive affect, as well as decreased anxiety and depression. A quasi-experimental study examined effects of an 8-week MBSR intervention among 58 female patients with fibromyalgia who underwent MBSR or an active social support procedure.

More