Subacute Atopic Dermatitis of the Vulva Described for First Time

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Subacute Atopic Dermatitis of the Vulva Described for First Time

Subacute atopic dermatitis of the vulva has been described for the first time by Dr. Albert Altchek, clinical professor of obstetrics and gynecology at Mount Sinai School of Medicine, New York, according to the physician.

Atopic dermatitis is a clinical diagnosis, according to Dr. Altchek. "There’s no corresponding biopsy."

His findings are based on his observations of a large number of the same girls over a long period of time at three separate clinics as well as his continuing private office consultation, which he presented at the 15th Annual Postgraduate CME Course on Pediatric, Adolescent, and Young Adult Gynecology held at New York’s Mount Sinai Hospital. He also has written a chapter on the topic in "Pediatric, Adolescent, & Young Adult Gynecology" (Oxford: Wiley-Blackwell, 2009), edited by Dr. Altchek and Dr. Liane Deligdisch.

The symptoms include recurrent itching, redness, fissures, and vulva dysuria. Diagnosis of vulvar atopic dermatitis includes gathering a family history of allergies, asthma, hay fever; looking at the past history of the patient; and conducting a physical examination starting from the head, said Dr. Altchek.

Atopic dermatitis fissures are symmetrical and narrow, and look as if they were "made with an artist with a scalpel," he said. The hymen is intact. In early stages, vulvar atopic dermatitis’ most pronounced part is bilateral symmetrical fissures between labia minora and majora. Sometimes the fissures are deep and may cause bleeding. In addition, there is a midline sagittal perineal fourchette to the anterior anus at 12 o’clock, where there is usually a papule. The latter is the result of an anterior anal fissure with red inflamed edges. When red and present for a long time, there is severe permanent swelling simulating a hemorrhoid. In more severe cases there is a fissure anterior to clitoris.

In younger girls, the fissures may cause a sudden jump up from sitting because of pain, which is at times misdiagnosed as a neurologic condition.

The condition is sometimes confused with sexual molestation or lichen sclerosis. In sexual molestation cases there may be general signs of trauma and any vulvar fissures are irregular, with lacerations in addition to the history. "Lichen sclerosis of the vulva has coarse, wide irregular fissures in the same areas. With slight trauma the labia and vulva have transient dark blue subcutaneous blood boils," said Dr. Altchek, also an attending ob.gyn. at Lenox Hill Hospital in New York. Lichen sclerosis has a specific biopsy finding, which vulvar atopic dermatitis does not.

Patients with vulvar atopic dermatitis also have the condition on other parts of their body, including behind the ears, in axilla, elbows, or behind the knees, highlighting the importance of whole body exam.

The condition is managed by avoiding things that could irritate the vulva, including wet bathing suits, hot water, perfume, and certain clothing such as leotards and tights. Otherwise, treatment is individualized to reduce irritation and symptoms, Dr. Altchek said.

The condition is most common among prepubertal and young pubertal girls, it may or may not disappear at puberty, and it is less common in adults, said Dr. Altchek.

"Basically, my message is ‘wake up, world.’ This is how you diagnose [vulvar atopic dermatitis], which has never been described before," said Dr. Altchek.

Dr. Altchek said he had no relevant financial disclosures.

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Subacute atopic dermatitis of the vulva has been described for the first time by Dr. Albert Altchek, clinical professor of obstetrics and gynecology at Mount Sinai School of Medicine, New York, according to the physician.

Atopic dermatitis is a clinical diagnosis, according to Dr. Altchek. "There’s no corresponding biopsy."

His findings are based on his observations of a large number of the same girls over a long period of time at three separate clinics as well as his continuing private office consultation, which he presented at the 15th Annual Postgraduate CME Course on Pediatric, Adolescent, and Young Adult Gynecology held at New York’s Mount Sinai Hospital. He also has written a chapter on the topic in "Pediatric, Adolescent, & Young Adult Gynecology" (Oxford: Wiley-Blackwell, 2009), edited by Dr. Altchek and Dr. Liane Deligdisch.

The symptoms include recurrent itching, redness, fissures, and vulva dysuria. Diagnosis of vulvar atopic dermatitis includes gathering a family history of allergies, asthma, hay fever; looking at the past history of the patient; and conducting a physical examination starting from the head, said Dr. Altchek.

Atopic dermatitis fissures are symmetrical and narrow, and look as if they were "made with an artist with a scalpel," he said. The hymen is intact. In early stages, vulvar atopic dermatitis’ most pronounced part is bilateral symmetrical fissures between labia minora and majora. Sometimes the fissures are deep and may cause bleeding. In addition, there is a midline sagittal perineal fourchette to the anterior anus at 12 o’clock, where there is usually a papule. The latter is the result of an anterior anal fissure with red inflamed edges. When red and present for a long time, there is severe permanent swelling simulating a hemorrhoid. In more severe cases there is a fissure anterior to clitoris.

In younger girls, the fissures may cause a sudden jump up from sitting because of pain, which is at times misdiagnosed as a neurologic condition.

The condition is sometimes confused with sexual molestation or lichen sclerosis. In sexual molestation cases there may be general signs of trauma and any vulvar fissures are irregular, with lacerations in addition to the history. "Lichen sclerosis of the vulva has coarse, wide irregular fissures in the same areas. With slight trauma the labia and vulva have transient dark blue subcutaneous blood boils," said Dr. Altchek, also an attending ob.gyn. at Lenox Hill Hospital in New York. Lichen sclerosis has a specific biopsy finding, which vulvar atopic dermatitis does not.

Patients with vulvar atopic dermatitis also have the condition on other parts of their body, including behind the ears, in axilla, elbows, or behind the knees, highlighting the importance of whole body exam.

The condition is managed by avoiding things that could irritate the vulva, including wet bathing suits, hot water, perfume, and certain clothing such as leotards and tights. Otherwise, treatment is individualized to reduce irritation and symptoms, Dr. Altchek said.

The condition is most common among prepubertal and young pubertal girls, it may or may not disappear at puberty, and it is less common in adults, said Dr. Altchek.

"Basically, my message is ‘wake up, world.’ This is how you diagnose [vulvar atopic dermatitis], which has never been described before," said Dr. Altchek.

Dr. Altchek said he had no relevant financial disclosures.

Subacute atopic dermatitis of the vulva has been described for the first time by Dr. Albert Altchek, clinical professor of obstetrics and gynecology at Mount Sinai School of Medicine, New York, according to the physician.

Atopic dermatitis is a clinical diagnosis, according to Dr. Altchek. "There’s no corresponding biopsy."

His findings are based on his observations of a large number of the same girls over a long period of time at three separate clinics as well as his continuing private office consultation, which he presented at the 15th Annual Postgraduate CME Course on Pediatric, Adolescent, and Young Adult Gynecology held at New York’s Mount Sinai Hospital. He also has written a chapter on the topic in "Pediatric, Adolescent, & Young Adult Gynecology" (Oxford: Wiley-Blackwell, 2009), edited by Dr. Altchek and Dr. Liane Deligdisch.

The symptoms include recurrent itching, redness, fissures, and vulva dysuria. Diagnosis of vulvar atopic dermatitis includes gathering a family history of allergies, asthma, hay fever; looking at the past history of the patient; and conducting a physical examination starting from the head, said Dr. Altchek.

Atopic dermatitis fissures are symmetrical and narrow, and look as if they were "made with an artist with a scalpel," he said. The hymen is intact. In early stages, vulvar atopic dermatitis’ most pronounced part is bilateral symmetrical fissures between labia minora and majora. Sometimes the fissures are deep and may cause bleeding. In addition, there is a midline sagittal perineal fourchette to the anterior anus at 12 o’clock, where there is usually a papule. The latter is the result of an anterior anal fissure with red inflamed edges. When red and present for a long time, there is severe permanent swelling simulating a hemorrhoid. In more severe cases there is a fissure anterior to clitoris.

In younger girls, the fissures may cause a sudden jump up from sitting because of pain, which is at times misdiagnosed as a neurologic condition.

The condition is sometimes confused with sexual molestation or lichen sclerosis. In sexual molestation cases there may be general signs of trauma and any vulvar fissures are irregular, with lacerations in addition to the history. "Lichen sclerosis of the vulva has coarse, wide irregular fissures in the same areas. With slight trauma the labia and vulva have transient dark blue subcutaneous blood boils," said Dr. Altchek, also an attending ob.gyn. at Lenox Hill Hospital in New York. Lichen sclerosis has a specific biopsy finding, which vulvar atopic dermatitis does not.

Patients with vulvar atopic dermatitis also have the condition on other parts of their body, including behind the ears, in axilla, elbows, or behind the knees, highlighting the importance of whole body exam.

The condition is managed by avoiding things that could irritate the vulva, including wet bathing suits, hot water, perfume, and certain clothing such as leotards and tights. Otherwise, treatment is individualized to reduce irritation and symptoms, Dr. Altchek said.

The condition is most common among prepubertal and young pubertal girls, it may or may not disappear at puberty, and it is less common in adults, said Dr. Altchek.

"Basically, my message is ‘wake up, world.’ This is how you diagnose [vulvar atopic dermatitis], which has never been described before," said Dr. Altchek.

Dr. Altchek said he had no relevant financial disclosures.

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Yoga Reduced Arrhythmias in Paroxysmal AF

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Yoga Reduced Arrhythmias in Paroxysmal AF

NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

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NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

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FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN COLLEGE OF CARDIOLOGY

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Yoga Reduced Arrhythmias in Paroxysmal AF

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Yoga Reduced Arrhythmias in Paroxysmal AF

NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

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NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

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Yoga Reduced Arrhythmias in Paroxysmal AF

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NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Photo credit: Elsevier Global Medical News Image Library.
    Researchers found that yoga helps to significantly reduce irregular heart beat episodes and improve anxiety and depression symptoms in patients with paroxysmal atrial fibrillation.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

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NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Photo credit: Elsevier Global Medical News Image Library.
    Researchers found that yoga helps to significantly reduce irregular heart beat episodes and improve anxiety and depression symptoms in patients with paroxysmal atrial fibrillation.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

NEW ORLEANS – Practicing yoga can significantly reduce irregular heart beat episodes and improve symptoms of anxiety and depression in patients with paroxysmal atrial fibrillation, according to a study of 49 patients.

“This drives home the point that yoga used as a supplement and complement to existing therapies could make a dramatic difference in the quality of life of people, bring down anxiety and bring down arrhythmia burden in a cumulative fashion,” said Dr. Dhanunjaya Lakkireddy, lead author and associate professor of medicine at University of Kansas Hospital, Kansas City, at the annual scientific sessions of the American College of Cardiology.

Photo credit: Elsevier Global Medical News Image Library.
    Researchers found that yoga helps to significantly reduce irregular heart beat episodes and improve anxiety and depression symptoms in patients with paroxysmal atrial fibrillation.

Previous research has shown that heart failure patients can benefit from yoga, and that it yoga has a positive impact on overall health of various types of patients, including those with cancer. But this is the first study to examine the benefits of yoga on patients with atrial fibrillation, said Dr. Lakkireddy and his coinvestigators. “Atrial fibrillation is the bane of cardiologists’ existence,” and the condition also interferes with patients’ lives, leading to anxiety and depression. “It also consumes a lot of health care dollars,” he said.

What prompted Dr. Lakkireddy to conduct the study was seeing the progress in one of his patients who practiced yoga regularly.

Dr. Janet Wright, senior vice president of science and quality at ACC, said that the study was suggested by a patient, and commended Dr. Lakkireddi for “listening to patients and to what works for them, and equipping patients with things they can do to self manage their chronic conditions.”

The investigators conducted a prospective, self-controlled, single-center study on 49 patients with atrial fibrillation who had no physical limitations. For the first 3 months, the control phase, the patients were allowed to engage in their previous physical activities. During the following 3 months, the intervention phase, the patients participated in a supervised yoga program (B.K.S. Iyengar’s conventional yoga program), which included breathing exercises, yoga postures, meditation and relaxation, for an average of 45 minutes, three times a week. They were also given an educational DVD to continue practice at home, depending on their comfort level. All participants were new to yoga.

Episodes of irregular heartbeat were measured during the 6-month study period with portable monitors and patient logs. Patients also completed surveys on anxiety, depression and quality of life.

Episodes of arrhythmia episodes decreased, from a mean of 3.8% in the control phase to 2.1% in the interventional phase. Likewise, asymptomatic episodes came down from 2.6 to 1.4 episodes, while quality of life improved: patients’ anxiety score decreased by 4 points, and their depression score by 5 points. All these differences were statistically significant, said Dr. Lakkireddy.

Here we have another piece of data showing the importance of stress and anxiety on atrial fibrillation events,” said Dr. Ralph Brindis, president of ACC. “The fact that yoga may decrease atrial fibrillation burden is fascinating. I am convinced totally that stress reduction technique would be an important armament for patients for minimizing atrial fibrillation burden and more importantly improving their quality of life.”

Dr. Lakkireddy speculated that yoga affects cardiac autonomic tone by creating a flattening effect and preventing abnormal surges in the autonomic nervous system. Stress and inflammation also play a role in atrial fibrillation, he said. “Yoga improves all of these things.”

The authors said that yoga can be considered in the treatment strategy for atrial fibrillation and other complex heart rhythm disorders, given that it is noninvasive, low cost, “with minimal side effects and reasonable safety and efficacy.” Dr. Lakkireddy said he prescribes yoga to his patients with atrial fibrillation. However, “yoga does not treat atrial fibrillation,” he stressed.

One of the main limitations of the study is the small number of participants, said Dr. Lakkireddy, adding that more research with a larger number of patients is needed.

Dr. Lakkireddy had no disclosures. “I practice yoga. That’s my only disclosure,” he said.

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yoga, irregular heart beat episodes, anxiety, depression, paroxysmal atrial fibrillation, Dr. Dhanunjaya Lakkireddy, the American College of Cardiology
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FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN COLLEGE OF CARDIOLOGY

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Index to Measure Diabetes in U.S.

An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (

www.usdireport.com

HEART Bill Reintroduced

A bill intended to end the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data that has been reported to the federal government to be broken down by sex, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. “Unfortunately, a majority of women and even some physicians are unfamiliar with the symptoms, diagnoses, and dangers of heart disease in women,” Sen. Stabenow said in a statement.

New Plan for Diabetes Research

The National Institute of Diabetes and Digestive and Kidney Diseases announced a 10-year plan to combat type 1 and 2 diabetes by guiding diabetes-related research. “By setting priorities and identifying the most compelling research opportunities, the strategic plan will guide NIH, other federal agencies, and the investigative community in efforts to improve diabetes treatments and identify ways to keep more people healthy,” said NIDDK Director Griffin P. Rodgers, in a statement. The plan focuses on 10 diabetes research areas, including the relationship between obesity and type 2 diabetes, autoimmune mechanisms of type 1 diabetes, and the biology of beta cells.

Drug Risk High for Older Adults

Drugs such as pain relievers and anxiety and insomnia medications were the cause of about one-fourth of emergency department visits by adults aged 50 years or older for adverse drug reactions in 2008, according the Drug Abuse Warning Network. Among medications acting on the central nervous system, narcotic pain relievers accounted for 9% of the year's 1,112,000 drug-related emergencies in this population and nonnarcotic pain relievers made up nearly 8%. In a separate category, psychotherapeutic drugs accounted for 5% of the emergencies. The study appeared in The Dawn Report, published by the Substance Abuse and Mental Health Services Administration. Nearly one-third of 50-and-older adults going to emergency departments for drug reactions in 2008 were admitted to the hospital.

Court Passes on 'Pay for Delay'

The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.

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Index to Measure Diabetes in U.S.

An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (

www.usdireport.com

HEART Bill Reintroduced

A bill intended to end the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data that has been reported to the federal government to be broken down by sex, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. “Unfortunately, a majority of women and even some physicians are unfamiliar with the symptoms, diagnoses, and dangers of heart disease in women,” Sen. Stabenow said in a statement.

New Plan for Diabetes Research

The National Institute of Diabetes and Digestive and Kidney Diseases announced a 10-year plan to combat type 1 and 2 diabetes by guiding diabetes-related research. “By setting priorities and identifying the most compelling research opportunities, the strategic plan will guide NIH, other federal agencies, and the investigative community in efforts to improve diabetes treatments and identify ways to keep more people healthy,” said NIDDK Director Griffin P. Rodgers, in a statement. The plan focuses on 10 diabetes research areas, including the relationship between obesity and type 2 diabetes, autoimmune mechanisms of type 1 diabetes, and the biology of beta cells.

Drug Risk High for Older Adults

Drugs such as pain relievers and anxiety and insomnia medications were the cause of about one-fourth of emergency department visits by adults aged 50 years or older for adverse drug reactions in 2008, according the Drug Abuse Warning Network. Among medications acting on the central nervous system, narcotic pain relievers accounted for 9% of the year's 1,112,000 drug-related emergencies in this population and nonnarcotic pain relievers made up nearly 8%. In a separate category, psychotherapeutic drugs accounted for 5% of the emergencies. The study appeared in The Dawn Report, published by the Substance Abuse and Mental Health Services Administration. Nearly one-third of 50-and-older adults going to emergency departments for drug reactions in 2008 were admitted to the hospital.

Court Passes on 'Pay for Delay'

The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.

Index to Measure Diabetes in U.S.

An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (

www.usdireport.com

HEART Bill Reintroduced

A bill intended to end the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data that has been reported to the federal government to be broken down by sex, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. “Unfortunately, a majority of women and even some physicians are unfamiliar with the symptoms, diagnoses, and dangers of heart disease in women,” Sen. Stabenow said in a statement.

New Plan for Diabetes Research

The National Institute of Diabetes and Digestive and Kidney Diseases announced a 10-year plan to combat type 1 and 2 diabetes by guiding diabetes-related research. “By setting priorities and identifying the most compelling research opportunities, the strategic plan will guide NIH, other federal agencies, and the investigative community in efforts to improve diabetes treatments and identify ways to keep more people healthy,” said NIDDK Director Griffin P. Rodgers, in a statement. The plan focuses on 10 diabetes research areas, including the relationship between obesity and type 2 diabetes, autoimmune mechanisms of type 1 diabetes, and the biology of beta cells.

Drug Risk High for Older Adults

Drugs such as pain relievers and anxiety and insomnia medications were the cause of about one-fourth of emergency department visits by adults aged 50 years or older for adverse drug reactions in 2008, according the Drug Abuse Warning Network. Among medications acting on the central nervous system, narcotic pain relievers accounted for 9% of the year's 1,112,000 drug-related emergencies in this population and nonnarcotic pain relievers made up nearly 8%. In a separate category, psychotherapeutic drugs accounted for 5% of the emergencies. The study appeared in The Dawn Report, published by the Substance Abuse and Mental Health Services Administration. Nearly one-third of 50-and-older adults going to emergency departments for drug reactions in 2008 were admitted to the hospital.

Court Passes on 'Pay for Delay'

The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.

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Survey: Use of Temporary Physicians on the Rise

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Survey: Use of Temporary Physicians on the Rise

Demand for temporary physicians, known as “locum tenens” positions, is rising, according to a survey of temporary physicians and the hospitals and health groups that employ them.

The findings suggest that there has been a shift in the reasons for hiring staff on a temporary basis.

“Historically, locum tenens doctors have been used to hold a place for ill, vacationing, or otherwise absent doctors pending their return. Today, national doctor shortages have prompted hospitals, medical groups, and others to use temporary doctors to maintain services in lieu of permanent doctors, who may be difficult to find,” according to the survey, which was conducted by Staff Care Inc., a company that matches temporary health care providers with medical institutions.

The number of facilities using locum tenens physicians rose from 72% in 2009 to 85% in 2010. Meanwhile, a slightly higher percentage of locum tenens physicians (33%) reported having less than 1 year of experience in 2010, compared with those in 2009 (30%), suggesting that locum tenens is attracting new physicians, according to the survey.

Demand was higher for physicians in certain specialties, especially in behavioral health, which topped the list for the type of temporary physicians requested most by health care groups, at 22%.

Primary care physicians were the next most requested (20%), and temporary physicians were used to fill internal medicine slots in 12% of the cases.

The company surveyed 626 locum tenens physicians and 105 groups that use temporary physicians, via e-mail, from August to November of 2010.

Staff Care estimates that 30,000–40,000 physicians worked on a locum tenens basis in 2010.

“This number could grow significantly in the next several years as health reform and other challenges push physicians to seek alternative practice styles,” according to the survey.

Dr. Robert T. London, who has been practicing psychiatry for 35 years, said that he regularly receives calls from staffing agencies for locum tenens opportunities.

“It pays very [well]. They provide you with room and board and sometimes a car. … Some people seem to like it,” he said in an interview.

Dr. London, who practices in New York City and is not a locum tenens physician, said that being a temporary physician is sometimes a good opportunity for older physicians who no longer want to work full time.

Among surveyed locum tenens physicians, the top reasons for working on a temporary basis were the ability to have freedom and flexibility and not to have to deal with medical politics.

Being away from home and the uncertainty of the assignments were the top two drawbacks.

Groups that hired temporary physicians listed continuity of care and prevention of revenue loss as the top two benefits of bringing in locum tenens providers.

Cost and lack of familiarity with the department or practice were the top two drawbacks.

Among the other survey findings were the following:

▸ In all, 41% of facilities were seeking locum tenens physicians in 2010, up from 40% in 2009. The slight uptick may suggest “that the downturn in physician utilization caused by the recession may be reversing,” according to the survey.

▸ Locum tenens physicians are mostly accepted by patients, colleagues, and administrators.

▸ Of groups that hired locum tenens physicians, 84% said that bringing them to their facility was “worth the cost,” compared with 79% in 2009.

▸ Some 55% of health care groups reported using one to three locum tenens physicians in a typical month; 37% reported using none, 7% reported using four to six, and 1% reported using seven or more.

▸ Of the physicians who were surveyed, 80% said that they find working on a locum tenens basis to be as satisfying as or more satisfying than conventional practice.

▸ Overall, 60% of the physicians said they plan to practice on a locum tenens basis for more than 3 years.

▸ The largest percentage of locum tenens physicians (28%) reported primary care as their specialty.

▸ In all, 68% of the physicians reported having 21 or more years of experience; 16% had 11–20 years; 7% had 6–10 years; 7% had 1–5 years, and 2% had less than 1 year.

▸ Some 63% of the physicians surveyed reported taking on one to three locum tenens assignments per year, 19% reported taking on four to six assignments annually, and 18% took on seven or more.

Source Elsevier Global Medical News

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Demand for temporary physicians, known as “locum tenens” positions, is rising, according to a survey of temporary physicians and the hospitals and health groups that employ them.

The findings suggest that there has been a shift in the reasons for hiring staff on a temporary basis.

“Historically, locum tenens doctors have been used to hold a place for ill, vacationing, or otherwise absent doctors pending their return. Today, national doctor shortages have prompted hospitals, medical groups, and others to use temporary doctors to maintain services in lieu of permanent doctors, who may be difficult to find,” according to the survey, which was conducted by Staff Care Inc., a company that matches temporary health care providers with medical institutions.

The number of facilities using locum tenens physicians rose from 72% in 2009 to 85% in 2010. Meanwhile, a slightly higher percentage of locum tenens physicians (33%) reported having less than 1 year of experience in 2010, compared with those in 2009 (30%), suggesting that locum tenens is attracting new physicians, according to the survey.

Demand was higher for physicians in certain specialties, especially in behavioral health, which topped the list for the type of temporary physicians requested most by health care groups, at 22%.

Primary care physicians were the next most requested (20%), and temporary physicians were used to fill internal medicine slots in 12% of the cases.

The company surveyed 626 locum tenens physicians and 105 groups that use temporary physicians, via e-mail, from August to November of 2010.

Staff Care estimates that 30,000–40,000 physicians worked on a locum tenens basis in 2010.

“This number could grow significantly in the next several years as health reform and other challenges push physicians to seek alternative practice styles,” according to the survey.

Dr. Robert T. London, who has been practicing psychiatry for 35 years, said that he regularly receives calls from staffing agencies for locum tenens opportunities.

“It pays very [well]. They provide you with room and board and sometimes a car. … Some people seem to like it,” he said in an interview.

Dr. London, who practices in New York City and is not a locum tenens physician, said that being a temporary physician is sometimes a good opportunity for older physicians who no longer want to work full time.

Among surveyed locum tenens physicians, the top reasons for working on a temporary basis were the ability to have freedom and flexibility and not to have to deal with medical politics.

Being away from home and the uncertainty of the assignments were the top two drawbacks.

Groups that hired temporary physicians listed continuity of care and prevention of revenue loss as the top two benefits of bringing in locum tenens providers.

Cost and lack of familiarity with the department or practice were the top two drawbacks.

Among the other survey findings were the following:

▸ In all, 41% of facilities were seeking locum tenens physicians in 2010, up from 40% in 2009. The slight uptick may suggest “that the downturn in physician utilization caused by the recession may be reversing,” according to the survey.

▸ Locum tenens physicians are mostly accepted by patients, colleagues, and administrators.

▸ Of groups that hired locum tenens physicians, 84% said that bringing them to their facility was “worth the cost,” compared with 79% in 2009.

▸ Some 55% of health care groups reported using one to three locum tenens physicians in a typical month; 37% reported using none, 7% reported using four to six, and 1% reported using seven or more.

▸ Of the physicians who were surveyed, 80% said that they find working on a locum tenens basis to be as satisfying as or more satisfying than conventional practice.

▸ Overall, 60% of the physicians said they plan to practice on a locum tenens basis for more than 3 years.

▸ The largest percentage of locum tenens physicians (28%) reported primary care as their specialty.

▸ In all, 68% of the physicians reported having 21 or more years of experience; 16% had 11–20 years; 7% had 6–10 years; 7% had 1–5 years, and 2% had less than 1 year.

▸ Some 63% of the physicians surveyed reported taking on one to three locum tenens assignments per year, 19% reported taking on four to six assignments annually, and 18% took on seven or more.

Source Elsevier Global Medical News

Demand for temporary physicians, known as “locum tenens” positions, is rising, according to a survey of temporary physicians and the hospitals and health groups that employ them.

The findings suggest that there has been a shift in the reasons for hiring staff on a temporary basis.

“Historically, locum tenens doctors have been used to hold a place for ill, vacationing, or otherwise absent doctors pending their return. Today, national doctor shortages have prompted hospitals, medical groups, and others to use temporary doctors to maintain services in lieu of permanent doctors, who may be difficult to find,” according to the survey, which was conducted by Staff Care Inc., a company that matches temporary health care providers with medical institutions.

The number of facilities using locum tenens physicians rose from 72% in 2009 to 85% in 2010. Meanwhile, a slightly higher percentage of locum tenens physicians (33%) reported having less than 1 year of experience in 2010, compared with those in 2009 (30%), suggesting that locum tenens is attracting new physicians, according to the survey.

Demand was higher for physicians in certain specialties, especially in behavioral health, which topped the list for the type of temporary physicians requested most by health care groups, at 22%.

Primary care physicians were the next most requested (20%), and temporary physicians were used to fill internal medicine slots in 12% of the cases.

The company surveyed 626 locum tenens physicians and 105 groups that use temporary physicians, via e-mail, from August to November of 2010.

Staff Care estimates that 30,000–40,000 physicians worked on a locum tenens basis in 2010.

“This number could grow significantly in the next several years as health reform and other challenges push physicians to seek alternative practice styles,” according to the survey.

Dr. Robert T. London, who has been practicing psychiatry for 35 years, said that he regularly receives calls from staffing agencies for locum tenens opportunities.

“It pays very [well]. They provide you with room and board and sometimes a car. … Some people seem to like it,” he said in an interview.

Dr. London, who practices in New York City and is not a locum tenens physician, said that being a temporary physician is sometimes a good opportunity for older physicians who no longer want to work full time.

Among surveyed locum tenens physicians, the top reasons for working on a temporary basis were the ability to have freedom and flexibility and not to have to deal with medical politics.

Being away from home and the uncertainty of the assignments were the top two drawbacks.

Groups that hired temporary physicians listed continuity of care and prevention of revenue loss as the top two benefits of bringing in locum tenens providers.

Cost and lack of familiarity with the department or practice were the top two drawbacks.

Among the other survey findings were the following:

▸ In all, 41% of facilities were seeking locum tenens physicians in 2010, up from 40% in 2009. The slight uptick may suggest “that the downturn in physician utilization caused by the recession may be reversing,” according to the survey.

▸ Locum tenens physicians are mostly accepted by patients, colleagues, and administrators.

▸ Of groups that hired locum tenens physicians, 84% said that bringing them to their facility was “worth the cost,” compared with 79% in 2009.

▸ Some 55% of health care groups reported using one to three locum tenens physicians in a typical month; 37% reported using none, 7% reported using four to six, and 1% reported using seven or more.

▸ Of the physicians who were surveyed, 80% said that they find working on a locum tenens basis to be as satisfying as or more satisfying than conventional practice.

▸ Overall, 60% of the physicians said they plan to practice on a locum tenens basis for more than 3 years.

▸ The largest percentage of locum tenens physicians (28%) reported primary care as their specialty.

▸ In all, 68% of the physicians reported having 21 or more years of experience; 16% had 11–20 years; 7% had 6–10 years; 7% had 1–5 years, and 2% had less than 1 year.

▸ Some 63% of the physicians surveyed reported taking on one to three locum tenens assignments per year, 19% reported taking on four to six assignments annually, and 18% took on seven or more.

Source Elsevier Global Medical News

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Atypical Fractures Rare With Bisphosphonates

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Atypical Fractures Rare With Bisphosphonates

Prolonged use of oral bisphosphonates is associated with an increased risk of subtrochanteric or femoral shaft fractures in older women. However, the absolute risk for these fractures is low, according to a large population-based study.

“There wasn't good research about what the absolute risk of the fractures was. This study adds that piece,” lead author Laura Y. Park-Wyllie, Pharm.D., said in an interview.

During the 7-year study period, researchers found that women aged 68 years or older who used bisphosphonates for 5 years or longer were 2.74 times more likely to have subtrochanteric or femoral shaft fractures after minimal trauma, compared with women who took the medications transiently (JAMA 2011;305:783-9).

The study also showed that the absolute risk of such atypical fractures was at 1 in 1,000 women.

“If you combine all the information that we have about osteoporosis and the information we have about the risk versus benefits [of bisphosphonates] they would favor the continuation of treatment,” Dr. Park-Wyllie said.

The growing number of reports on the issue and conflicting studies prompted the group to launch the study, said Dr. Park-Wyllie, a research fellow at Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.

The American Society for Bone and Mineral Research recently released a task force report about the issue. The Food and Drug Administration has announced that it intends to monitor instances of such cases. There have also been several studies on the topic, but the authors of this report say that the studies were too small to establish or negate an association.

The population-based, nested case-control study examined 205,466 women 68 years or older who were treated with bisphosphonates between April 1, 2002, and March 31, 2008. The women were followed until the first fracture, death, or end of the study. Women with a history of conditions that could affect bone integrity were excluded.

In the group, 716 women (0.35%) had subtrochanteric (411) or femoral shaft fractures (305). Each case was matched with up to five controls – 3,580 total – from the cohort not hospitalized for either type of fracture, according to the study.

When compared with women who had used bisphosphonates transiently during the study period (less than 100 days in total), women who used the medication for 5 years or longer had an increased risk of subtrochanteric or femoral shaft fracture, the authors concluded.

To validate their findings, the investigators also conducted a secondary analysis, examining the risk of typical osteoporotic fractures among women who used bisphosphonates for 5 years or more, compared with women who used the medication transiently. Of the cohort, 9,723 women sustained femoral neck or intertrochanteric region fractures. “As expected, we found that extended bisphosphonate use was associated with a reduced risk of fracture compared with transient use,” the authors wrote.

The absolute risk was estimated from 52,595 women in the cohort with at least 5 years of bisphosphonate therapy. Seventy-one, or 0.13%, sustained subtrochanteric or femoral shaft fractures during the following year and 117 (0.22%) within 2 years.

The authors noted that during their study period (2002–2008) only a small proportion of the cohort received 5 or more years of bisphosphonate therapy. “It is likely that the prevalence of long-term bisphosphonate exposure will increase over time as more women achieve 5 cumulative years of therapy because these drugs are still relatively new and because sustained adherence to bisphosphonates is actively promoted in the community setting,” they wrote.

The study should not deter physicians and patients from the use of bisphosphonates, they said, noting that typical hip fractures were far more common than were subtrochanteric or femoral shaft fractures during the study period (9,723 vs. 716).

One of the coauthors – Muhammad M. Mamdani, Pharm.D. – reported financial relationships with Boehringer Ingelheim, Janssen-Ortho, Novartis, and Pfizer. The study was funded by the Ontario Ministry of Health and Long-Term Care.

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Prolonged use of oral bisphosphonates is associated with an increased risk of subtrochanteric or femoral shaft fractures in older women. However, the absolute risk for these fractures is low, according to a large population-based study.

“There wasn't good research about what the absolute risk of the fractures was. This study adds that piece,” lead author Laura Y. Park-Wyllie, Pharm.D., said in an interview.

During the 7-year study period, researchers found that women aged 68 years or older who used bisphosphonates for 5 years or longer were 2.74 times more likely to have subtrochanteric or femoral shaft fractures after minimal trauma, compared with women who took the medications transiently (JAMA 2011;305:783-9).

The study also showed that the absolute risk of such atypical fractures was at 1 in 1,000 women.

“If you combine all the information that we have about osteoporosis and the information we have about the risk versus benefits [of bisphosphonates] they would favor the continuation of treatment,” Dr. Park-Wyllie said.

The growing number of reports on the issue and conflicting studies prompted the group to launch the study, said Dr. Park-Wyllie, a research fellow at Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.

The American Society for Bone and Mineral Research recently released a task force report about the issue. The Food and Drug Administration has announced that it intends to monitor instances of such cases. There have also been several studies on the topic, but the authors of this report say that the studies were too small to establish or negate an association.

The population-based, nested case-control study examined 205,466 women 68 years or older who were treated with bisphosphonates between April 1, 2002, and March 31, 2008. The women were followed until the first fracture, death, or end of the study. Women with a history of conditions that could affect bone integrity were excluded.

In the group, 716 women (0.35%) had subtrochanteric (411) or femoral shaft fractures (305). Each case was matched with up to five controls – 3,580 total – from the cohort not hospitalized for either type of fracture, according to the study.

When compared with women who had used bisphosphonates transiently during the study period (less than 100 days in total), women who used the medication for 5 years or longer had an increased risk of subtrochanteric or femoral shaft fracture, the authors concluded.

To validate their findings, the investigators also conducted a secondary analysis, examining the risk of typical osteoporotic fractures among women who used bisphosphonates for 5 years or more, compared with women who used the medication transiently. Of the cohort, 9,723 women sustained femoral neck or intertrochanteric region fractures. “As expected, we found that extended bisphosphonate use was associated with a reduced risk of fracture compared with transient use,” the authors wrote.

The absolute risk was estimated from 52,595 women in the cohort with at least 5 years of bisphosphonate therapy. Seventy-one, or 0.13%, sustained subtrochanteric or femoral shaft fractures during the following year and 117 (0.22%) within 2 years.

The authors noted that during their study period (2002–2008) only a small proportion of the cohort received 5 or more years of bisphosphonate therapy. “It is likely that the prevalence of long-term bisphosphonate exposure will increase over time as more women achieve 5 cumulative years of therapy because these drugs are still relatively new and because sustained adherence to bisphosphonates is actively promoted in the community setting,” they wrote.

The study should not deter physicians and patients from the use of bisphosphonates, they said, noting that typical hip fractures were far more common than were subtrochanteric or femoral shaft fractures during the study period (9,723 vs. 716).

One of the coauthors – Muhammad M. Mamdani, Pharm.D. – reported financial relationships with Boehringer Ingelheim, Janssen-Ortho, Novartis, and Pfizer. The study was funded by the Ontario Ministry of Health and Long-Term Care.

Prolonged use of oral bisphosphonates is associated with an increased risk of subtrochanteric or femoral shaft fractures in older women. However, the absolute risk for these fractures is low, according to a large population-based study.

“There wasn't good research about what the absolute risk of the fractures was. This study adds that piece,” lead author Laura Y. Park-Wyllie, Pharm.D., said in an interview.

During the 7-year study period, researchers found that women aged 68 years or older who used bisphosphonates for 5 years or longer were 2.74 times more likely to have subtrochanteric or femoral shaft fractures after minimal trauma, compared with women who took the medications transiently (JAMA 2011;305:783-9).

The study also showed that the absolute risk of such atypical fractures was at 1 in 1,000 women.

“If you combine all the information that we have about osteoporosis and the information we have about the risk versus benefits [of bisphosphonates] they would favor the continuation of treatment,” Dr. Park-Wyllie said.

The growing number of reports on the issue and conflicting studies prompted the group to launch the study, said Dr. Park-Wyllie, a research fellow at Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.

The American Society for Bone and Mineral Research recently released a task force report about the issue. The Food and Drug Administration has announced that it intends to monitor instances of such cases. There have also been several studies on the topic, but the authors of this report say that the studies were too small to establish or negate an association.

The population-based, nested case-control study examined 205,466 women 68 years or older who were treated with bisphosphonates between April 1, 2002, and March 31, 2008. The women were followed until the first fracture, death, or end of the study. Women with a history of conditions that could affect bone integrity were excluded.

In the group, 716 women (0.35%) had subtrochanteric (411) or femoral shaft fractures (305). Each case was matched with up to five controls – 3,580 total – from the cohort not hospitalized for either type of fracture, according to the study.

When compared with women who had used bisphosphonates transiently during the study period (less than 100 days in total), women who used the medication for 5 years or longer had an increased risk of subtrochanteric or femoral shaft fracture, the authors concluded.

To validate their findings, the investigators also conducted a secondary analysis, examining the risk of typical osteoporotic fractures among women who used bisphosphonates for 5 years or more, compared with women who used the medication transiently. Of the cohort, 9,723 women sustained femoral neck or intertrochanteric region fractures. “As expected, we found that extended bisphosphonate use was associated with a reduced risk of fracture compared with transient use,” the authors wrote.

The absolute risk was estimated from 52,595 women in the cohort with at least 5 years of bisphosphonate therapy. Seventy-one, or 0.13%, sustained subtrochanteric or femoral shaft fractures during the following year and 117 (0.22%) within 2 years.

The authors noted that during their study period (2002–2008) only a small proportion of the cohort received 5 or more years of bisphosphonate therapy. “It is likely that the prevalence of long-term bisphosphonate exposure will increase over time as more women achieve 5 cumulative years of therapy because these drugs are still relatively new and because sustained adherence to bisphosphonates is actively promoted in the community setting,” they wrote.

The study should not deter physicians and patients from the use of bisphosphonates, they said, noting that typical hip fractures were far more common than were subtrochanteric or femoral shaft fractures during the study period (9,723 vs. 716).

One of the coauthors – Muhammad M. Mamdani, Pharm.D. – reported financial relationships with Boehringer Ingelheim, Janssen-Ortho, Novartis, and Pfizer. The study was funded by the Ontario Ministry of Health and Long-Term Care.

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Bisphosphonates: Absolute Risk of Atypical Fractures Is Low

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Bisphosphonates: Absolute Risk of Atypical Fractures Is Low

Prolonged use of oral bisphosphonates is associated with an increased risk of subtrochanteric or femoral shaft fractures in older women. However, the absolute risk for these fractures is low, according to a large population-based study.

“This study adds another piece to the puzzle,” lead author Laura Y. Park-Wyllie, Pharm.D., said in an interview. “There wasn't good research about what the absolute risk of the fractures was. This study adds that piece.”

During the 7-year study period, women aged 68 years or older who used bisphosphonates for 5 years or longer were 2.74 times more likely to have subtrochanteric or femoral shaft fractures after minimal trauma, compared with women who took the medications transiently (JAMA 2011;305:783-9). The study also showed that the absolute risk of such atypical fractures was at 1 in 1,000 women.

“If you combine all the information that we have about osteoporosis and the information we have about the risk versus benefits [of bisphosphonates] they would favor the continuation of treatment,” Dr. Park-Wyllie said.

Bisphosphonate therapy reduces the risk of osteoporotic fractures, judging from findings from a number of studies. But bisphosphonate-related suppression of bone remodeling could have an adverse effect on bone strength, resulting in atypical fractures, the authors noted.

The growing number of reports on the issue and conflicting studies prompted the group to launch the study, said Dr. Park-Wyllie, a research fellow at Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.

The American Society for Bone and Mineral Research recently released a task force report about the issue. The Food and Drug Administration has announced that it intends to monitor instances of such cases. There have also been several studies on the topic, but the authors of this report say that the studies were too small to establish or negate an association. The population-based, nested case-control study examined 205,466 women 68 years or older who were treated with bisphosphonates between April 1, 2002, and March 31, 2008. The women were followed until the first fracture, death, or end of the study. Women with a history of conditions that could affect bone integrity were excluded.

In the group, 716 women (0.35%) had subtrochanteric (411) or femoral shaft fractures (305). Each case was matched with up to five controls – 3,580 - total – from the cohort not hospitalized for either type of fracture, according to the study.

When compared with women who had used bisphosphonates transiently during the study period (less than 100 days in total), women who used the medication for 5 years or longer had an increased risk of subtrochanteric or femoral shaft fracture, the authors concluded.

To validate their findings, the investigators also conducted a secondary analysis, examining the risk of typical osteoporotic fractures among women who used bisphosphonates for 5 years or more, compared with women who used the medication transiently. Of the cohort, 9,723 women sustained femoral neck or intertrochanteric region fractures. “As expected, we found that extended bisphosphonate use was associated with a reduced risk of fracture compared with transient use,” the authors wrote.

The absolute risk was estimated from 52,595 women in the cohort with at least 5 years of bisphosphonate therapy. Seventy-one, or 0.13%, sustained subtrochanteric or femoral shaft fractures during the following year and 117 (0.22%) within 2 years.

One of the coauthors – Muhammad M. Mamdani, Pharm.D. – reported financial relationships with Boehringer Ingelheim, Janssen-Ortho, Novartis, and Pfizer. The study was funded by the Ontario Ministry of Health and Long-Term Care.

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Prolonged use of oral bisphosphonates is associated with an increased risk of subtrochanteric or femoral shaft fractures in older women. However, the absolute risk for these fractures is low, according to a large population-based study.

“This study adds another piece to the puzzle,” lead author Laura Y. Park-Wyllie, Pharm.D., said in an interview. “There wasn't good research about what the absolute risk of the fractures was. This study adds that piece.”

During the 7-year study period, women aged 68 years or older who used bisphosphonates for 5 years or longer were 2.74 times more likely to have subtrochanteric or femoral shaft fractures after minimal trauma, compared with women who took the medications transiently (JAMA 2011;305:783-9). The study also showed that the absolute risk of such atypical fractures was at 1 in 1,000 women.

“If you combine all the information that we have about osteoporosis and the information we have about the risk versus benefits [of bisphosphonates] they would favor the continuation of treatment,” Dr. Park-Wyllie said.

Bisphosphonate therapy reduces the risk of osteoporotic fractures, judging from findings from a number of studies. But bisphosphonate-related suppression of bone remodeling could have an adverse effect on bone strength, resulting in atypical fractures, the authors noted.

The growing number of reports on the issue and conflicting studies prompted the group to launch the study, said Dr. Park-Wyllie, a research fellow at Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.

The American Society for Bone and Mineral Research recently released a task force report about the issue. The Food and Drug Administration has announced that it intends to monitor instances of such cases. There have also been several studies on the topic, but the authors of this report say that the studies were too small to establish or negate an association. The population-based, nested case-control study examined 205,466 women 68 years or older who were treated with bisphosphonates between April 1, 2002, and March 31, 2008. The women were followed until the first fracture, death, or end of the study. Women with a history of conditions that could affect bone integrity were excluded.

In the group, 716 women (0.35%) had subtrochanteric (411) or femoral shaft fractures (305). Each case was matched with up to five controls – 3,580 - total – from the cohort not hospitalized for either type of fracture, according to the study.

When compared with women who had used bisphosphonates transiently during the study period (less than 100 days in total), women who used the medication for 5 years or longer had an increased risk of subtrochanteric or femoral shaft fracture, the authors concluded.

To validate their findings, the investigators also conducted a secondary analysis, examining the risk of typical osteoporotic fractures among women who used bisphosphonates for 5 years or more, compared with women who used the medication transiently. Of the cohort, 9,723 women sustained femoral neck or intertrochanteric region fractures. “As expected, we found that extended bisphosphonate use was associated with a reduced risk of fracture compared with transient use,” the authors wrote.

The absolute risk was estimated from 52,595 women in the cohort with at least 5 years of bisphosphonate therapy. Seventy-one, or 0.13%, sustained subtrochanteric or femoral shaft fractures during the following year and 117 (0.22%) within 2 years.

One of the coauthors – Muhammad M. Mamdani, Pharm.D. – reported financial relationships with Boehringer Ingelheim, Janssen-Ortho, Novartis, and Pfizer. The study was funded by the Ontario Ministry of Health and Long-Term Care.

Prolonged use of oral bisphosphonates is associated with an increased risk of subtrochanteric or femoral shaft fractures in older women. However, the absolute risk for these fractures is low, according to a large population-based study.

“This study adds another piece to the puzzle,” lead author Laura Y. Park-Wyllie, Pharm.D., said in an interview. “There wasn't good research about what the absolute risk of the fractures was. This study adds that piece.”

During the 7-year study period, women aged 68 years or older who used bisphosphonates for 5 years or longer were 2.74 times more likely to have subtrochanteric or femoral shaft fractures after minimal trauma, compared with women who took the medications transiently (JAMA 2011;305:783-9). The study also showed that the absolute risk of such atypical fractures was at 1 in 1,000 women.

“If you combine all the information that we have about osteoporosis and the information we have about the risk versus benefits [of bisphosphonates] they would favor the continuation of treatment,” Dr. Park-Wyllie said.

Bisphosphonate therapy reduces the risk of osteoporotic fractures, judging from findings from a number of studies. But bisphosphonate-related suppression of bone remodeling could have an adverse effect on bone strength, resulting in atypical fractures, the authors noted.

The growing number of reports on the issue and conflicting studies prompted the group to launch the study, said Dr. Park-Wyllie, a research fellow at Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.

The American Society for Bone and Mineral Research recently released a task force report about the issue. The Food and Drug Administration has announced that it intends to monitor instances of such cases. There have also been several studies on the topic, but the authors of this report say that the studies were too small to establish or negate an association. The population-based, nested case-control study examined 205,466 women 68 years or older who were treated with bisphosphonates between April 1, 2002, and March 31, 2008. The women were followed until the first fracture, death, or end of the study. Women with a history of conditions that could affect bone integrity were excluded.

In the group, 716 women (0.35%) had subtrochanteric (411) or femoral shaft fractures (305). Each case was matched with up to five controls – 3,580 - total – from the cohort not hospitalized for either type of fracture, according to the study.

When compared with women who had used bisphosphonates transiently during the study period (less than 100 days in total), women who used the medication for 5 years or longer had an increased risk of subtrochanteric or femoral shaft fracture, the authors concluded.

To validate their findings, the investigators also conducted a secondary analysis, examining the risk of typical osteoporotic fractures among women who used bisphosphonates for 5 years or more, compared with women who used the medication transiently. Of the cohort, 9,723 women sustained femoral neck or intertrochanteric region fractures. “As expected, we found that extended bisphosphonate use was associated with a reduced risk of fracture compared with transient use,” the authors wrote.

The absolute risk was estimated from 52,595 women in the cohort with at least 5 years of bisphosphonate therapy. Seventy-one, or 0.13%, sustained subtrochanteric or femoral shaft fractures during the following year and 117 (0.22%) within 2 years.

One of the coauthors – Muhammad M. Mamdani, Pharm.D. – reported financial relationships with Boehringer Ingelheim, Janssen-Ortho, Novartis, and Pfizer. The study was funded by the Ontario Ministry of Health and Long-Term Care.

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Public Citizen Health Research Group has urged the Food and Drug Administration to reject florbetapir F18 (Amyvid) injections for diagnosing Alzheimer's disease. “Given the significant inter-reader variability that was seen in the single-phase III clinical trial evaluating the performance of florbetapir positron-emission tomographic (PET) imaging, such PET scans would have little clinical utility in the evaluation of patients presenting with cognitive deficits or early dementia and suspected of having Alzheimer's disease,” the group wrote. The letter followed the January vote of an FDA advisory panel to endorse florbetapir if Avid Radiopharmaceuticals Inc. and Eli Lilly and Co., the companies developing the compound, train readers in a consistent technique and then reevaluate trials of the imaging agent. In its letter, the advocacy group wrote, “It is unlikely that better training and a new study in the more appropriate patient population are realistic hurdles to overcome.”

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Bill Would Track Neuro Diseases

Researchers need better data on neurologic diseases, according to Sen. Mark Udall (D-Colo.), so he has introduced a bill to create national registries for Parkinson's disease and multiple sclerosis. The National Neurological Diseases Surveillance System Act (S. 425) “would give the research community a one-stop shop for data being collected on these diseases from around the country,” Sen. Udall said in remarks accompanying the bill. Currently, “the frustrating truth is that we actually don't know how many people are living with Parkinson's disease in America,” Parkinson's Action Network CEO Amy Comstock Rick said in a statement. The registries would include data on the prevalence, common patient characteristics, geographic similarities, and other information about neurological diseases.

Group Asks FDA to Reject Drug

Public Citizen Health Research Group has urged the Food and Drug Administration to reject florbetapir F18 (Amyvid) injections for diagnosing Alzheimer's disease. “Given the significant inter-reader variability that was seen in the single-phase III clinical trial evaluating the performance of florbetapir positron-emission tomographic (PET) imaging, such PET scans would have little clinical utility in the evaluation of patients presenting with cognitive deficits or early dementia and suspected of having Alzheimer's disease,” the group wrote. The letter followed the January vote of an FDA advisory panel to endorse florbetapir if Avid Radiopharmaceuticals Inc. and Eli Lilly and Co., the companies developing the compound, train readers in a consistent technique and then reevaluate trials of the imaging agent. In its letter, the advocacy group wrote, “It is unlikely that better training and a new study in the more appropriate patient population are realistic hurdles to overcome.”

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The FDA has denied approval of cladribine, an investigational oral drug for the long-term treatment of relapsing forms of multiple sclerosis. “The announcement was disappointing to members of the MS community, who were hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS,” according to the Multiple Sclerosis Association of America. In its own statement, cladribine maker EMD Serono acknowledged the FDA letter but said the agency found the drug effective while asking for additional information on safety. The tablets have been approved in Russia and Australia.

Drug Risk High for Older Adults

Drugs such as pain relievers and anxiety and insomnia medications were the cause of about one-fourth of emergency department visits by adults aged 50 or older for adverse drug reactions in 2008, according the Drug Abuse Warning Network. Among medications acting on the central nervous system, narcotic pain relievers accounted for 9% of the year's 1,112,000 drug-related emergencies in this population and nonnarcotic pain relievers made up nearly 8%. In a separate category, psychotherapeutic drugs accounted for 5% of the emergencies. The study appeared in The Dawn Report, published by the Substance Abuse and Mental Health Services Administration. Nearly one-third of 50-and-older adults going to emergency departments for drug reactions in 2008 were admitted to the hospital.

Bill to Prevent Drug Shortages

New federal legislation aims to prevent shortages of critical prescription drugs by giving more information to the Food and Drug Administration. The bill would require drug manufacturers to notify the FDA early of any problems that could lead to a shortage of medications. Those factors might include changes to raw material supplies, adjustments to manufacturing capabilities, and business changes such as mergers. “Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no long be available – that's not right,” Sen. Amy Klobuchar (D-Minn.), one of the sponsors of the bill, said in a statement. The Preserving Access to Life-Saving Medications Act (S. 296) also directs the FDA to notify the public of shortages and what the agency is doing to address them.

Bill Would Track Neuro Diseases

Researchers need better data on neurologic diseases, according to Sen. Mark Udall (D-Colo.), so he has introduced a bill to create national registries for Parkinson's disease and multiple sclerosis. The National Neurological Diseases Surveillance System Act (S. 425) “would give the research community a one-stop shop for data being collected on these diseases from around the country,” Sen. Udall said in remarks accompanying the bill. Currently, “the frustrating truth is that we actually don't know how many people are living with Parkinson's disease in America,” Parkinson's Action Network CEO Amy Comstock Rick said in a statement. The registries would include data on the prevalence, common patient characteristics, geographic similarities, and other information about neurological diseases.

Group Asks FDA to Reject Drug

Public Citizen Health Research Group has urged the Food and Drug Administration to reject florbetapir F18 (Amyvid) injections for diagnosing Alzheimer's disease. “Given the significant inter-reader variability that was seen in the single-phase III clinical trial evaluating the performance of florbetapir positron-emission tomographic (PET) imaging, such PET scans would have little clinical utility in the evaluation of patients presenting with cognitive deficits or early dementia and suspected of having Alzheimer's disease,” the group wrote. The letter followed the January vote of an FDA advisory panel to endorse florbetapir if Avid Radiopharmaceuticals Inc. and Eli Lilly and Co., the companies developing the compound, train readers in a consistent technique and then reevaluate trials of the imaging agent. In its letter, the advocacy group wrote, “It is unlikely that better training and a new study in the more appropriate patient population are realistic hurdles to overcome.”

FDA Denies MS Drug

The FDA has denied approval of cladribine, an investigational oral drug for the long-term treatment of relapsing forms of multiple sclerosis. “The announcement was disappointing to members of the MS community, who were hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS,” according to the Multiple Sclerosis Association of America. In its own statement, cladribine maker EMD Serono acknowledged the FDA letter but said the agency found the drug effective while asking for additional information on safety. The tablets have been approved in Russia and Australia.

Drug Risk High for Older Adults

Drugs such as pain relievers and anxiety and insomnia medications were the cause of about one-fourth of emergency department visits by adults aged 50 or older for adverse drug reactions in 2008, according the Drug Abuse Warning Network. Among medications acting on the central nervous system, narcotic pain relievers accounted for 9% of the year's 1,112,000 drug-related emergencies in this population and nonnarcotic pain relievers made up nearly 8%. In a separate category, psychotherapeutic drugs accounted for 5% of the emergencies. The study appeared in The Dawn Report, published by the Substance Abuse and Mental Health Services Administration. Nearly one-third of 50-and-older adults going to emergency departments for drug reactions in 2008 were admitted to the hospital.

Bill to Prevent Drug Shortages

New federal legislation aims to prevent shortages of critical prescription drugs by giving more information to the Food and Drug Administration. The bill would require drug manufacturers to notify the FDA early of any problems that could lead to a shortage of medications. Those factors might include changes to raw material supplies, adjustments to manufacturing capabilities, and business changes such as mergers. “Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no long be available – that's not right,” Sen. Amy Klobuchar (D-Minn.), one of the sponsors of the bill, said in a statement. The Preserving Access to Life-Saving Medications Act (S. 296) also directs the FDA to notify the public of shortages and what the agency is doing to address them.

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Chondroitin Slows Joint Destruction in Knee Osteoarthritis

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Chondroitin Slows Joint Destruction in Knee Osteoarthritis

Chondroitin sulfate slows the progression of knee osteoarthritis, according to findings from a pilot study that used magnetic resonance imaging to assess joint structural changes.

“It's reassuring to see that the four major x-ray studies are now confirmed by high technology in the assessment of disease progression,” said the study's lead author, Dr. Jean-Pierre Pelletier, in an interview (Osteoarthr. Cartil. 1998;6:39-46; Osteoarthr. Cartil. 2004;12:269-76; Arthritis Rheum. 2005;52:779-86; Arthritis Rheum. 2009;60:524-33).

The randomized, double-blind, placebo-controlled study showed that chondroitin sulfate reduced the cartilage loss volume in 69 patients with knee osteoarthritis in as early as 6 months. (Ann. Rheum. Dis. 2011 March 1).

The findings show that magnetic resonance imaging (MRI) “is a good quantitative technique to find answers in a shorter period of time with a smaller number of patients,” said Dr. Roy D. Altman, professor of medicine at the University of California, Los Angeles, who is not involved with the study.

The effect of the disease-modifying drug chondroitin sulfate on cartilage volume loss, bone marrow lesions (BML), and disease symptoms has been controversial (BMJ 2010;341:c4675). However, the authors of this study said that the MRI findings provided additional evidence regarding the joint structure protective effect of chondroitin sulfate.

Several studies have also shown that MRI can quantitatively and reliably assess the volume and cartilage thickness in addition to joint structural changes in subchondral bone, menisci, and synovium, according to the authors.

“MRI provides you with direct visualization of the cartilage,” said Dr. Pelletier, director of the osteoarthritis research unit at the University of Montreal Hospital Research Centre. “And the beauty of MRI is that it provides assessment of progression of change not only in cartilage, but also in many other tissues of the joint, like the subchondral bone and the synovium.

“In addition, the pronounced reduction in OA cartilage loss found in patients treated with chondroitin sulfate was also associated with a reduction in the size of BML. This finding is most interesting as BML are believed to be associated with the progression of OA cartilage lesions,” according to a number of studies, said Dr. Pelletier.

The study also showed that patients being treated with nonsteroidal anti-inflammatory drugs in addition to chondroitin sulfate showed a significant reduction in synovial membrane thickness (1.3 plus or minus 0.3 mm in 6 months vs. 1.6 plus or minus 0.3 mm with placebo), and a lower incidence of joint swelling, compared with the placebo group (0% in chondroitin sulfate vs. 11.4% in placebo). The finding “is interesting with practical clinical impact, and definitely needs future exploration,” the authors wrote.

Dr. Pelletier and his colleagues recruited 69 patients of both sexes between 40 and 80 years of age from rheumatology clinics in Quebec province. All patients had clinical signs of synovitis.

The study had two phases. For the double-blind phase, the patients were randomly assigned to once-daily placebo or 800 mg of chondroitin sulfate for 6 months. During the following 6 months, or the open-label phase, both study groups received 800 mg of chondroitin sulfate daily.

Cartilage volume and BML were assessed by MRI at baseline, 6 months, and 12 months. Synovial membrane thickness was assessed at baseline and 6 months.

Patients who took a daily oral dose of chondroitin sulfate had a significant reduction in cartilage volume loss at 6 months (–2.87%) and 12 months (–3.71%) in the global knee, compared with the placebo group (–4.67% at 6 months and –6.12% at 12 months).

There were no differences in BML during the first 6 months of the study. But at 12 months, reductions in BML were observed in the chondroitin sulfate group (–0.57%), especially in the lateral compartment (–0.13%) and the lateral condyle (–0.43). The additional 6 months needed to see the difference in BML between the groupsccould suggest that “BML are consequential to cartilage degradation and thus reducing cartilage lesions could lead to fewer BML. Alternatively, BML were shown to be involved in an inflammatory/catabolic process on which chondroitin sulfate could act directly, leading to structural repair,” according to the study authors.

No significant differences in disease symptoms were measured by visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires. “The main aim of the study was not the symptoms. The main goal was to find out whether chondroitin sulfate can reduce progression of knee OA,” said Dr. Pelletier.

The study had a number of limitations, including its small sample size. In addition, the system used did not allow the detection of the cartilage in the patella, the researchers reported. They added that long-term studies are needed to find the impact of chondroitin sulfate in disease symptoms.

 

 

Whether the quantitative MRI technique will eventually replace x-ray technology in such studies is unclear, said Dr. Pelletier. “That's for regulatory bodies to decide,” he said.

“But it's quite clear that MRI is the technology of the future. It's very helpful, because you can truly speed up drug development in the field of OA and with less expense, using a smaller number of patients and in a shorter period of time.”

Dr. Jean-Pierre Pelletier and Dr. Johanne Martel-Pelletier are consultants for and shareholders in ArthroLab and ArthroVision. Jean-Pierre Raynauld is a consultant for ArthroVision. Dr. André Beaulieu, Dr. Louis Bassette, and Dr. Frédéric Morin received honoraria from ArthroLab. François Abram is an employee of ArthroVision. Marc Dorais is a consultant for ArthroVision. Dr. Altman had no relevant financial conflicts of interest.

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Chondroitin sulfate slows the progression of knee osteoarthritis, according to findings from a pilot study that used magnetic resonance imaging to assess joint structural changes.

“It's reassuring to see that the four major x-ray studies are now confirmed by high technology in the assessment of disease progression,” said the study's lead author, Dr. Jean-Pierre Pelletier, in an interview (Osteoarthr. Cartil. 1998;6:39-46; Osteoarthr. Cartil. 2004;12:269-76; Arthritis Rheum. 2005;52:779-86; Arthritis Rheum. 2009;60:524-33).

The randomized, double-blind, placebo-controlled study showed that chondroitin sulfate reduced the cartilage loss volume in 69 patients with knee osteoarthritis in as early as 6 months. (Ann. Rheum. Dis. 2011 March 1).

The findings show that magnetic resonance imaging (MRI) “is a good quantitative technique to find answers in a shorter period of time with a smaller number of patients,” said Dr. Roy D. Altman, professor of medicine at the University of California, Los Angeles, who is not involved with the study.

The effect of the disease-modifying drug chondroitin sulfate on cartilage volume loss, bone marrow lesions (BML), and disease symptoms has been controversial (BMJ 2010;341:c4675). However, the authors of this study said that the MRI findings provided additional evidence regarding the joint structure protective effect of chondroitin sulfate.

Several studies have also shown that MRI can quantitatively and reliably assess the volume and cartilage thickness in addition to joint structural changes in subchondral bone, menisci, and synovium, according to the authors.

“MRI provides you with direct visualization of the cartilage,” said Dr. Pelletier, director of the osteoarthritis research unit at the University of Montreal Hospital Research Centre. “And the beauty of MRI is that it provides assessment of progression of change not only in cartilage, but also in many other tissues of the joint, like the subchondral bone and the synovium.

“In addition, the pronounced reduction in OA cartilage loss found in patients treated with chondroitin sulfate was also associated with a reduction in the size of BML. This finding is most interesting as BML are believed to be associated with the progression of OA cartilage lesions,” according to a number of studies, said Dr. Pelletier.

The study also showed that patients being treated with nonsteroidal anti-inflammatory drugs in addition to chondroitin sulfate showed a significant reduction in synovial membrane thickness (1.3 plus or minus 0.3 mm in 6 months vs. 1.6 plus or minus 0.3 mm with placebo), and a lower incidence of joint swelling, compared with the placebo group (0% in chondroitin sulfate vs. 11.4% in placebo). The finding “is interesting with practical clinical impact, and definitely needs future exploration,” the authors wrote.

Dr. Pelletier and his colleagues recruited 69 patients of both sexes between 40 and 80 years of age from rheumatology clinics in Quebec province. All patients had clinical signs of synovitis.

The study had two phases. For the double-blind phase, the patients were randomly assigned to once-daily placebo or 800 mg of chondroitin sulfate for 6 months. During the following 6 months, or the open-label phase, both study groups received 800 mg of chondroitin sulfate daily.

Cartilage volume and BML were assessed by MRI at baseline, 6 months, and 12 months. Synovial membrane thickness was assessed at baseline and 6 months.

Patients who took a daily oral dose of chondroitin sulfate had a significant reduction in cartilage volume loss at 6 months (–2.87%) and 12 months (–3.71%) in the global knee, compared with the placebo group (–4.67% at 6 months and –6.12% at 12 months).

There were no differences in BML during the first 6 months of the study. But at 12 months, reductions in BML were observed in the chondroitin sulfate group (–0.57%), especially in the lateral compartment (–0.13%) and the lateral condyle (–0.43). The additional 6 months needed to see the difference in BML between the groupsccould suggest that “BML are consequential to cartilage degradation and thus reducing cartilage lesions could lead to fewer BML. Alternatively, BML were shown to be involved in an inflammatory/catabolic process on which chondroitin sulfate could act directly, leading to structural repair,” according to the study authors.

No significant differences in disease symptoms were measured by visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires. “The main aim of the study was not the symptoms. The main goal was to find out whether chondroitin sulfate can reduce progression of knee OA,” said Dr. Pelletier.

The study had a number of limitations, including its small sample size. In addition, the system used did not allow the detection of the cartilage in the patella, the researchers reported. They added that long-term studies are needed to find the impact of chondroitin sulfate in disease symptoms.

 

 

Whether the quantitative MRI technique will eventually replace x-ray technology in such studies is unclear, said Dr. Pelletier. “That's for regulatory bodies to decide,” he said.

“But it's quite clear that MRI is the technology of the future. It's very helpful, because you can truly speed up drug development in the field of OA and with less expense, using a smaller number of patients and in a shorter period of time.”

Dr. Jean-Pierre Pelletier and Dr. Johanne Martel-Pelletier are consultants for and shareholders in ArthroLab and ArthroVision. Jean-Pierre Raynauld is a consultant for ArthroVision. Dr. André Beaulieu, Dr. Louis Bassette, and Dr. Frédéric Morin received honoraria from ArthroLab. François Abram is an employee of ArthroVision. Marc Dorais is a consultant for ArthroVision. Dr. Altman had no relevant financial conflicts of interest.

Chondroitin sulfate slows the progression of knee osteoarthritis, according to findings from a pilot study that used magnetic resonance imaging to assess joint structural changes.

“It's reassuring to see that the four major x-ray studies are now confirmed by high technology in the assessment of disease progression,” said the study's lead author, Dr. Jean-Pierre Pelletier, in an interview (Osteoarthr. Cartil. 1998;6:39-46; Osteoarthr. Cartil. 2004;12:269-76; Arthritis Rheum. 2005;52:779-86; Arthritis Rheum. 2009;60:524-33).

The randomized, double-blind, placebo-controlled study showed that chondroitin sulfate reduced the cartilage loss volume in 69 patients with knee osteoarthritis in as early as 6 months. (Ann. Rheum. Dis. 2011 March 1).

The findings show that magnetic resonance imaging (MRI) “is a good quantitative technique to find answers in a shorter period of time with a smaller number of patients,” said Dr. Roy D. Altman, professor of medicine at the University of California, Los Angeles, who is not involved with the study.

The effect of the disease-modifying drug chondroitin sulfate on cartilage volume loss, bone marrow lesions (BML), and disease symptoms has been controversial (BMJ 2010;341:c4675). However, the authors of this study said that the MRI findings provided additional evidence regarding the joint structure protective effect of chondroitin sulfate.

Several studies have also shown that MRI can quantitatively and reliably assess the volume and cartilage thickness in addition to joint structural changes in subchondral bone, menisci, and synovium, according to the authors.

“MRI provides you with direct visualization of the cartilage,” said Dr. Pelletier, director of the osteoarthritis research unit at the University of Montreal Hospital Research Centre. “And the beauty of MRI is that it provides assessment of progression of change not only in cartilage, but also in many other tissues of the joint, like the subchondral bone and the synovium.

“In addition, the pronounced reduction in OA cartilage loss found in patients treated with chondroitin sulfate was also associated with a reduction in the size of BML. This finding is most interesting as BML are believed to be associated with the progression of OA cartilage lesions,” according to a number of studies, said Dr. Pelletier.

The study also showed that patients being treated with nonsteroidal anti-inflammatory drugs in addition to chondroitin sulfate showed a significant reduction in synovial membrane thickness (1.3 plus or minus 0.3 mm in 6 months vs. 1.6 plus or minus 0.3 mm with placebo), and a lower incidence of joint swelling, compared with the placebo group (0% in chondroitin sulfate vs. 11.4% in placebo). The finding “is interesting with practical clinical impact, and definitely needs future exploration,” the authors wrote.

Dr. Pelletier and his colleagues recruited 69 patients of both sexes between 40 and 80 years of age from rheumatology clinics in Quebec province. All patients had clinical signs of synovitis.

The study had two phases. For the double-blind phase, the patients were randomly assigned to once-daily placebo or 800 mg of chondroitin sulfate for 6 months. During the following 6 months, or the open-label phase, both study groups received 800 mg of chondroitin sulfate daily.

Cartilage volume and BML were assessed by MRI at baseline, 6 months, and 12 months. Synovial membrane thickness was assessed at baseline and 6 months.

Patients who took a daily oral dose of chondroitin sulfate had a significant reduction in cartilage volume loss at 6 months (–2.87%) and 12 months (–3.71%) in the global knee, compared with the placebo group (–4.67% at 6 months and –6.12% at 12 months).

There were no differences in BML during the first 6 months of the study. But at 12 months, reductions in BML were observed in the chondroitin sulfate group (–0.57%), especially in the lateral compartment (–0.13%) and the lateral condyle (–0.43). The additional 6 months needed to see the difference in BML between the groupsccould suggest that “BML are consequential to cartilage degradation and thus reducing cartilage lesions could lead to fewer BML. Alternatively, BML were shown to be involved in an inflammatory/catabolic process on which chondroitin sulfate could act directly, leading to structural repair,” according to the study authors.

No significant differences in disease symptoms were measured by visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires. “The main aim of the study was not the symptoms. The main goal was to find out whether chondroitin sulfate can reduce progression of knee OA,” said Dr. Pelletier.

The study had a number of limitations, including its small sample size. In addition, the system used did not allow the detection of the cartilage in the patella, the researchers reported. They added that long-term studies are needed to find the impact of chondroitin sulfate in disease symptoms.

 

 

Whether the quantitative MRI technique will eventually replace x-ray technology in such studies is unclear, said Dr. Pelletier. “That's for regulatory bodies to decide,” he said.

“But it's quite clear that MRI is the technology of the future. It's very helpful, because you can truly speed up drug development in the field of OA and with less expense, using a smaller number of patients and in a shorter period of time.”

Dr. Jean-Pierre Pelletier and Dr. Johanne Martel-Pelletier are consultants for and shareholders in ArthroLab and ArthroVision. Jean-Pierre Raynauld is a consultant for ArthroVision. Dr. André Beaulieu, Dr. Louis Bassette, and Dr. Frédéric Morin received honoraria from ArthroLab. François Abram is an employee of ArthroVision. Marc Dorais is a consultant for ArthroVision. Dr. Altman had no relevant financial conflicts of interest.

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