Damian McNamara is a journalist for Medscape Medical News and MDedge. He worked full-time for MDedge as the Miami Bureau covering a dozen medical specialties during 2001-2012, then as a freelancer for Medscape and MDedge, before being hired on staff by Medscape in 2018. Now the two companies are one. He uses what he learned in school – Damian has a BS in chemistry and an MS in science, health and environmental reporting/journalism. He works out of a home office in Miami, with a 100-pound chocolate lab known to snore under his desk during work hours.

Migraine With Aura May Mean Higher Lipids

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Migraine With Aura May Mean Higher Lipids

Major Finding: Patients with migraine with aura had sixfold greater odds of being in the highest tertile for total cholesterol than did patients without headache after adjustment for confounding variables.

Data Source: Cross-sectional study of 1,155 participants in the EVA study.

Disclosures: Dr. Kurth reported that did not have any relevant disclosures.

BERLIN – Do you have older patients who experience migraines with aura? You might want to check their lipid levels.

Older patients who experience migraines with aura may be at increased risk for elevated lipids, particularly total cholesterol and triglycerides, according to the EVA (Epidemiology of Vascular Aging) study.

Migraine with aura has been linked to increased risk of ischemic vascular events, Dr. Tobias Kurth said at the congress, which was sponsored by the International Headache Society and the American Headache Society. “Migraine with aura is also associated with increased prevalence of cardiovascular risk factors, including elevated levels of some vascular biomarkers” (Eur. J. Neurol. 2011;18:504-11; Neurology 2005;64:614-20).

However, “there is a lack of data in the elderly, a group with increased lipids,” Dr. Kurth said.

The researchers conducted a cross-sectional, longitudinal study of 1,155 EVA participants with complete lipid and headache information. The patients were classified into groups of three (called tertiles), based on their levels of different blood biomarkers. Their average age was 69 years.

A total of 166 participants had a history of migraine, including 23 who reported migraine with aura. Another 64 had nonmigraine headaches, and the remaining 925 people reported no severe headaches. Researchers determined the presence and type of headache through telephone interviews.

“There was a strong association with migraine with aura and increasing levels of cholesterol, with nearly a sixfold risk of being in third tertile” of total cholesterol, compared with patients without headache, said Dr. Kurth, director of research in the neuroepidemiology unit at INSERM (Institut National de la Santé et de la Recherche Médicale) in Paris.

Those with migraine with aura had greater adjusted odds (odds ratio, 5.97) of being in the third tertile for total cholesterol. Their risk for being in the second tertile also was greater (OR, 4.67), compared with those without headache.

Researchers also found a strong association between migraine with aura and elevated triglycerides (OR, 4.42 for the third tertile).

The findings confirm previous reports in the literature, Dr. Kurth said.

Interestingly, the associations held only for migraine with aura. “Migraine with aura is associated with an unfavorable lipid profile. Migraine with aura could be a marker for increased lipid levels,” he said.

A meeting attendee asked if the findings would warrant prescription of statin medication for patients with migraine with aura. “Enough is now published from population-based science that we can try, but I wouldn't say statins are medications to treat migraine at this point,” Dr. Kurth replied.

The large, population-based nature of the study was a strength, Dr. Kurth said. Headache assessment by neurologists via a telephone interview is a possible weakness, he added.

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Major Finding: Patients with migraine with aura had sixfold greater odds of being in the highest tertile for total cholesterol than did patients without headache after adjustment for confounding variables.

Data Source: Cross-sectional study of 1,155 participants in the EVA study.

Disclosures: Dr. Kurth reported that did not have any relevant disclosures.

BERLIN – Do you have older patients who experience migraines with aura? You might want to check their lipid levels.

Older patients who experience migraines with aura may be at increased risk for elevated lipids, particularly total cholesterol and triglycerides, according to the EVA (Epidemiology of Vascular Aging) study.

Migraine with aura has been linked to increased risk of ischemic vascular events, Dr. Tobias Kurth said at the congress, which was sponsored by the International Headache Society and the American Headache Society. “Migraine with aura is also associated with increased prevalence of cardiovascular risk factors, including elevated levels of some vascular biomarkers” (Eur. J. Neurol. 2011;18:504-11; Neurology 2005;64:614-20).

However, “there is a lack of data in the elderly, a group with increased lipids,” Dr. Kurth said.

The researchers conducted a cross-sectional, longitudinal study of 1,155 EVA participants with complete lipid and headache information. The patients were classified into groups of three (called tertiles), based on their levels of different blood biomarkers. Their average age was 69 years.

A total of 166 participants had a history of migraine, including 23 who reported migraine with aura. Another 64 had nonmigraine headaches, and the remaining 925 people reported no severe headaches. Researchers determined the presence and type of headache through telephone interviews.

“There was a strong association with migraine with aura and increasing levels of cholesterol, with nearly a sixfold risk of being in third tertile” of total cholesterol, compared with patients without headache, said Dr. Kurth, director of research in the neuroepidemiology unit at INSERM (Institut National de la Santé et de la Recherche Médicale) in Paris.

Those with migraine with aura had greater adjusted odds (odds ratio, 5.97) of being in the third tertile for total cholesterol. Their risk for being in the second tertile also was greater (OR, 4.67), compared with those without headache.

Researchers also found a strong association between migraine with aura and elevated triglycerides (OR, 4.42 for the third tertile).

The findings confirm previous reports in the literature, Dr. Kurth said.

Interestingly, the associations held only for migraine with aura. “Migraine with aura is associated with an unfavorable lipid profile. Migraine with aura could be a marker for increased lipid levels,” he said.

A meeting attendee asked if the findings would warrant prescription of statin medication for patients with migraine with aura. “Enough is now published from population-based science that we can try, but I wouldn't say statins are medications to treat migraine at this point,” Dr. Kurth replied.

The large, population-based nature of the study was a strength, Dr. Kurth said. Headache assessment by neurologists via a telephone interview is a possible weakness, he added.

Major Finding: Patients with migraine with aura had sixfold greater odds of being in the highest tertile for total cholesterol than did patients without headache after adjustment for confounding variables.

Data Source: Cross-sectional study of 1,155 participants in the EVA study.

Disclosures: Dr. Kurth reported that did not have any relevant disclosures.

BERLIN – Do you have older patients who experience migraines with aura? You might want to check their lipid levels.

Older patients who experience migraines with aura may be at increased risk for elevated lipids, particularly total cholesterol and triglycerides, according to the EVA (Epidemiology of Vascular Aging) study.

Migraine with aura has been linked to increased risk of ischemic vascular events, Dr. Tobias Kurth said at the congress, which was sponsored by the International Headache Society and the American Headache Society. “Migraine with aura is also associated with increased prevalence of cardiovascular risk factors, including elevated levels of some vascular biomarkers” (Eur. J. Neurol. 2011;18:504-11; Neurology 2005;64:614-20).

However, “there is a lack of data in the elderly, a group with increased lipids,” Dr. Kurth said.

The researchers conducted a cross-sectional, longitudinal study of 1,155 EVA participants with complete lipid and headache information. The patients were classified into groups of three (called tertiles), based on their levels of different blood biomarkers. Their average age was 69 years.

A total of 166 participants had a history of migraine, including 23 who reported migraine with aura. Another 64 had nonmigraine headaches, and the remaining 925 people reported no severe headaches. Researchers determined the presence and type of headache through telephone interviews.

“There was a strong association with migraine with aura and increasing levels of cholesterol, with nearly a sixfold risk of being in third tertile” of total cholesterol, compared with patients without headache, said Dr. Kurth, director of research in the neuroepidemiology unit at INSERM (Institut National de la Santé et de la Recherche Médicale) in Paris.

Those with migraine with aura had greater adjusted odds (odds ratio, 5.97) of being in the third tertile for total cholesterol. Their risk for being in the second tertile also was greater (OR, 4.67), compared with those without headache.

Researchers also found a strong association between migraine with aura and elevated triglycerides (OR, 4.42 for the third tertile).

The findings confirm previous reports in the literature, Dr. Kurth said.

Interestingly, the associations held only for migraine with aura. “Migraine with aura is associated with an unfavorable lipid profile. Migraine with aura could be a marker for increased lipid levels,” he said.

A meeting attendee asked if the findings would warrant prescription of statin medication for patients with migraine with aura. “Enough is now published from population-based science that we can try, but I wouldn't say statins are medications to treat migraine at this point,” Dr. Kurth replied.

The large, population-based nature of the study was a strength, Dr. Kurth said. Headache assessment by neurologists via a telephone interview is a possible weakness, he added.

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Botox Works Regardless of Medication History

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Major Finding: A total 45% of 575 first-line treatment-naive chronic migraine sufferers significantly responded to onabotulinumtoxinA treatment vs. 50% of 809 others with no such medication history.

Data Source: Post hoc analysis of the PREEMPT chronic migraine study.

Disclosures: The study was funded by Allergan. Dr. Aurora is on the Allergan medical advisory board. Dr. Blumenfeld and Dr. Dodick have received funding from Allergan.

BERLIN – People never treated for their chronic migraines and those who failed a previous first-line medication reported similar reductions in frequency of headache days after treatment with onabotulinumtoxinA in a post hoc comparison of the two phase III studies that Allergan used to gain approval for the new indication.

Some migraine medications work better in treatment-naive patients, compared with those with a past marred by partial responses or one or more failures to first-line prophylactic therapies.

For this reason, Dr. Sheena K. Aurora and her associates assessed data from the two phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) studies (Headache 2010;50:921-36) to determine if onabotulinumtoxinA treatment works the same way. They compared 575 participants with a history of migraine prophylaxis use to another 809 participants who never tried such a first-line medication, as defined by the British Association for the Study of Headache (BASH). Amitriptyline and propranolol were the most common previous medications.

There was no significant difference in the reduction of frequency of headache days with onabotulinumtoxinA between previously treated and untreated patients, Dr. Aurora said at the meeting, which was sponsored by the International Headache Society and the American Headache Society. A total 45% of patients with a history of first-line medication use versus 50% of those with no such history had a significant reduction in frequency of headache days.

“OnabotulinumtoxinA is an effective treatment of chronic migraine patients who previously failed BASH first-line migraine prophylactic meds and those naive to BASH first-line migraine prophylactic treatment,” said Dr. Aurora, a neurologist specializing in headache, migraine, and movement disorders at the Swedish Pain and Headache Center in Seattle.

Patients also experienced significant improvements in several secondary outcome measures that did not differ significantly between groups. These outcomes included frequency of migraine days, number of moderate to severe headache days, total cumulative hours of headache on headache days, and percentage of participants who reported severe migraines with a score of 60 or higher on the Headache Impact Test (HIT-6). Patient reports of improvements in health-related quality of life and disability did not differ significantly between groups, Dr. Aurora said.

The BASH guidelines assign medications to first-, second-, and third-line categories for prophylaxis against episodic migraines. However, many physicians use the same medicines to help chronic migraine sufferers, Dr. Aurora said, so the study answers a clinically relevant question.

Chronic migraine affects approximately 2% of the global population. Chronic migraine sufferers also report greater disability than patients with episodic migraine, according to Dr. Andrew Blumenfeld, who spoke during a separate session at the congress. “Chronic migraineurs experience a higher percentage of severe disability on more headache days than episodic migraineurs.”

The burden of illness could be an additional criterion to define chronic migraine beyond the traditional cutoff of 15 or more affected days per month, said Dr. Blumenfeld, who was the lead author on a study comparing disability status and migraine frequency (Cephalalgia 2011;31:301-15). He is a neurologist in private practice in Encinitas, Calif.

The PREEMPT studies included 1,384 highly disabled migraine patients who reported 15 or more days per month with a headache lasting at least 4 hours per day. In the 24-week, multicenter, double-blind study, researchers randomized 688 of these men and women aged 18-65 years to onabotulinumtoxinA and another 696 to placebo. A 32-week, open-label phase followed the acute treatment study.

“There was a cumulative benefit over time – most patients continued to receive treatment benefit after five treatment cycles,” Dr. David Dodick, one of the PREEMPT investigators, said in a separate presentation at the congress. “In clinical practice, patients should be administered at least two treatment cycles. If they have absolutely no response, do not proceed.”

“You can tell patients that almost 70% of patients treated with [onabotulinumtoxinA] had 50% or more reduction in headache days at 56 weeks,” said Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix.

The mechanism of action of onabotulinumtoxinA in chronic migraine remains to be elucidated, he said.

A recommended injection method for chronic migraine based on the PREEMPT studies, including a diagram of injection sites, was published in 2010 (Headache 2010;50:1406-18).

A video interview with Dr. Aurora can be viewed by using the QR code, or by visiting www.clinicalneurologynews.com

 

 

Patients should undergo at least two treatment cycles. If they have absolutely no response, do not proceed.

Source DR. DODICK

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Major Finding: A total 45% of 575 first-line treatment-naive chronic migraine sufferers significantly responded to onabotulinumtoxinA treatment vs. 50% of 809 others with no such medication history.

Data Source: Post hoc analysis of the PREEMPT chronic migraine study.

Disclosures: The study was funded by Allergan. Dr. Aurora is on the Allergan medical advisory board. Dr. Blumenfeld and Dr. Dodick have received funding from Allergan.

BERLIN – People never treated for their chronic migraines and those who failed a previous first-line medication reported similar reductions in frequency of headache days after treatment with onabotulinumtoxinA in a post hoc comparison of the two phase III studies that Allergan used to gain approval for the new indication.

Some migraine medications work better in treatment-naive patients, compared with those with a past marred by partial responses or one or more failures to first-line prophylactic therapies.

For this reason, Dr. Sheena K. Aurora and her associates assessed data from the two phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) studies (Headache 2010;50:921-36) to determine if onabotulinumtoxinA treatment works the same way. They compared 575 participants with a history of migraine prophylaxis use to another 809 participants who never tried such a first-line medication, as defined by the British Association for the Study of Headache (BASH). Amitriptyline and propranolol were the most common previous medications.

There was no significant difference in the reduction of frequency of headache days with onabotulinumtoxinA between previously treated and untreated patients, Dr. Aurora said at the meeting, which was sponsored by the International Headache Society and the American Headache Society. A total 45% of patients with a history of first-line medication use versus 50% of those with no such history had a significant reduction in frequency of headache days.

“OnabotulinumtoxinA is an effective treatment of chronic migraine patients who previously failed BASH first-line migraine prophylactic meds and those naive to BASH first-line migraine prophylactic treatment,” said Dr. Aurora, a neurologist specializing in headache, migraine, and movement disorders at the Swedish Pain and Headache Center in Seattle.

Patients also experienced significant improvements in several secondary outcome measures that did not differ significantly between groups. These outcomes included frequency of migraine days, number of moderate to severe headache days, total cumulative hours of headache on headache days, and percentage of participants who reported severe migraines with a score of 60 or higher on the Headache Impact Test (HIT-6). Patient reports of improvements in health-related quality of life and disability did not differ significantly between groups, Dr. Aurora said.

The BASH guidelines assign medications to first-, second-, and third-line categories for prophylaxis against episodic migraines. However, many physicians use the same medicines to help chronic migraine sufferers, Dr. Aurora said, so the study answers a clinically relevant question.

Chronic migraine affects approximately 2% of the global population. Chronic migraine sufferers also report greater disability than patients with episodic migraine, according to Dr. Andrew Blumenfeld, who spoke during a separate session at the congress. “Chronic migraineurs experience a higher percentage of severe disability on more headache days than episodic migraineurs.”

The burden of illness could be an additional criterion to define chronic migraine beyond the traditional cutoff of 15 or more affected days per month, said Dr. Blumenfeld, who was the lead author on a study comparing disability status and migraine frequency (Cephalalgia 2011;31:301-15). He is a neurologist in private practice in Encinitas, Calif.

The PREEMPT studies included 1,384 highly disabled migraine patients who reported 15 or more days per month with a headache lasting at least 4 hours per day. In the 24-week, multicenter, double-blind study, researchers randomized 688 of these men and women aged 18-65 years to onabotulinumtoxinA and another 696 to placebo. A 32-week, open-label phase followed the acute treatment study.

“There was a cumulative benefit over time – most patients continued to receive treatment benefit after five treatment cycles,” Dr. David Dodick, one of the PREEMPT investigators, said in a separate presentation at the congress. “In clinical practice, patients should be administered at least two treatment cycles. If they have absolutely no response, do not proceed.”

“You can tell patients that almost 70% of patients treated with [onabotulinumtoxinA] had 50% or more reduction in headache days at 56 weeks,” said Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix.

The mechanism of action of onabotulinumtoxinA in chronic migraine remains to be elucidated, he said.

A recommended injection method for chronic migraine based on the PREEMPT studies, including a diagram of injection sites, was published in 2010 (Headache 2010;50:1406-18).

A video interview with Dr. Aurora can be viewed by using the QR code, or by visiting www.clinicalneurologynews.com

 

 

Patients should undergo at least two treatment cycles. If they have absolutely no response, do not proceed.

Source DR. DODICK

Major Finding: A total 45% of 575 first-line treatment-naive chronic migraine sufferers significantly responded to onabotulinumtoxinA treatment vs. 50% of 809 others with no such medication history.

Data Source: Post hoc analysis of the PREEMPT chronic migraine study.

Disclosures: The study was funded by Allergan. Dr. Aurora is on the Allergan medical advisory board. Dr. Blumenfeld and Dr. Dodick have received funding from Allergan.

BERLIN – People never treated for their chronic migraines and those who failed a previous first-line medication reported similar reductions in frequency of headache days after treatment with onabotulinumtoxinA in a post hoc comparison of the two phase III studies that Allergan used to gain approval for the new indication.

Some migraine medications work better in treatment-naive patients, compared with those with a past marred by partial responses or one or more failures to first-line prophylactic therapies.

For this reason, Dr. Sheena K. Aurora and her associates assessed data from the two phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) studies (Headache 2010;50:921-36) to determine if onabotulinumtoxinA treatment works the same way. They compared 575 participants with a history of migraine prophylaxis use to another 809 participants who never tried such a first-line medication, as defined by the British Association for the Study of Headache (BASH). Amitriptyline and propranolol were the most common previous medications.

There was no significant difference in the reduction of frequency of headache days with onabotulinumtoxinA between previously treated and untreated patients, Dr. Aurora said at the meeting, which was sponsored by the International Headache Society and the American Headache Society. A total 45% of patients with a history of first-line medication use versus 50% of those with no such history had a significant reduction in frequency of headache days.

“OnabotulinumtoxinA is an effective treatment of chronic migraine patients who previously failed BASH first-line migraine prophylactic meds and those naive to BASH first-line migraine prophylactic treatment,” said Dr. Aurora, a neurologist specializing in headache, migraine, and movement disorders at the Swedish Pain and Headache Center in Seattle.

Patients also experienced significant improvements in several secondary outcome measures that did not differ significantly between groups. These outcomes included frequency of migraine days, number of moderate to severe headache days, total cumulative hours of headache on headache days, and percentage of participants who reported severe migraines with a score of 60 or higher on the Headache Impact Test (HIT-6). Patient reports of improvements in health-related quality of life and disability did not differ significantly between groups, Dr. Aurora said.

The BASH guidelines assign medications to first-, second-, and third-line categories for prophylaxis against episodic migraines. However, many physicians use the same medicines to help chronic migraine sufferers, Dr. Aurora said, so the study answers a clinically relevant question.

Chronic migraine affects approximately 2% of the global population. Chronic migraine sufferers also report greater disability than patients with episodic migraine, according to Dr. Andrew Blumenfeld, who spoke during a separate session at the congress. “Chronic migraineurs experience a higher percentage of severe disability on more headache days than episodic migraineurs.”

The burden of illness could be an additional criterion to define chronic migraine beyond the traditional cutoff of 15 or more affected days per month, said Dr. Blumenfeld, who was the lead author on a study comparing disability status and migraine frequency (Cephalalgia 2011;31:301-15). He is a neurologist in private practice in Encinitas, Calif.

The PREEMPT studies included 1,384 highly disabled migraine patients who reported 15 or more days per month with a headache lasting at least 4 hours per day. In the 24-week, multicenter, double-blind study, researchers randomized 688 of these men and women aged 18-65 years to onabotulinumtoxinA and another 696 to placebo. A 32-week, open-label phase followed the acute treatment study.

“There was a cumulative benefit over time – most patients continued to receive treatment benefit after five treatment cycles,” Dr. David Dodick, one of the PREEMPT investigators, said in a separate presentation at the congress. “In clinical practice, patients should be administered at least two treatment cycles. If they have absolutely no response, do not proceed.”

“You can tell patients that almost 70% of patients treated with [onabotulinumtoxinA] had 50% or more reduction in headache days at 56 weeks,” said Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix.

The mechanism of action of onabotulinumtoxinA in chronic migraine remains to be elucidated, he said.

A recommended injection method for chronic migraine based on the PREEMPT studies, including a diagram of injection sites, was published in 2010 (Headache 2010;50:1406-18).

A video interview with Dr. Aurora can be viewed by using the QR code, or by visiting www.clinicalneurologynews.com

 

 

Patients should undergo at least two treatment cycles. If they have absolutely no response, do not proceed.

Source DR. DODICK

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More Evidence Supports Migraine-Endometriosis Link

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BERLIN – Women with endometriosis have nearly twice the odds of experiencing migraine headaches within a year of diagnosis than do those without the condition, according to a large, population-based, case-control study.

The findings of that study join conflicting data in the literature regarding comorbidity between migraines and endometriosis. For example, a genetic study of twins supports the relationship with an odds ratio of 1.57 (Genet. Epidemiol. 2009;33:105-13). Other researchers found a higher incidence of endometriosis among 22% of 171 women with migraine and 10% of 104 controls without migraine (Headache 2007;47:1069-78). In contrast, other investigators found that migraine was associated with chronic pelvic pain in a study of 108 women, but that endometriosis was not a significant factor (Fertil. Steril. 2011;95;895-9).

First author of the current study, Dr. Jong-Ling Fuh, a neurologist at the Neurological Institute of Taipei (Taiwan) Veterans General Hospital, said at the International Headache Congress that "there are many similarities between migraine and endometriosis."

For example, early menarche is a well-known risk factor for endometriosis, Dr. Fuh said. Menarche before age 12 years is also associated with increased prevalence of both migraine and nonmigraine headache (Eur. J. Neurol. 2011;18:321-8).

In addition, menorrhagia is a frequent complaint among women with endometriosis, Dr. Fuh said. In one study, for example, 63% of migraine patients reported recent history of menorrhagia, compared with 37% of controls (Headache 2006;46:422-8).

In the current study, migraines occurred in 1% of 20,220 women with endometriosis, which was significantly different from the rate of 0.5% seen in 101,100 women in a control group (odds ratio, 1.91).

Women with both conditions had similarly higher odds of first developing migraine (OR, 2.00) or endometriosis (OR, 1.85). However, after controlling for other clinical factors, researchers found that the association remained significant only when migraine preceded endometriosis (OR, 2.40), which suggests these headaches could predict endometriosis in some patients, Dr. Fuh said.

"Migraine was still an independent risk factor for endometriosis" after researchers controlled for patient age, medical history of infertility or pelvic pain, and previous laparoscopic surgery, Dr. Fuh added at the congress, which was sponsored by the International Headache Society and the American Headache Society. The data came from inpatient and outpatient ICD-9 codes in 2000-2007 in Taiwan’s National Health Insurance Research Database.

The study population included women aged 18-51 years (mean age, 38). Dr. Fuh reported that when the researchers examined only the 707 women who had migraine from either group, they found that endometriosis was more common among these migraineurs (28%) than in 19% of 120,613 of women without migraine.

A meeting attendee asked if the current endometriosis findings would remain statistically significant if pelvic pain was removed. "We did control for pelvic pain in our regression model, and pelvic pain and endometriosis were both independent risk factors [for migraine]," Dr. Fuh responded.

Although the physiological link between migraine and endometriosis remains unclear, Dr. Fuh proposed that the underlying mechanism for the comorbid association could be the "activation of sensory fibers within ectopic endometrial tissue, [leading] to hyperactivity of neurons throughout the central nervous system."

Use of a large database is a strength of the study, Dr. Fuh said. Potential limitations include a reliance on administrative coding and possible underdiagnosis of migraine. A meeting attendee commented that underdiagnosis of migraine could be a "big factor" with only 1% prevalence in the study. "I agree with you," Dr. Fuh said. "We need more education of primary care physicians about migraine ... to diagnose more."

Dr. Fuh had no relevant financial disclosures.

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BERLIN – Women with endometriosis have nearly twice the odds of experiencing migraine headaches within a year of diagnosis than do those without the condition, according to a large, population-based, case-control study.

The findings of that study join conflicting data in the literature regarding comorbidity between migraines and endometriosis. For example, a genetic study of twins supports the relationship with an odds ratio of 1.57 (Genet. Epidemiol. 2009;33:105-13). Other researchers found a higher incidence of endometriosis among 22% of 171 women with migraine and 10% of 104 controls without migraine (Headache 2007;47:1069-78). In contrast, other investigators found that migraine was associated with chronic pelvic pain in a study of 108 women, but that endometriosis was not a significant factor (Fertil. Steril. 2011;95;895-9).

First author of the current study, Dr. Jong-Ling Fuh, a neurologist at the Neurological Institute of Taipei (Taiwan) Veterans General Hospital, said at the International Headache Congress that "there are many similarities between migraine and endometriosis."

For example, early menarche is a well-known risk factor for endometriosis, Dr. Fuh said. Menarche before age 12 years is also associated with increased prevalence of both migraine and nonmigraine headache (Eur. J. Neurol. 2011;18:321-8).

In addition, menorrhagia is a frequent complaint among women with endometriosis, Dr. Fuh said. In one study, for example, 63% of migraine patients reported recent history of menorrhagia, compared with 37% of controls (Headache 2006;46:422-8).

In the current study, migraines occurred in 1% of 20,220 women with endometriosis, which was significantly different from the rate of 0.5% seen in 101,100 women in a control group (odds ratio, 1.91).

Women with both conditions had similarly higher odds of first developing migraine (OR, 2.00) or endometriosis (OR, 1.85). However, after controlling for other clinical factors, researchers found that the association remained significant only when migraine preceded endometriosis (OR, 2.40), which suggests these headaches could predict endometriosis in some patients, Dr. Fuh said.

"Migraine was still an independent risk factor for endometriosis" after researchers controlled for patient age, medical history of infertility or pelvic pain, and previous laparoscopic surgery, Dr. Fuh added at the congress, which was sponsored by the International Headache Society and the American Headache Society. The data came from inpatient and outpatient ICD-9 codes in 2000-2007 in Taiwan’s National Health Insurance Research Database.

The study population included women aged 18-51 years (mean age, 38). Dr. Fuh reported that when the researchers examined only the 707 women who had migraine from either group, they found that endometriosis was more common among these migraineurs (28%) than in 19% of 120,613 of women without migraine.

A meeting attendee asked if the current endometriosis findings would remain statistically significant if pelvic pain was removed. "We did control for pelvic pain in our regression model, and pelvic pain and endometriosis were both independent risk factors [for migraine]," Dr. Fuh responded.

Although the physiological link between migraine and endometriosis remains unclear, Dr. Fuh proposed that the underlying mechanism for the comorbid association could be the "activation of sensory fibers within ectopic endometrial tissue, [leading] to hyperactivity of neurons throughout the central nervous system."

Use of a large database is a strength of the study, Dr. Fuh said. Potential limitations include a reliance on administrative coding and possible underdiagnosis of migraine. A meeting attendee commented that underdiagnosis of migraine could be a "big factor" with only 1% prevalence in the study. "I agree with you," Dr. Fuh said. "We need more education of primary care physicians about migraine ... to diagnose more."

Dr. Fuh had no relevant financial disclosures.

BERLIN – Women with endometriosis have nearly twice the odds of experiencing migraine headaches within a year of diagnosis than do those without the condition, according to a large, population-based, case-control study.

The findings of that study join conflicting data in the literature regarding comorbidity between migraines and endometriosis. For example, a genetic study of twins supports the relationship with an odds ratio of 1.57 (Genet. Epidemiol. 2009;33:105-13). Other researchers found a higher incidence of endometriosis among 22% of 171 women with migraine and 10% of 104 controls without migraine (Headache 2007;47:1069-78). In contrast, other investigators found that migraine was associated with chronic pelvic pain in a study of 108 women, but that endometriosis was not a significant factor (Fertil. Steril. 2011;95;895-9).

First author of the current study, Dr. Jong-Ling Fuh, a neurologist at the Neurological Institute of Taipei (Taiwan) Veterans General Hospital, said at the International Headache Congress that "there are many similarities between migraine and endometriosis."

For example, early menarche is a well-known risk factor for endometriosis, Dr. Fuh said. Menarche before age 12 years is also associated with increased prevalence of both migraine and nonmigraine headache (Eur. J. Neurol. 2011;18:321-8).

In addition, menorrhagia is a frequent complaint among women with endometriosis, Dr. Fuh said. In one study, for example, 63% of migraine patients reported recent history of menorrhagia, compared with 37% of controls (Headache 2006;46:422-8).

In the current study, migraines occurred in 1% of 20,220 women with endometriosis, which was significantly different from the rate of 0.5% seen in 101,100 women in a control group (odds ratio, 1.91).

Women with both conditions had similarly higher odds of first developing migraine (OR, 2.00) or endometriosis (OR, 1.85). However, after controlling for other clinical factors, researchers found that the association remained significant only when migraine preceded endometriosis (OR, 2.40), which suggests these headaches could predict endometriosis in some patients, Dr. Fuh said.

"Migraine was still an independent risk factor for endometriosis" after researchers controlled for patient age, medical history of infertility or pelvic pain, and previous laparoscopic surgery, Dr. Fuh added at the congress, which was sponsored by the International Headache Society and the American Headache Society. The data came from inpatient and outpatient ICD-9 codes in 2000-2007 in Taiwan’s National Health Insurance Research Database.

The study population included women aged 18-51 years (mean age, 38). Dr. Fuh reported that when the researchers examined only the 707 women who had migraine from either group, they found that endometriosis was more common among these migraineurs (28%) than in 19% of 120,613 of women without migraine.

A meeting attendee asked if the current endometriosis findings would remain statistically significant if pelvic pain was removed. "We did control for pelvic pain in our regression model, and pelvic pain and endometriosis were both independent risk factors [for migraine]," Dr. Fuh responded.

Although the physiological link between migraine and endometriosis remains unclear, Dr. Fuh proposed that the underlying mechanism for the comorbid association could be the "activation of sensory fibers within ectopic endometrial tissue, [leading] to hyperactivity of neurons throughout the central nervous system."

Use of a large database is a strength of the study, Dr. Fuh said. Potential limitations include a reliance on administrative coding and possible underdiagnosis of migraine. A meeting attendee commented that underdiagnosis of migraine could be a "big factor" with only 1% prevalence in the study. "I agree with you," Dr. Fuh said. "We need more education of primary care physicians about migraine ... to diagnose more."

Dr. Fuh had no relevant financial disclosures.

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Major Finding: Migraines occurred in 1% of 20,220 women with endometriosis, which was significantly different from the rate of 0.5% seen in 101,100 women in a control group (OR, 1.91).

Data Source: Population-based study of 20,220 women with endometriosis and 101,100 matched controls in Taiwan.

Disclosures: Dr. Fuh had no relevant disclosures.

Depressed Migraineurs Have High Rate of Cutaneous Allodynia

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BERLIN – Patients with migraine and depression have more than twice the odds of experiencing cutaneous allodynia during a headache attack than do patients with migraine but no depression, according to a survey of 2,597 patients.

Current depression or history of depression was associated with 2.4 times greater odds of cutaneous allodynia (the perception of pain caused by non-noxious stimuli to normal skin), Dr. Mark Louter said at the International Headache Congress.

Allodynia also was clearly predicted by gender, age at onset of headaches, and increased frequency of migraine, Dr. Louter said.

Nearly 70%, or 1,810 of the 2,597 migraineurs who completed the digital depression questionnaire, reported cutaneous allodynia during their migraine attacks.

Women had significantly greater odds of reporting cutaneous allodynia, compared with men (odds ratio, 3.3).

Looked at another way, the odds for migraineurs who reported cutaneous allodynia to also report depression in their lifetime was significantly greater than for those who did not report allodynia (OR, 2.2). This multivariate logistic regression analysis was adjusted for age, gender, frequency of attack, type of migraine, and use of prophylactic medication.

A meeting attendee asked about depression severity. "That is a good question, but for this analysis, we dichotomized the patients into depression versus no depression," Dr. Louter responded.

"Cutaneous allodynia was associated with higher headache frequency, symptoms of anxiety and depression, and a younger onset of headache," said Dr. Louter, a physician-researcher in neurology and psychiatry at Leiden (Netherlands) University Medical Center.

The study was cross-sectional, so causality cannot be demonstrated, Dr. Louter said at the congress, which was sponsored by the International Headache Society and the American Headache Society. Respondents were adults with migraine aged 18-74 years who had been identified from the Leiden University Medical Centre Migraine Neuro-Analysis Program (LUMINA) database.

Migraine type and body mass index were not significantly associated with presence of cutaneous allodynia.

A total 3,029 self-reported migraineurs completed a headache questionnaire based on ICHD-II migraine criteria; 2,597 completed a depression questionnaire that included the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D), the Center for Epidemiologic Studies Depression (CES-D) scale, and additional questions about lifetime depression. Another 2,269 answered a follow-up questionnaire on headache frequency. Cutaneous allodynia was assessed with a validated 12-item scale, similar to the Allodynia Symptom Checklist.

This study demonstrates that two-thirds of migraineurs have cutaneous allodynia during their attacks, Dr. Louter said. Important findings include a preponderance of cutaneous allodynia among women with migraine, but most importantly, in migraineurs with lifetime depression, he added.

"We think more research is needed to evaluate this further," Dr. Louter said.

Dr. Louter said that he had no relevant disclosures.

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BERLIN – Patients with migraine and depression have more than twice the odds of experiencing cutaneous allodynia during a headache attack than do patients with migraine but no depression, according to a survey of 2,597 patients.

Current depression or history of depression was associated with 2.4 times greater odds of cutaneous allodynia (the perception of pain caused by non-noxious stimuli to normal skin), Dr. Mark Louter said at the International Headache Congress.

Allodynia also was clearly predicted by gender, age at onset of headaches, and increased frequency of migraine, Dr. Louter said.

Nearly 70%, or 1,810 of the 2,597 migraineurs who completed the digital depression questionnaire, reported cutaneous allodynia during their migraine attacks.

Women had significantly greater odds of reporting cutaneous allodynia, compared with men (odds ratio, 3.3).

Looked at another way, the odds for migraineurs who reported cutaneous allodynia to also report depression in their lifetime was significantly greater than for those who did not report allodynia (OR, 2.2). This multivariate logistic regression analysis was adjusted for age, gender, frequency of attack, type of migraine, and use of prophylactic medication.

A meeting attendee asked about depression severity. "That is a good question, but for this analysis, we dichotomized the patients into depression versus no depression," Dr. Louter responded.

"Cutaneous allodynia was associated with higher headache frequency, symptoms of anxiety and depression, and a younger onset of headache," said Dr. Louter, a physician-researcher in neurology and psychiatry at Leiden (Netherlands) University Medical Center.

The study was cross-sectional, so causality cannot be demonstrated, Dr. Louter said at the congress, which was sponsored by the International Headache Society and the American Headache Society. Respondents were adults with migraine aged 18-74 years who had been identified from the Leiden University Medical Centre Migraine Neuro-Analysis Program (LUMINA) database.

Migraine type and body mass index were not significantly associated with presence of cutaneous allodynia.

A total 3,029 self-reported migraineurs completed a headache questionnaire based on ICHD-II migraine criteria; 2,597 completed a depression questionnaire that included the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D), the Center for Epidemiologic Studies Depression (CES-D) scale, and additional questions about lifetime depression. Another 2,269 answered a follow-up questionnaire on headache frequency. Cutaneous allodynia was assessed with a validated 12-item scale, similar to the Allodynia Symptom Checklist.

This study demonstrates that two-thirds of migraineurs have cutaneous allodynia during their attacks, Dr. Louter said. Important findings include a preponderance of cutaneous allodynia among women with migraine, but most importantly, in migraineurs with lifetime depression, he added.

"We think more research is needed to evaluate this further," Dr. Louter said.

Dr. Louter said that he had no relevant disclosures.

BERLIN – Patients with migraine and depression have more than twice the odds of experiencing cutaneous allodynia during a headache attack than do patients with migraine but no depression, according to a survey of 2,597 patients.

Current depression or history of depression was associated with 2.4 times greater odds of cutaneous allodynia (the perception of pain caused by non-noxious stimuli to normal skin), Dr. Mark Louter said at the International Headache Congress.

Allodynia also was clearly predicted by gender, age at onset of headaches, and increased frequency of migraine, Dr. Louter said.

Nearly 70%, or 1,810 of the 2,597 migraineurs who completed the digital depression questionnaire, reported cutaneous allodynia during their migraine attacks.

Women had significantly greater odds of reporting cutaneous allodynia, compared with men (odds ratio, 3.3).

Looked at another way, the odds for migraineurs who reported cutaneous allodynia to also report depression in their lifetime was significantly greater than for those who did not report allodynia (OR, 2.2). This multivariate logistic regression analysis was adjusted for age, gender, frequency of attack, type of migraine, and use of prophylactic medication.

A meeting attendee asked about depression severity. "That is a good question, but for this analysis, we dichotomized the patients into depression versus no depression," Dr. Louter responded.

"Cutaneous allodynia was associated with higher headache frequency, symptoms of anxiety and depression, and a younger onset of headache," said Dr. Louter, a physician-researcher in neurology and psychiatry at Leiden (Netherlands) University Medical Center.

The study was cross-sectional, so causality cannot be demonstrated, Dr. Louter said at the congress, which was sponsored by the International Headache Society and the American Headache Society. Respondents were adults with migraine aged 18-74 years who had been identified from the Leiden University Medical Centre Migraine Neuro-Analysis Program (LUMINA) database.

Migraine type and body mass index were not significantly associated with presence of cutaneous allodynia.

A total 3,029 self-reported migraineurs completed a headache questionnaire based on ICHD-II migraine criteria; 2,597 completed a depression questionnaire that included the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D), the Center for Epidemiologic Studies Depression (CES-D) scale, and additional questions about lifetime depression. Another 2,269 answered a follow-up questionnaire on headache frequency. Cutaneous allodynia was assessed with a validated 12-item scale, similar to the Allodynia Symptom Checklist.

This study demonstrates that two-thirds of migraineurs have cutaneous allodynia during their attacks, Dr. Louter said. Important findings include a preponderance of cutaneous allodynia among women with migraine, but most importantly, in migraineurs with lifetime depression, he added.

"We think more research is needed to evaluate this further," Dr. Louter said.

Dr. Louter said that he had no relevant disclosures.

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Major Finding: Current depression or history of depression was associated with 2.4 times greater odds of experiencing cutaneous allodynia during a headache attack than in nondepressed patients.

Data Source: Cross-sectional study of 2,597 migraineurs responding to digital questionnaires.

Disclosures: Dr. Louter said that he had no relevant disclosures.

Daily Headache Diary Improves Diagnosis

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BERLIN – Asking patients to fill out a daily diary 1 month before their initial evaluation improves the accuracy of their headache diagnosis compared with clinical evaluation alone, according to a prospective, multicenter study.

"The basic daily headache diary was well accepted by patients and was well accepted by physicians," Dr. Rigmor Jensen said at the International Headache Congress.

An earlier pilot study with 76 patients demonstrated the paper-based diary improved diagnostic sensitivity from 75% to 92% and specificity from 58% to 87% when combined with a clinical interview and examination (Cephalalgia 2008;28:1023-30). In addition, the diary provided useful data on the frequency of different types of headaches within the same patient, and patients reported that it was easy to use, said Dr. Jensen, an investigator on both studies.

Following this initial success, Dr. Jensen and her associates expanded their research to multiple clinical sites in Europe and South America. They randomized newly referred patients on a waiting list to two groups. They then compared 321 patients given a daily diary to complete 1 month prior to first consultation with 305 patients who received usual care (clinical evaluation and examination only).

Participants in the diary group recorded headache symptoms, medications taken, and whether their pain was unilateral or bilateral. This group provided their physicians with more complete diagnostic information. "The adequacy of the diary and clinical interview for headache diagnosis was 98% compared to 87% for the interview alone," Dr. Jensen said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

The mean number of diagnoses per patient was significantly higher in patients who kept a diary than among those who received usual care (1.22 vs. 1.14). Only tension-type headache (episodic or chronic) was diagnosed more often in the usual care group than in the diary group (39% vs. 25%). Otherwise, there were no significant differences by headache type, said Dr. Jensen, director of the Danish headache center at Glostrup (Denmark) Hospital.

A meeting attendee asked how much additional time it takes physicians to read the diaries. "We did not record the timing," Dr. Jensen said. "But we asked the doctors, and for some it was time saving and for others it was time consuming." She added, "In my experience, the patients are prepared for questions, so it’s time saving for most of us used to using the diary. In the long run, we find it is time saving."

A total 97% of physicians reported they were satisfied with the diary. Incompleteness of some diaries and a lack of specificity for migraines with aura were among the reported problems. Dr. Jensen said a separate diary for patients who experience headache with aura is in development.

The same percentage of patients in the diary group reported satisfaction. Two patients each reported problems with understanding the questions; describing their headache intensity; the small size of the text; and the time it took to complete the daily entries. "These were not the same two patients complaining on each one," said Dr. Jensen, who also is professor of headache and neurologic pain at the University of Copenhagen.

The diary works in multiple cultures and languages. The study sites were in Italy, Denmark, Russia, Serbia, Portugal, Georgia, Germany, Chile, and Argentina.

An electronic version of the diary is in development.

Dr. Jensen said that she had no relevant financial disclosures.

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BERLIN – Asking patients to fill out a daily diary 1 month before their initial evaluation improves the accuracy of their headache diagnosis compared with clinical evaluation alone, according to a prospective, multicenter study.

"The basic daily headache diary was well accepted by patients and was well accepted by physicians," Dr. Rigmor Jensen said at the International Headache Congress.

An earlier pilot study with 76 patients demonstrated the paper-based diary improved diagnostic sensitivity from 75% to 92% and specificity from 58% to 87% when combined with a clinical interview and examination (Cephalalgia 2008;28:1023-30). In addition, the diary provided useful data on the frequency of different types of headaches within the same patient, and patients reported that it was easy to use, said Dr. Jensen, an investigator on both studies.

Following this initial success, Dr. Jensen and her associates expanded their research to multiple clinical sites in Europe and South America. They randomized newly referred patients on a waiting list to two groups. They then compared 321 patients given a daily diary to complete 1 month prior to first consultation with 305 patients who received usual care (clinical evaluation and examination only).

Participants in the diary group recorded headache symptoms, medications taken, and whether their pain was unilateral or bilateral. This group provided their physicians with more complete diagnostic information. "The adequacy of the diary and clinical interview for headache diagnosis was 98% compared to 87% for the interview alone," Dr. Jensen said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

The mean number of diagnoses per patient was significantly higher in patients who kept a diary than among those who received usual care (1.22 vs. 1.14). Only tension-type headache (episodic or chronic) was diagnosed more often in the usual care group than in the diary group (39% vs. 25%). Otherwise, there were no significant differences by headache type, said Dr. Jensen, director of the Danish headache center at Glostrup (Denmark) Hospital.

A meeting attendee asked how much additional time it takes physicians to read the diaries. "We did not record the timing," Dr. Jensen said. "But we asked the doctors, and for some it was time saving and for others it was time consuming." She added, "In my experience, the patients are prepared for questions, so it’s time saving for most of us used to using the diary. In the long run, we find it is time saving."

A total 97% of physicians reported they were satisfied with the diary. Incompleteness of some diaries and a lack of specificity for migraines with aura were among the reported problems. Dr. Jensen said a separate diary for patients who experience headache with aura is in development.

The same percentage of patients in the diary group reported satisfaction. Two patients each reported problems with understanding the questions; describing their headache intensity; the small size of the text; and the time it took to complete the daily entries. "These were not the same two patients complaining on each one," said Dr. Jensen, who also is professor of headache and neurologic pain at the University of Copenhagen.

The diary works in multiple cultures and languages. The study sites were in Italy, Denmark, Russia, Serbia, Portugal, Georgia, Germany, Chile, and Argentina.

An electronic version of the diary is in development.

Dr. Jensen said that she had no relevant financial disclosures.

BERLIN – Asking patients to fill out a daily diary 1 month before their initial evaluation improves the accuracy of their headache diagnosis compared with clinical evaluation alone, according to a prospective, multicenter study.

"The basic daily headache diary was well accepted by patients and was well accepted by physicians," Dr. Rigmor Jensen said at the International Headache Congress.

An earlier pilot study with 76 patients demonstrated the paper-based diary improved diagnostic sensitivity from 75% to 92% and specificity from 58% to 87% when combined with a clinical interview and examination (Cephalalgia 2008;28:1023-30). In addition, the diary provided useful data on the frequency of different types of headaches within the same patient, and patients reported that it was easy to use, said Dr. Jensen, an investigator on both studies.

Following this initial success, Dr. Jensen and her associates expanded their research to multiple clinical sites in Europe and South America. They randomized newly referred patients on a waiting list to two groups. They then compared 321 patients given a daily diary to complete 1 month prior to first consultation with 305 patients who received usual care (clinical evaluation and examination only).

Participants in the diary group recorded headache symptoms, medications taken, and whether their pain was unilateral or bilateral. This group provided their physicians with more complete diagnostic information. "The adequacy of the diary and clinical interview for headache diagnosis was 98% compared to 87% for the interview alone," Dr. Jensen said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

The mean number of diagnoses per patient was significantly higher in patients who kept a diary than among those who received usual care (1.22 vs. 1.14). Only tension-type headache (episodic or chronic) was diagnosed more often in the usual care group than in the diary group (39% vs. 25%). Otherwise, there were no significant differences by headache type, said Dr. Jensen, director of the Danish headache center at Glostrup (Denmark) Hospital.

A meeting attendee asked how much additional time it takes physicians to read the diaries. "We did not record the timing," Dr. Jensen said. "But we asked the doctors, and for some it was time saving and for others it was time consuming." She added, "In my experience, the patients are prepared for questions, so it’s time saving for most of us used to using the diary. In the long run, we find it is time saving."

A total 97% of physicians reported they were satisfied with the diary. Incompleteness of some diaries and a lack of specificity for migraines with aura were among the reported problems. Dr. Jensen said a separate diary for patients who experience headache with aura is in development.

The same percentage of patients in the diary group reported satisfaction. Two patients each reported problems with understanding the questions; describing their headache intensity; the small size of the text; and the time it took to complete the daily entries. "These were not the same two patients complaining on each one," said Dr. Jensen, who also is professor of headache and neurologic pain at the University of Copenhagen.

The diary works in multiple cultures and languages. The study sites were in Italy, Denmark, Russia, Serbia, Portugal, Georgia, Germany, Chile, and Argentina.

An electronic version of the diary is in development.

Dr. Jensen said that she had no relevant financial disclosures.

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Major Finding: Completion of a daily headache diary for 30 days before consultation, along with a clinical interview, provided 98% of required diagnostic information, compared with 87% learned through an interview alone.

Data Source: Prospective multicenter study of 626 patients randomized to a diary or usual care group in nine countries.

Disclosures: Dr. Jensen said that she had no relevant financial disclosures.

Migraine With Aura May Mean Higher Cholesterol

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BERLIN – Do you have older patients who experience migraines with aura? You might want to check their lipid levels.

Older patients who experience migraines with aura may be at increased risk for elevated lipids, particularly total cholesterol and triglycerides, according to the EVA (Epidemiology of Vascular Aging) study.

Migraine with aura has been linked to increased risk of ischemic vascular events, Dr. Tobias Kurth said at the International Headache Congress, which was sponsored by the International Headache Society and the American Headache Society. "Migraine with aura is also associated with increased prevalence of cardiovascular risk factors, including elevated levels of some vascular biomarkers" (Eur. J. Neurol. 2011;18:504-11; Neurology. 2005;64:614-20).

However, "there is a lack of data in the elderly, a group with increased lipids," Dr. Kurth said.

The researchers conducted a cross-sectional study of 1,155 EVA participants with complete lipid and headache information. The patients were classified into groups of three (called tertiles), based on their levels of different blood biomarkers. Their average age was 69 years.

A total of 166 participants had a history of migraine, including 23 who reported migraine with aura. Another 64 had nonmigraine headaches, and the vast majority (925 people) reported no severe headaches. Researchers determined the presence and type of headache through telephone interviews in this longitudinal study.

"There was a strong association with migraine with aura and increasing levels of cholesterol, with nearly a sixfold risk of being in third tertile" of total cholesterol, compared with patients without headache, said Dr. Kurth, director of research in the neuroepidemiology unit at Inserm (Institut National de la Santé et de la Recherche Médicale) in Paris.

Those with migraine with aura had greater adjusted odds (odds ratio, 5.97) of being in the third tertile for total cholesterol. Their risk for being in the second tertile also was greater (OR, 4.67), compared with those without headache.

Researchers also found a strong association between migraine with aura and elevated triglycerides (OR, 4.42 for the third tertile).

The findings confirm previous reports in the literature, Dr. Kurth said. "We observed a pattern consistent with other studies."

Interestingly, the associations held only for migraine with aura. No other headache forms in this elderly population were associated with increased lipid levels, Dr. Kurth said. "Migraine with aura is associated with an unfavorable lipid profile. Migraine with aura could be a marker for increased lipid levels."

A meeting attendee asked if the findings would warrant prescription of statin medication for patients with migraine with aura. "Enough is now published from population-based science that we can try, but I wouldn’t say statins are medications to treat migraine at this point," Dr. Kurth replied.

The large, population-based nature of the study was a strength, Dr. Kurth said. Headache assessment by neurologists via a telephone interview is a possible weakness, he added.

Further targeted research is needed, said Dr. Kurth, who reported that he had no relevant disclosures.

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BERLIN – Do you have older patients who experience migraines with aura? You might want to check their lipid levels.

Older patients who experience migraines with aura may be at increased risk for elevated lipids, particularly total cholesterol and triglycerides, according to the EVA (Epidemiology of Vascular Aging) study.

Migraine with aura has been linked to increased risk of ischemic vascular events, Dr. Tobias Kurth said at the International Headache Congress, which was sponsored by the International Headache Society and the American Headache Society. "Migraine with aura is also associated with increased prevalence of cardiovascular risk factors, including elevated levels of some vascular biomarkers" (Eur. J. Neurol. 2011;18:504-11; Neurology. 2005;64:614-20).

However, "there is a lack of data in the elderly, a group with increased lipids," Dr. Kurth said.

The researchers conducted a cross-sectional study of 1,155 EVA participants with complete lipid and headache information. The patients were classified into groups of three (called tertiles), based on their levels of different blood biomarkers. Their average age was 69 years.

A total of 166 participants had a history of migraine, including 23 who reported migraine with aura. Another 64 had nonmigraine headaches, and the vast majority (925 people) reported no severe headaches. Researchers determined the presence and type of headache through telephone interviews in this longitudinal study.

"There was a strong association with migraine with aura and increasing levels of cholesterol, with nearly a sixfold risk of being in third tertile" of total cholesterol, compared with patients without headache, said Dr. Kurth, director of research in the neuroepidemiology unit at Inserm (Institut National de la Santé et de la Recherche Médicale) in Paris.

Those with migraine with aura had greater adjusted odds (odds ratio, 5.97) of being in the third tertile for total cholesterol. Their risk for being in the second tertile also was greater (OR, 4.67), compared with those without headache.

Researchers also found a strong association between migraine with aura and elevated triglycerides (OR, 4.42 for the third tertile).

The findings confirm previous reports in the literature, Dr. Kurth said. "We observed a pattern consistent with other studies."

Interestingly, the associations held only for migraine with aura. No other headache forms in this elderly population were associated with increased lipid levels, Dr. Kurth said. "Migraine with aura is associated with an unfavorable lipid profile. Migraine with aura could be a marker for increased lipid levels."

A meeting attendee asked if the findings would warrant prescription of statin medication for patients with migraine with aura. "Enough is now published from population-based science that we can try, but I wouldn’t say statins are medications to treat migraine at this point," Dr. Kurth replied.

The large, population-based nature of the study was a strength, Dr. Kurth said. Headache assessment by neurologists via a telephone interview is a possible weakness, he added.

Further targeted research is needed, said Dr. Kurth, who reported that he had no relevant disclosures.

BERLIN – Do you have older patients who experience migraines with aura? You might want to check their lipid levels.

Older patients who experience migraines with aura may be at increased risk for elevated lipids, particularly total cholesterol and triglycerides, according to the EVA (Epidemiology of Vascular Aging) study.

Migraine with aura has been linked to increased risk of ischemic vascular events, Dr. Tobias Kurth said at the International Headache Congress, which was sponsored by the International Headache Society and the American Headache Society. "Migraine with aura is also associated with increased prevalence of cardiovascular risk factors, including elevated levels of some vascular biomarkers" (Eur. J. Neurol. 2011;18:504-11; Neurology. 2005;64:614-20).

However, "there is a lack of data in the elderly, a group with increased lipids," Dr. Kurth said.

The researchers conducted a cross-sectional study of 1,155 EVA participants with complete lipid and headache information. The patients were classified into groups of three (called tertiles), based on their levels of different blood biomarkers. Their average age was 69 years.

A total of 166 participants had a history of migraine, including 23 who reported migraine with aura. Another 64 had nonmigraine headaches, and the vast majority (925 people) reported no severe headaches. Researchers determined the presence and type of headache through telephone interviews in this longitudinal study.

"There was a strong association with migraine with aura and increasing levels of cholesterol, with nearly a sixfold risk of being in third tertile" of total cholesterol, compared with patients without headache, said Dr. Kurth, director of research in the neuroepidemiology unit at Inserm (Institut National de la Santé et de la Recherche Médicale) in Paris.

Those with migraine with aura had greater adjusted odds (odds ratio, 5.97) of being in the third tertile for total cholesterol. Their risk for being in the second tertile also was greater (OR, 4.67), compared with those without headache.

Researchers also found a strong association between migraine with aura and elevated triglycerides (OR, 4.42 for the third tertile).

The findings confirm previous reports in the literature, Dr. Kurth said. "We observed a pattern consistent with other studies."

Interestingly, the associations held only for migraine with aura. No other headache forms in this elderly population were associated with increased lipid levels, Dr. Kurth said. "Migraine with aura is associated with an unfavorable lipid profile. Migraine with aura could be a marker for increased lipid levels."

A meeting attendee asked if the findings would warrant prescription of statin medication for patients with migraine with aura. "Enough is now published from population-based science that we can try, but I wouldn’t say statins are medications to treat migraine at this point," Dr. Kurth replied.

The large, population-based nature of the study was a strength, Dr. Kurth said. Headache assessment by neurologists via a telephone interview is a possible weakness, he added.

Further targeted research is needed, said Dr. Kurth, who reported that he had no relevant disclosures.

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Major Finding: Patients with migraine with aura had sixfold greater odds of being in the highest tertile for total cholesterol than did patients without headache after adjustment for confounding variables.

Data Source: Cross-sectional study of 1,155 participants in the EVA study

Disclosures: Dr. Kurth reported that did not have any relevant disclosures.

Pharmacogenomics and Psychiatry: Time to Tailor the Treatment

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Thanks to technologic advances in genetic testing, psychiatrists can predict which patients might experience adverse effects from commonly prescribed psychotropic medications, and, to a lesser extent, who might respond well to a particular drug.

Commercially available pharmacogenomic testing "can improve the probability of your selecting a medication that will be helpful to your patient. It can do that most certainly by avoiding adverse effects, but additionally, you can increase the probability of finding a medication that is more likely to be efficacious," Dr. David Mrazek said in an interview.

"When I started teaching doctors about this 10 years ago, it was about what could be. Now we’re teaching them how to use this tool, and I think it’s going to change the way we practice," said Dr. Mrazek, professor of pediatrics and psychiatry at the Mayo Clinic in Rochester, Minn.

Dr. Joel Winner agreed.

"Pharmacogenetic testing is here and will only become more entrenched in psychiatric treatment over the next several years," Dr. Winner, medical director of AssureRx Health Inc., a company that provides a pharmacogenomic test, said in an interview.

"Currently, I recommend testing for the complicated patient," Dr. Winner said. "I treat mostly anxiety and depression. I have found it to be the most helpful in those patients who have failed one or two medications. Anxious and somatic patients often have a difficult time with medications, because they obsess about them."

More precision with prescribing may be necessary with more complex patients. "If you’re dealing with mild or low-priority problems, it’s not as important to get the drug dead-on straight the first time," Dr. Mrazek said. "You have a little more latitude to do the trial and error [prescribing]."

Pharmacogenomic testing is based on assessment of how an individual patient metabolizes a particular drug through the body’s cytochrome P450 system. Results can identify a patient as a poor or ultra-rapid metabolizer. For example, a poor metabolizer of a CYP2D6 medication will not break a particular drug down at a normal rate. As a result, prolonged exposure to high serum levels puts that patient at risk for more adverse events.

"This is first and foremost a safety issue," said Dr. Winner, a psychiatrist in private practice in Boulder, Colo.

For example, Dr. Winner recently consulted on a patient experiencing "fairly severe side effects," including weight gain and sexual side effects, associated with high-dose paroxetine treatment. The patient was on paroxetine for several years and, despite the side effects, was concerned about stopping the medication. Pharmacogenomic testing revealed the patient was a poor metabolizer of CYP2D6. "He was likely not breaking down the paroxetine appropriately and likely had high levels of paroxetine in his system. My recommendation was to transition to another medication that would be more appropriately dosed according to his genotype," Dr. Winner said.

Through a referral, Dr. Mrazek also recently evaluated a poor 2D6 metabolizer. The patient had been treated for years by clinicians unaware of her impaired drug metabolism. "They did figure out that she could only tolerate low doses of psychotropics, but that was through trial and error," Dr. Mrazek said. Prior to the genetic testing revelation, the patient was taken to the emergency department for an episode of acute anxiety. She received haloperidol, a drug primarily cleared through the 2D6 pathway that "also has one of the highest frequencies of extrapyramidal side effects." The patient later was released but experienced a dystonic reaction. "She had a pretty powerful medicine on board at a high dose for a long time and she ended up in the ICU. She remained there for 5 days until she cleared herself of the medication," Dr. Mrazek said. "That’s a very unusual story, but 5 days in the ICU is a very expensive and very scary proposition."

The clearest indication for pharmacogenomic testing is prevention of such adverse effects, Dr. Mrazek said. "We’re much better at knowing which patient is going to have a poor reaction than we are being able to say, with any certainty, whether they will definitely respond or not."

Currently, the biggest barrier to testing is cost, and cost is highly variable, Dr. Mrazek said. "I can’t even keep it straight. It varies from company to company and from month to month." Specific genetic testing can cost between $300 and $700, with full genome testing approaching $10,000, according to a previous report from this news organization.

The cost for full genome sequencing is coming down, Dr. Winner said. "We should expect the $1,000 genome in the next few years." He predicted that more and more patients will come in expecting guidance in this area. "Shrewd clinicians who continue to educate themselves and become comfortable with the genetic information we can offer now are leading the way." Future research will ... continue to help guide decisions at the point of care.

 

 

Insurance reimbursement also is improving, Dr. Mrazek said. "As insurance companies become aware there is a cost benefit to this, [because] you can avoid unsuccessful medication trials by doing a one-time and not-astronomically-expensive test, insurance companies will learn it’s in their best interest to approve these, and many do already.

"It’s very rapidly evolving. What we called pharmacogenomic testing a few years ago and what we call it now is different," Dr. Mrazek said. He predicted use of this testing will increase exponentially as the cost comes down and as the algorithms used by laboratories to interpret the results become more sophisticated. In the meantime, "it’s a tool people can choose to use or not to use. But once you get used to being more accurate [with prescribing], it’s hard for most people to go back and just take the dart and throw it at the board again."

It is important to choose a laboratory that provides easy-to-understand reports, Dr. Mrazek added. "Some of the reference labs will send you a report that takes a biochemist to understand what the results mean."

"There are many genes now we are starting to test," Dr. Mrazek said. The easiest genes to understand are the ones that produce these metabolic enzymes. "We’re also learning about target genes that code for the receptors and the transporters in the body, and patients can have problems with those as well."

The future will be more about gene sequencing in a particular patient versus looking at a few key variants, Dr. Mrazek predicted. "When we do this sequencing, instead of just genotyping, we are going to discover lots more of the relevant variation in the genes. It’s like a microscope. [Currently] we are looking at it out of focus, but it’s still better than no microscope. With sequencing, all kinds of things we can’t see now will come into focus. The image will get sharper, the resolution will get better."

Dr. Mrazek invented a patented algorithm for interpretation of pharmacogenomic test results. The Mayo Clinic licenses the algorithm to companies, and Dr. Mrazek said he might receive a financial benefit from this patent in the future.

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Thanks to technologic advances in genetic testing, psychiatrists can predict which patients might experience adverse effects from commonly prescribed psychotropic medications, and, to a lesser extent, who might respond well to a particular drug.

Commercially available pharmacogenomic testing "can improve the probability of your selecting a medication that will be helpful to your patient. It can do that most certainly by avoiding adverse effects, but additionally, you can increase the probability of finding a medication that is more likely to be efficacious," Dr. David Mrazek said in an interview.

"When I started teaching doctors about this 10 years ago, it was about what could be. Now we’re teaching them how to use this tool, and I think it’s going to change the way we practice," said Dr. Mrazek, professor of pediatrics and psychiatry at the Mayo Clinic in Rochester, Minn.

Dr. Joel Winner agreed.

"Pharmacogenetic testing is here and will only become more entrenched in psychiatric treatment over the next several years," Dr. Winner, medical director of AssureRx Health Inc., a company that provides a pharmacogenomic test, said in an interview.

"Currently, I recommend testing for the complicated patient," Dr. Winner said. "I treat mostly anxiety and depression. I have found it to be the most helpful in those patients who have failed one or two medications. Anxious and somatic patients often have a difficult time with medications, because they obsess about them."

More precision with prescribing may be necessary with more complex patients. "If you’re dealing with mild or low-priority problems, it’s not as important to get the drug dead-on straight the first time," Dr. Mrazek said. "You have a little more latitude to do the trial and error [prescribing]."

Pharmacogenomic testing is based on assessment of how an individual patient metabolizes a particular drug through the body’s cytochrome P450 system. Results can identify a patient as a poor or ultra-rapid metabolizer. For example, a poor metabolizer of a CYP2D6 medication will not break a particular drug down at a normal rate. As a result, prolonged exposure to high serum levels puts that patient at risk for more adverse events.

"This is first and foremost a safety issue," said Dr. Winner, a psychiatrist in private practice in Boulder, Colo.

For example, Dr. Winner recently consulted on a patient experiencing "fairly severe side effects," including weight gain and sexual side effects, associated with high-dose paroxetine treatment. The patient was on paroxetine for several years and, despite the side effects, was concerned about stopping the medication. Pharmacogenomic testing revealed the patient was a poor metabolizer of CYP2D6. "He was likely not breaking down the paroxetine appropriately and likely had high levels of paroxetine in his system. My recommendation was to transition to another medication that would be more appropriately dosed according to his genotype," Dr. Winner said.

Through a referral, Dr. Mrazek also recently evaluated a poor 2D6 metabolizer. The patient had been treated for years by clinicians unaware of her impaired drug metabolism. "They did figure out that she could only tolerate low doses of psychotropics, but that was through trial and error," Dr. Mrazek said. Prior to the genetic testing revelation, the patient was taken to the emergency department for an episode of acute anxiety. She received haloperidol, a drug primarily cleared through the 2D6 pathway that "also has one of the highest frequencies of extrapyramidal side effects." The patient later was released but experienced a dystonic reaction. "She had a pretty powerful medicine on board at a high dose for a long time and she ended up in the ICU. She remained there for 5 days until she cleared herself of the medication," Dr. Mrazek said. "That’s a very unusual story, but 5 days in the ICU is a very expensive and very scary proposition."

The clearest indication for pharmacogenomic testing is prevention of such adverse effects, Dr. Mrazek said. "We’re much better at knowing which patient is going to have a poor reaction than we are being able to say, with any certainty, whether they will definitely respond or not."

Currently, the biggest barrier to testing is cost, and cost is highly variable, Dr. Mrazek said. "I can’t even keep it straight. It varies from company to company and from month to month." Specific genetic testing can cost between $300 and $700, with full genome testing approaching $10,000, according to a previous report from this news organization.

The cost for full genome sequencing is coming down, Dr. Winner said. "We should expect the $1,000 genome in the next few years." He predicted that more and more patients will come in expecting guidance in this area. "Shrewd clinicians who continue to educate themselves and become comfortable with the genetic information we can offer now are leading the way." Future research will ... continue to help guide decisions at the point of care.

 

 

Insurance reimbursement also is improving, Dr. Mrazek said. "As insurance companies become aware there is a cost benefit to this, [because] you can avoid unsuccessful medication trials by doing a one-time and not-astronomically-expensive test, insurance companies will learn it’s in their best interest to approve these, and many do already.

"It’s very rapidly evolving. What we called pharmacogenomic testing a few years ago and what we call it now is different," Dr. Mrazek said. He predicted use of this testing will increase exponentially as the cost comes down and as the algorithms used by laboratories to interpret the results become more sophisticated. In the meantime, "it’s a tool people can choose to use or not to use. But once you get used to being more accurate [with prescribing], it’s hard for most people to go back and just take the dart and throw it at the board again."

It is important to choose a laboratory that provides easy-to-understand reports, Dr. Mrazek added. "Some of the reference labs will send you a report that takes a biochemist to understand what the results mean."

"There are many genes now we are starting to test," Dr. Mrazek said. The easiest genes to understand are the ones that produce these metabolic enzymes. "We’re also learning about target genes that code for the receptors and the transporters in the body, and patients can have problems with those as well."

The future will be more about gene sequencing in a particular patient versus looking at a few key variants, Dr. Mrazek predicted. "When we do this sequencing, instead of just genotyping, we are going to discover lots more of the relevant variation in the genes. It’s like a microscope. [Currently] we are looking at it out of focus, but it’s still better than no microscope. With sequencing, all kinds of things we can’t see now will come into focus. The image will get sharper, the resolution will get better."

Dr. Mrazek invented a patented algorithm for interpretation of pharmacogenomic test results. The Mayo Clinic licenses the algorithm to companies, and Dr. Mrazek said he might receive a financial benefit from this patent in the future.

Thanks to technologic advances in genetic testing, psychiatrists can predict which patients might experience adverse effects from commonly prescribed psychotropic medications, and, to a lesser extent, who might respond well to a particular drug.

Commercially available pharmacogenomic testing "can improve the probability of your selecting a medication that will be helpful to your patient. It can do that most certainly by avoiding adverse effects, but additionally, you can increase the probability of finding a medication that is more likely to be efficacious," Dr. David Mrazek said in an interview.

"When I started teaching doctors about this 10 years ago, it was about what could be. Now we’re teaching them how to use this tool, and I think it’s going to change the way we practice," said Dr. Mrazek, professor of pediatrics and psychiatry at the Mayo Clinic in Rochester, Minn.

Dr. Joel Winner agreed.

"Pharmacogenetic testing is here and will only become more entrenched in psychiatric treatment over the next several years," Dr. Winner, medical director of AssureRx Health Inc., a company that provides a pharmacogenomic test, said in an interview.

"Currently, I recommend testing for the complicated patient," Dr. Winner said. "I treat mostly anxiety and depression. I have found it to be the most helpful in those patients who have failed one or two medications. Anxious and somatic patients often have a difficult time with medications, because they obsess about them."

More precision with prescribing may be necessary with more complex patients. "If you’re dealing with mild or low-priority problems, it’s not as important to get the drug dead-on straight the first time," Dr. Mrazek said. "You have a little more latitude to do the trial and error [prescribing]."

Pharmacogenomic testing is based on assessment of how an individual patient metabolizes a particular drug through the body’s cytochrome P450 system. Results can identify a patient as a poor or ultra-rapid metabolizer. For example, a poor metabolizer of a CYP2D6 medication will not break a particular drug down at a normal rate. As a result, prolonged exposure to high serum levels puts that patient at risk for more adverse events.

"This is first and foremost a safety issue," said Dr. Winner, a psychiatrist in private practice in Boulder, Colo.

For example, Dr. Winner recently consulted on a patient experiencing "fairly severe side effects," including weight gain and sexual side effects, associated with high-dose paroxetine treatment. The patient was on paroxetine for several years and, despite the side effects, was concerned about stopping the medication. Pharmacogenomic testing revealed the patient was a poor metabolizer of CYP2D6. "He was likely not breaking down the paroxetine appropriately and likely had high levels of paroxetine in his system. My recommendation was to transition to another medication that would be more appropriately dosed according to his genotype," Dr. Winner said.

Through a referral, Dr. Mrazek also recently evaluated a poor 2D6 metabolizer. The patient had been treated for years by clinicians unaware of her impaired drug metabolism. "They did figure out that she could only tolerate low doses of psychotropics, but that was through trial and error," Dr. Mrazek said. Prior to the genetic testing revelation, the patient was taken to the emergency department for an episode of acute anxiety. She received haloperidol, a drug primarily cleared through the 2D6 pathway that "also has one of the highest frequencies of extrapyramidal side effects." The patient later was released but experienced a dystonic reaction. "She had a pretty powerful medicine on board at a high dose for a long time and she ended up in the ICU. She remained there for 5 days until she cleared herself of the medication," Dr. Mrazek said. "That’s a very unusual story, but 5 days in the ICU is a very expensive and very scary proposition."

The clearest indication for pharmacogenomic testing is prevention of such adverse effects, Dr. Mrazek said. "We’re much better at knowing which patient is going to have a poor reaction than we are being able to say, with any certainty, whether they will definitely respond or not."

Currently, the biggest barrier to testing is cost, and cost is highly variable, Dr. Mrazek said. "I can’t even keep it straight. It varies from company to company and from month to month." Specific genetic testing can cost between $300 and $700, with full genome testing approaching $10,000, according to a previous report from this news organization.

The cost for full genome sequencing is coming down, Dr. Winner said. "We should expect the $1,000 genome in the next few years." He predicted that more and more patients will come in expecting guidance in this area. "Shrewd clinicians who continue to educate themselves and become comfortable with the genetic information we can offer now are leading the way." Future research will ... continue to help guide decisions at the point of care.

 

 

Insurance reimbursement also is improving, Dr. Mrazek said. "As insurance companies become aware there is a cost benefit to this, [because] you can avoid unsuccessful medication trials by doing a one-time and not-astronomically-expensive test, insurance companies will learn it’s in their best interest to approve these, and many do already.

"It’s very rapidly evolving. What we called pharmacogenomic testing a few years ago and what we call it now is different," Dr. Mrazek said. He predicted use of this testing will increase exponentially as the cost comes down and as the algorithms used by laboratories to interpret the results become more sophisticated. In the meantime, "it’s a tool people can choose to use or not to use. But once you get used to being more accurate [with prescribing], it’s hard for most people to go back and just take the dart and throw it at the board again."

It is important to choose a laboratory that provides easy-to-understand reports, Dr. Mrazek added. "Some of the reference labs will send you a report that takes a biochemist to understand what the results mean."

"There are many genes now we are starting to test," Dr. Mrazek said. The easiest genes to understand are the ones that produce these metabolic enzymes. "We’re also learning about target genes that code for the receptors and the transporters in the body, and patients can have problems with those as well."

The future will be more about gene sequencing in a particular patient versus looking at a few key variants, Dr. Mrazek predicted. "When we do this sequencing, instead of just genotyping, we are going to discover lots more of the relevant variation in the genes. It’s like a microscope. [Currently] we are looking at it out of focus, but it’s still better than no microscope. With sequencing, all kinds of things we can’t see now will come into focus. The image will get sharper, the resolution will get better."

Dr. Mrazek invented a patented algorithm for interpretation of pharmacogenomic test results. The Mayo Clinic licenses the algorithm to companies, and Dr. Mrazek said he might receive a financial benefit from this patent in the future.

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Hospital System Sends HIV Screening Soaring With EMR Prompt

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Hospital System Sends HIV Screening Soaring With EMR Prompt

A large hospital system in Cleveland implemented a simple and cost-effective strategy that rapidly and significantly increased the percentage of people receiving HIV testing for the first time.

Starting in July 2010, MetroHealth Medical Center and 11 affiliated community health centers added a prompt to their electronic medical record system. The prompt reminds providers to discuss and offer HIV testing to all untested patients aged 13-64 years, which the Centers for Disease Control and Prevention recommends for health care settings.

"About a week after the implementation went live, testing doubled, which was fabulous," Dr. Ann Avery said during a press telebriefing at the 2011 National HIV Prevention Conference sponsored by the Centers for Disease Control and Prevention. Dr. Avery holds dual positions as an infectious disease attending physician at MetroHealth and as medical director of the Cleveland Department of Public Health.

HIV testing nearly doubled in the 6 months after implementation at five of the outpatient health centers. Patient encounters led to 6,313 instances of HIV testing between July and December 2010, up from 3,851 instances in the first half of the year.

After the intervention, first-time testing among men increased from 2.9% to 6.1%, a significant difference. Researchers also found the proportion of patients never tested for HIV dropped from 58% to 54%.

"As of March 2011, testing has continued to increase on a significant basis among those getting first-time tested," Dr. Avery said.

"We see this as a cost-effective and fairly simple structural intervention that helped normalize testing for the providers and decreased barriers to getting individuals tested," Dr. Avery said. "We believe in settings where an electronic medical record system is in place [that] this may be a helpful structural intervention."

The study included a total of 524,074 outpatient clinic encounters and 49,046 hospital inpatient encounters between January 2008 and December 2010.

Dr. Avery and her associates were motivated by initial data that revealed only 4% of approximately 372,000 primary care encounters included HIV testing during 2008 and 2009 at MetroHealth’s primary care clinics and five outpatient sites. The low testing rate existed despite provider education efforts on CDC testing guidelines, she added.

The majority of men, 79%, had never been tested and therefore missed an opportunity for HIV screening between 1999 and their encounter in 2008 or 2009, Dr. Avery said. The women fared a little better, she added, with 50% of women of childbearing age tested, largely because of prenatal care screening.

"We have dramatically decreased missed opportunities for men of all ages and women, especially [those] 40 and older, although all women also benefited."

Dr. Avery and her associates used these findings to educate providers and to leverage the health system’s administrative power to add HIV to their list of preventive screening for health maintenance.

"We also updated our educational effort to focus on some of the [provider] barriers like communication and fear of talking," Dr. Avery said. MetroHealth offered a 1-hour, voluntary clinician education on improvement of communications skills and comfort level and knowledge related to HIV screening, relevant Ohio laws, and provision of test results.

Although patient and provider education can help to reduce barriers to HIV testing, this study indicates those efforts alone are insufficient, Dr. Avery said. An operational change added to education efforts may be required to increase routine HIV testing.

"These are impressive results," Dr. Jonathan Mermin, director of the CDC’s Division of HIV/AIDS Prevention, said at the press briefing "A relatively simple change ... has had a major impact on increasing uptake of routine HIV."

"I hope that the changes they were able to make in Cleveland will serve as an inspiration and model to other health care systems," he said.

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A large hospital system in Cleveland implemented a simple and cost-effective strategy that rapidly and significantly increased the percentage of people receiving HIV testing for the first time.

Starting in July 2010, MetroHealth Medical Center and 11 affiliated community health centers added a prompt to their electronic medical record system. The prompt reminds providers to discuss and offer HIV testing to all untested patients aged 13-64 years, which the Centers for Disease Control and Prevention recommends for health care settings.

"About a week after the implementation went live, testing doubled, which was fabulous," Dr. Ann Avery said during a press telebriefing at the 2011 National HIV Prevention Conference sponsored by the Centers for Disease Control and Prevention. Dr. Avery holds dual positions as an infectious disease attending physician at MetroHealth and as medical director of the Cleveland Department of Public Health.

HIV testing nearly doubled in the 6 months after implementation at five of the outpatient health centers. Patient encounters led to 6,313 instances of HIV testing between July and December 2010, up from 3,851 instances in the first half of the year.

After the intervention, first-time testing among men increased from 2.9% to 6.1%, a significant difference. Researchers also found the proportion of patients never tested for HIV dropped from 58% to 54%.

"As of March 2011, testing has continued to increase on a significant basis among those getting first-time tested," Dr. Avery said.

"We see this as a cost-effective and fairly simple structural intervention that helped normalize testing for the providers and decreased barriers to getting individuals tested," Dr. Avery said. "We believe in settings where an electronic medical record system is in place [that] this may be a helpful structural intervention."

The study included a total of 524,074 outpatient clinic encounters and 49,046 hospital inpatient encounters between January 2008 and December 2010.

Dr. Avery and her associates were motivated by initial data that revealed only 4% of approximately 372,000 primary care encounters included HIV testing during 2008 and 2009 at MetroHealth’s primary care clinics and five outpatient sites. The low testing rate existed despite provider education efforts on CDC testing guidelines, she added.

The majority of men, 79%, had never been tested and therefore missed an opportunity for HIV screening between 1999 and their encounter in 2008 or 2009, Dr. Avery said. The women fared a little better, she added, with 50% of women of childbearing age tested, largely because of prenatal care screening.

"We have dramatically decreased missed opportunities for men of all ages and women, especially [those] 40 and older, although all women also benefited."

Dr. Avery and her associates used these findings to educate providers and to leverage the health system’s administrative power to add HIV to their list of preventive screening for health maintenance.

"We also updated our educational effort to focus on some of the [provider] barriers like communication and fear of talking," Dr. Avery said. MetroHealth offered a 1-hour, voluntary clinician education on improvement of communications skills and comfort level and knowledge related to HIV screening, relevant Ohio laws, and provision of test results.

Although patient and provider education can help to reduce barriers to HIV testing, this study indicates those efforts alone are insufficient, Dr. Avery said. An operational change added to education efforts may be required to increase routine HIV testing.

"These are impressive results," Dr. Jonathan Mermin, director of the CDC’s Division of HIV/AIDS Prevention, said at the press briefing "A relatively simple change ... has had a major impact on increasing uptake of routine HIV."

"I hope that the changes they were able to make in Cleveland will serve as an inspiration and model to other health care systems," he said.

A large hospital system in Cleveland implemented a simple and cost-effective strategy that rapidly and significantly increased the percentage of people receiving HIV testing for the first time.

Starting in July 2010, MetroHealth Medical Center and 11 affiliated community health centers added a prompt to their electronic medical record system. The prompt reminds providers to discuss and offer HIV testing to all untested patients aged 13-64 years, which the Centers for Disease Control and Prevention recommends for health care settings.

"About a week after the implementation went live, testing doubled, which was fabulous," Dr. Ann Avery said during a press telebriefing at the 2011 National HIV Prevention Conference sponsored by the Centers for Disease Control and Prevention. Dr. Avery holds dual positions as an infectious disease attending physician at MetroHealth and as medical director of the Cleveland Department of Public Health.

HIV testing nearly doubled in the 6 months after implementation at five of the outpatient health centers. Patient encounters led to 6,313 instances of HIV testing between July and December 2010, up from 3,851 instances in the first half of the year.

After the intervention, first-time testing among men increased from 2.9% to 6.1%, a significant difference. Researchers also found the proportion of patients never tested for HIV dropped from 58% to 54%.

"As of March 2011, testing has continued to increase on a significant basis among those getting first-time tested," Dr. Avery said.

"We see this as a cost-effective and fairly simple structural intervention that helped normalize testing for the providers and decreased barriers to getting individuals tested," Dr. Avery said. "We believe in settings where an electronic medical record system is in place [that] this may be a helpful structural intervention."

The study included a total of 524,074 outpatient clinic encounters and 49,046 hospital inpatient encounters between January 2008 and December 2010.

Dr. Avery and her associates were motivated by initial data that revealed only 4% of approximately 372,000 primary care encounters included HIV testing during 2008 and 2009 at MetroHealth’s primary care clinics and five outpatient sites. The low testing rate existed despite provider education efforts on CDC testing guidelines, she added.

The majority of men, 79%, had never been tested and therefore missed an opportunity for HIV screening between 1999 and their encounter in 2008 or 2009, Dr. Avery said. The women fared a little better, she added, with 50% of women of childbearing age tested, largely because of prenatal care screening.

"We have dramatically decreased missed opportunities for men of all ages and women, especially [those] 40 and older, although all women also benefited."

Dr. Avery and her associates used these findings to educate providers and to leverage the health system’s administrative power to add HIV to their list of preventive screening for health maintenance.

"We also updated our educational effort to focus on some of the [provider] barriers like communication and fear of talking," Dr. Avery said. MetroHealth offered a 1-hour, voluntary clinician education on improvement of communications skills and comfort level and knowledge related to HIV screening, relevant Ohio laws, and provision of test results.

Although patient and provider education can help to reduce barriers to HIV testing, this study indicates those efforts alone are insufficient, Dr. Avery said. An operational change added to education efforts may be required to increase routine HIV testing.

"These are impressive results," Dr. Jonathan Mermin, director of the CDC’s Division of HIV/AIDS Prevention, said at the press briefing "A relatively simple change ... has had a major impact on increasing uptake of routine HIV."

"I hope that the changes they were able to make in Cleveland will serve as an inspiration and model to other health care systems," he said.

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FROM THE 2011 NATIONAL HIV PREVENTION CONFERENCE

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Major Finding: In 6 months after addition of an HIV testing EMR prompt, 6,313 patient encounters included testing, compared with 3,851 such encounters in the prior 6 months.

Data Source: A study of 524,074 outpatient clinic encounters and 49,046 hospital inpatient encounters between January 2008 and December 2010.

Heavier Kids May Need More Migraine Medication

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Heavier Kids May Need More Migraine Medication

BERLIN – Rizatriptan fought migraine more effectively in children and adolescents when it was dosed according to body weight in a randomized, double-blind parallel group trial.

Previous industry-sponsored rizatriptan studies in children revealed no significant treatment effects, Dr. Tony W. Ho said. For example, in one study of 291 adolescents, the 2-hour response rate was 66% with treatment versus 56% with placebo. The lack of significant efficacy could be due to all patients receiving the same 5-mg tablets, a dose that can be insufficient given the increase in body mass index among 12- to 17-year-olds, he added.

"If you think about it, many adolescents are as heavy as some adults nowadays but may receive a lower dose," said Dr. Ho, a researcher at Merck Sharp & Dohme Corp., Whitehouse Station, N.J., a subsidiary of Merck & Co., which markets rizatriptan as Maxalt.

In the current study, Dr. Ho and his associates tried weight-based dosing in children aged 12-17 years with a history of moderate to severe attacks. Those who weighed less than 40 kg received 5-mg of rizatriptan orally disintegrating tablets (ODT; Maxalt-MLT), and those 40 kg or heavier received 10 mg within 30 minutes of a moderate to severe attack.

"These teenagers were heavier than we expected, with a mean BMI of 22.6 [kg/m2]. The majority of patients were from the U.S.," Dr. Ho said at the International Headache Congress, which was sponsored by the International Headache Society and the American Headache Society.

A total 570 of the 702 participants were evaluable for efficacy analyses and were studied further. The researchers found 31% of the treatment group (87 of 284 participants) reported freedom from pain at 2 hours (the primary outcome), compared with 22% (63 of 286) of the placebo group. The odds ratio favoring rizatriptan was 1.55. Patients rated their pain from 1 (a happy face meaning no head pain) up to 5 (a frowning face reflecting very bad head pain).

"Weight-based rizatriptan ODT treatment demonstrated a statistically significant difference versus placebo in eliminating pain," Dr. Ho said.

The study featured a double-blind, run-in phase design. "Even with a design to reduce the placebo effect, we still had a 22% rate," Dr. Ho said.

Patients randomized to rizatriptan also experienced significantly less nausea, vomiting, and impairment of activities of daily living, compared with those who received placebo, Dr. Ho said. "This supports a weight-based approach to treating pediatric migraine."

A meeting attendee questioned the incidence of vomiting reported in the study, stating that "usually the rate of severe vomiting is 60%-70%, but you had lower than 15%."

The children rated severity of associated symptoms, including vomiting, using a five-face scale, Dr. Ho replied. "I don’t know how that is related to other definitions of severity."

There was no statistically significant difference in 2-hour pain relief, a secondary outcome experienced by 59% of the treated group and 51% of the placebo group.

Rizatriptan use is off label in pediatric patients. The Food and Drug Administration cleared this selective 5-hydroxytryptamine1B/1D receptor agonist for acute treatment of migraine attacks with or without aura in adults 18 years and older.

Rizatriptan was generally well tolerated, Dr. Ho said. The overall adverse event rate within 14 days was 24% in the treatment group and 23% in the placebo group.

Of the 702 patients enrolled, 91% were female. All participants had a history of migraine (with or without aura) for at least 6 months. They also reported one to eight moderate to severe migraine attacks per month and a lack of satisfactory relief with the use of nonsteroidal anti-inflammatory drugs.

Dr. Ho said additional data on children 6 years and older are forthcoming.

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BERLIN – Rizatriptan fought migraine more effectively in children and adolescents when it was dosed according to body weight in a randomized, double-blind parallel group trial.

Previous industry-sponsored rizatriptan studies in children revealed no significant treatment effects, Dr. Tony W. Ho said. For example, in one study of 291 adolescents, the 2-hour response rate was 66% with treatment versus 56% with placebo. The lack of significant efficacy could be due to all patients receiving the same 5-mg tablets, a dose that can be insufficient given the increase in body mass index among 12- to 17-year-olds, he added.

"If you think about it, many adolescents are as heavy as some adults nowadays but may receive a lower dose," said Dr. Ho, a researcher at Merck Sharp & Dohme Corp., Whitehouse Station, N.J., a subsidiary of Merck & Co., which markets rizatriptan as Maxalt.

In the current study, Dr. Ho and his associates tried weight-based dosing in children aged 12-17 years with a history of moderate to severe attacks. Those who weighed less than 40 kg received 5-mg of rizatriptan orally disintegrating tablets (ODT; Maxalt-MLT), and those 40 kg or heavier received 10 mg within 30 minutes of a moderate to severe attack.

"These teenagers were heavier than we expected, with a mean BMI of 22.6 [kg/m2]. The majority of patients were from the U.S.," Dr. Ho said at the International Headache Congress, which was sponsored by the International Headache Society and the American Headache Society.

A total 570 of the 702 participants were evaluable for efficacy analyses and were studied further. The researchers found 31% of the treatment group (87 of 284 participants) reported freedom from pain at 2 hours (the primary outcome), compared with 22% (63 of 286) of the placebo group. The odds ratio favoring rizatriptan was 1.55. Patients rated their pain from 1 (a happy face meaning no head pain) up to 5 (a frowning face reflecting very bad head pain).

"Weight-based rizatriptan ODT treatment demonstrated a statistically significant difference versus placebo in eliminating pain," Dr. Ho said.

The study featured a double-blind, run-in phase design. "Even with a design to reduce the placebo effect, we still had a 22% rate," Dr. Ho said.

Patients randomized to rizatriptan also experienced significantly less nausea, vomiting, and impairment of activities of daily living, compared with those who received placebo, Dr. Ho said. "This supports a weight-based approach to treating pediatric migraine."

A meeting attendee questioned the incidence of vomiting reported in the study, stating that "usually the rate of severe vomiting is 60%-70%, but you had lower than 15%."

The children rated severity of associated symptoms, including vomiting, using a five-face scale, Dr. Ho replied. "I don’t know how that is related to other definitions of severity."

There was no statistically significant difference in 2-hour pain relief, a secondary outcome experienced by 59% of the treated group and 51% of the placebo group.

Rizatriptan use is off label in pediatric patients. The Food and Drug Administration cleared this selective 5-hydroxytryptamine1B/1D receptor agonist for acute treatment of migraine attacks with or without aura in adults 18 years and older.

Rizatriptan was generally well tolerated, Dr. Ho said. The overall adverse event rate within 14 days was 24% in the treatment group and 23% in the placebo group.

Of the 702 patients enrolled, 91% were female. All participants had a history of migraine (with or without aura) for at least 6 months. They also reported one to eight moderate to severe migraine attacks per month and a lack of satisfactory relief with the use of nonsteroidal anti-inflammatory drugs.

Dr. Ho said additional data on children 6 years and older are forthcoming.

BERLIN – Rizatriptan fought migraine more effectively in children and adolescents when it was dosed according to body weight in a randomized, double-blind parallel group trial.

Previous industry-sponsored rizatriptan studies in children revealed no significant treatment effects, Dr. Tony W. Ho said. For example, in one study of 291 adolescents, the 2-hour response rate was 66% with treatment versus 56% with placebo. The lack of significant efficacy could be due to all patients receiving the same 5-mg tablets, a dose that can be insufficient given the increase in body mass index among 12- to 17-year-olds, he added.

"If you think about it, many adolescents are as heavy as some adults nowadays but may receive a lower dose," said Dr. Ho, a researcher at Merck Sharp & Dohme Corp., Whitehouse Station, N.J., a subsidiary of Merck & Co., which markets rizatriptan as Maxalt.

In the current study, Dr. Ho and his associates tried weight-based dosing in children aged 12-17 years with a history of moderate to severe attacks. Those who weighed less than 40 kg received 5-mg of rizatriptan orally disintegrating tablets (ODT; Maxalt-MLT), and those 40 kg or heavier received 10 mg within 30 minutes of a moderate to severe attack.

"These teenagers were heavier than we expected, with a mean BMI of 22.6 [kg/m2]. The majority of patients were from the U.S.," Dr. Ho said at the International Headache Congress, which was sponsored by the International Headache Society and the American Headache Society.

A total 570 of the 702 participants were evaluable for efficacy analyses and were studied further. The researchers found 31% of the treatment group (87 of 284 participants) reported freedom from pain at 2 hours (the primary outcome), compared with 22% (63 of 286) of the placebo group. The odds ratio favoring rizatriptan was 1.55. Patients rated their pain from 1 (a happy face meaning no head pain) up to 5 (a frowning face reflecting very bad head pain).

"Weight-based rizatriptan ODT treatment demonstrated a statistically significant difference versus placebo in eliminating pain," Dr. Ho said.

The study featured a double-blind, run-in phase design. "Even with a design to reduce the placebo effect, we still had a 22% rate," Dr. Ho said.

Patients randomized to rizatriptan also experienced significantly less nausea, vomiting, and impairment of activities of daily living, compared with those who received placebo, Dr. Ho said. "This supports a weight-based approach to treating pediatric migraine."

A meeting attendee questioned the incidence of vomiting reported in the study, stating that "usually the rate of severe vomiting is 60%-70%, but you had lower than 15%."

The children rated severity of associated symptoms, including vomiting, using a five-face scale, Dr. Ho replied. "I don’t know how that is related to other definitions of severity."

There was no statistically significant difference in 2-hour pain relief, a secondary outcome experienced by 59% of the treated group and 51% of the placebo group.

Rizatriptan use is off label in pediatric patients. The Food and Drug Administration cleared this selective 5-hydroxytryptamine1B/1D receptor agonist for acute treatment of migraine attacks with or without aura in adults 18 years and older.

Rizatriptan was generally well tolerated, Dr. Ho said. The overall adverse event rate within 14 days was 24% in the treatment group and 23% in the placebo group.

Of the 702 patients enrolled, 91% were female. All participants had a history of migraine (with or without aura) for at least 6 months. They also reported one to eight moderate to severe migraine attacks per month and a lack of satisfactory relief with the use of nonsteroidal anti-inflammatory drugs.

Dr. Ho said additional data on children 6 years and older are forthcoming.

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FROM THE INTERNATIONAL HEADACHE CONGRESS

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Major Finding: Significantly more children and adolescents reported freedom from migraine pain at 2 hours with weight-based rizatriptan treatment (31%) versus placebo (22%).

Data Source: A double-blind parallel group trial of 702 children and adolescents randomized to rizatriptan or placebo within 30 minutes of a moderate to severe migraine attack.

Disclosures: The study was funded by Merck & Co. Dr. Ho is an employee of Merck Sharp & Dohme Corp.

Patients Prefer New Scale for Depression Remission

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BOCA RATON, FLA. – "Just what we need – another scale," Dr. Mark Zimmerman said, tongue-in-cheek, as he started to explain why he and his colleagues developed the Remission From Depression Questionnaire.

Current measures define remission based on a lack of depressive symptoms alone, which is insufficient, Dr. Zimmerman said at the annual meeting of the New Clinical Drug Evaluation Unit, sponsored by the National Institute of Mental Health.

    Dr. Mark Zimmerman

In a previous study of 514 depressed outpatients (J. Psychiatr. Res. 2008;42:797-801), "we found symptom resolution was not the most important consideration of depression remission," Dr. Zimmerman said. "Multiple factors were identified, so from a patient point of view, symptom-based definitions of remission are too narrow."

So Dr. Zimmerman and his colleagues developed the multidimensional Remission From Depression Questionnaire (RDQ), and conducted two studies to test reliability, validity, and patient preferences.

The RDQ assesses seven constructs: symptoms of depression, other symptoms, coping ability, positive mental health, functioning, life satisfaction, and general sense of well being. When the researchers compared remitters to nonremitters, significant differences were found on the RDQ total scale, depressive symptoms, and other symptoms. These findings support the RDQ as a valid measure, said Dr. Zimmerman, director of outpatient psychiatry at Rhode Island Hospital and with the department of psychiatry and human behavior at Brown University, both in Providence.

In the first study, Dr. Zimmerman and his colleagues compared responses from 102 depressed outpatients on the 41-item RDQ and the 16-item Quick Inventory of Depressive Symptomatology (QIDS). "They did not know we had developed one of these measures," he said.

There were no differences between the two measures on completion time. They were "equally burdensome and equally understandable," Dr. Zimmerman said.

Participants also reported their preference using a nine-item measure. Twice as many reported the RDQ more accurately described their overall state, 48%, vs. 24% for the QIDS. Nearly half said they preferred to complete the RDQ, 46%, compared with 22% who preferred completing the QIDS.

"Our conclusion from the first study is ... patients prefer the multifactorial RDQ scale more than a symptoms-based measure."

In a second study, the investigators asked 247 mildly depressed outpatients in ongoing treatment to complete the RDQ. The QIDS average score was 9.8, and the Hamilton Depression Rating Scale average score was 8.6. The RDQ correlated 0.62 with Hamilton scale and 0.70 with the Clinical Global Impression-Severity scale.

Dr. Zimmerman and his colleagues also split the cohort into remitters vs. nonremitters. Significant differences were found between these groups on the RDQ total score, 18 vs. 43; the depressive symptoms score, 5 vs. 12; and the other symptoms score, 2.8 vs. 5.7.

"The RDQ is a reliable and valid measure that evaluates multiple domains," Dr. Zimmerman said.

A group of 60 of the 247 patients waited and completed the RDQ measure a second time to test its reliability. The test-retest reliability and internal consistency were all greater than 0.8, Dr. Zimmerman said.

The next step is to assess the RDQ as an outcome measure in an acute treatment study of depression, Dr. Zimmerman said. An unanswered question is: Does the RDQ do a better job of predicting relapse compared to just a symptom-based scale?

Dr. Zimmerman said he had no disclosures. The studies were funded by Eli Lilly.

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BOCA RATON, FLA. – "Just what we need – another scale," Dr. Mark Zimmerman said, tongue-in-cheek, as he started to explain why he and his colleagues developed the Remission From Depression Questionnaire.

Current measures define remission based on a lack of depressive symptoms alone, which is insufficient, Dr. Zimmerman said at the annual meeting of the New Clinical Drug Evaluation Unit, sponsored by the National Institute of Mental Health.

    Dr. Mark Zimmerman

In a previous study of 514 depressed outpatients (J. Psychiatr. Res. 2008;42:797-801), "we found symptom resolution was not the most important consideration of depression remission," Dr. Zimmerman said. "Multiple factors were identified, so from a patient point of view, symptom-based definitions of remission are too narrow."

So Dr. Zimmerman and his colleagues developed the multidimensional Remission From Depression Questionnaire (RDQ), and conducted two studies to test reliability, validity, and patient preferences.

The RDQ assesses seven constructs: symptoms of depression, other symptoms, coping ability, positive mental health, functioning, life satisfaction, and general sense of well being. When the researchers compared remitters to nonremitters, significant differences were found on the RDQ total scale, depressive symptoms, and other symptoms. These findings support the RDQ as a valid measure, said Dr. Zimmerman, director of outpatient psychiatry at Rhode Island Hospital and with the department of psychiatry and human behavior at Brown University, both in Providence.

In the first study, Dr. Zimmerman and his colleagues compared responses from 102 depressed outpatients on the 41-item RDQ and the 16-item Quick Inventory of Depressive Symptomatology (QIDS). "They did not know we had developed one of these measures," he said.

There were no differences between the two measures on completion time. They were "equally burdensome and equally understandable," Dr. Zimmerman said.

Participants also reported their preference using a nine-item measure. Twice as many reported the RDQ more accurately described their overall state, 48%, vs. 24% for the QIDS. Nearly half said they preferred to complete the RDQ, 46%, compared with 22% who preferred completing the QIDS.

"Our conclusion from the first study is ... patients prefer the multifactorial RDQ scale more than a symptoms-based measure."

In a second study, the investigators asked 247 mildly depressed outpatients in ongoing treatment to complete the RDQ. The QIDS average score was 9.8, and the Hamilton Depression Rating Scale average score was 8.6. The RDQ correlated 0.62 with Hamilton scale and 0.70 with the Clinical Global Impression-Severity scale.

Dr. Zimmerman and his colleagues also split the cohort into remitters vs. nonremitters. Significant differences were found between these groups on the RDQ total score, 18 vs. 43; the depressive symptoms score, 5 vs. 12; and the other symptoms score, 2.8 vs. 5.7.

"The RDQ is a reliable and valid measure that evaluates multiple domains," Dr. Zimmerman said.

A group of 60 of the 247 patients waited and completed the RDQ measure a second time to test its reliability. The test-retest reliability and internal consistency were all greater than 0.8, Dr. Zimmerman said.

The next step is to assess the RDQ as an outcome measure in an acute treatment study of depression, Dr. Zimmerman said. An unanswered question is: Does the RDQ do a better job of predicting relapse compared to just a symptom-based scale?

Dr. Zimmerman said he had no disclosures. The studies were funded by Eli Lilly.

BOCA RATON, FLA. – "Just what we need – another scale," Dr. Mark Zimmerman said, tongue-in-cheek, as he started to explain why he and his colleagues developed the Remission From Depression Questionnaire.

Current measures define remission based on a lack of depressive symptoms alone, which is insufficient, Dr. Zimmerman said at the annual meeting of the New Clinical Drug Evaluation Unit, sponsored by the National Institute of Mental Health.

    Dr. Mark Zimmerman

In a previous study of 514 depressed outpatients (J. Psychiatr. Res. 2008;42:797-801), "we found symptom resolution was not the most important consideration of depression remission," Dr. Zimmerman said. "Multiple factors were identified, so from a patient point of view, symptom-based definitions of remission are too narrow."

So Dr. Zimmerman and his colleagues developed the multidimensional Remission From Depression Questionnaire (RDQ), and conducted two studies to test reliability, validity, and patient preferences.

The RDQ assesses seven constructs: symptoms of depression, other symptoms, coping ability, positive mental health, functioning, life satisfaction, and general sense of well being. When the researchers compared remitters to nonremitters, significant differences were found on the RDQ total scale, depressive symptoms, and other symptoms. These findings support the RDQ as a valid measure, said Dr. Zimmerman, director of outpatient psychiatry at Rhode Island Hospital and with the department of psychiatry and human behavior at Brown University, both in Providence.

In the first study, Dr. Zimmerman and his colleagues compared responses from 102 depressed outpatients on the 41-item RDQ and the 16-item Quick Inventory of Depressive Symptomatology (QIDS). "They did not know we had developed one of these measures," he said.

There were no differences between the two measures on completion time. They were "equally burdensome and equally understandable," Dr. Zimmerman said.

Participants also reported their preference using a nine-item measure. Twice as many reported the RDQ more accurately described their overall state, 48%, vs. 24% for the QIDS. Nearly half said they preferred to complete the RDQ, 46%, compared with 22% who preferred completing the QIDS.

"Our conclusion from the first study is ... patients prefer the multifactorial RDQ scale more than a symptoms-based measure."

In a second study, the investigators asked 247 mildly depressed outpatients in ongoing treatment to complete the RDQ. The QIDS average score was 9.8, and the Hamilton Depression Rating Scale average score was 8.6. The RDQ correlated 0.62 with Hamilton scale and 0.70 with the Clinical Global Impression-Severity scale.

Dr. Zimmerman and his colleagues also split the cohort into remitters vs. nonremitters. Significant differences were found between these groups on the RDQ total score, 18 vs. 43; the depressive symptoms score, 5 vs. 12; and the other symptoms score, 2.8 vs. 5.7.

"The RDQ is a reliable and valid measure that evaluates multiple domains," Dr. Zimmerman said.

A group of 60 of the 247 patients waited and completed the RDQ measure a second time to test its reliability. The test-retest reliability and internal consistency were all greater than 0.8, Dr. Zimmerman said.

The next step is to assess the RDQ as an outcome measure in an acute treatment study of depression, Dr. Zimmerman said. An unanswered question is: Does the RDQ do a better job of predicting relapse compared to just a symptom-based scale?

Dr. Zimmerman said he had no disclosures. The studies were funded by Eli Lilly.

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EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE NEW CLINICAL DRUG EVALUATION UNIT

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Major Finding: A total 48% of patients said the Remission From Depression Questionnaire more accurately described their overall state, compared with 24% who preferred the Quick Inventory of Depressive Symptomatology.

Data Source: Survey of 102 depressed outpatients.

Disclosures: Eli Lilly sponsored the studies. Dr. Zimmerman said he had no relevant disclosures.