Michele G. Sullivan

Disclosures: The NEAD study is funded by the National Institutes of Health. Dr. Baker said he had no financial disclosures.

BANGKOK, THAILAND — Expressive and receptive language abilities are significantly poorer in 3-year-olds who were exposed to sodium valproate in utero than they are in children who were exposed to other individual antiepileptic drugs during gestation, based on a subanalysis of the Neurodevelopmental Effects of Antiepileptic Drugs study.

Valproate exposure was associated with a 10-point difference on both language measures compared with exposure to phenytoin, carbamazepine, or lamotrigine—a difference that is not only statistically significant, but clinically important as well, Gus A. Baker, Ph.D., said at the World Congress of Neurology.

The differences apparent in these 3-year-old subjects will likely expand as the groups grow older, said Dr. Baker, director of the division of neurosciences at the Walton Centre for Neurology and Neurosurgery in Liverpool, England. “We can expect the difference in the magnitude to get greater and not smaller with age,” he said. Already, Dr. Baker noted, valproate-exposed 3-year-olds in the U.K. portion of the study are lagging behind a group of matched controls. “Well over a third of those exposed to valproate have been referred for speech therapy, so we see that this 10-point difference has real meaning in terms of day-to-day practice.”

The prospective, observational Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study included 303 pregnant women who were taking sodium valproate, carbamazepine, lamotrigine, or phenytoin as monotherapy. Enrollment occurred during 1999-2004 in 25 epilepsy centers in the United States and the United Kingdom. Separate investigations in the United States and the United Kingdom were later combined. The primary outcome was cognitive performance of the children at 6 years of age.

Dr. Baker, a primary investigator in the U.K. study and coinvestigator in the overall study, presented the results of the drugs' effect on expressive and receptive language development among 234 children who were 3 years old at assessment. The children all underwent testing of verbal and nonverbal communication, including expressive and receptive language, visual motor construction, and nonverbal intellectual ability.

Their abilities in these areas were determined by calculating subscores on screening tests called the Differential Ability Scales (2nd ed.) and the Preschool Language Scale (4th Ed.). The scores were adjusted for factors known to affect child intellect.

“We saw that maternal IQ, antiepileptic drug (AED) dose, maternal age, gestational age, and preconceptional exposure to folate were significant factors predicting the scores, as we would expect,” he said. “But we also showed that overall, the scores for valproate-exposed children were significantly lower than all other drugs and the magnitude of the effect was greater for verbal than nonverbal language.”

Testing showed that the children exposed to valproate scored significantly lower on measures of expressive language (mean score of 91 vs. 102 for carbamazepine, 104 for lamotrigine, and 101 for phenytoin) and receptive language (mean score of 89 vs. 97 for carbamazepine, 101 for lamotrigine, and 101 for phenytoin). On visual motor construction and nonverbal intellectual ability, children exposed to valproate scored lower, but not significantly lower, than children exposed to the other drugs.

In terms of developmental milestones, this finding could bode ill for the valproate-exposed children, said Dr. Baker. “Without a cohesive and intact language system, a child's neurodevelopmental progress will be limited.”

Unlike the physical results of in utero valproate exposure, which can be surgically corrected to at least some degree, the cognitive effects cannot be erased, he pointed out. The best hope for such children is early identification and intervention. “If we identify them now, we have to think about an appropriate intervention now. If we leave it for later, the gains they might make will be limited.”

“For women for whom sodium valproate is the first choice because of the nature of their seizures, we should be thinking about reducing the dose to the least possible effective level,” he said.

“In an ideal world, we would have preconception counseling and would be thinking of an alternative drug several years before pregnancy.”

Disclosures: The NEAD study is funded by the National Institutes of Health. Dr. Baker said he had no financial disclosures.

BANGKOK, THAILAND — Expressive and receptive language abilities are significantly poorer in 3-year-olds who were exposed to sodium valproate in utero than they are in children who were exposed to other individual antiepileptic drugs during gestation, based on a subanalysis of the Neurodevelopmental Effects of Antiepileptic Drugs study.

Valproate exposure was associated with a 10-point difference on both language measures compared with exposure to phenytoin, carbamazepine, or lamotrigine—a difference that is not only statistically significant, but clinically important as well, Gus A. Baker, Ph.D., said at the World Congress of Neurology.

The differences apparent in these 3-year-old subjects will likely expand as the groups grow older, said Dr. Baker, director of the division of neurosciences at the Walton Centre for Neurology and Neurosurgery in Liverpool, England. “We can expect the difference in the magnitude to get greater and not smaller with age,” he said. Already, Dr. Baker noted, valproate-exposed 3-year-olds in the U.K. portion of the study are lagging behind a group of matched controls. “Well over a third of those exposed to valproate have been referred for speech therapy, so we see that this 10-point difference has real meaning in terms of day-to-day practice.”

The prospective, observational Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study included 303 pregnant women who were taking sodium valproate, carbamazepine, lamotrigine, or phenytoin as monotherapy. Enrollment occurred during 1999-2004 in 25 epilepsy centers in the United States and the United Kingdom. Separate investigations in the United States and the United Kingdom were later combined. The primary outcome was cognitive performance of the children at 6 years of age.

Dr. Baker, a primary investigator in the U.K. study and coinvestigator in the overall study, presented the results of the drugs' effect on expressive and receptive language development among 234 children who were 3 years old at assessment. The children all underwent testing of verbal and nonverbal communication, including expressive and receptive language, visual motor construction, and nonverbal intellectual ability.

Their abilities in these areas were determined by calculating subscores on screening tests called the Differential Ability Scales (2nd ed.) and the Preschool Language Scale (4th Ed.). The scores were adjusted for factors known to affect child intellect.

“We saw that maternal IQ, antiepileptic drug (AED) dose, maternal age, gestational age, and preconceptional exposure to folate were significant factors predicting the scores, as we would expect,” he said. “But we also showed that overall, the scores for valproate-exposed children were significantly lower than all other drugs and the magnitude of the effect was greater for verbal than nonverbal language.”

Testing showed that the children exposed to valproate scored significantly lower on measures of expressive language (mean score of 91 vs. 102 for carbamazepine, 104 for lamotrigine, and 101 for phenytoin) and receptive language (mean score of 89 vs. 97 for carbamazepine, 101 for lamotrigine, and 101 for phenytoin). On visual motor construction and nonverbal intellectual ability, children exposed to valproate scored lower, but not significantly lower, than children exposed to the other drugs.

In terms of developmental milestones, this finding could bode ill for the valproate-exposed children, said Dr. Baker. “Without a cohesive and intact language system, a child's neurodevelopmental progress will be limited.”

Unlike the physical results of in utero valproate exposure, which can be surgically corrected to at least some degree, the cognitive effects cannot be erased, he pointed out. The best hope for such children is early identification and intervention. “If we identify them now, we have to think about an appropriate intervention now. If we leave it for later, the gains they might make will be limited.”

“For women for whom sodium valproate is the first choice because of the nature of their seizures, we should be thinking about reducing the dose to the least possible effective level,” he said.

“In an ideal world, we would have preconception counseling and would be thinking of an alternative drug several years before pregnancy.”

Disclosures: The NEAD study is funded by the National Institutes of Health. Dr. Baker said he had no financial disclosures.

BANGKOK, THAILAND — Expressive and receptive language abilities are significantly poorer in 3-year-olds who were exposed to sodium valproate in utero than they are in children who were exposed to other individual antiepileptic drugs during gestation, based on a subanalysis of the Neurodevelopmental Effects of Antiepileptic Drugs study.

Valproate exposure was associated with a 10-point difference on both language measures compared with exposure to phenytoin, carbamazepine, or lamotrigine—a difference that is not only statistically significant, but clinically important as well, Gus A. Baker, Ph.D., said at the World Congress of Neurology.

The differences apparent in these 3-year-old subjects will likely expand as the groups grow older, said Dr. Baker, director of the division of neurosciences at the Walton Centre for Neurology and Neurosurgery in Liverpool, England. “We can expect the difference in the magnitude to get greater and not smaller with age,” he said. Already, Dr. Baker noted, valproate-exposed 3-year-olds in the U.K. portion of the study are lagging behind a group of matched controls. “Well over a third of those exposed to valproate have been referred for speech therapy, so we see that this 10-point difference has real meaning in terms of day-to-day practice.”

The prospective, observational Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study included 303 pregnant women who were taking sodium valproate, carbamazepine, lamotrigine, or phenytoin as monotherapy. Enrollment occurred during 1999-2004 in 25 epilepsy centers in the United States and the United Kingdom. Separate investigations in the United States and the United Kingdom were later combined. The primary outcome was cognitive performance of the children at 6 years of age.

Dr. Baker, a primary investigator in the U.K. study and coinvestigator in the overall study, presented the results of the drugs' effect on expressive and receptive language development among 234 children who were 3 years old at assessment. The children all underwent testing of verbal and nonverbal communication, including expressive and receptive language, visual motor construction, and nonverbal intellectual ability.

Their abilities in these areas were determined by calculating subscores on screening tests called the Differential Ability Scales (2nd ed.) and the Preschool Language Scale (4th Ed.). The scores were adjusted for factors known to affect child intellect.

“We saw that maternal IQ, antiepileptic drug (AED) dose, maternal age, gestational age, and preconceptional exposure to folate were significant factors predicting the scores, as we would expect,” he said. “But we also showed that overall, the scores for valproate-exposed children were significantly lower than all other drugs and the magnitude of the effect was greater for verbal than nonverbal language.”

Testing showed that the children exposed to valproate scored significantly lower on measures of expressive language (mean score of 91 vs. 102 for carbamazepine, 104 for lamotrigine, and 101 for phenytoin) and receptive language (mean score of 89 vs. 97 for carbamazepine, 101 for lamotrigine, and 101 for phenytoin). On visual motor construction and nonverbal intellectual ability, children exposed to valproate scored lower, but not significantly lower, than children exposed to the other drugs.

In terms of developmental milestones, this finding could bode ill for the valproate-exposed children, said Dr. Baker. “Without a cohesive and intact language system, a child's neurodevelopmental progress will be limited.”

Unlike the physical results of in utero valproate exposure, which can be surgically corrected to at least some degree, the cognitive effects cannot be erased, he pointed out. The best hope for such children is early identification and intervention. “If we identify them now, we have to think about an appropriate intervention now. If we leave it for later, the gains they might make will be limited.”

“For women for whom sodium valproate is the first choice because of the nature of their seizures, we should be thinking about reducing the dose to the least possible effective level,” he said.

“In an ideal world, we would have preconception counseling and would be thinking of an alternative drug several years before pregnancy.”

Disclosures: Dr. Chang said she had no relevant financial disclosures.

KISSIMMEE, FLA. — Color Doppler imaging is highly sensitive for endometrial polyps, because it can identify the feeding vessel that allows the polyp to grow, according to Dr. Pauline L. Chang.

A retrospective study of 74 women found that color Doppler had an overall sensitivity of 89% and a positive predictive value of 80% for endometrial polyps. Among only premenopausal women, the sensitivity was even better at 96%, she said at the annual meeting of the AAGL.

In fact, said Dr. Chang of Stanford (Calif.) University, the test's diagnostic values are so good that a positive color Doppler should eliminate the need for second-line testing.

“For women with a positive transvaginal color Doppler, additional imaging, such as saline-infusion sonohysterography, is not necessary for confirmation before proceeding to definitive management with hysteroscopy,” she said.

All 74 of the women in the study had undergone a transvaginal pelvic sonogram that suggested endometrial polyps. However, color Doppler imaging revealed vascularity in 64 patients, and hysteroscopy confirmed this finding in 51 of them.

There were 13 false-positive results, which hysteroscopy confirmed as normal in five women, fibroids in seven, and a dense adhesion in one Thus, Dr. Chang said, “vascularity on Doppler imaging had a sensitivity of 89.5% and a positive predictive value of 80% for detection of endometrial polyps.”

Dr. Chang then divided the group into premenopausal and postmenopausal women. For the 61 premenopausal women who had evidence of endometrial polyps on transvaginal ultrasound, color Doppler found vascularity in 55; there were 11 false positives confirmed by hysteroscopy. For this group, the sensitivity of color Doppler for endometrial polyps was 96%, and the positive predictive value was 80%.

In the group of 13 menopausal women, color Doppler identified 9 with vascular polyps; there were two false positives, Dr. Chang reported. For the menopausal group, Doppler had a sensitivity of 67% and a 78% positive predictive value.

A focal abnormality on grayscale ultrasound suggests an endometrial polyp.

Color Doppler reveals vascularity, increasing the suspicion of a polyp.

Source Images courtesy Dr. Pauline L. Chang

Disclosures: Dr. Chang said she had no relevant financial disclosures.

KISSIMMEE, FLA. — Color Doppler imaging is highly sensitive for endometrial polyps, because it can identify the feeding vessel that allows the polyp to grow, according to Dr. Pauline L. Chang.

A retrospective study of 74 women found that color Doppler had an overall sensitivity of 89% and a positive predictive value of 80% for endometrial polyps. Among only premenopausal women, the sensitivity was even better at 96%, she said at the annual meeting of the AAGL.

In fact, said Dr. Chang of Stanford (Calif.) University, the test's diagnostic values are so good that a positive color Doppler should eliminate the need for second-line testing.

“For women with a positive transvaginal color Doppler, additional imaging, such as saline-infusion sonohysterography, is not necessary for confirmation before proceeding to definitive management with hysteroscopy,” she said.

All 74 of the women in the study had undergone a transvaginal pelvic sonogram that suggested endometrial polyps. However, color Doppler imaging revealed vascularity in 64 patients, and hysteroscopy confirmed this finding in 51 of them.

There were 13 false-positive results, which hysteroscopy confirmed as normal in five women, fibroids in seven, and a dense adhesion in one Thus, Dr. Chang said, “vascularity on Doppler imaging had a sensitivity of 89.5% and a positive predictive value of 80% for detection of endometrial polyps.”

Dr. Chang then divided the group into premenopausal and postmenopausal women. For the 61 premenopausal women who had evidence of endometrial polyps on transvaginal ultrasound, color Doppler found vascularity in 55; there were 11 false positives confirmed by hysteroscopy. For this group, the sensitivity of color Doppler for endometrial polyps was 96%, and the positive predictive value was 80%.

In the group of 13 menopausal women, color Doppler identified 9 with vascular polyps; there were two false positives, Dr. Chang reported. For the menopausal group, Doppler had a sensitivity of 67% and a 78% positive predictive value.

A focal abnormality on grayscale ultrasound suggests an endometrial polyp.

Color Doppler reveals vascularity, increasing the suspicion of a polyp.

Source Images courtesy Dr. Pauline L. Chang

Disclosures: Dr. Chang said she had no relevant financial disclosures.

KISSIMMEE, FLA. — Color Doppler imaging is highly sensitive for endometrial polyps, because it can identify the feeding vessel that allows the polyp to grow, according to Dr. Pauline L. Chang.

A retrospective study of 74 women found that color Doppler had an overall sensitivity of 89% and a positive predictive value of 80% for endometrial polyps. Among only premenopausal women, the sensitivity was even better at 96%, she said at the annual meeting of the AAGL.

In fact, said Dr. Chang of Stanford (Calif.) University, the test's diagnostic values are so good that a positive color Doppler should eliminate the need for second-line testing.

“For women with a positive transvaginal color Doppler, additional imaging, such as saline-infusion sonohysterography, is not necessary for confirmation before proceeding to definitive management with hysteroscopy,” she said.

All 74 of the women in the study had undergone a transvaginal pelvic sonogram that suggested endometrial polyps. However, color Doppler imaging revealed vascularity in 64 patients, and hysteroscopy confirmed this finding in 51 of them.

There were 13 false-positive results, which hysteroscopy confirmed as normal in five women, fibroids in seven, and a dense adhesion in one Thus, Dr. Chang said, “vascularity on Doppler imaging had a sensitivity of 89.5% and a positive predictive value of 80% for detection of endometrial polyps.”

Dr. Chang then divided the group into premenopausal and postmenopausal women. For the 61 premenopausal women who had evidence of endometrial polyps on transvaginal ultrasound, color Doppler found vascularity in 55; there were 11 false positives confirmed by hysteroscopy. For this group, the sensitivity of color Doppler for endometrial polyps was 96%, and the positive predictive value was 80%.

In the group of 13 menopausal women, color Doppler identified 9 with vascular polyps; there were two false positives, Dr. Chang reported. For the menopausal group, Doppler had a sensitivity of 67% and a 78% positive predictive value.

A focal abnormality on grayscale ultrasound suggests an endometrial polyp.

Color Doppler reveals vascularity, increasing the suspicion of a polyp.

Source Images courtesy Dr. Pauline L. Chang

Disclosures: Dr. Kim said she had no conflicts of interest to disclose.

KISSIMMEE, FLA. — Robotic-assisted laparoscopic hysterectomy appears to be feasible and safe in morbidly obese women, with intraoperative and postoperative surgical outcomes similar to those seen in women with a lower body mass index, according to Dr. Jin Hee Kim.

At the annual meeting of the AAGL, she said, “Given these findings, we feel [that] robotic-assisted laparoscopy may play a role in decreasing the technical difficulties encountered in laparoscopic surgery, especially in overweight women.” Dr. Kim presented the results of a retrospective cohort study she performed with her colleagues at the University of Michigan, Ann Arbor. Since then, she has moved to Columbia University, New York.

The study group included 157 consecutive patients who underwent robotic-assisted laparoscopic hysterectomy at a single center from 2002 to 2009. All surgical indications were benign, including fibroids, endometriosis, pain, and abnormal bleeding. The patients were divided into two groups—those with a body mass index of less than 35 kg/m

The only significant surgical difference was operative time, Dr. Kim said. Women in the higher-weight group had a mean operative time of 214 minutes, compared with 189 minutes in the lower-weight group.

Mean blood loss was 97 mL in the higher-weight group and 72 mL in the lower-weight group, not significantly different. There was no intraoperative organ/vascular injury in the higher-weight group, while two such injuries occurred in the lower-weight group; again, this was not a significant difference. There were no significant differences in conversion to open surgery, postoperative vaginal cuff complications, and unplanned readmission within 60 days, reoperation, or length of hospital stay.

“Although women with a BMI of 35 kg/m

Disclosures: Dr. Kim said she had no conflicts of interest to disclose.

KISSIMMEE, FLA. — Robotic-assisted laparoscopic hysterectomy appears to be feasible and safe in morbidly obese women, with intraoperative and postoperative surgical outcomes similar to those seen in women with a lower body mass index, according to Dr. Jin Hee Kim.

At the annual meeting of the AAGL, she said, “Given these findings, we feel [that] robotic-assisted laparoscopy may play a role in decreasing the technical difficulties encountered in laparoscopic surgery, especially in overweight women.” Dr. Kim presented the results of a retrospective cohort study she performed with her colleagues at the University of Michigan, Ann Arbor. Since then, she has moved to Columbia University, New York.

The study group included 157 consecutive patients who underwent robotic-assisted laparoscopic hysterectomy at a single center from 2002 to 2009. All surgical indications were benign, including fibroids, endometriosis, pain, and abnormal bleeding. The patients were divided into two groups—those with a body mass index of less than 35 kg/m

The only significant surgical difference was operative time, Dr. Kim said. Women in the higher-weight group had a mean operative time of 214 minutes, compared with 189 minutes in the lower-weight group.

Mean blood loss was 97 mL in the higher-weight group and 72 mL in the lower-weight group, not significantly different. There was no intraoperative organ/vascular injury in the higher-weight group, while two such injuries occurred in the lower-weight group; again, this was not a significant difference. There were no significant differences in conversion to open surgery, postoperative vaginal cuff complications, and unplanned readmission within 60 days, reoperation, or length of hospital stay.

“Although women with a BMI of 35 kg/m

Disclosures: Dr. Kim said she had no conflicts of interest to disclose.

KISSIMMEE, FLA. — Robotic-assisted laparoscopic hysterectomy appears to be feasible and safe in morbidly obese women, with intraoperative and postoperative surgical outcomes similar to those seen in women with a lower body mass index, according to Dr. Jin Hee Kim.

At the annual meeting of the AAGL, she said, “Given these findings, we feel [that] robotic-assisted laparoscopy may play a role in decreasing the technical difficulties encountered in laparoscopic surgery, especially in overweight women.” Dr. Kim presented the results of a retrospective cohort study she performed with her colleagues at the University of Michigan, Ann Arbor. Since then, she has moved to Columbia University, New York.

The study group included 157 consecutive patients who underwent robotic-assisted laparoscopic hysterectomy at a single center from 2002 to 2009. All surgical indications were benign, including fibroids, endometriosis, pain, and abnormal bleeding. The patients were divided into two groups—those with a body mass index of less than 35 kg/m

The only significant surgical difference was operative time, Dr. Kim said. Women in the higher-weight group had a mean operative time of 214 minutes, compared with 189 minutes in the lower-weight group.

Mean blood loss was 97 mL in the higher-weight group and 72 mL in the lower-weight group, not significantly different. There was no intraoperative organ/vascular injury in the higher-weight group, while two such injuries occurred in the lower-weight group; again, this was not a significant difference. There were no significant differences in conversion to open surgery, postoperative vaginal cuff complications, and unplanned readmission within 60 days, reoperation, or length of hospital stay.

“Although women with a BMI of 35 kg/m

Disclosures: Dr. Sakhel said he had no disclosures.

KISSIMMEE, FLA. — Robotic-assisted laparoscopic hysterectomy is a safe alternative to total laparoscopic hysterectomy, offering the advantages of shorter operating room time, significantly less blood loss, and fewer conversions to open surgery, according to Dr. Khaled Sakhel.

“The room time in our study was significantly shorter in the robotic-assisted group, despite the fact that the induction time was 6 minutes longer,” he said at the annual meeting of the AAGL. “The surgeon was able to make up that lost time and more,” leaving the operating room a mean of 10 minutes sooner than surgeons who performed a total laparoscopic procedure.

Dr. Sakhel reported a prospective comparative study conducted while he was at Michigan State University, East Lansing; he has since moved to Eastern Medical School, Norfolk, Va.

The cohort consisted of 136 women (mean age 46 years) who underwent total laparoscopic hysterectomy or robotic-assisted laparoscopic hysterectomy at two Michigan hospitals. Patients were not randomized; instead, insurance companies decided which hospital would be used.

Group 1 consisted of 73 women who were assigned to a hospital that had a robotic surgical system; the 63 patients in group 2 were assigned to a hospital without such a system. The patients' mean weight was 180 pounds. There were no significant demographic or diagnostic differences between the two groups. A single surgeon performed all the procedures.

The study examined three time outcomes in addition to clinical outcomes. Total room time was defined as “wheels in, wheels out.” Induction time was defined as “wheels in to incision time.” Procedure time was defined as incision to closure time.

Total room time was significantly less in the robotic group (125 vs. 135 minutes). Induction time was significantly longer in the robotic group (27 vs. 21 minutes), because of the additional time in docking the robotic system. Procedure time was significantly shorter in the robotic group (82 vs. 108 minutes).

Mean blood loss was significantly less in the robotic group (46 mL vs. 114 mL). There was one complication in the robotic group (a retained asepto bulb due to miscommunication among the surgical team), and two complications in the total laparoscopic group—both cystotomies. The difference in complications was not statistically significant.

Significantly more patients were discharged postoperatively on the day of the robotic surgery procedure, compared with those who had total laparoscopy (90% vs. 70%). On the second postoperative day, all of the remaining robotic surgery patients went home, compared with 93% of those remaining who underwent total laparoscopy, although this difference was not statistically significant.

Elsevier Global Medical News

Disclosures: Dr. Sakhel said he had no disclosures.

KISSIMMEE, FLA. — Robotic-assisted laparoscopic hysterectomy is a safe alternative to total laparoscopic hysterectomy, offering the advantages of shorter operating room time, significantly less blood loss, and fewer conversions to open surgery, according to Dr. Khaled Sakhel.

“The room time in our study was significantly shorter in the robotic-assisted group, despite the fact that the induction time was 6 minutes longer,” he said at the annual meeting of the AAGL. “The surgeon was able to make up that lost time and more,” leaving the operating room a mean of 10 minutes sooner than surgeons who performed a total laparoscopic procedure.

Dr. Sakhel reported a prospective comparative study conducted while he was at Michigan State University, East Lansing; he has since moved to Eastern Medical School, Norfolk, Va.

The cohort consisted of 136 women (mean age 46 years) who underwent total laparoscopic hysterectomy or robotic-assisted laparoscopic hysterectomy at two Michigan hospitals. Patients were not randomized; instead, insurance companies decided which hospital would be used.

Group 1 consisted of 73 women who were assigned to a hospital that had a robotic surgical system; the 63 patients in group 2 were assigned to a hospital without such a system. The patients' mean weight was 180 pounds. There were no significant demographic or diagnostic differences between the two groups. A single surgeon performed all the procedures.

The study examined three time outcomes in addition to clinical outcomes. Total room time was defined as “wheels in, wheels out.” Induction time was defined as “wheels in to incision time.” Procedure time was defined as incision to closure time.

Total room time was significantly less in the robotic group (125 vs. 135 minutes). Induction time was significantly longer in the robotic group (27 vs. 21 minutes), because of the additional time in docking the robotic system. Procedure time was significantly shorter in the robotic group (82 vs. 108 minutes).

Mean blood loss was significantly less in the robotic group (46 mL vs. 114 mL). There was one complication in the robotic group (a retained asepto bulb due to miscommunication among the surgical team), and two complications in the total laparoscopic group—both cystotomies. The difference in complications was not statistically significant.

Significantly more patients were discharged postoperatively on the day of the robotic surgery procedure, compared with those who had total laparoscopy (90% vs. 70%). On the second postoperative day, all of the remaining robotic surgery patients went home, compared with 93% of those remaining who underwent total laparoscopy, although this difference was not statistically significant.

Elsevier Global Medical News

Disclosures: Dr. Sakhel said he had no disclosures.

KISSIMMEE, FLA. — Robotic-assisted laparoscopic hysterectomy is a safe alternative to total laparoscopic hysterectomy, offering the advantages of shorter operating room time, significantly less blood loss, and fewer conversions to open surgery, according to Dr. Khaled Sakhel.

“The room time in our study was significantly shorter in the robotic-assisted group, despite the fact that the induction time was 6 minutes longer,” he said at the annual meeting of the AAGL. “The surgeon was able to make up that lost time and more,” leaving the operating room a mean of 10 minutes sooner than surgeons who performed a total laparoscopic procedure.

Dr. Sakhel reported a prospective comparative study conducted while he was at Michigan State University, East Lansing; he has since moved to Eastern Medical School, Norfolk, Va.

The cohort consisted of 136 women (mean age 46 years) who underwent total laparoscopic hysterectomy or robotic-assisted laparoscopic hysterectomy at two Michigan hospitals. Patients were not randomized; instead, insurance companies decided which hospital would be used.

Group 1 consisted of 73 women who were assigned to a hospital that had a robotic surgical system; the 63 patients in group 2 were assigned to a hospital without such a system. The patients' mean weight was 180 pounds. There were no significant demographic or diagnostic differences between the two groups. A single surgeon performed all the procedures.

The study examined three time outcomes in addition to clinical outcomes. Total room time was defined as “wheels in, wheels out.” Induction time was defined as “wheels in to incision time.” Procedure time was defined as incision to closure time.

Total room time was significantly less in the robotic group (125 vs. 135 minutes). Induction time was significantly longer in the robotic group (27 vs. 21 minutes), because of the additional time in docking the robotic system. Procedure time was significantly shorter in the robotic group (82 vs. 108 minutes).

Mean blood loss was significantly less in the robotic group (46 mL vs. 114 mL). There was one complication in the robotic group (a retained asepto bulb due to miscommunication among the surgical team), and two complications in the total laparoscopic group—both cystotomies. The difference in complications was not statistically significant.

Significantly more patients were discharged postoperatively on the day of the robotic surgery procedure, compared with those who had total laparoscopy (90% vs. 70%). On the second postoperative day, all of the remaining robotic surgery patients went home, compared with 93% of those remaining who underwent total laparoscopy, although this difference was not statistically significant.

Elsevier Global Medical News

Major Finding: “Real-world” multiple sclerosis patients treated with natalizumab had rates of adverse events and reduction in relapses similar to those observed in patients in phase III trials.

Data Source: Ongoing postmarketing observational study of 1,011 patients.

Disclosures: Study funded by Biogen Idec Inc.; Dr. Trojano, consulting or speaking fees from Biogen Idec and research funding from Merck Serono.

BANGKOK, THAILAND — The effects and adverse event profile of natalizumab in multiple sclerosis patients seen in highly controlled phase III trials continue to be observed in patients who are participating in an ongoing, postmarketing observational trial of the drug.

The Tysabri Observational Program (TOP) is an ongoing evaluation of the drug's effect in 1,011 patients, whose baseline characteristics were quite different from those of patients included in the AFFIRM (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis) trials, on which the drug's approval was based, said Dr. Maria Trojano, who presented the results at the World Congress of Neurology.

The AFFIRM trial lasted 2 years, and showed a 68% reduction in the relapse rate among all patients, as well as a 42% reduction in sustained EDSS progression. Natalizumab (Tysabri) was also effective in patients with highly active disease, reducing the annual relapse rate by 81%, and the EDSS progression rate by 53%. Safety was good, with a 4% rate of adverse events, 1% of which were considered serious.

The TOP study (www.clinicaltrials.gov/ct2/show/NCT00493298

The question TOP must answer, Dr. Trojano said, is: “Does natalizumab in real life produce a similar highly reducing effect on disease activity and progression, while keeping the same safety?”

At baseline, TOP's cohort was significantly older than those in AFFIRM (38 vs. 36 years), with a longer mean duration of disease (7.5 vs. 5 years), and a worse mean score on the Expanded Disability Status Scale (EDSS; 3.7 vs. 2.3). TOP patients also had a higher annual relapse rate than did AFFIRM patients (2.03 vs. 1.53), noted Dr. Trojano of the University of Bari, Italy.

As of July 2009, patients in TOP had taken a mean of 7 doses of natalizumab, giving a base of 556 person-years to evaluate.

Natalizumab was associated with a steep decline in annualized relapse rate, dropping from a mean of 2 to less than 0.5 in the first month of therapy. Throughout the next 12 months, the mean relapse rate stayed below 0.5. This pattern mirrors that seen in the AFFIRM trial, which found relapse rates below 0.5 throughout its 24-month follow-up period.

The 292 TOP patients who have completed a full 12 months of follow-up have remained clinically stable, with an EDSS score of 3.6, compared with 3.8 at baseline.

As of July 14, there had been 46 serious adverse events reported in TOP patients (4.3%). Those included 10 infections (including 4 cases of herpes zoster and 2 pneumonias); 9 hypersensitivity reactions; 19 “miscellaneous” events; and 8 events that were not yet coded.

However, Dr. Trojano said, since TOP lacked a randomized control group, an independent 5-year study will create an external patient cohort to be used for a comparison to TOP patients.

The Multiple Sclerosis Comparator Study of Efficacy of Treatment (MSCOMET) trial will provide more reliable information about the effectiveness of natalizumab.

MSCOMET will prospectively assesses clinical effectiveness of interferon-beta or glatiramer acetate in a cohort of patients with relapsing-remitting MS.

Patients will be recruited from some centers participating in the International MSBase Registry in Melbourne, Australia. The external cohort will be selected in the MSBase Registry by a propensity score-matching technique.

Major Finding: “Real-world” multiple sclerosis patients treated with natalizumab had rates of adverse events and reduction in relapses similar to those observed in patients in phase III trials.

Data Source: Ongoing postmarketing observational study of 1,011 patients.

Disclosures: Study funded by Biogen Idec Inc.; Dr. Trojano, consulting or speaking fees from Biogen Idec and research funding from Merck Serono.

BANGKOK, THAILAND — The effects and adverse event profile of natalizumab in multiple sclerosis patients seen in highly controlled phase III trials continue to be observed in patients who are participating in an ongoing, postmarketing observational trial of the drug.

The Tysabri Observational Program (TOP) is an ongoing evaluation of the drug's effect in 1,011 patients, whose baseline characteristics were quite different from those of patients included in the AFFIRM (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis) trials, on which the drug's approval was based, said Dr. Maria Trojano, who presented the results at the World Congress of Neurology.

The AFFIRM trial lasted 2 years, and showed a 68% reduction in the relapse rate among all patients, as well as a 42% reduction in sustained EDSS progression. Natalizumab (Tysabri) was also effective in patients with highly active disease, reducing the annual relapse rate by 81%, and the EDSS progression rate by 53%. Safety was good, with a 4% rate of adverse events, 1% of which were considered serious.

The TOP study (www.clinicaltrials.gov/ct2/show/NCT00493298

The question TOP must answer, Dr. Trojano said, is: “Does natalizumab in real life produce a similar highly reducing effect on disease activity and progression, while keeping the same safety?”

At baseline, TOP's cohort was significantly older than those in AFFIRM (38 vs. 36 years), with a longer mean duration of disease (7.5 vs. 5 years), and a worse mean score on the Expanded Disability Status Scale (EDSS; 3.7 vs. 2.3). TOP patients also had a higher annual relapse rate than did AFFIRM patients (2.03 vs. 1.53), noted Dr. Trojano of the University of Bari, Italy.

As of July 2009, patients in TOP had taken a mean of 7 doses of natalizumab, giving a base of 556 person-years to evaluate.

Natalizumab was associated with a steep decline in annualized relapse rate, dropping from a mean of 2 to less than 0.5 in the first month of therapy. Throughout the next 12 months, the mean relapse rate stayed below 0.5. This pattern mirrors that seen in the AFFIRM trial, which found relapse rates below 0.5 throughout its 24-month follow-up period.

The 292 TOP patients who have completed a full 12 months of follow-up have remained clinically stable, with an EDSS score of 3.6, compared with 3.8 at baseline.

As of July 14, there had been 46 serious adverse events reported in TOP patients (4.3%). Those included 10 infections (including 4 cases of herpes zoster and 2 pneumonias); 9 hypersensitivity reactions; 19 “miscellaneous” events; and 8 events that were not yet coded.

However, Dr. Trojano said, since TOP lacked a randomized control group, an independent 5-year study will create an external patient cohort to be used for a comparison to TOP patients.

The Multiple Sclerosis Comparator Study of Efficacy of Treatment (MSCOMET) trial will provide more reliable information about the effectiveness of natalizumab.

MSCOMET will prospectively assesses clinical effectiveness of interferon-beta or glatiramer acetate in a cohort of patients with relapsing-remitting MS.

Patients will be recruited from some centers participating in the International MSBase Registry in Melbourne, Australia. The external cohort will be selected in the MSBase Registry by a propensity score-matching technique.

Major Finding: “Real-world” multiple sclerosis patients treated with natalizumab had rates of adverse events and reduction in relapses similar to those observed in patients in phase III trials.

Data Source: Ongoing postmarketing observational study of 1,011 patients.

Disclosures: Study funded by Biogen Idec Inc.; Dr. Trojano, consulting or speaking fees from Biogen Idec and research funding from Merck Serono.

BANGKOK, THAILAND — The effects and adverse event profile of natalizumab in multiple sclerosis patients seen in highly controlled phase III trials continue to be observed in patients who are participating in an ongoing, postmarketing observational trial of the drug.

The Tysabri Observational Program (TOP) is an ongoing evaluation of the drug's effect in 1,011 patients, whose baseline characteristics were quite different from those of patients included in the AFFIRM (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis) trials, on which the drug's approval was based, said Dr. Maria Trojano, who presented the results at the World Congress of Neurology.

The AFFIRM trial lasted 2 years, and showed a 68% reduction in the relapse rate among all patients, as well as a 42% reduction in sustained EDSS progression. Natalizumab (Tysabri) was also effective in patients with highly active disease, reducing the annual relapse rate by 81%, and the EDSS progression rate by 53%. Safety was good, with a 4% rate of adverse events, 1% of which were considered serious.

The TOP study (www.clinicaltrials.gov/ct2/show/NCT00493298

The question TOP must answer, Dr. Trojano said, is: “Does natalizumab in real life produce a similar highly reducing effect on disease activity and progression, while keeping the same safety?”

At baseline, TOP's cohort was significantly older than those in AFFIRM (38 vs. 36 years), with a longer mean duration of disease (7.5 vs. 5 years), and a worse mean score on the Expanded Disability Status Scale (EDSS; 3.7 vs. 2.3). TOP patients also had a higher annual relapse rate than did AFFIRM patients (2.03 vs. 1.53), noted Dr. Trojano of the University of Bari, Italy.

As of July 2009, patients in TOP had taken a mean of 7 doses of natalizumab, giving a base of 556 person-years to evaluate.

Natalizumab was associated with a steep decline in annualized relapse rate, dropping from a mean of 2 to less than 0.5 in the first month of therapy. Throughout the next 12 months, the mean relapse rate stayed below 0.5. This pattern mirrors that seen in the AFFIRM trial, which found relapse rates below 0.5 throughout its 24-month follow-up period.

The 292 TOP patients who have completed a full 12 months of follow-up have remained clinically stable, with an EDSS score of 3.6, compared with 3.8 at baseline.

As of July 14, there had been 46 serious adverse events reported in TOP patients (4.3%). Those included 10 infections (including 4 cases of herpes zoster and 2 pneumonias); 9 hypersensitivity reactions; 19 “miscellaneous” events; and 8 events that were not yet coded.

However, Dr. Trojano said, since TOP lacked a randomized control group, an independent 5-year study will create an external patient cohort to be used for a comparison to TOP patients.

The Multiple Sclerosis Comparator Study of Efficacy of Treatment (MSCOMET) trial will provide more reliable information about the effectiveness of natalizumab.

MSCOMET will prospectively assesses clinical effectiveness of interferon-beta or glatiramer acetate in a cohort of patients with relapsing-remitting MS.

Patients will be recruited from some centers participating in the International MSBase Registry in Melbourne, Australia. The external cohort will be selected in the MSBase Registry by a propensity score-matching technique.

Major Finding: Abrupt discontinuation of natalizumab coincided with a surge in gadolinium-enhancing lesions on MRI that mostly resolved by 9 months without any clinical deterioration.

Data Source: Case series of 11 patients who had received natalizumab infusions before abruptly discontinuing the therapy

Disclosures: Dr. Khan said the study was independently funded and he did not have any financial declarations to make.

BANGKOK, THAILAND — Patients with multiple sclerosis who abruptly discontinue natalizumab treatment may develop a sudden surge in the number of gadolinium-enhancing lesions apparent on imaging, which seems to resolve by 9 months.

The phenomenon is probably a reaction to the sudden resurgence of lymphocytes into the brain—a central nervous system form of immune reconstitution inflammatory syndrome, Dr. Omar Khan said at the World Congress of Neurology.

Although the dramatic imaging changes aren't accompanied by clinical deterioration, about 22% of the lesions did develop into nonenhancing T1 hypointensities, said Dr. Khan, director of the Wayne State University Multiple Sclerosis Clinical Research Center and Radiology Image Analysis Laboratory, Detroit. “Some patients may accumulate a lot of irreversible neuronal damage in this short period of time. And although it's too soon to know for sure, my gut feeling is that over 3 or 4 years, there might be some consequences.”

Dr. Khan presented a case series of 11 patients with MS who had received natalizumab infusions before stopping the treatment abruptly. The reasons for discontinuation included infusion site reactions, the development of neutralizing antibodies, changes in insurance coverage, and worries about developing progressive multifocal leukoencephalopathy.

The patients' mean age was 36 years. They had undergone a mean of 13 natalizumab infusions, although that number ranged from 8 to 21. Before taking natalizumab, their mean relapse rate was 1.6/year; the mean relapse rate at discontinuation of the drug was 0.1/year. All patients were negative for John Cunningham (JC) virus.

Before beginning natalizumab, the patients had a mean of 12 T2 lesions, two T1 lesions and 20 gadolinium-enhancing lesions on MRI. Three months after stopping the drug, the numbers of lesions increased significantly, to 17 T2 lesions, 13 T1 lesions, and 137 gadolinium-enhancing lesions. Overall, 93 of the lesions appeared in brain areas that were previously normal-appearing on imaging.

Before natalizumab discontinuation, the mean magnetization transfer ratio value of the gadolinium-enhancing lesions was 31%; at month 3, the mean value had dropped to 19%. “This is a pretty impressive decline, something telling us there might be some fairly intense inflammatory injury on these sites,” Dr. Khan said.

Despite the “alarming” scans, Dr. Khan said, the patients did not show corresponding clinical deterioration. Their mean Expanded Disability Status Scale (EDSS) was 3.2 at discontinuation and did not increase significantly by 3 months.

By 9 months, however, the scans had almost universally improved. The mean number of T2, T1, and gadolinium-enhancing lesions had dropped and were not significantly different from the number of lesions seen at baseline.

Clinically, the patients remained stable, Dr. Khan said. Their mean EDSS at 9 months was 4.0—not significantly worse than it was at natalizumab discontinuation. The mean relapse rate was also not significantly different.

The phenomenon is probably a reaction to the sudden resurgence of lymphocytes into the brain.

Source DR. KHAN

Major Finding: Abrupt discontinuation of natalizumab coincided with a surge in gadolinium-enhancing lesions on MRI that mostly resolved by 9 months without any clinical deterioration.

Data Source: Case series of 11 patients who had received natalizumab infusions before abruptly discontinuing the therapy

Disclosures: Dr. Khan said the study was independently funded and he did not have any financial declarations to make.

BANGKOK, THAILAND — Patients with multiple sclerosis who abruptly discontinue natalizumab treatment may develop a sudden surge in the number of gadolinium-enhancing lesions apparent on imaging, which seems to resolve by 9 months.

The phenomenon is probably a reaction to the sudden resurgence of lymphocytes into the brain—a central nervous system form of immune reconstitution inflammatory syndrome, Dr. Omar Khan said at the World Congress of Neurology.

Although the dramatic imaging changes aren't accompanied by clinical deterioration, about 22% of the lesions did develop into nonenhancing T1 hypointensities, said Dr. Khan, director of the Wayne State University Multiple Sclerosis Clinical Research Center and Radiology Image Analysis Laboratory, Detroit. “Some patients may accumulate a lot of irreversible neuronal damage in this short period of time. And although it's too soon to know for sure, my gut feeling is that over 3 or 4 years, there might be some consequences.”

Dr. Khan presented a case series of 11 patients with MS who had received natalizumab infusions before stopping the treatment abruptly. The reasons for discontinuation included infusion site reactions, the development of neutralizing antibodies, changes in insurance coverage, and worries about developing progressive multifocal leukoencephalopathy.

The patients' mean age was 36 years. They had undergone a mean of 13 natalizumab infusions, although that number ranged from 8 to 21. Before taking natalizumab, their mean relapse rate was 1.6/year; the mean relapse rate at discontinuation of the drug was 0.1/year. All patients were negative for John Cunningham (JC) virus.

Before beginning natalizumab, the patients had a mean of 12 T2 lesions, two T1 lesions and 20 gadolinium-enhancing lesions on MRI. Three months after stopping the drug, the numbers of lesions increased significantly, to 17 T2 lesions, 13 T1 lesions, and 137 gadolinium-enhancing lesions. Overall, 93 of the lesions appeared in brain areas that were previously normal-appearing on imaging.

Before natalizumab discontinuation, the mean magnetization transfer ratio value of the gadolinium-enhancing lesions was 31%; at month 3, the mean value had dropped to 19%. “This is a pretty impressive decline, something telling us there might be some fairly intense inflammatory injury on these sites,” Dr. Khan said.

Despite the “alarming” scans, Dr. Khan said, the patients did not show corresponding clinical deterioration. Their mean Expanded Disability Status Scale (EDSS) was 3.2 at discontinuation and did not increase significantly by 3 months.

By 9 months, however, the scans had almost universally improved. The mean number of T2, T1, and gadolinium-enhancing lesions had dropped and were not significantly different from the number of lesions seen at baseline.

Clinically, the patients remained stable, Dr. Khan said. Their mean EDSS at 9 months was 4.0—not significantly worse than it was at natalizumab discontinuation. The mean relapse rate was also not significantly different.

The phenomenon is probably a reaction to the sudden resurgence of lymphocytes into the brain.

Source DR. KHAN

Major Finding: Abrupt discontinuation of natalizumab coincided with a surge in gadolinium-enhancing lesions on MRI that mostly resolved by 9 months without any clinical deterioration.

Data Source: Case series of 11 patients who had received natalizumab infusions before abruptly discontinuing the therapy

Disclosures: Dr. Khan said the study was independently funded and he did not have any financial declarations to make.

BANGKOK, THAILAND — Patients with multiple sclerosis who abruptly discontinue natalizumab treatment may develop a sudden surge in the number of gadolinium-enhancing lesions apparent on imaging, which seems to resolve by 9 months.

The phenomenon is probably a reaction to the sudden resurgence of lymphocytes into the brain—a central nervous system form of immune reconstitution inflammatory syndrome, Dr. Omar Khan said at the World Congress of Neurology.

Although the dramatic imaging changes aren't accompanied by clinical deterioration, about 22% of the lesions did develop into nonenhancing T1 hypointensities, said Dr. Khan, director of the Wayne State University Multiple Sclerosis Clinical Research Center and Radiology Image Analysis Laboratory, Detroit. “Some patients may accumulate a lot of irreversible neuronal damage in this short period of time. And although it's too soon to know for sure, my gut feeling is that over 3 or 4 years, there might be some consequences.”

Dr. Khan presented a case series of 11 patients with MS who had received natalizumab infusions before stopping the treatment abruptly. The reasons for discontinuation included infusion site reactions, the development of neutralizing antibodies, changes in insurance coverage, and worries about developing progressive multifocal leukoencephalopathy.

The patients' mean age was 36 years. They had undergone a mean of 13 natalizumab infusions, although that number ranged from 8 to 21. Before taking natalizumab, their mean relapse rate was 1.6/year; the mean relapse rate at discontinuation of the drug was 0.1/year. All patients were negative for John Cunningham (JC) virus.

Before beginning natalizumab, the patients had a mean of 12 T2 lesions, two T1 lesions and 20 gadolinium-enhancing lesions on MRI. Three months after stopping the drug, the numbers of lesions increased significantly, to 17 T2 lesions, 13 T1 lesions, and 137 gadolinium-enhancing lesions. Overall, 93 of the lesions appeared in brain areas that were previously normal-appearing on imaging.

Before natalizumab discontinuation, the mean magnetization transfer ratio value of the gadolinium-enhancing lesions was 31%; at month 3, the mean value had dropped to 19%. “This is a pretty impressive decline, something telling us there might be some fairly intense inflammatory injury on these sites,” Dr. Khan said.

Despite the “alarming” scans, Dr. Khan said, the patients did not show corresponding clinical deterioration. Their mean Expanded Disability Status Scale (EDSS) was 3.2 at discontinuation and did not increase significantly by 3 months.

By 9 months, however, the scans had almost universally improved. The mean number of T2, T1, and gadolinium-enhancing lesions had dropped and were not significantly different from the number of lesions seen at baseline.

Clinically, the patients remained stable, Dr. Khan said. Their mean EDSS at 9 months was 4.0—not significantly worse than it was at natalizumab discontinuation. The mean relapse rate was also not significantly different.

The phenomenon is probably a reaction to the sudden resurgence of lymphocytes into the brain.

Source DR. KHAN

With 100 million doses of pandemic H1N1 influenza now available, Americans have a “unique opportunity” to minimize—or even prevent—a third wave of the disease this winter.

Thus far, most vaccine has been reserved for high-priority groups that are most vulnerable to H1N1, but vaccine production is now in full swing and federal officials are urging everyone to get immunized.

“For a while, low-risk groups were told to get to the back of the line and let the high-priority folks get vaccinated,” Health and Human Services Secretary Kathleen Sebelius said during a press conference in December. “Our message now is to take advantage of the increased supply and get vaccinated as soon as you can.”

Cases of H1N1 have been tapering off in the past weeks, said Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, Atlanta. However, the country is just 2 months into the normal flu season, which runs from October to May, and peaks in January and February.

“The situation we have now is an ebbing second wave, but the future is uncertain,” he said. “We just don't know how many cases we will have from now until the end of the flu season. What we need now is perseverance.”

The past may provide some insight into the future, he said. “In 1967–1968, there were large numbers of [H1N1] infections in the spring and they fell during the fall. This resulted in no vaccinations in the fall and no one realized there was still lots of flu around until there were increased deaths from pneumonia in the winter.”

Complacency is a mistake, they agreed. “H1N1 has had a substantial effect,” Dr. Frieden said. “As of mid-November, there have been 47 million cases, 213,000 hospitalizations, and 10,000 deaths. This strain has been much harder on children and young adults; the number killed through mid-November was five times more than an average flu season.”

Officials also tried to dispel some public concern that the government rushed the vaccine through development with insufficient safety testing. While it's true that the vaccine was developed, tested, and licensed in “record time,” the steps remained methodical, science-based, and complete, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“The process of identification and growing of the virus, and vaccine development and production, was exactly the same [as that for seasonal flu]. It was an orderly scientific process” that resulted in a highly immunogenic vaccine safe for adults, children, pregnant women, and the elderly, as well as those with asthma and HIV infection.

With 100 million doses of pandemic H1N1 influenza now available, Americans have a “unique opportunity” to minimize—or even prevent—a third wave of the disease this winter.

Thus far, most vaccine has been reserved for high-priority groups that are most vulnerable to H1N1, but vaccine production is now in full swing and federal officials are urging everyone to get immunized.

“For a while, low-risk groups were told to get to the back of the line and let the high-priority folks get vaccinated,” Health and Human Services Secretary Kathleen Sebelius said during a press conference in December. “Our message now is to take advantage of the increased supply and get vaccinated as soon as you can.”

Cases of H1N1 have been tapering off in the past weeks, said Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, Atlanta. However, the country is just 2 months into the normal flu season, which runs from October to May, and peaks in January and February.

“The situation we have now is an ebbing second wave, but the future is uncertain,” he said. “We just don't know how many cases we will have from now until the end of the flu season. What we need now is perseverance.”

The past may provide some insight into the future, he said. “In 1967–1968, there were large numbers of [H1N1] infections in the spring and they fell during the fall. This resulted in no vaccinations in the fall and no one realized there was still lots of flu around until there were increased deaths from pneumonia in the winter.”

Complacency is a mistake, they agreed. “H1N1 has had a substantial effect,” Dr. Frieden said. “As of mid-November, there have been 47 million cases, 213,000 hospitalizations, and 10,000 deaths. This strain has been much harder on children and young adults; the number killed through mid-November was five times more than an average flu season.”

Officials also tried to dispel some public concern that the government rushed the vaccine through development with insufficient safety testing. While it's true that the vaccine was developed, tested, and licensed in “record time,” the steps remained methodical, science-based, and complete, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“The process of identification and growing of the virus, and vaccine development and production, was exactly the same [as that for seasonal flu]. It was an orderly scientific process” that resulted in a highly immunogenic vaccine safe for adults, children, pregnant women, and the elderly, as well as those with asthma and HIV infection.

With 100 million doses of pandemic H1N1 influenza now available, Americans have a “unique opportunity” to minimize—or even prevent—a third wave of the disease this winter.

Thus far, most vaccine has been reserved for high-priority groups that are most vulnerable to H1N1, but vaccine production is now in full swing and federal officials are urging everyone to get immunized.

“For a while, low-risk groups were told to get to the back of the line and let the high-priority folks get vaccinated,” Health and Human Services Secretary Kathleen Sebelius said during a press conference in December. “Our message now is to take advantage of the increased supply and get vaccinated as soon as you can.”

Cases of H1N1 have been tapering off in the past weeks, said Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, Atlanta. However, the country is just 2 months into the normal flu season, which runs from October to May, and peaks in January and February.

“The situation we have now is an ebbing second wave, but the future is uncertain,” he said. “We just don't know how many cases we will have from now until the end of the flu season. What we need now is perseverance.”

The past may provide some insight into the future, he said. “In 1967–1968, there were large numbers of [H1N1] infections in the spring and they fell during the fall. This resulted in no vaccinations in the fall and no one realized there was still lots of flu around until there were increased deaths from pneumonia in the winter.”

Complacency is a mistake, they agreed. “H1N1 has had a substantial effect,” Dr. Frieden said. “As of mid-November, there have been 47 million cases, 213,000 hospitalizations, and 10,000 deaths. This strain has been much harder on children and young adults; the number killed through mid-November was five times more than an average flu season.”

Officials also tried to dispel some public concern that the government rushed the vaccine through development with insufficient safety testing. While it's true that the vaccine was developed, tested, and licensed in “record time,” the steps remained methodical, science-based, and complete, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“The process of identification and growing of the virus, and vaccine development and production, was exactly the same [as that for seasonal flu]. It was an orderly scientific process” that resulted in a highly immunogenic vaccine safe for adults, children, pregnant women, and the elderly, as well as those with asthma and HIV infection.

PHILADELPHIA – The comorbidities of anxiety and depression may not portend poorer outcome in patients being treated for severe migraine.

In fact, compared with patients who did not have anxiety or depression, patients with those disorders actually experienced greater improvement in their headache-related disability scores in a study conducted over 16 months, said Elizabeth Seng, a doctoral student in the department of psychology at Ohio University, Athens.

The results seem to belie conventional clinical wisdom that patients with psychiatric comorbidities don't respond to headache therapy as well as others, Ms. Seng said at a poster session at the International Headache Congress.

But clinician perception, rather than clinical response, is probably the root of this belief, she said in an interview. “I don't think this speaks as much to the relationship between psychiatric comorbidity and migraine, as to our assumptions about how that relationship impacts migraine treatment. In this study, participants who had comorbid depression and anxiety actually changed more over treatment,” reaching the same end points as those without depression or anxiety.

She extracted her results from the unpublished Treatment of Severe Migraine trial, led by Kenneth Holroyd, Ph.D., also of Ohio University. The trial randomized 232 patients with severe migraine. Everyone received optimal acute therapy including an abortive medication. Patients were then assigned to one of four treatment arms: placebo, beta blocker, behavioral management plus placebo, or behavioral management plus beta blocker.

The trial consisted of a 4-month run-in period and 12 months of treatment. Behavioral management consisted of clinic visits, telephone calls, and homework. The homework focused on relaxation, migraine warning signs and effective medication use, stress management or thermal biofeedback, and establishing an individual migraine management plan.

The cohort was 79% women, with a mean age of 38 years. They had an average of five headaches a month.

At baseline, patients with either anxiety or depression had higher average scores on the Headache Disability Inventory (HDI) than did those without the disorders (56 vs. 41, respectively). They also had higher scores on the Migraine-Specific Quality of Life (MSQOL) Questionnaire (43 vs. 37).

After 1 year, both groups improved significantly and similarly on both scales, regardless of their randomization group. On the HDI, those with comorbidities decreased an average of 33 points, to a score of 23; those without comorbidities dropped an average of 21 points, to a score of 20, Ms. Seng reported at the congress, sponsored by the International Headache Society and the American Headache Society.

On the MSQOL, the group with comorbidities dropped an average of 22 points to a final score of 21. The group without comorbidities dropped an average of 15 points to 22.

Ms. Seng cautioned that the results are preliminar, and the trial exncluded patients with medication overuse headache.

The study was supported by the National Institutes of Health. Merck and GlaxoSmithKline provided the study medication. Ms. Seng had no disclosures to report.

PHILADELPHIA – The comorbidities of anxiety and depression may not portend poorer outcome in patients being treated for severe migraine.

In fact, compared with patients who did not have anxiety or depression, patients with those disorders actually experienced greater improvement in their headache-related disability scores in a study conducted over 16 months, said Elizabeth Seng, a doctoral student in the department of psychology at Ohio University, Athens.

The results seem to belie conventional clinical wisdom that patients with psychiatric comorbidities don't respond to headache therapy as well as others, Ms. Seng said at a poster session at the International Headache Congress.

But clinician perception, rather than clinical response, is probably the root of this belief, she said in an interview. “I don't think this speaks as much to the relationship between psychiatric comorbidity and migraine, as to our assumptions about how that relationship impacts migraine treatment. In this study, participants who had comorbid depression and anxiety actually changed more over treatment,” reaching the same end points as those without depression or anxiety.

She extracted her results from the unpublished Treatment of Severe Migraine trial, led by Kenneth Holroyd, Ph.D., also of Ohio University. The trial randomized 232 patients with severe migraine. Everyone received optimal acute therapy including an abortive medication. Patients were then assigned to one of four treatment arms: placebo, beta blocker, behavioral management plus placebo, or behavioral management plus beta blocker.

The trial consisted of a 4-month run-in period and 12 months of treatment. Behavioral management consisted of clinic visits, telephone calls, and homework. The homework focused on relaxation, migraine warning signs and effective medication use, stress management or thermal biofeedback, and establishing an individual migraine management plan.

The cohort was 79% women, with a mean age of 38 years. They had an average of five headaches a month.

At baseline, patients with either anxiety or depression had higher average scores on the Headache Disability Inventory (HDI) than did those without the disorders (56 vs. 41, respectively). They also had higher scores on the Migraine-Specific Quality of Life (MSQOL) Questionnaire (43 vs. 37).

After 1 year, both groups improved significantly and similarly on both scales, regardless of their randomization group. On the HDI, those with comorbidities decreased an average of 33 points, to a score of 23; those without comorbidities dropped an average of 21 points, to a score of 20, Ms. Seng reported at the congress, sponsored by the International Headache Society and the American Headache Society.

On the MSQOL, the group with comorbidities dropped an average of 22 points to a final score of 21. The group without comorbidities dropped an average of 15 points to 22.

Ms. Seng cautioned that the results are preliminar, and the trial exncluded patients with medication overuse headache.

The study was supported by the National Institutes of Health. Merck and GlaxoSmithKline provided the study medication. Ms. Seng had no disclosures to report.

PHILADELPHIA – The comorbidities of anxiety and depression may not portend poorer outcome in patients being treated for severe migraine.

In fact, compared with patients who did not have anxiety or depression, patients with those disorders actually experienced greater improvement in their headache-related disability scores in a study conducted over 16 months, said Elizabeth Seng, a doctoral student in the department of psychology at Ohio University, Athens.

The results seem to belie conventional clinical wisdom that patients with psychiatric comorbidities don't respond to headache therapy as well as others, Ms. Seng said at a poster session at the International Headache Congress.

But clinician perception, rather than clinical response, is probably the root of this belief, she said in an interview. “I don't think this speaks as much to the relationship between psychiatric comorbidity and migraine, as to our assumptions about how that relationship impacts migraine treatment. In this study, participants who had comorbid depression and anxiety actually changed more over treatment,” reaching the same end points as those without depression or anxiety.

She extracted her results from the unpublished Treatment of Severe Migraine trial, led by Kenneth Holroyd, Ph.D., also of Ohio University. The trial randomized 232 patients with severe migraine. Everyone received optimal acute therapy including an abortive medication. Patients were then assigned to one of four treatment arms: placebo, beta blocker, behavioral management plus placebo, or behavioral management plus beta blocker.

The trial consisted of a 4-month run-in period and 12 months of treatment. Behavioral management consisted of clinic visits, telephone calls, and homework. The homework focused on relaxation, migraine warning signs and effective medication use, stress management or thermal biofeedback, and establishing an individual migraine management plan.

The cohort was 79% women, with a mean age of 38 years. They had an average of five headaches a month.

At baseline, patients with either anxiety or depression had higher average scores on the Headache Disability Inventory (HDI) than did those without the disorders (56 vs. 41, respectively). They also had higher scores on the Migraine-Specific Quality of Life (MSQOL) Questionnaire (43 vs. 37).

After 1 year, both groups improved significantly and similarly on both scales, regardless of their randomization group. On the HDI, those with comorbidities decreased an average of 33 points, to a score of 23; those without comorbidities dropped an average of 21 points, to a score of 20, Ms. Seng reported at the congress, sponsored by the International Headache Society and the American Headache Society.

On the MSQOL, the group with comorbidities dropped an average of 22 points to a final score of 21. The group without comorbidities dropped an average of 15 points to 22.

Ms. Seng cautioned that the results are preliminar, and the trial exncluded patients with medication overuse headache.

The study was supported by the National Institutes of Health. Merck and GlaxoSmithKline provided the study medication. Ms. Seng had no disclosures to report.

PHILADELPHIA – Migraine with aura seems to be a risk factor for cervical artery dissection, Dr. Ville Artto concluded in a poster presented at the International Headache Congress.

His study of 626 subjects found that migraine and migraine with aura were significantly more common in men and women who had experienced a cervical artery dissection than in controls.

The pathophysiologic link between migraine and cervical artery dissection remains unclear, Dr. Artto said. More than 60% of the cases who had active migraines at the time of their dissections, however, reported that their migraines were alleviated after the incident.

Patients with migraine and cervical artery dissection may represent a link between ischemic stroke and migraine, wrote Dr. Artto of the Helsinki (Finland) University Central Hospital. “This connection may represent common pathophysiological or genetic background, or both.”

The study included 313 patients, mean age 46 years, with cervical artery dissection and 313 age-matched controls. Cases were significantly more likely to smoke than were controls (37% vs. 23%) and female cases were significantly more likely than female controls to be using oral contraceptives (36% vs. 25%).

Migraine was present in 36% of cases and in 23% of controls. Migraine with aura was present in 23% of cases and 12% of controls. Both differences were significant. In women, migraine was present in 54% of cases and 35% of controls; migraine with aura was present in 35% of cases and 18% of controls. Among males, migraine was present in 27% cases and in 16% of controls; migraine with aura was present in 16% of cases and 0.4% of controls.

When the investigators compared the characteristics of the dissection between cases with and without migraines, they found similar rates of vertebrobasilar dissection, bilateral dissection, occlusion, and intracranial dissection. The National Institutes of Health Stroke Scale score was not different at onset (3 in migraineurs and 4 in nonmigraineurs). The Rankin score was similar at 3 months (1 in both groups). The rate of ischemic stroke was 68% in migraineurs and 73% in nonmigraineurs–not a significant difference.

The International Headache Society and the American Headache Society sponsored the congress. Dr. Artto report no potential conflicts of interest.

PHILADELPHIA – Migraine with aura seems to be a risk factor for cervical artery dissection, Dr. Ville Artto concluded in a poster presented at the International Headache Congress.

His study of 626 subjects found that migraine and migraine with aura were significantly more common in men and women who had experienced a cervical artery dissection than in controls.

The pathophysiologic link between migraine and cervical artery dissection remains unclear, Dr. Artto said. More than 60% of the cases who had active migraines at the time of their dissections, however, reported that their migraines were alleviated after the incident.

Patients with migraine and cervical artery dissection may represent a link between ischemic stroke and migraine, wrote Dr. Artto of the Helsinki (Finland) University Central Hospital. “This connection may represent common pathophysiological or genetic background, or both.”

The study included 313 patients, mean age 46 years, with cervical artery dissection and 313 age-matched controls. Cases were significantly more likely to smoke than were controls (37% vs. 23%) and female cases were significantly more likely than female controls to be using oral contraceptives (36% vs. 25%).

Migraine was present in 36% of cases and in 23% of controls. Migraine with aura was present in 23% of cases and 12% of controls. Both differences were significant. In women, migraine was present in 54% of cases and 35% of controls; migraine with aura was present in 35% of cases and 18% of controls. Among males, migraine was present in 27% cases and in 16% of controls; migraine with aura was present in 16% of cases and 0.4% of controls.

When the investigators compared the characteristics of the dissection between cases with and without migraines, they found similar rates of vertebrobasilar dissection, bilateral dissection, occlusion, and intracranial dissection. The National Institutes of Health Stroke Scale score was not different at onset (3 in migraineurs and 4 in nonmigraineurs). The Rankin score was similar at 3 months (1 in both groups). The rate of ischemic stroke was 68% in migraineurs and 73% in nonmigraineurs–not a significant difference.

The International Headache Society and the American Headache Society sponsored the congress. Dr. Artto report no potential conflicts of interest.

PHILADELPHIA – Migraine with aura seems to be a risk factor for cervical artery dissection, Dr. Ville Artto concluded in a poster presented at the International Headache Congress.

His study of 626 subjects found that migraine and migraine with aura were significantly more common in men and women who had experienced a cervical artery dissection than in controls.

The pathophysiologic link between migraine and cervical artery dissection remains unclear, Dr. Artto said. More than 60% of the cases who had active migraines at the time of their dissections, however, reported that their migraines were alleviated after the incident.

Patients with migraine and cervical artery dissection may represent a link between ischemic stroke and migraine, wrote Dr. Artto of the Helsinki (Finland) University Central Hospital. “This connection may represent common pathophysiological or genetic background, or both.”

The study included 313 patients, mean age 46 years, with cervical artery dissection and 313 age-matched controls. Cases were significantly more likely to smoke than were controls (37% vs. 23%) and female cases were significantly more likely than female controls to be using oral contraceptives (36% vs. 25%).

Migraine was present in 36% of cases and in 23% of controls. Migraine with aura was present in 23% of cases and 12% of controls. Both differences were significant. In women, migraine was present in 54% of cases and 35% of controls; migraine with aura was present in 35% of cases and 18% of controls. Among males, migraine was present in 27% cases and in 16% of controls; migraine with aura was present in 16% of cases and 0.4% of controls.

When the investigators compared the characteristics of the dissection between cases with and without migraines, they found similar rates of vertebrobasilar dissection, bilateral dissection, occlusion, and intracranial dissection. The National Institutes of Health Stroke Scale score was not different at onset (3 in migraineurs and 4 in nonmigraineurs). The Rankin score was similar at 3 months (1 in both groups). The rate of ischemic stroke was 68% in migraineurs and 73% in nonmigraineurs–not a significant difference.

The International Headache Society and the American Headache Society sponsored the congress. Dr. Artto report no potential conflicts of interest.

PHILADELPHIA – Chronic migraine is a much more disabling disorder than episodic migraine, causing patients to miss more than five times as many days of work, school, or household activity, according to a new subanalysis of the American Migraine Prevalence and Prevention Study.

The gap between the two disorders in missed or impaired work time is largest in young adulthood, during a person's typically most productive years, Dawn C. Buse, Ph.D., and her colleagues wrote in a poster presented at the International Headache Congress.

“Chronic migraine is a remarkably disabling disease when compared with episodic migraine in terms of lost productive time or reduced effectiveness at work, school, or home,” wrote Dr. Buse, director of psychology at the Montefiore Headache Center, New York.

“This marked difference may be even greater between chronic and episodic migraine, as our model may underestimate the impact due to the number of respondents who are occupationally disabled,”she said.

The American Migraine Prevalence and Prevention Study (AMPP) defined chronic migraine as a diagnosis of migraine with at least 15 headache days a month.

Episodic migraine was a diagnosis of migraine with 0–14 headache days a month. The assessment tool used in this subanalysis was the Migraine Disability Assessment (MIDAS) questionnaire. Days of school, work, or housework with disability were assessed by adding missed days and days when effectiveness at those venues was reduced by at least 50%. All of the numbers of missed or disabled days were estimated from a statistical model based on data from the AMPP study.

In the cohort, 11,249 participants had episodic migraine and 655 had chronic migraine.

Occupational disability was reported by 903 subjects, including 820 (7%) with episodic migraine and 83 (13%) with chronic migraine.

The number of impaired or missed work days declined with age: at 34, the average was closer to 14 days during the preceding 3 months; 12 days at age 44; and 10 days at age 54. By age 74, respondents with chronic migraine were predicted to experience an average of 6 missed or impaired work days per 3 months.

Those with episodic migraine reported many fewer missed or impaired days, without much age-related variation. At age 24, subjects were predicted to experience an average of 4 missed or disabled work or school days in the preceding 3 months. This lessened to about 2 days by age 54 and 1 by age 64.

Subjects with chronic migraine who reported household work disability days fared considerably worse. At age 24, estimates predicted an average of 43 days over the preceding 3 months when they could not perform household work or could perform only 50% or less of it. This also declined with age, but not as sharply as work/school disability days.

By age 54, the statistical models predicted an average of 35 days during the preceding 3 months when they could not perform their household chores or could do only 50% or less. By age 74, the disability days had lessened to about 30 in the preceding 3 months.

Again, the estimated number of missed or disabled housework days were lower for those with episodic migraine, with little age-related variation. At age 24, the estimated average days missed or with reduced ability were 8 during the preceding 3 months. By age 74, that had changed to an average of 5 missed or reduced housework days.

“These findings suggest that the burden of chronic migraine on productivity is substantially greater than that of episodic migraine throughout adult life,” Dr. Buse said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Vitals

Major Finding: Missed or disabled days for people with chronic migraine peak at age 24 years, with an average of 18 days during the preceding 3 months.

Data Source: Data on nearly 12,000 of 24,000 subjects in the American Migraine Prevalence and Prevention Study, an ongoing, longitudinal, prospective questionnaire study.

Disclosures: The National Headache Foundation, Ortho-McNeil Neurologics Inc., and Allergan Inc. fund the ongoing study. Dr. Buse said she had no relevant financial disclosures.

PHILADELPHIA – Chronic migraine is a much more disabling disorder than episodic migraine, causing patients to miss more than five times as many days of work, school, or household activity, according to a new subanalysis of the American Migraine Prevalence and Prevention Study.

The gap between the two disorders in missed or impaired work time is largest in young adulthood, during a person's typically most productive years, Dawn C. Buse, Ph.D., and her colleagues wrote in a poster presented at the International Headache Congress.

“Chronic migraine is a remarkably disabling disease when compared with episodic migraine in terms of lost productive time or reduced effectiveness at work, school, or home,” wrote Dr. Buse, director of psychology at the Montefiore Headache Center, New York.

“This marked difference may be even greater between chronic and episodic migraine, as our model may underestimate the impact due to the number of respondents who are occupationally disabled,”she said.

The American Migraine Prevalence and Prevention Study (AMPP) defined chronic migraine as a diagnosis of migraine with at least 15 headache days a month.

Episodic migraine was a diagnosis of migraine with 0–14 headache days a month. The assessment tool used in this subanalysis was the Migraine Disability Assessment (MIDAS) questionnaire. Days of school, work, or housework with disability were assessed by adding missed days and days when effectiveness at those venues was reduced by at least 50%. All of the numbers of missed or disabled days were estimated from a statistical model based on data from the AMPP study.

In the cohort, 11,249 participants had episodic migraine and 655 had chronic migraine.

Occupational disability was reported by 903 subjects, including 820 (7%) with episodic migraine and 83 (13%) with chronic migraine.

The number of impaired or missed work days declined with age: at 34, the average was closer to 14 days during the preceding 3 months; 12 days at age 44; and 10 days at age 54. By age 74, respondents with chronic migraine were predicted to experience an average of 6 missed or impaired work days per 3 months.

Those with episodic migraine reported many fewer missed or impaired days, without much age-related variation. At age 24, subjects were predicted to experience an average of 4 missed or disabled work or school days in the preceding 3 months. This lessened to about 2 days by age 54 and 1 by age 64.

Subjects with chronic migraine who reported household work disability days fared considerably worse. At age 24, estimates predicted an average of 43 days over the preceding 3 months when they could not perform household work or could perform only 50% or less of it. This also declined with age, but not as sharply as work/school disability days.

By age 54, the statistical models predicted an average of 35 days during the preceding 3 months when they could not perform their household chores or could do only 50% or less. By age 74, the disability days had lessened to about 30 in the preceding 3 months.

Again, the estimated number of missed or disabled housework days were lower for those with episodic migraine, with little age-related variation. At age 24, the estimated average days missed or with reduced ability were 8 during the preceding 3 months. By age 74, that had changed to an average of 5 missed or reduced housework days.

“These findings suggest that the burden of chronic migraine on productivity is substantially greater than that of episodic migraine throughout adult life,” Dr. Buse said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Vitals

Major Finding: Missed or disabled days for people with chronic migraine peak at age 24 years, with an average of 18 days during the preceding 3 months.

Data Source: Data on nearly 12,000 of 24,000 subjects in the American Migraine Prevalence and Prevention Study, an ongoing, longitudinal, prospective questionnaire study.

Disclosures: The National Headache Foundation, Ortho-McNeil Neurologics Inc., and Allergan Inc. fund the ongoing study. Dr. Buse said she had no relevant financial disclosures.

PHILADELPHIA – Chronic migraine is a much more disabling disorder than episodic migraine, causing patients to miss more than five times as many days of work, school, or household activity, according to a new subanalysis of the American Migraine Prevalence and Prevention Study.

The gap between the two disorders in missed or impaired work time is largest in young adulthood, during a person's typically most productive years, Dawn C. Buse, Ph.D., and her colleagues wrote in a poster presented at the International Headache Congress.

“Chronic migraine is a remarkably disabling disease when compared with episodic migraine in terms of lost productive time or reduced effectiveness at work, school, or home,” wrote Dr. Buse, director of psychology at the Montefiore Headache Center, New York.

“This marked difference may be even greater between chronic and episodic migraine, as our model may underestimate the impact due to the number of respondents who are occupationally disabled,”she said.

The American Migraine Prevalence and Prevention Study (AMPP) defined chronic migraine as a diagnosis of migraine with at least 15 headache days a month.

Episodic migraine was a diagnosis of migraine with 0–14 headache days a month. The assessment tool used in this subanalysis was the Migraine Disability Assessment (MIDAS) questionnaire. Days of school, work, or housework with disability were assessed by adding missed days and days when effectiveness at those venues was reduced by at least 50%. All of the numbers of missed or disabled days were estimated from a statistical model based on data from the AMPP study.

In the cohort, 11,249 participants had episodic migraine and 655 had chronic migraine.

Occupational disability was reported by 903 subjects, including 820 (7%) with episodic migraine and 83 (13%) with chronic migraine.

The number of impaired or missed work days declined with age: at 34, the average was closer to 14 days during the preceding 3 months; 12 days at age 44; and 10 days at age 54. By age 74, respondents with chronic migraine were predicted to experience an average of 6 missed or impaired work days per 3 months.

Those with episodic migraine reported many fewer missed or impaired days, without much age-related variation. At age 24, subjects were predicted to experience an average of 4 missed or disabled work or school days in the preceding 3 months. This lessened to about 2 days by age 54 and 1 by age 64.

Subjects with chronic migraine who reported household work disability days fared considerably worse. At age 24, estimates predicted an average of 43 days over the preceding 3 months when they could not perform household work or could perform only 50% or less of it. This also declined with age, but not as sharply as work/school disability days.

By age 54, the statistical models predicted an average of 35 days during the preceding 3 months when they could not perform their household chores or could do only 50% or less. By age 74, the disability days had lessened to about 30 in the preceding 3 months.

Again, the estimated number of missed or disabled housework days were lower for those with episodic migraine, with little age-related variation. At age 24, the estimated average days missed or with reduced ability were 8 during the preceding 3 months. By age 74, that had changed to an average of 5 missed or reduced housework days.

“These findings suggest that the burden of chronic migraine on productivity is substantially greater than that of episodic migraine throughout adult life,” Dr. Buse said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Vitals

Major Finding: Missed or disabled days for people with chronic migraine peak at age 24 years, with an average of 18 days during the preceding 3 months.

Data Source: Data on nearly 12,000 of 24,000 subjects in the American Migraine Prevalence and Prevention Study, an ongoing, longitudinal, prospective questionnaire study.

Disclosures: The National Headache Foundation, Ortho-McNeil Neurologics Inc., and Allergan Inc. fund the ongoing study. Dr. Buse said she had no relevant financial disclosures.