Michele G. Sullivan

PHILADELPHIA – Sumatriptan and naratriptan do not appear to significantly raise the risk of major congenital malformations in fetuses that are exposed to the drugs in utero, according to the latest analysis of an international pregnancy registry.

Established in 1996, the GlaxoSmithKline registry has accumulated data on 849 pregnancies exposed to the drugs. Birth defects occurred in 4.5% of infants exposed in the first trimester or during all of their gestation, which was not significantly higher than that previously identified for women with migraines. Major congenital malformations are known to occur in the offspring of women with migraines at a slightly higher rate than in the general population (3.4% vs. 2%-3%, respectively), Marianne C. Cunnington, Ph.D., and her colleague Sara A. Ephross, Ph.D., reported in a poster at the International Headache Congress. Both are employees of GlaxoSmithKline.

The registry relies on a voluntary reporting strategy that encourages healthcare providers to submit information on exposed pregnancies as early as possible. Retrospective case reporting also is accepted. Pregnancy outcome is ascertained by medical records that the provider forwards after birth, or by medical records confirming other outcomes, including fetal demise or abortion.

At the outset, the registry collects data on the timing, dosage, duration, indication, and administration of the drugs; maternal demographics; expected date of delivery; and any prenatal testing. At follow-up, there is a review of the pregnancy outcome, drug exposure during the pregnancy, and the women's headache history during pregnancy.

So far, the registry has amassed information on 761 pregnancies exposed to sumatriptan and 88 exposed to naratriptan. Outcomes are known for 570 of the sumatriptan-exposed pregnancies and 57 of the naratriptan-exposed pregnancies. Twenty-one sumatriptan-exposed pregnancies and 31 naratriptan-exposed pregnancies are pending delivery. The rest have been lost to follow-up, the investigators noted in their poster at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Among the sumatriptan-exposed pregnancies, there were 23 birth defects, 4 fetal deaths, 32 spontaneous fetal losses, and 11 induced abortions.

The malformations that occurred in infants who were exposed to sumatriptan in the first trimester included abnormal head circumference, single palmar crease and systolic murmur; moderate craniosynostosis; cerebral abnormality with developmental delay; partial cleft lip; ventricular septal defects (4); biliary atresia; diaphragmatic hernia; pyloric stenosis (3); anterior displacement of anus; hip dysplasia; polydactyly; malformation of left hand; and Down syndrome (3). No data were available for the three birth defects that occurred in infants who were exposed to sumatriptan after the first trimester.

Among fetuses exposed to naratriptan, there were five spontaneous losses, one induced abortion, and one live infant with a 2.5-mm ventricular septal defect that was expected to close spontaneously.

The pregnancy registry did not contain any data on the exposure to the combination of sumatriptan and naproxen.

Dr. Cunnington noted that five additional independent studies, including a Swedish study of more than 2,000 sumatriptan recipients, have failed to find an increase in birth defects associated with in utero exposure.

“While its use in pregnancy cannot be encouraged,” she wrote, “there is consistent evidence that sumatriptan is not associated with a substantial increase in the risk of major congenital malformations following exposure.”

To report pregnancies exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen combination, North American physicians can call 800-336-2176, and international physicians can call 910-256-0549.

The full report was published in Headache (doi: 10.1111/j.1526-4610.2009.01529.x).

PHILADELPHIA – Sumatriptan and naratriptan do not appear to significantly raise the risk of major congenital malformations in fetuses that are exposed to the drugs in utero, according to the latest analysis of an international pregnancy registry.

Established in 1996, the GlaxoSmithKline registry has accumulated data on 849 pregnancies exposed to the drugs. Birth defects occurred in 4.5% of infants exposed in the first trimester or during all of their gestation, which was not significantly higher than that previously identified for women with migraines. Major congenital malformations are known to occur in the offspring of women with migraines at a slightly higher rate than in the general population (3.4% vs. 2%-3%, respectively), Marianne C. Cunnington, Ph.D., and her colleague Sara A. Ephross, Ph.D., reported in a poster at the International Headache Congress. Both are employees of GlaxoSmithKline.

The registry relies on a voluntary reporting strategy that encourages healthcare providers to submit information on exposed pregnancies as early as possible. Retrospective case reporting also is accepted. Pregnancy outcome is ascertained by medical records that the provider forwards after birth, or by medical records confirming other outcomes, including fetal demise or abortion.

At the outset, the registry collects data on the timing, dosage, duration, indication, and administration of the drugs; maternal demographics; expected date of delivery; and any prenatal testing. At follow-up, there is a review of the pregnancy outcome, drug exposure during the pregnancy, and the women's headache history during pregnancy.

So far, the registry has amassed information on 761 pregnancies exposed to sumatriptan and 88 exposed to naratriptan. Outcomes are known for 570 of the sumatriptan-exposed pregnancies and 57 of the naratriptan-exposed pregnancies. Twenty-one sumatriptan-exposed pregnancies and 31 naratriptan-exposed pregnancies are pending delivery. The rest have been lost to follow-up, the investigators noted in their poster at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Among the sumatriptan-exposed pregnancies, there were 23 birth defects, 4 fetal deaths, 32 spontaneous fetal losses, and 11 induced abortions.

The malformations that occurred in infants who were exposed to sumatriptan in the first trimester included abnormal head circumference, single palmar crease and systolic murmur; moderate craniosynostosis; cerebral abnormality with developmental delay; partial cleft lip; ventricular septal defects (4); biliary atresia; diaphragmatic hernia; pyloric stenosis (3); anterior displacement of anus; hip dysplasia; polydactyly; malformation of left hand; and Down syndrome (3). No data were available for the three birth defects that occurred in infants who were exposed to sumatriptan after the first trimester.

Among fetuses exposed to naratriptan, there were five spontaneous losses, one induced abortion, and one live infant with a 2.5-mm ventricular septal defect that was expected to close spontaneously.

The pregnancy registry did not contain any data on the exposure to the combination of sumatriptan and naproxen.

Dr. Cunnington noted that five additional independent studies, including a Swedish study of more than 2,000 sumatriptan recipients, have failed to find an increase in birth defects associated with in utero exposure.

“While its use in pregnancy cannot be encouraged,” she wrote, “there is consistent evidence that sumatriptan is not associated with a substantial increase in the risk of major congenital malformations following exposure.”

To report pregnancies exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen combination, North American physicians can call 800-336-2176, and international physicians can call 910-256-0549.

The full report was published in Headache (doi: 10.1111/j.1526-4610.2009.01529.x).

PHILADELPHIA – Sumatriptan and naratriptan do not appear to significantly raise the risk of major congenital malformations in fetuses that are exposed to the drugs in utero, according to the latest analysis of an international pregnancy registry.

Established in 1996, the GlaxoSmithKline registry has accumulated data on 849 pregnancies exposed to the drugs. Birth defects occurred in 4.5% of infants exposed in the first trimester or during all of their gestation, which was not significantly higher than that previously identified for women with migraines. Major congenital malformations are known to occur in the offspring of women with migraines at a slightly higher rate than in the general population (3.4% vs. 2%-3%, respectively), Marianne C. Cunnington, Ph.D., and her colleague Sara A. Ephross, Ph.D., reported in a poster at the International Headache Congress. Both are employees of GlaxoSmithKline.

The registry relies on a voluntary reporting strategy that encourages healthcare providers to submit information on exposed pregnancies as early as possible. Retrospective case reporting also is accepted. Pregnancy outcome is ascertained by medical records that the provider forwards after birth, or by medical records confirming other outcomes, including fetal demise or abortion.

At the outset, the registry collects data on the timing, dosage, duration, indication, and administration of the drugs; maternal demographics; expected date of delivery; and any prenatal testing. At follow-up, there is a review of the pregnancy outcome, drug exposure during the pregnancy, and the women's headache history during pregnancy.

So far, the registry has amassed information on 761 pregnancies exposed to sumatriptan and 88 exposed to naratriptan. Outcomes are known for 570 of the sumatriptan-exposed pregnancies and 57 of the naratriptan-exposed pregnancies. Twenty-one sumatriptan-exposed pregnancies and 31 naratriptan-exposed pregnancies are pending delivery. The rest have been lost to follow-up, the investigators noted in their poster at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Among the sumatriptan-exposed pregnancies, there were 23 birth defects, 4 fetal deaths, 32 spontaneous fetal losses, and 11 induced abortions.

The malformations that occurred in infants who were exposed to sumatriptan in the first trimester included abnormal head circumference, single palmar crease and systolic murmur; moderate craniosynostosis; cerebral abnormality with developmental delay; partial cleft lip; ventricular septal defects (4); biliary atresia; diaphragmatic hernia; pyloric stenosis (3); anterior displacement of anus; hip dysplasia; polydactyly; malformation of left hand; and Down syndrome (3). No data were available for the three birth defects that occurred in infants who were exposed to sumatriptan after the first trimester.

Among fetuses exposed to naratriptan, there were five spontaneous losses, one induced abortion, and one live infant with a 2.5-mm ventricular septal defect that was expected to close spontaneously.

The pregnancy registry did not contain any data on the exposure to the combination of sumatriptan and naproxen.

Dr. Cunnington noted that five additional independent studies, including a Swedish study of more than 2,000 sumatriptan recipients, have failed to find an increase in birth defects associated with in utero exposure.

“While its use in pregnancy cannot be encouraged,” she wrote, “there is consistent evidence that sumatriptan is not associated with a substantial increase in the risk of major congenital malformations following exposure.”

To report pregnancies exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen combination, North American physicians can call 800-336-2176, and international physicians can call 910-256-0549.

The full report was published in Headache (doi: 10.1111/j.1526-4610.2009.01529.x).

VIENNA – Dimebon–the abandoned Russian antihistamine that burst onto the Alzheimer's study scene with the only positive clinical data of 2008–may throw yet another curve ball into a research world that for years has focused almost entirely on the amyloid hypothesis.

Rather than lowering amyloid beta (Abeta) levels, as two failed investigational drugs–tramiprosate and tarenflurbil–have attempted, dimebon appears to almost immediately increase them, raising Abeta by as much as 200% in three mouse models of Alzheimer's disease (AD), Dr. Samuel Gandy reported at the International Conference on Alzheimer's Disease.

While preliminary, the findings–combined with the nearly unprecedented cognitive benefit dimebon conferred in its phase II trial–could be enough to dethrone the long-reigning amyloid hypothesis, according to Mark A. Smith, Ph.D., an Alzheimer's researcher. “This drug is clearly not targeting amyloid, but increasing it acutely,” said Dr. Smith of Case Western Reserve University, Cleveland. “If you believe the dogma, therefore, you should believe that this increase will cause Alzheimer's. These results question that dogma. If this holds up, it could be enough to wound the amyloid theory, potentially mortally.”

Dimebon's 2008 phase II study found that patients with mild to moderate AD who took the drug for 12 months gained about 2 points on the Alzheimer's Disease Assessment Scale-Cognition (ADAS-cog), while those taking placebo declined almost 6 points from baseline (Lancet 2008;372:207-15). A 6-month open-label extension trial found similarly positive results. Patients who completed a full 18 months of dimebon continued to show benefit on ADAS-cog. Former placebo patients who crossed over to dimebon stabilized their cognitive decline.

Dr. Gandy of the Mount Sinai School of Medicine, New York, investigated the drug's effect on amyloid in three models of the disease: cultured nerve cells, isolated synaptic terminals, and brains from mice that overexpress human amyloid. “In every single system dimebon stimulated amyloid secretion,” Dr. Gandy said in an interview. “The levels of the amyloid peptides in the interstitial brain fluid roughly doubled whenever the drug was given. If we think about the increased risk of Alzheimer's in Down syndrome patients who have a 50% increase in amyloid, this acute increase with dimebon could be significant over a period of many years of prescribed use.”

Dr. Gandy noted that similar results were obtained by John Cirrito, Ph.D., and Dr. David Holtzman of Washington University, St. Louis, who collaborated with him in studying the brains of freely moving transgenic mice that overexpress human Abeta.

Dr. Gandy's suggested that this acute release may be followed by a chronic lowering of Abeta–something he is now investigating. Combined with dimebon's positive clinical data, this finding would imply that neurons benefit from dumping their intracellular amyloid load.

“This is reminiscent of the evidence suggesting that healthy nerve cells seem to release more amyloid,” Dr. Gandy said, referring to another study from the Dr. Holtzman group, in which they reported that brain amyloid release increased as head-injured patients began to recover. “Why do happy, functioning neurons release more amyloid beta? The challenge now is how to reconcile that with research that is trying hard to develop medications to lower amyloid levels.”

The clinical and lab data highlight the essential mystery of amyloid, both researchers said. “It all seemed so simple when we discovered genes that implicated amyloid,” Dr. Gandy said. “It was all amyloid toxicity and that was the end of it. But the truth is, we still don't really know what amyloid does locally. It is clear to me that amyloid beta causes the rare genetic forms of Alzheimer's, but there remains the possibility that some injurious event [e.g., calcium dysregulation or oxidative injury] is both directly neurotoxic and pro-amyloidogenic. Gary Gibson, Ph.D., of Cornell University and I have seen this in an experimental oxidative stress model, and if something like this is the case in common forms of AD, then lowering amyloid won't be sufficient. Still, I don't think we'll know that until we succeed in purging the brain of amyloid oligomers at an early age and follow the natural history of the amyloid-free brain.”

Some researchers, including Dr. Smith, have contended that amyloid is not the direct cause of AD, but a downstream product of some other dysfunction. The plaques themselves might be largely inert, or even be protecting the brain by binding and neutralizing neurotoxins.

“It could very well be that releasing Abeta is good, and that's why drugs that lower it are ineffective, or even damaging,” Dr. Smith said. A wealth of recent data seems to support that idea: in the last 2 years, four antiamyloid agents have failed their phase III trials, and both active and passive immunotherapy studies have seen about a 10% rate of vasogenic brain edema associated with plaque dissolution.

“We have to face it,” Dr. Smith said. “We don't know what amyloid is doing in the brain and just trying to get rid of it may not be a good thing.”

Neither Dr. Gandy nor Dr. Smith had any relevant disclosures.

VIENNA – Dimebon–the abandoned Russian antihistamine that burst onto the Alzheimer's study scene with the only positive clinical data of 2008–may throw yet another curve ball into a research world that for years has focused almost entirely on the amyloid hypothesis.

Rather than lowering amyloid beta (Abeta) levels, as two failed investigational drugs–tramiprosate and tarenflurbil–have attempted, dimebon appears to almost immediately increase them, raising Abeta by as much as 200% in three mouse models of Alzheimer's disease (AD), Dr. Samuel Gandy reported at the International Conference on Alzheimer's Disease.

While preliminary, the findings–combined with the nearly unprecedented cognitive benefit dimebon conferred in its phase II trial–could be enough to dethrone the long-reigning amyloid hypothesis, according to Mark A. Smith, Ph.D., an Alzheimer's researcher. “This drug is clearly not targeting amyloid, but increasing it acutely,” said Dr. Smith of Case Western Reserve University, Cleveland. “If you believe the dogma, therefore, you should believe that this increase will cause Alzheimer's. These results question that dogma. If this holds up, it could be enough to wound the amyloid theory, potentially mortally.”

Dimebon's 2008 phase II study found that patients with mild to moderate AD who took the drug for 12 months gained about 2 points on the Alzheimer's Disease Assessment Scale-Cognition (ADAS-cog), while those taking placebo declined almost 6 points from baseline (Lancet 2008;372:207-15). A 6-month open-label extension trial found similarly positive results. Patients who completed a full 18 months of dimebon continued to show benefit on ADAS-cog. Former placebo patients who crossed over to dimebon stabilized their cognitive decline.

Dr. Gandy of the Mount Sinai School of Medicine, New York, investigated the drug's effect on amyloid in three models of the disease: cultured nerve cells, isolated synaptic terminals, and brains from mice that overexpress human amyloid. “In every single system dimebon stimulated amyloid secretion,” Dr. Gandy said in an interview. “The levels of the amyloid peptides in the interstitial brain fluid roughly doubled whenever the drug was given. If we think about the increased risk of Alzheimer's in Down syndrome patients who have a 50% increase in amyloid, this acute increase with dimebon could be significant over a period of many years of prescribed use.”

Dr. Gandy noted that similar results were obtained by John Cirrito, Ph.D., and Dr. David Holtzman of Washington University, St. Louis, who collaborated with him in studying the brains of freely moving transgenic mice that overexpress human Abeta.

Dr. Gandy's suggested that this acute release may be followed by a chronic lowering of Abeta–something he is now investigating. Combined with dimebon's positive clinical data, this finding would imply that neurons benefit from dumping their intracellular amyloid load.

“This is reminiscent of the evidence suggesting that healthy nerve cells seem to release more amyloid,” Dr. Gandy said, referring to another study from the Dr. Holtzman group, in which they reported that brain amyloid release increased as head-injured patients began to recover. “Why do happy, functioning neurons release more amyloid beta? The challenge now is how to reconcile that with research that is trying hard to develop medications to lower amyloid levels.”

The clinical and lab data highlight the essential mystery of amyloid, both researchers said. “It all seemed so simple when we discovered genes that implicated amyloid,” Dr. Gandy said. “It was all amyloid toxicity and that was the end of it. But the truth is, we still don't really know what amyloid does locally. It is clear to me that amyloid beta causes the rare genetic forms of Alzheimer's, but there remains the possibility that some injurious event [e.g., calcium dysregulation or oxidative injury] is both directly neurotoxic and pro-amyloidogenic. Gary Gibson, Ph.D., of Cornell University and I have seen this in an experimental oxidative stress model, and if something like this is the case in common forms of AD, then lowering amyloid won't be sufficient. Still, I don't think we'll know that until we succeed in purging the brain of amyloid oligomers at an early age and follow the natural history of the amyloid-free brain.”

Some researchers, including Dr. Smith, have contended that amyloid is not the direct cause of AD, but a downstream product of some other dysfunction. The plaques themselves might be largely inert, or even be protecting the brain by binding and neutralizing neurotoxins.

“It could very well be that releasing Abeta is good, and that's why drugs that lower it are ineffective, or even damaging,” Dr. Smith said. A wealth of recent data seems to support that idea: in the last 2 years, four antiamyloid agents have failed their phase III trials, and both active and passive immunotherapy studies have seen about a 10% rate of vasogenic brain edema associated with plaque dissolution.

“We have to face it,” Dr. Smith said. “We don't know what amyloid is doing in the brain and just trying to get rid of it may not be a good thing.”

Neither Dr. Gandy nor Dr. Smith had any relevant disclosures.

VIENNA – Dimebon–the abandoned Russian antihistamine that burst onto the Alzheimer's study scene with the only positive clinical data of 2008–may throw yet another curve ball into a research world that for years has focused almost entirely on the amyloid hypothesis.

Rather than lowering amyloid beta (Abeta) levels, as two failed investigational drugs–tramiprosate and tarenflurbil–have attempted, dimebon appears to almost immediately increase them, raising Abeta by as much as 200% in three mouse models of Alzheimer's disease (AD), Dr. Samuel Gandy reported at the International Conference on Alzheimer's Disease.

While preliminary, the findings–combined with the nearly unprecedented cognitive benefit dimebon conferred in its phase II trial–could be enough to dethrone the long-reigning amyloid hypothesis, according to Mark A. Smith, Ph.D., an Alzheimer's researcher. “This drug is clearly not targeting amyloid, but increasing it acutely,” said Dr. Smith of Case Western Reserve University, Cleveland. “If you believe the dogma, therefore, you should believe that this increase will cause Alzheimer's. These results question that dogma. If this holds up, it could be enough to wound the amyloid theory, potentially mortally.”

Dimebon's 2008 phase II study found that patients with mild to moderate AD who took the drug for 12 months gained about 2 points on the Alzheimer's Disease Assessment Scale-Cognition (ADAS-cog), while those taking placebo declined almost 6 points from baseline (Lancet 2008;372:207-15). A 6-month open-label extension trial found similarly positive results. Patients who completed a full 18 months of dimebon continued to show benefit on ADAS-cog. Former placebo patients who crossed over to dimebon stabilized their cognitive decline.

Dr. Gandy of the Mount Sinai School of Medicine, New York, investigated the drug's effect on amyloid in three models of the disease: cultured nerve cells, isolated synaptic terminals, and brains from mice that overexpress human amyloid. “In every single system dimebon stimulated amyloid secretion,” Dr. Gandy said in an interview. “The levels of the amyloid peptides in the interstitial brain fluid roughly doubled whenever the drug was given. If we think about the increased risk of Alzheimer's in Down syndrome patients who have a 50% increase in amyloid, this acute increase with dimebon could be significant over a period of many years of prescribed use.”

Dr. Gandy noted that similar results were obtained by John Cirrito, Ph.D., and Dr. David Holtzman of Washington University, St. Louis, who collaborated with him in studying the brains of freely moving transgenic mice that overexpress human Abeta.

Dr. Gandy's suggested that this acute release may be followed by a chronic lowering of Abeta–something he is now investigating. Combined with dimebon's positive clinical data, this finding would imply that neurons benefit from dumping their intracellular amyloid load.

“This is reminiscent of the evidence suggesting that healthy nerve cells seem to release more amyloid,” Dr. Gandy said, referring to another study from the Dr. Holtzman group, in which they reported that brain amyloid release increased as head-injured patients began to recover. “Why do happy, functioning neurons release more amyloid beta? The challenge now is how to reconcile that with research that is trying hard to develop medications to lower amyloid levels.”

The clinical and lab data highlight the essential mystery of amyloid, both researchers said. “It all seemed so simple when we discovered genes that implicated amyloid,” Dr. Gandy said. “It was all amyloid toxicity and that was the end of it. But the truth is, we still don't really know what amyloid does locally. It is clear to me that amyloid beta causes the rare genetic forms of Alzheimer's, but there remains the possibility that some injurious event [e.g., calcium dysregulation or oxidative injury] is both directly neurotoxic and pro-amyloidogenic. Gary Gibson, Ph.D., of Cornell University and I have seen this in an experimental oxidative stress model, and if something like this is the case in common forms of AD, then lowering amyloid won't be sufficient. Still, I don't think we'll know that until we succeed in purging the brain of amyloid oligomers at an early age and follow the natural history of the amyloid-free brain.”

Some researchers, including Dr. Smith, have contended that amyloid is not the direct cause of AD, but a downstream product of some other dysfunction. The plaques themselves might be largely inert, or even be protecting the brain by binding and neutralizing neurotoxins.

“It could very well be that releasing Abeta is good, and that's why drugs that lower it are ineffective, or even damaging,” Dr. Smith said. A wealth of recent data seems to support that idea: in the last 2 years, four antiamyloid agents have failed their phase III trials, and both active and passive immunotherapy studies have seen about a 10% rate of vasogenic brain edema associated with plaque dissolution.

“We have to face it,” Dr. Smith said. “We don't know what amyloid is doing in the brain and just trying to get rid of it may not be a good thing.”

Neither Dr. Gandy nor Dr. Smith had any relevant disclosures.

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized, controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over 24 weeks, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinumtoxinA (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test-6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U. The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in headache days and migraine days than those taking placebo (−8 vs. −6, respectively). The HIT-6 score also declined significantly more among the active group (−5 vs. −2 points). Patients receiving the study drug experienced a greater decrease in cumulative headache hours per month (−120 vs. −80 hours), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group, compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference. There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization. Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%). Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

Patients in the active group had a significantly greater reduction in migraine days than those taking placebo.

Source Dr. Dodick

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized, controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over 24 weeks, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinumtoxinA (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test-6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U. The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in headache days and migraine days than those taking placebo (−8 vs. −6, respectively). The HIT-6 score also declined significantly more among the active group (−5 vs. −2 points). Patients receiving the study drug experienced a greater decrease in cumulative headache hours per month (−120 vs. −80 hours), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group, compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference. There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization. Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%). Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

Patients in the active group had a significantly greater reduction in migraine days than those taking placebo.

Source Dr. Dodick

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized, controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over 24 weeks, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinumtoxinA (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test-6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U. The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in headache days and migraine days than those taking placebo (−8 vs. −6, respectively). The HIT-6 score also declined significantly more among the active group (−5 vs. −2 points). Patients receiving the study drug experienced a greater decrease in cumulative headache hours per month (−120 vs. −80 hours), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group, compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference. There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization. Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%). Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

Patients in the active group had a significantly greater reduction in migraine days than those taking placebo.

Source Dr. Dodick

Heparin-induced skin lesions are fairly common among patients receiving heparin for treatment or prophylaxis, especially among women, and those who are overweight or who have taken the drug for more than 9 days, a new study has determined.

Prior research had suggested that many cases were caused by heparin-induced thrombocytopenia. The study by Dr. Marc Schindewolf and colleagues contradicts those data: A delayed-type hypersensitivity reaction caused the lesions in all 24 of the cases they observed (CMAJ 2009 Sept. 28 [doi:10.1503/cmaj.081729

Dr. Schindewolf of the Hospital of the Johann Wolfgang Goethe University in Frankfurt, Germany, and his coauthors also postulated that heparin-induced skin lesions are probably much more common than currently believed. Their observed incidence of 7.5% far exceeded their expected findings of 2%, which were based on prior clinical observations. “During the study we were surprised by the high number of patients with [lesions],” they wrote. “For most of the patients, the diagnosis was made because of our study. Therefore, it is tempting to speculate that many cases of heparin-induced skin lesions are undiagnosed.”

The study comprised 320 patients enrolled over a 12-month period, all of whom were taking some form of heparin as treatment or prophylaxis. The patients' mean age was 61 years; the median duration of heparin use was 9 days, but it ranged from 7 to 1,095 days. Most (60%) were taking enoxaparin; 31% were taking nadroparin. The remainder was taking other forms of heparin.

In all, 24 patients developed heparin-induced skin lesions. Most of the cases were small eczema-like plaques at the injection site. A few patients had generalized itchy erythematous plaques. In 23 patients, a delayed-type hypersensitivity response was the confirmed cause. One patient refused to consent to a punch biopsy or allergologic testing. Although all of these patients were screened for immune-mediated heparin-induced thrombocytopenia, it was detected in only one patient.

Compared with those who did not develop lesions, more of those who did were women (71% vs. 45%), had a higher body mass index (30 kg/m

The lesions should be viewed as a symptom requiring an investigation of some underlying etiology, they wrote: “We recommend obtaining a punch biopsy; comparing platelet counts before, during, and after therapy; and performing appropriate laboratory investigations to exclude heparin-induced thrombocytopenia.”

The authors reported having no financial conflicts with regard to the study.

Heparin-induced skin lesions are fairly common among patients receiving heparin for treatment or prophylaxis, especially among women, and those who are overweight or who have taken the drug for more than 9 days, a new study has determined.

Prior research had suggested that many cases were caused by heparin-induced thrombocytopenia. The study by Dr. Marc Schindewolf and colleagues contradicts those data: A delayed-type hypersensitivity reaction caused the lesions in all 24 of the cases they observed (CMAJ 2009 Sept. 28 [doi:10.1503/cmaj.081729

Dr. Schindewolf of the Hospital of the Johann Wolfgang Goethe University in Frankfurt, Germany, and his coauthors also postulated that heparin-induced skin lesions are probably much more common than currently believed. Their observed incidence of 7.5% far exceeded their expected findings of 2%, which were based on prior clinical observations. “During the study we were surprised by the high number of patients with [lesions],” they wrote. “For most of the patients, the diagnosis was made because of our study. Therefore, it is tempting to speculate that many cases of heparin-induced skin lesions are undiagnosed.”

The study comprised 320 patients enrolled over a 12-month period, all of whom were taking some form of heparin as treatment or prophylaxis. The patients' mean age was 61 years; the median duration of heparin use was 9 days, but it ranged from 7 to 1,095 days. Most (60%) were taking enoxaparin; 31% were taking nadroparin. The remainder was taking other forms of heparin.

In all, 24 patients developed heparin-induced skin lesions. Most of the cases were small eczema-like plaques at the injection site. A few patients had generalized itchy erythematous plaques. In 23 patients, a delayed-type hypersensitivity response was the confirmed cause. One patient refused to consent to a punch biopsy or allergologic testing. Although all of these patients were screened for immune-mediated heparin-induced thrombocytopenia, it was detected in only one patient.

Compared with those who did not develop lesions, more of those who did were women (71% vs. 45%), had a higher body mass index (30 kg/m

The lesions should be viewed as a symptom requiring an investigation of some underlying etiology, they wrote: “We recommend obtaining a punch biopsy; comparing platelet counts before, during, and after therapy; and performing appropriate laboratory investigations to exclude heparin-induced thrombocytopenia.”

The authors reported having no financial conflicts with regard to the study.

Heparin-induced skin lesions are fairly common among patients receiving heparin for treatment or prophylaxis, especially among women, and those who are overweight or who have taken the drug for more than 9 days, a new study has determined.

Prior research had suggested that many cases were caused by heparin-induced thrombocytopenia. The study by Dr. Marc Schindewolf and colleagues contradicts those data: A delayed-type hypersensitivity reaction caused the lesions in all 24 of the cases they observed (CMAJ 2009 Sept. 28 [doi:10.1503/cmaj.081729

Dr. Schindewolf of the Hospital of the Johann Wolfgang Goethe University in Frankfurt, Germany, and his coauthors also postulated that heparin-induced skin lesions are probably much more common than currently believed. Their observed incidence of 7.5% far exceeded their expected findings of 2%, which were based on prior clinical observations. “During the study we were surprised by the high number of patients with [lesions],” they wrote. “For most of the patients, the diagnosis was made because of our study. Therefore, it is tempting to speculate that many cases of heparin-induced skin lesions are undiagnosed.”

The study comprised 320 patients enrolled over a 12-month period, all of whom were taking some form of heparin as treatment or prophylaxis. The patients' mean age was 61 years; the median duration of heparin use was 9 days, but it ranged from 7 to 1,095 days. Most (60%) were taking enoxaparin; 31% were taking nadroparin. The remainder was taking other forms of heparin.

In all, 24 patients developed heparin-induced skin lesions. Most of the cases were small eczema-like plaques at the injection site. A few patients had generalized itchy erythematous plaques. In 23 patients, a delayed-type hypersensitivity response was the confirmed cause. One patient refused to consent to a punch biopsy or allergologic testing. Although all of these patients were screened for immune-mediated heparin-induced thrombocytopenia, it was detected in only one patient.

Compared with those who did not develop lesions, more of those who did were women (71% vs. 45%), had a higher body mass index (30 kg/m

The lesions should be viewed as a symptom requiring an investigation of some underlying etiology, they wrote: “We recommend obtaining a punch biopsy; comparing platelet counts before, during, and after therapy; and performing appropriate laboratory investigations to exclude heparin-induced thrombocytopenia.”

The authors reported having no financial conflicts with regard to the study.

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

Despite clinical evidence suggesting that children are at higher risk for pandemic influenza A(H1N1) complications, only 40% of parents surveyed said they plan to have their children vaccinated against that strain of the flu.

The survey, conducted by the C.S. Mott Children's Hospital National Poll on Children's Health, also found that 54% of parents intended to have their children vaccinated against the regular seasonal flu.

The survey shows that many parents don't grasp the full implications of pandemic flu's possible effect on children, Dr. Matthew M. Davis wrote in the survey report.

“In both their intentions to vaccinate children and their comparisons of H1N1 and seasonal flu, many parents do not feel that H1N1 is a significant health threat,” wrote Dr. Davis of the University of Michigan, Ann Arbor. “Nearly one-half of parents who do not plan to vaccinate their children indicated that they were not worried about their children getting H1N1 disease; nearly one in five believed that H1N1 flu is not a serious disease.”

The survey cohort comprised 1,678 adult parents; the sample was then weighted to reflect population figures from the U.S. Census Bureau. Although 40% of parents said they were definitely or probably going to have their children vaccinated against pandemic flu, 29% said that they definitely or probably would not have their children vaccinated.

Most of these (56%) said they were worried about side effects of the vaccine. Other reasons for declining included not being concerned that their children would get H1N1 influenza (46%); that medication can treat the flu, rendering vaccination unnecessary (42%); too much hassle to get two vaccine doses (30%); their school or day care provider doesn't require the vaccination (25%); worry about the vaccine's cost (23%); and the belief that H1N1 is not a serious disease (20%).

Parents who planned to have their children vaccinated held the converse views, with most believing that pandemic flu is a serious disease (83%) and 80% being worried that their children will contract it.

A racial/ethnic breakdown of the results showed that Hispanic parents were far more likely than white or black parents to plan on having their children vaccinated against pandemic flu (52% vs. 38% and 30%, respectively). This was a “notable finding,” Dr. Davis said. “It may reflect a higher perceived risk among Hispanics, given the well-publicized outbreak of H1N1 flu in Mexico in early 2009.”

The survey also asked parents to compare the perceived risks of H1N1 with those of seasonal flu. About half of the respondents said the two flus will be comparable in the number of children who catch it, the number who will need to be hospitalized, and the number of school days children will miss. About a third said that H1N1 will be worse than seasonal flu in all those ways, and 20% said seasonal flu will be worse.

Dr. Davis suggested that health care providers can help parents understand the risk that H1N1 flu may present to their children. “Health care providers must play a critical role in ensuring that parents understand the risks of H1N1 flu illness and H1N1 flu vaccination, and that children have adequate and timely access to the vaccine,” he wrote.

To see the full report, visit www.med.umich.edu/mott/npch/pdf/092409report.pdf

Despite clinical evidence suggesting that children are at higher risk for pandemic influenza A(H1N1) complications, only 40% of parents surveyed said they plan to have their children vaccinated against that strain of the flu.

The survey, conducted by the C.S. Mott Children's Hospital National Poll on Children's Health, also found that 54% of parents intended to have their children vaccinated against the regular seasonal flu.

The survey shows that many parents don't grasp the full implications of pandemic flu's possible effect on children, Dr. Matthew M. Davis wrote in the survey report.

“In both their intentions to vaccinate children and their comparisons of H1N1 and seasonal flu, many parents do not feel that H1N1 is a significant health threat,” wrote Dr. Davis of the University of Michigan, Ann Arbor. “Nearly one-half of parents who do not plan to vaccinate their children indicated that they were not worried about their children getting H1N1 disease; nearly one in five believed that H1N1 flu is not a serious disease.”

The survey cohort comprised 1,678 adult parents; the sample was then weighted to reflect population figures from the U.S. Census Bureau. Although 40% of parents said they were definitely or probably going to have their children vaccinated against pandemic flu, 29% said that they definitely or probably would not have their children vaccinated.

Most of these (56%) said they were worried about side effects of the vaccine. Other reasons for declining included not being concerned that their children would get H1N1 influenza (46%); that medication can treat the flu, rendering vaccination unnecessary (42%); too much hassle to get two vaccine doses (30%); their school or day care provider doesn't require the vaccination (25%); worry about the vaccine's cost (23%); and the belief that H1N1 is not a serious disease (20%).

Parents who planned to have their children vaccinated held the converse views, with most believing that pandemic flu is a serious disease (83%) and 80% being worried that their children will contract it.

A racial/ethnic breakdown of the results showed that Hispanic parents were far more likely than white or black parents to plan on having their children vaccinated against pandemic flu (52% vs. 38% and 30%, respectively). This was a “notable finding,” Dr. Davis said. “It may reflect a higher perceived risk among Hispanics, given the well-publicized outbreak of H1N1 flu in Mexico in early 2009.”

The survey also asked parents to compare the perceived risks of H1N1 with those of seasonal flu. About half of the respondents said the two flus will be comparable in the number of children who catch it, the number who will need to be hospitalized, and the number of school days children will miss. About a third said that H1N1 will be worse than seasonal flu in all those ways, and 20% said seasonal flu will be worse.

Dr. Davis suggested that health care providers can help parents understand the risk that H1N1 flu may present to their children. “Health care providers must play a critical role in ensuring that parents understand the risks of H1N1 flu illness and H1N1 flu vaccination, and that children have adequate and timely access to the vaccine,” he wrote.

To see the full report, visit www.med.umich.edu/mott/npch/pdf/092409report.pdf

Despite clinical evidence suggesting that children are at higher risk for pandemic influenza A(H1N1) complications, only 40% of parents surveyed said they plan to have their children vaccinated against that strain of the flu.

The survey, conducted by the C.S. Mott Children's Hospital National Poll on Children's Health, also found that 54% of parents intended to have their children vaccinated against the regular seasonal flu.

The survey shows that many parents don't grasp the full implications of pandemic flu's possible effect on children, Dr. Matthew M. Davis wrote in the survey report.

“In both their intentions to vaccinate children and their comparisons of H1N1 and seasonal flu, many parents do not feel that H1N1 is a significant health threat,” wrote Dr. Davis of the University of Michigan, Ann Arbor. “Nearly one-half of parents who do not plan to vaccinate their children indicated that they were not worried about their children getting H1N1 disease; nearly one in five believed that H1N1 flu is not a serious disease.”

The survey cohort comprised 1,678 adult parents; the sample was then weighted to reflect population figures from the U.S. Census Bureau. Although 40% of parents said they were definitely or probably going to have their children vaccinated against pandemic flu, 29% said that they definitely or probably would not have their children vaccinated.

Most of these (56%) said they were worried about side effects of the vaccine. Other reasons for declining included not being concerned that their children would get H1N1 influenza (46%); that medication can treat the flu, rendering vaccination unnecessary (42%); too much hassle to get two vaccine doses (30%); their school or day care provider doesn't require the vaccination (25%); worry about the vaccine's cost (23%); and the belief that H1N1 is not a serious disease (20%).

Parents who planned to have their children vaccinated held the converse views, with most believing that pandemic flu is a serious disease (83%) and 80% being worried that their children will contract it.

A racial/ethnic breakdown of the results showed that Hispanic parents were far more likely than white or black parents to plan on having their children vaccinated against pandemic flu (52% vs. 38% and 30%, respectively). This was a “notable finding,” Dr. Davis said. “It may reflect a higher perceived risk among Hispanics, given the well-publicized outbreak of H1N1 flu in Mexico in early 2009.”

The survey also asked parents to compare the perceived risks of H1N1 with those of seasonal flu. About half of the respondents said the two flus will be comparable in the number of children who catch it, the number who will need to be hospitalized, and the number of school days children will miss. About a third said that H1N1 will be worse than seasonal flu in all those ways, and 20% said seasonal flu will be worse.

Dr. Davis suggested that health care providers can help parents understand the risk that H1N1 flu may present to their children. “Health care providers must play a critical role in ensuring that parents understand the risks of H1N1 flu illness and H1N1 flu vaccination, and that children have adequate and timely access to the vaccine,” he wrote.

To see the full report, visit www.med.umich.edu/mott/npch/pdf/092409report.pdf

Despite clinical evidence suggesting that children are at higher risk for pandemic influenza A(H1N1) complications, only 40% of parents surveyed said they plan to have their children vaccinated against that strain of the flu.

The survey, conducted in August by the C.S. Mott Children's Hospital National Poll on Children's Health, also found that 54% of parents intended to have their children vaccinated against the regular seasonal flu.

The survey shows that many parents don't grasp the full implications of pandemic flu's possible effect on children, wrote Dr. Matthew M. Davis of the University of Michigan, Ann Arbor.

The survey cohort comprised 1,678 adult parents; the sample was then weighted to reflect population figures from the U.S. Census Bureau. Although 40% of parents said they were definitely or probably going to have their children vaccinated against pandemic flu, 29% said that they definitely or probably would not have their children vaccinated.

Most of these (56%) said they were worried about side effects of the vaccine. Other reasons for declining included not being concerned that their children would get H1N1 flu (46%); that medication can treat the flu, rendering vaccination unnecessary (42%); too much hassle to get two vaccine doses (30%); their school or day care provider doesn't require the vaccination (25%); worry about the vaccine's cost (23%); and the belief that H1N1 is not a serious disease (20%)

Parents who planned to have their children vaccinated held the converse views, with most believing that H1N1 is a serious disease (83%) and 80% being worried that their children with contract it.

A racial/ethnic breakdown of the results showed that Hispanic parents were far more likely than white or black parents to plan on having their children vaccinated against pandemic flu (52% vs. 38% and 30%, respectively). This was a “notable finding,” Dr. Davis said. “It may reflect a higher perceived risk among Hispanics, given the well-publicized outbreak of H1N1 flu in Mexico in early 2009.”

Dr. Davis suggested that health care providers can help parents understand the risk that H1N1 flu may present to their children.

“Public health officials and health care providers must play a critical role in ensuring that parents understand the risks of H1N1 flu illness and H1N1 flu vaccination, and that children have adequate and timely access to the vaccine,” he wrote.

Despite clinical evidence suggesting that children are at higher risk for pandemic influenza A(H1N1) complications, only 40% of parents surveyed said they plan to have their children vaccinated against that strain of the flu.

The survey, conducted in August by the C.S. Mott Children's Hospital National Poll on Children's Health, also found that 54% of parents intended to have their children vaccinated against the regular seasonal flu.

The survey shows that many parents don't grasp the full implications of pandemic flu's possible effect on children, wrote Dr. Matthew M. Davis of the University of Michigan, Ann Arbor.

The survey cohort comprised 1,678 adult parents; the sample was then weighted to reflect population figures from the U.S. Census Bureau. Although 40% of parents said they were definitely or probably going to have their children vaccinated against pandemic flu, 29% said that they definitely or probably would not have their children vaccinated.

Most of these (56%) said they were worried about side effects of the vaccine. Other reasons for declining included not being concerned that their children would get H1N1 flu (46%); that medication can treat the flu, rendering vaccination unnecessary (42%); too much hassle to get two vaccine doses (30%); their school or day care provider doesn't require the vaccination (25%); worry about the vaccine's cost (23%); and the belief that H1N1 is not a serious disease (20%)

Parents who planned to have their children vaccinated held the converse views, with most believing that H1N1 is a serious disease (83%) and 80% being worried that their children with contract it.

A racial/ethnic breakdown of the results showed that Hispanic parents were far more likely than white or black parents to plan on having their children vaccinated against pandemic flu (52% vs. 38% and 30%, respectively). This was a “notable finding,” Dr. Davis said. “It may reflect a higher perceived risk among Hispanics, given the well-publicized outbreak of H1N1 flu in Mexico in early 2009.”

Dr. Davis suggested that health care providers can help parents understand the risk that H1N1 flu may present to their children.

“Public health officials and health care providers must play a critical role in ensuring that parents understand the risks of H1N1 flu illness and H1N1 flu vaccination, and that children have adequate and timely access to the vaccine,” he wrote.

Despite clinical evidence suggesting that children are at higher risk for pandemic influenza A(H1N1) complications, only 40% of parents surveyed said they plan to have their children vaccinated against that strain of the flu.

The survey, conducted in August by the C.S. Mott Children's Hospital National Poll on Children's Health, also found that 54% of parents intended to have their children vaccinated against the regular seasonal flu.

The survey shows that many parents don't grasp the full implications of pandemic flu's possible effect on children, wrote Dr. Matthew M. Davis of the University of Michigan, Ann Arbor.

The survey cohort comprised 1,678 adult parents; the sample was then weighted to reflect population figures from the U.S. Census Bureau. Although 40% of parents said they were definitely or probably going to have their children vaccinated against pandemic flu, 29% said that they definitely or probably would not have their children vaccinated.

Most of these (56%) said they were worried about side effects of the vaccine. Other reasons for declining included not being concerned that their children would get H1N1 flu (46%); that medication can treat the flu, rendering vaccination unnecessary (42%); too much hassle to get two vaccine doses (30%); their school or day care provider doesn't require the vaccination (25%); worry about the vaccine's cost (23%); and the belief that H1N1 is not a serious disease (20%)

Parents who planned to have their children vaccinated held the converse views, with most believing that H1N1 is a serious disease (83%) and 80% being worried that their children with contract it.

A racial/ethnic breakdown of the results showed that Hispanic parents were far more likely than white or black parents to plan on having their children vaccinated against pandemic flu (52% vs. 38% and 30%, respectively). This was a “notable finding,” Dr. Davis said. “It may reflect a higher perceived risk among Hispanics, given the well-publicized outbreak of H1N1 flu in Mexico in early 2009.”

Dr. Davis suggested that health care providers can help parents understand the risk that H1N1 flu may present to their children.

“Public health officials and health care providers must play a critical role in ensuring that parents understand the risks of H1N1 flu illness and H1N1 flu vaccination, and that children have adequate and timely access to the vaccine,” he wrote.

An investigational HIV vaccine regimen tested in Thailand has been shown to reduce new infections by 31%.

The placebo-controlled study, consisting of a prime vaccine and three booster shots, was conducted in more than 16,000 Thai citizens who were HIV-negative at baseline. After a 3-year follow-up period, infections occurred in 74 of those who received placebo and 51 of those who received the active vaccine—a 31% rate reduction, according to a statement issued by Global Solutions for Infectious Diseases, the South San Francisco-based company that produces the booster dose.

There were no significant safety concerns noted at any of the six safety monitoring points during the trial. The RV144 trial is the first HIV vaccine study to show significant disease reduction, Dr. Anthony S. Fauci said in a statement issued by the National Institutes of Health.

The vaccine and booster were based on the subtype B and E HIV strains, which commonly circulate in Thailand.

The trial comprised noninfected volunteers aged 18-30 years who were considered at risk of contracting HIV; 40% of the population were women.

Participants received HIV protection counseling. They then received the active vaccine or placebo; these were administered again at months 1, 3, and 6. The booster or placebo was also give at months 3 and 6. Subjects were tested for HIV infection every 6 months for 3 years.

The vaccine did not meet its secondary end point, failing to reduce the amount of HIV circulating in those who became infected during the trial. But because of its success in reducing incident infections, investigation into the prime-boost regimen will continue, the U.S. Military HIV Research Program said in a statement.

The cosponsors of the RV144 trial are the United States Army Medical Research and Material Command, the National Institutes of Allergy and Infectious Diseases, and the Thailand Ministry of Public Health.

An investigational HIV vaccine regimen tested in Thailand has been shown to reduce new infections by 31%.

The placebo-controlled study, consisting of a prime vaccine and three booster shots, was conducted in more than 16,000 Thai citizens who were HIV-negative at baseline. After a 3-year follow-up period, infections occurred in 74 of those who received placebo and 51 of those who received the active vaccine—a 31% rate reduction, according to a statement issued by Global Solutions for Infectious Diseases, the South San Francisco-based company that produces the booster dose.

There were no significant safety concerns noted at any of the six safety monitoring points during the trial. The RV144 trial is the first HIV vaccine study to show significant disease reduction, Dr. Anthony S. Fauci said in a statement issued by the National Institutes of Health.

The vaccine and booster were based on the subtype B and E HIV strains, which commonly circulate in Thailand.

The trial comprised noninfected volunteers aged 18-30 years who were considered at risk of contracting HIV; 40% of the population were women.

Participants received HIV protection counseling. They then received the active vaccine or placebo; these were administered again at months 1, 3, and 6. The booster or placebo was also give at months 3 and 6. Subjects were tested for HIV infection every 6 months for 3 years.

The vaccine did not meet its secondary end point, failing to reduce the amount of HIV circulating in those who became infected during the trial. But because of its success in reducing incident infections, investigation into the prime-boost regimen will continue, the U.S. Military HIV Research Program said in a statement.

The cosponsors of the RV144 trial are the United States Army Medical Research and Material Command, the National Institutes of Allergy and Infectious Diseases, and the Thailand Ministry of Public Health.

An investigational HIV vaccine regimen tested in Thailand has been shown to reduce new infections by 31%.

The placebo-controlled study, consisting of a prime vaccine and three booster shots, was conducted in more than 16,000 Thai citizens who were HIV-negative at baseline. After a 3-year follow-up period, infections occurred in 74 of those who received placebo and 51 of those who received the active vaccine—a 31% rate reduction, according to a statement issued by Global Solutions for Infectious Diseases, the South San Francisco-based company that produces the booster dose.

There were no significant safety concerns noted at any of the six safety monitoring points during the trial. The RV144 trial is the first HIV vaccine study to show significant disease reduction, Dr. Anthony S. Fauci said in a statement issued by the National Institutes of Health.

The vaccine and booster were based on the subtype B and E HIV strains, which commonly circulate in Thailand.

The trial comprised noninfected volunteers aged 18-30 years who were considered at risk of contracting HIV; 40% of the population were women.

Participants received HIV protection counseling. They then received the active vaccine or placebo; these were administered again at months 1, 3, and 6. The booster or placebo was also give at months 3 and 6. Subjects were tested for HIV infection every 6 months for 3 years.

The vaccine did not meet its secondary end point, failing to reduce the amount of HIV circulating in those who became infected during the trial. But because of its success in reducing incident infections, investigation into the prime-boost regimen will continue, the U.S. Military HIV Research Program said in a statement.

The cosponsors of the RV144 trial are the United States Army Medical Research and Material Command, the National Institutes of Allergy and Infectious Diseases, and the Thailand Ministry of Public Health.

An investigational HIV vaccine regimen being tested in Thailand has been shown to reduce new infections by 31%.

The placebo-controlled study, consisting of a prime vaccine and three booster shots, was conducted in more than 16,000 Thai citizens who were HIV negative at baseline. After a 3-year follow-up period, infections occurred in 74 of those who received placebo and 51 of those who received the active vaccine—a 31% rate reduction, according to a statement issued by Global Solutions for Infectious Diseases, the company that produces the booster dose.

The reduction was statistically significant, with a Pvalue of .04, the statement said. There were no significant safety concerns noted at any of the six safety monitoring points during the trial.

The RV144 trial is the first HIV vaccine study to show significant disease reduction, Dr. Anthony S. Fauci said in a statement issued by the National Institutes of Health.

“These new findings represent an important step forward in HIV research,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases. “For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.”

The priming vaccine, Sanofi Pasteur's ALVAC-HIV, is a modified canarypox vaccine. The booster dose, AIDSVAX B/E, is a glycoprotein 120 vaccine. The trial began in October 2003. The vaccines are based on the subtype B and E HIV strains, which commonly circulate in Thailand. The subtype B is the one most commonly seen in the United States.

“Separate versions of the vaccine may have to be manufactured and developed for HIV strains that predominate elsewhere in the world, including North America,” the GSID statement noted.

The trial comprised noninfected volunteers aged 18-30 years who were considered at risk of contracting HIV. Women comprised 40% of the study population.

Participants who acquired HIV during the trial were given free access to HIV therapy, including highly active antiretroviral therapy, according to the National Institutes of Health statement.

At baseline, participants received HIV protection counseling. They then received the active vaccine or placebo; these were administered again at months 1, 3, and 6. The booster or placebo was also given at months 3 and 6. Subjects were tested for HIV infection every 6 months for 3 years.

The vaccine did not meet its secondary end point, failing to reduce the amount of HIV circulating in the blood of those who became infected during the trial. But because of its success in reducing incident infections, investigation into the prime-boost regimen will continue, the U.S. Military HIV Research Program said in a statement. “Because RV144 is designed to examine plasma viremia soon after infection, trial collaborators have undertaken a second study, RV152, to follow infected individuals over a longer period of time. The results of this study will help to establish the durability of the vaccine effect, if any, on viral load, and assess whether this effect is associated with improved clinical outcome.”

The cosponsors of the RV144 trial are the United States Army Medical Research and Material Command, the National Institutes of Allergy and Infectious Diseases, and the Thailand Ministry of Public Health.

An investigational HIV vaccine regimen being tested in Thailand has been shown to reduce new infections by 31%.

The placebo-controlled study, consisting of a prime vaccine and three booster shots, was conducted in more than 16,000 Thai citizens who were HIV negative at baseline. After a 3-year follow-up period, infections occurred in 74 of those who received placebo and 51 of those who received the active vaccine—a 31% rate reduction, according to a statement issued by Global Solutions for Infectious Diseases, the company that produces the booster dose.

The reduction was statistically significant, with a Pvalue of .04, the statement said. There were no significant safety concerns noted at any of the six safety monitoring points during the trial.

The RV144 trial is the first HIV vaccine study to show significant disease reduction, Dr. Anthony S. Fauci said in a statement issued by the National Institutes of Health.

“These new findings represent an important step forward in HIV research,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases. “For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.”

The priming vaccine, Sanofi Pasteur's ALVAC-HIV, is a modified canarypox vaccine. The booster dose, AIDSVAX B/E, is a glycoprotein 120 vaccine. The trial began in October 2003. The vaccines are based on the subtype B and E HIV strains, which commonly circulate in Thailand. The subtype B is the one most commonly seen in the United States.

“Separate versions of the vaccine may have to be manufactured and developed for HIV strains that predominate elsewhere in the world, including North America,” the GSID statement noted.

The trial comprised noninfected volunteers aged 18-30 years who were considered at risk of contracting HIV. Women comprised 40% of the study population.

Participants who acquired HIV during the trial were given free access to HIV therapy, including highly active antiretroviral therapy, according to the National Institutes of Health statement.

At baseline, participants received HIV protection counseling. They then received the active vaccine or placebo; these were administered again at months 1, 3, and 6. The booster or placebo was also given at months 3 and 6. Subjects were tested for HIV infection every 6 months for 3 years.

The vaccine did not meet its secondary end point, failing to reduce the amount of HIV circulating in the blood of those who became infected during the trial. But because of its success in reducing incident infections, investigation into the prime-boost regimen will continue, the U.S. Military HIV Research Program said in a statement. “Because RV144 is designed to examine plasma viremia soon after infection, trial collaborators have undertaken a second study, RV152, to follow infected individuals over a longer period of time. The results of this study will help to establish the durability of the vaccine effect, if any, on viral load, and assess whether this effect is associated with improved clinical outcome.”

The cosponsors of the RV144 trial are the United States Army Medical Research and Material Command, the National Institutes of Allergy and Infectious Diseases, and the Thailand Ministry of Public Health.

An investigational HIV vaccine regimen being tested in Thailand has been shown to reduce new infections by 31%.

The placebo-controlled study, consisting of a prime vaccine and three booster shots, was conducted in more than 16,000 Thai citizens who were HIV negative at baseline. After a 3-year follow-up period, infections occurred in 74 of those who received placebo and 51 of those who received the active vaccine—a 31% rate reduction, according to a statement issued by Global Solutions for Infectious Diseases, the company that produces the booster dose.

The reduction was statistically significant, with a Pvalue of .04, the statement said. There were no significant safety concerns noted at any of the six safety monitoring points during the trial.

The RV144 trial is the first HIV vaccine study to show significant disease reduction, Dr. Anthony S. Fauci said in a statement issued by the National Institutes of Health.

“These new findings represent an important step forward in HIV research,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases. “For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.”

The priming vaccine, Sanofi Pasteur's ALVAC-HIV, is a modified canarypox vaccine. The booster dose, AIDSVAX B/E, is a glycoprotein 120 vaccine. The trial began in October 2003. The vaccines are based on the subtype B and E HIV strains, which commonly circulate in Thailand. The subtype B is the one most commonly seen in the United States.

“Separate versions of the vaccine may have to be manufactured and developed for HIV strains that predominate elsewhere in the world, including North America,” the GSID statement noted.

The trial comprised noninfected volunteers aged 18-30 years who were considered at risk of contracting HIV. Women comprised 40% of the study population.

Participants who acquired HIV during the trial were given free access to HIV therapy, including highly active antiretroviral therapy, according to the National Institutes of Health statement.

At baseline, participants received HIV protection counseling. They then received the active vaccine or placebo; these were administered again at months 1, 3, and 6. The booster or placebo was also given at months 3 and 6. Subjects were tested for HIV infection every 6 months for 3 years.

The vaccine did not meet its secondary end point, failing to reduce the amount of HIV circulating in the blood of those who became infected during the trial. But because of its success in reducing incident infections, investigation into the prime-boost regimen will continue, the U.S. Military HIV Research Program said in a statement. “Because RV144 is designed to examine plasma viremia soon after infection, trial collaborators have undertaken a second study, RV152, to follow infected individuals over a longer period of time. The results of this study will help to establish the durability of the vaccine effect, if any, on viral load, and assess whether this effect is associated with improved clinical outcome.”

The cosponsors of the RV144 trial are the United States Army Medical Research and Material Command, the National Institutes of Allergy and Infectious Diseases, and the Thailand Ministry of Public Health.

VIENNA — Statin treatment may reduce the risk of later dementia by more than 50%, a national Finnish study has determined.

“Disturbances in cholesterol metabolism have previously been linked to dementia development,” Dr. Alina Solomon wrote in a poster presented at the International Conference on Alzheimer's Disease. However, noted Dr. Solomon, of the University of Kuopio, Finland, not all studies have concluded that statins are protective against dementia onset.

The investigators examined this question using data from the national FINRISK study, a large, population-based survey of cardiovascular risk factors among Finnish citizens. The survey began in 1972 and is conducted every 5 years.

Dr. Solomon's substudy of FINRISK included data on 17,257 citizens who were included in the 1997 and 2002 cohorts, and who were at least 60 years old in 1995, when statins became available in Finland.

By the study's end at 2007, 1,551 of the subjects had developed dementia and 15,706 had not. Only 18% of those who developed dementia had taken at least 1 year of statin therapy, while 37% of those who were dementia free had taken a statin—a significant difference.

No significant associations were found between dementia and the use of other cholesterol-lowering medications, Dr. Solomon said, suggesting that “the effect of statins in dementia is partly independent of their cholesterol-lowering effect.”

Subjects who developed dementia also had significantly higher baseline total cholesterol and baseline systolic and diastolic blood pressure. But a multivariate regression model that controlled for age, gender, education, cholesterol, weight, and blood pressure still found that statins conferred a 57% risk reduction for dementia over the course of the study.

The finding does not prove that statins prevent dementia, but it does suggest that further studies should explore the idea, focusing on statin types, dosages, and duration of treatment, Dr. Solomon said at the meeting, which was sponsored by the Alzheimer's Association.

Neither she nor her coinvestigators declared any potential conflict of interest in regard to the study.

VIENNA — Statin treatment may reduce the risk of later dementia by more than 50%, a national Finnish study has determined.

“Disturbances in cholesterol metabolism have previously been linked to dementia development,” Dr. Alina Solomon wrote in a poster presented at the International Conference on Alzheimer's Disease. However, noted Dr. Solomon, of the University of Kuopio, Finland, not all studies have concluded that statins are protective against dementia onset.

The investigators examined this question using data from the national FINRISK study, a large, population-based survey of cardiovascular risk factors among Finnish citizens. The survey began in 1972 and is conducted every 5 years.

Dr. Solomon's substudy of FINRISK included data on 17,257 citizens who were included in the 1997 and 2002 cohorts, and who were at least 60 years old in 1995, when statins became available in Finland.

By the study's end at 2007, 1,551 of the subjects had developed dementia and 15,706 had not. Only 18% of those who developed dementia had taken at least 1 year of statin therapy, while 37% of those who were dementia free had taken a statin—a significant difference.

No significant associations were found between dementia and the use of other cholesterol-lowering medications, Dr. Solomon said, suggesting that “the effect of statins in dementia is partly independent of their cholesterol-lowering effect.”

Subjects who developed dementia also had significantly higher baseline total cholesterol and baseline systolic and diastolic blood pressure. But a multivariate regression model that controlled for age, gender, education, cholesterol, weight, and blood pressure still found that statins conferred a 57% risk reduction for dementia over the course of the study.

The finding does not prove that statins prevent dementia, but it does suggest that further studies should explore the idea, focusing on statin types, dosages, and duration of treatment, Dr. Solomon said at the meeting, which was sponsored by the Alzheimer's Association.

Neither she nor her coinvestigators declared any potential conflict of interest in regard to the study.

VIENNA — Statin treatment may reduce the risk of later dementia by more than 50%, a national Finnish study has determined.

“Disturbances in cholesterol metabolism have previously been linked to dementia development,” Dr. Alina Solomon wrote in a poster presented at the International Conference on Alzheimer's Disease. However, noted Dr. Solomon, of the University of Kuopio, Finland, not all studies have concluded that statins are protective against dementia onset.

The investigators examined this question using data from the national FINRISK study, a large, population-based survey of cardiovascular risk factors among Finnish citizens. The survey began in 1972 and is conducted every 5 years.

Dr. Solomon's substudy of FINRISK included data on 17,257 citizens who were included in the 1997 and 2002 cohorts, and who were at least 60 years old in 1995, when statins became available in Finland.

By the study's end at 2007, 1,551 of the subjects had developed dementia and 15,706 had not. Only 18% of those who developed dementia had taken at least 1 year of statin therapy, while 37% of those who were dementia free had taken a statin—a significant difference.

No significant associations were found between dementia and the use of other cholesterol-lowering medications, Dr. Solomon said, suggesting that “the effect of statins in dementia is partly independent of their cholesterol-lowering effect.”

Subjects who developed dementia also had significantly higher baseline total cholesterol and baseline systolic and diastolic blood pressure. But a multivariate regression model that controlled for age, gender, education, cholesterol, weight, and blood pressure still found that statins conferred a 57% risk reduction for dementia over the course of the study.

The finding does not prove that statins prevent dementia, but it does suggest that further studies should explore the idea, focusing on statin types, dosages, and duration of treatment, Dr. Solomon said at the meeting, which was sponsored by the Alzheimer's Association.

Neither she nor her coinvestigators declared any potential conflict of interest in regard to the study.