Miriam E. Tucker

VIENNA — Guidelines are sorely needed for postpartum blood pressure management in women who experience hypertension during pregnancy, speakers said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

“It's a problem we have very little guidance on and very little information about,” said Jason Waugh, a senior lecturer in the Reproductive Science Section at the University of Leicester, England. He presented one of two studies highlighting the knowledge gaps regarding postpartum diagnosis and treatment of women with pregnancies complicated by hypertension.

Determining whether a woman has underlying chronic hypertension can be difficult. Professional societies such as the ISSHP and the American College of Obstetricians and Gynecologists define chronic hypertension in pregnancy as that occurring prior to pregnancy or diagnosed before 20 weeks' gestation.

But a study of 501 women with hypertension at delivery suggests that the 20-week cutoff is not a reliable one. Instead, thorough postnatal follow-up is essential for accurate diagnosis, Mr. Waugh said.

The women were given preliminary diagnoses at the time of delivery. They subsequently performed home blood pressure monitoring—during which they followed a strict protocol for medication dosage reduction—for 1–8 weeks and were given final diagnoses.

The final diagnoses were preeclampsia in 36% (178 women), gestational hypertension in 42% (210), new diagnosis of chronic hypertension in 10% (51), and preexisting hypertension in 12% (49 with essential hypertension and 13 with renal disease).

Standard risk factors were poor predictors of underlying hypertension during pregnancy: Among the 51 women with chronic hypertension not diagnosed prior to pregnancy, only parity and gestation diagnosis were predictive of the final diagnosis, with smoking also showing a nonsignificant trend.

Age, weight, and body mass index were not related to the final diagnosis, nor was antenatal suspicion of hypertension. Of the 28 women with blood pressures greater than 140/90 mm Hg at less than 20 weeks' gestation, 16 (57%) were later proved to have only gestational hypertension, while 12 (43%) were ultimately found to have chronic hypertension. On the flip side, this means that of the 51 women newly diagnosed with chronic hypertension postnatally, just 12, or 24%, had been hypertensive prior to 20 weeks.

“We must proceed with great caution in both clinical and research practice if a postnatal confirmation of blood pressure is not available following antenatal hypertension,” Mr. Waugh remarked.

Findings from another study suggest that gestational hypertension commonly persists post partum, particularly in older women.

Tiina Podymow, M.D., of the division of nephrology and hypertension at Weill Medical College, Cornell University, New York City, reviewed clinic charts of 29 women who developed gestational hypertension or preeclampsia; all had been normotensive prior to pregnancy.

The women had a mean age of 35 years. Hypertension had developed at gestational age 15–40 weeks, with 13 developing hypertension within 3 days of delivery and the remainder at 1–18 weeks prior to delivery. The average blood pressure was 161/94 mm Hg, and the mean arterial pressure was 116. Eleven women were diagnosed with preeclampsia, and 25 were treated with antihypertensive drugs in the puerperium.

Blood pressure normalized between 0 and 4 weeks post partum in 12 women, between 5 and 12 weeks in 7, and between 13 and 20 weeks in 3. However, blood pressure remained elevated beyond 6 months in seven women, of whom one was found to have primary hyperaldosteronism. This finding suggests that secondary causes of hypertension should be considered in patients with hypertension persisting beyond 6 months, Dr. Podymow said.

Age was a significant risk factor. The women who remained persistently hypertensive had a mean age of 41 years, compared with 33.5 years among those whose hypertension resolved, she reported.

Few data are available to guide physicians in treating these patients, Susan Sadeghi, M.D., of the University of British Columbia, Vancouver, reported in a poster presentation.

“Peak postpartum blood pressure occurs on days 3–6 after delivery, when most women have already been discharged home. [Yet] there is little information on how best to treat postpartum hypertension in order to minimize maternal hospital stay and optimize maternal safety,” she pointed out.

Indeed, in an extensive review of the literature dating back to 1980, only six randomized clinical trials involving 459 women addressed postpartum anti-hypertensive treatment with regard to maternal and neonatal efficacy and safety outcomes. The largest study involved 266 subjects and the smallest, just 18.

Three of the six trials looked at prevention of postpartum hypertension in a total of 315 women. All compared drug vs. placebo or no treatment; two involved oral furosemide, 20–40 mg/day, and the other involved nifedipine capsules, 10 mg every 4 hours. There were no cases of hypotension, serious maternal morbidity, or maternal death. Only one study—which included just 18 patients—examined maternal length of stay, finding an insignificant difference of 7.3 vs. 7.6 days.

The other three trials were treatment studies that included just 144 women. None compared antihypertensive medication with placebo or no treatment for mild to moderate hypertension.

Two of the studies—involving 106 women—compared oral timolol or hydralazine with methyldopa for mild to moderate hypertension, and the third compared hydralazine plus nifedipine with nifedipine alone for severe postpartum hypertension.

There were no maternal deaths in the three treatment studies, and the need for additional antihypertensive therapy did not differ between groups.

Based on these minimal data, Dr. Sadeghi and her associates concluded: “If a clinician feels that antihypertensive therapy is needed, the agent used should be based on his/her familiarity with the drug.”

VIENNA — Guidelines are sorely needed for postpartum blood pressure management in women who experience hypertension during pregnancy, speakers said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

“It's a problem we have very little guidance on and very little information about,” said Jason Waugh, a senior lecturer in the Reproductive Science Section at the University of Leicester, England. He presented one of two studies highlighting the knowledge gaps regarding postpartum diagnosis and treatment of women with pregnancies complicated by hypertension.

Determining whether a woman has underlying chronic hypertension can be difficult. Professional societies such as the ISSHP and the American College of Obstetricians and Gynecologists define chronic hypertension in pregnancy as that occurring prior to pregnancy or diagnosed before 20 weeks' gestation.

But a study of 501 women with hypertension at delivery suggests that the 20-week cutoff is not a reliable one. Instead, thorough postnatal follow-up is essential for accurate diagnosis, Mr. Waugh said.

The women were given preliminary diagnoses at the time of delivery. They subsequently performed home blood pressure monitoring—during which they followed a strict protocol for medication dosage reduction—for 1–8 weeks and were given final diagnoses.

The final diagnoses were preeclampsia in 36% (178 women), gestational hypertension in 42% (210), new diagnosis of chronic hypertension in 10% (51), and preexisting hypertension in 12% (49 with essential hypertension and 13 with renal disease).

Standard risk factors were poor predictors of underlying hypertension during pregnancy: Among the 51 women with chronic hypertension not diagnosed prior to pregnancy, only parity and gestation diagnosis were predictive of the final diagnosis, with smoking also showing a nonsignificant trend.

Age, weight, and body mass index were not related to the final diagnosis, nor was antenatal suspicion of hypertension. Of the 28 women with blood pressures greater than 140/90 mm Hg at less than 20 weeks' gestation, 16 (57%) were later proved to have only gestational hypertension, while 12 (43%) were ultimately found to have chronic hypertension. On the flip side, this means that of the 51 women newly diagnosed with chronic hypertension postnatally, just 12, or 24%, had been hypertensive prior to 20 weeks.

“We must proceed with great caution in both clinical and research practice if a postnatal confirmation of blood pressure is not available following antenatal hypertension,” Mr. Waugh remarked.

Findings from another study suggest that gestational hypertension commonly persists post partum, particularly in older women.

Tiina Podymow, M.D., of the division of nephrology and hypertension at Weill Medical College, Cornell University, New York City, reviewed clinic charts of 29 women who developed gestational hypertension or preeclampsia; all had been normotensive prior to pregnancy.

The women had a mean age of 35 years. Hypertension had developed at gestational age 15–40 weeks, with 13 developing hypertension within 3 days of delivery and the remainder at 1–18 weeks prior to delivery. The average blood pressure was 161/94 mm Hg, and the mean arterial pressure was 116. Eleven women were diagnosed with preeclampsia, and 25 were treated with antihypertensive drugs in the puerperium.

Blood pressure normalized between 0 and 4 weeks post partum in 12 women, between 5 and 12 weeks in 7, and between 13 and 20 weeks in 3. However, blood pressure remained elevated beyond 6 months in seven women, of whom one was found to have primary hyperaldosteronism. This finding suggests that secondary causes of hypertension should be considered in patients with hypertension persisting beyond 6 months, Dr. Podymow said.

Age was a significant risk factor. The women who remained persistently hypertensive had a mean age of 41 years, compared with 33.5 years among those whose hypertension resolved, she reported.

Few data are available to guide physicians in treating these patients, Susan Sadeghi, M.D., of the University of British Columbia, Vancouver, reported in a poster presentation.

“Peak postpartum blood pressure occurs on days 3–6 after delivery, when most women have already been discharged home. [Yet] there is little information on how best to treat postpartum hypertension in order to minimize maternal hospital stay and optimize maternal safety,” she pointed out.

Indeed, in an extensive review of the literature dating back to 1980, only six randomized clinical trials involving 459 women addressed postpartum anti-hypertensive treatment with regard to maternal and neonatal efficacy and safety outcomes. The largest study involved 266 subjects and the smallest, just 18.

Three of the six trials looked at prevention of postpartum hypertension in a total of 315 women. All compared drug vs. placebo or no treatment; two involved oral furosemide, 20–40 mg/day, and the other involved nifedipine capsules, 10 mg every 4 hours. There were no cases of hypotension, serious maternal morbidity, or maternal death. Only one study—which included just 18 patients—examined maternal length of stay, finding an insignificant difference of 7.3 vs. 7.6 days.

The other three trials were treatment studies that included just 144 women. None compared antihypertensive medication with placebo or no treatment for mild to moderate hypertension.

Two of the studies—involving 106 women—compared oral timolol or hydralazine with methyldopa for mild to moderate hypertension, and the third compared hydralazine plus nifedipine with nifedipine alone for severe postpartum hypertension.

There were no maternal deaths in the three treatment studies, and the need for additional antihypertensive therapy did not differ between groups.

Based on these minimal data, Dr. Sadeghi and her associates concluded: “If a clinician feels that antihypertensive therapy is needed, the agent used should be based on his/her familiarity with the drug.”

VIENNA — Guidelines are sorely needed for postpartum blood pressure management in women who experience hypertension during pregnancy, speakers said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

“It's a problem we have very little guidance on and very little information about,” said Jason Waugh, a senior lecturer in the Reproductive Science Section at the University of Leicester, England. He presented one of two studies highlighting the knowledge gaps regarding postpartum diagnosis and treatment of women with pregnancies complicated by hypertension.

Determining whether a woman has underlying chronic hypertension can be difficult. Professional societies such as the ISSHP and the American College of Obstetricians and Gynecologists define chronic hypertension in pregnancy as that occurring prior to pregnancy or diagnosed before 20 weeks' gestation.

But a study of 501 women with hypertension at delivery suggests that the 20-week cutoff is not a reliable one. Instead, thorough postnatal follow-up is essential for accurate diagnosis, Mr. Waugh said.

The women were given preliminary diagnoses at the time of delivery. They subsequently performed home blood pressure monitoring—during which they followed a strict protocol for medication dosage reduction—for 1–8 weeks and were given final diagnoses.

The final diagnoses were preeclampsia in 36% (178 women), gestational hypertension in 42% (210), new diagnosis of chronic hypertension in 10% (51), and preexisting hypertension in 12% (49 with essential hypertension and 13 with renal disease).

Standard risk factors were poor predictors of underlying hypertension during pregnancy: Among the 51 women with chronic hypertension not diagnosed prior to pregnancy, only parity and gestation diagnosis were predictive of the final diagnosis, with smoking also showing a nonsignificant trend.

Age, weight, and body mass index were not related to the final diagnosis, nor was antenatal suspicion of hypertension. Of the 28 women with blood pressures greater than 140/90 mm Hg at less than 20 weeks' gestation, 16 (57%) were later proved to have only gestational hypertension, while 12 (43%) were ultimately found to have chronic hypertension. On the flip side, this means that of the 51 women newly diagnosed with chronic hypertension postnatally, just 12, or 24%, had been hypertensive prior to 20 weeks.

“We must proceed with great caution in both clinical and research practice if a postnatal confirmation of blood pressure is not available following antenatal hypertension,” Mr. Waugh remarked.

Findings from another study suggest that gestational hypertension commonly persists post partum, particularly in older women.

Tiina Podymow, M.D., of the division of nephrology and hypertension at Weill Medical College, Cornell University, New York City, reviewed clinic charts of 29 women who developed gestational hypertension or preeclampsia; all had been normotensive prior to pregnancy.

The women had a mean age of 35 years. Hypertension had developed at gestational age 15–40 weeks, with 13 developing hypertension within 3 days of delivery and the remainder at 1–18 weeks prior to delivery. The average blood pressure was 161/94 mm Hg, and the mean arterial pressure was 116. Eleven women were diagnosed with preeclampsia, and 25 were treated with antihypertensive drugs in the puerperium.

Blood pressure normalized between 0 and 4 weeks post partum in 12 women, between 5 and 12 weeks in 7, and between 13 and 20 weeks in 3. However, blood pressure remained elevated beyond 6 months in seven women, of whom one was found to have primary hyperaldosteronism. This finding suggests that secondary causes of hypertension should be considered in patients with hypertension persisting beyond 6 months, Dr. Podymow said.

Age was a significant risk factor. The women who remained persistently hypertensive had a mean age of 41 years, compared with 33.5 years among those whose hypertension resolved, she reported.

Few data are available to guide physicians in treating these patients, Susan Sadeghi, M.D., of the University of British Columbia, Vancouver, reported in a poster presentation.

“Peak postpartum blood pressure occurs on days 3–6 after delivery, when most women have already been discharged home. [Yet] there is little information on how best to treat postpartum hypertension in order to minimize maternal hospital stay and optimize maternal safety,” she pointed out.

Indeed, in an extensive review of the literature dating back to 1980, only six randomized clinical trials involving 459 women addressed postpartum anti-hypertensive treatment with regard to maternal and neonatal efficacy and safety outcomes. The largest study involved 266 subjects and the smallest, just 18.

Three of the six trials looked at prevention of postpartum hypertension in a total of 315 women. All compared drug vs. placebo or no treatment; two involved oral furosemide, 20–40 mg/day, and the other involved nifedipine capsules, 10 mg every 4 hours. There were no cases of hypotension, serious maternal morbidity, or maternal death. Only one study—which included just 18 patients—examined maternal length of stay, finding an insignificant difference of 7.3 vs. 7.6 days.

The other three trials were treatment studies that included just 144 women. None compared antihypertensive medication with placebo or no treatment for mild to moderate hypertension.

Two of the studies—involving 106 women—compared oral timolol or hydralazine with methyldopa for mild to moderate hypertension, and the third compared hydralazine plus nifedipine with nifedipine alone for severe postpartum hypertension.

There were no maternal deaths in the three treatment studies, and the need for additional antihypertensive therapy did not differ between groups.

Based on these minimal data, Dr. Sadeghi and her associates concluded: “If a clinician feels that antihypertensive therapy is needed, the agent used should be based on his/her familiarity with the drug.”

ORLANDO, FLA.–Early implementation of intensive blood glucose control reduces the risk for neuropathy in patients with type 1 diabetes, even if their control worsens down the line, Catherine L. Martin reported at the annual scientific sessions of the American Diabetes Association.

“Intensive therapy should be implemented as early as possible so as to obtain maximal long-term benefit,” said Ms. Martin of the University of Michigan, Ann Arbor.

The finding is the latest to come from the Epidemiology of Diabetes Interventions and Complications (EDIC) study, a long-term follow-up of 96% of the original 1,441 participants in the landmark Diabetes Control and Complications Trial (DCCT), which confirmed the link between intensive glucose control and a reduced risk of microvascular complications in patients with type 1 diabetes (N. Engl. J. Med. 1993;329:977–86).

In the DCCT, patients who practiced intensive blood glucose control and achieved an average hemoglobin A_1C level of 7.2% had a 64% lower risk for developing clinical neuropathy at an average follow-up of 5 years, compared with the conventionally treated group whose HbA_1C levels averaged 9%.

After the trial ended in 1993, the subjects in the conventionally treated group were instructed in intensive glucose management techniques, and all subjects were referred back to their personal physicians while continuing to be monitored annually in EDIC from 1994 onward, said Ms. Martin, the study coordinator for DCCT/EDIC at the University of Michigan.

By year 8 of EDIC, glucose control had improved in the DCCT conventionally treated patients to a mean HbA_1C level of 8.2%, while at the same time it had worsened in the former intensive treatment group to a mean of 8%.

But despite the convergence, 9.4% of the DCCT conventional group scored 7 or greater on the 15-item Michigan Neuropathy Screening Instrument (MNSI) symptom questionnaire at year 8, compared with 5% of the DCCT intensive group. On the five-component MNSI foot exam (appearance, ulceration, vibration, ankle reflex, and response to the 10-g monofilament), 33% of the DCCT conventional group scored 2.5 or greater vs. 23% of the intensive group.

Differences between the two groups on both neuropathy measures had reached significance by year 1 and remained so for each of the 8 years. Overall, the relative risk for neuropathy in the DCCT intensive group was reduced by 36% for the MNSI exam and by 50% for the MNSI questionnaire.

Similar findings of a persistent, beneficial effect of a prior period of glycemic control on the subsequent development of retinopathy and nephropathy at 8 years were reported at last year's ADA meeting by another EDIC investigator.

And in a published report, the progression of intima-media thickness, a measure of atherosclerosis, was also significantly lower 6 years later in the DCCT intensive group (N. Engl. J. Med. 2003;348:2294–303).

ORLANDO, FLA.–Early implementation of intensive blood glucose control reduces the risk for neuropathy in patients with type 1 diabetes, even if their control worsens down the line, Catherine L. Martin reported at the annual scientific sessions of the American Diabetes Association.

“Intensive therapy should be implemented as early as possible so as to obtain maximal long-term benefit,” said Ms. Martin of the University of Michigan, Ann Arbor.

The finding is the latest to come from the Epidemiology of Diabetes Interventions and Complications (EDIC) study, a long-term follow-up of 96% of the original 1,441 participants in the landmark Diabetes Control and Complications Trial (DCCT), which confirmed the link between intensive glucose control and a reduced risk of microvascular complications in patients with type 1 diabetes (N. Engl. J. Med. 1993;329:977–86).

In the DCCT, patients who practiced intensive blood glucose control and achieved an average hemoglobin A_1C level of 7.2% had a 64% lower risk for developing clinical neuropathy at an average follow-up of 5 years, compared with the conventionally treated group whose HbA_1C levels averaged 9%.

After the trial ended in 1993, the subjects in the conventionally treated group were instructed in intensive glucose management techniques, and all subjects were referred back to their personal physicians while continuing to be monitored annually in EDIC from 1994 onward, said Ms. Martin, the study coordinator for DCCT/EDIC at the University of Michigan.

By year 8 of EDIC, glucose control had improved in the DCCT conventionally treated patients to a mean HbA_1C level of 8.2%, while at the same time it had worsened in the former intensive treatment group to a mean of 8%.

But despite the convergence, 9.4% of the DCCT conventional group scored 7 or greater on the 15-item Michigan Neuropathy Screening Instrument (MNSI) symptom questionnaire at year 8, compared with 5% of the DCCT intensive group. On the five-component MNSI foot exam (appearance, ulceration, vibration, ankle reflex, and response to the 10-g monofilament), 33% of the DCCT conventional group scored 2.5 or greater vs. 23% of the intensive group.

Differences between the two groups on both neuropathy measures had reached significance by year 1 and remained so for each of the 8 years. Overall, the relative risk for neuropathy in the DCCT intensive group was reduced by 36% for the MNSI exam and by 50% for the MNSI questionnaire.

Similar findings of a persistent, beneficial effect of a prior period of glycemic control on the subsequent development of retinopathy and nephropathy at 8 years were reported at last year's ADA meeting by another EDIC investigator.

And in a published report, the progression of intima-media thickness, a measure of atherosclerosis, was also significantly lower 6 years later in the DCCT intensive group (N. Engl. J. Med. 2003;348:2294–303).

ORLANDO, FLA.–Early implementation of intensive blood glucose control reduces the risk for neuropathy in patients with type 1 diabetes, even if their control worsens down the line, Catherine L. Martin reported at the annual scientific sessions of the American Diabetes Association.

“Intensive therapy should be implemented as early as possible so as to obtain maximal long-term benefit,” said Ms. Martin of the University of Michigan, Ann Arbor.

The finding is the latest to come from the Epidemiology of Diabetes Interventions and Complications (EDIC) study, a long-term follow-up of 96% of the original 1,441 participants in the landmark Diabetes Control and Complications Trial (DCCT), which confirmed the link between intensive glucose control and a reduced risk of microvascular complications in patients with type 1 diabetes (N. Engl. J. Med. 1993;329:977–86).

In the DCCT, patients who practiced intensive blood glucose control and achieved an average hemoglobin A_1C level of 7.2% had a 64% lower risk for developing clinical neuropathy at an average follow-up of 5 years, compared with the conventionally treated group whose HbA_1C levels averaged 9%.

After the trial ended in 1993, the subjects in the conventionally treated group were instructed in intensive glucose management techniques, and all subjects were referred back to their personal physicians while continuing to be monitored annually in EDIC from 1994 onward, said Ms. Martin, the study coordinator for DCCT/EDIC at the University of Michigan.

By year 8 of EDIC, glucose control had improved in the DCCT conventionally treated patients to a mean HbA_1C level of 8.2%, while at the same time it had worsened in the former intensive treatment group to a mean of 8%.

But despite the convergence, 9.4% of the DCCT conventional group scored 7 or greater on the 15-item Michigan Neuropathy Screening Instrument (MNSI) symptom questionnaire at year 8, compared with 5% of the DCCT intensive group. On the five-component MNSI foot exam (appearance, ulceration, vibration, ankle reflex, and response to the 10-g monofilament), 33% of the DCCT conventional group scored 2.5 or greater vs. 23% of the intensive group.

Differences between the two groups on both neuropathy measures had reached significance by year 1 and remained so for each of the 8 years. Overall, the relative risk for neuropathy in the DCCT intensive group was reduced by 36% for the MNSI exam and by 50% for the MNSI questionnaire.

Similar findings of a persistent, beneficial effect of a prior period of glycemic control on the subsequent development of retinopathy and nephropathy at 8 years were reported at last year's ADA meeting by another EDIC investigator.

And in a published report, the progression of intima-media thickness, a measure of atherosclerosis, was also significantly lower 6 years later in the DCCT intensive group (N. Engl. J. Med. 2003;348:2294–303).

PHILADELPHIA – The diabetes drug rosiglitazone appears to preserve cognitive function in patients with mild cognitive impairment and Alzheimer's disease, G. Stennis Watson, Ph.D., reported at the Ninth International Conference on Alzheimer's Disease and Related Disorders.

The finding, from a small randomized clinical trial funded by GlaxoSmithKline, suggests that “there may be a therapeutic window … a novel approach to treating cognitive dysfunction,” study coauthor Dr. Suzanne Craft said at a press briefing.

Twenty subjects with either mild cognitive impairment or Alzheimer's disease were randomized to receive 4 mg/day of rosiglitazone for 24 weeks, while another 10 subjects with similar degrees of cognitive impairment were randomized to receive placebo. Tests of cognition were performed at 2, 4, and 6 months, said Dr. Watson of the University of Washington, Seattle.

On the eight-word delayed recall part of the Buschke Selective Reminding Test, subjects who received rosiglitazone remembered significantly more words than did the placebo subjects at 4 months (5.7 vs. 5.4) and 6 months (5.4 vs. 4.9), after adjustment for baseline performance. Similarly, the rosiglitazone group made fewer errors on the Stroop Color-Word Interference test, which measures selective attention. At 6 months, the rosiglitazone subjects made an average of 1.9 errors, compared with the expected 3.2 in the placebo group.

The effects are likely due to the drug's insulin-sensitizing and anti-inflammatory properties, and perhaps also to the amyloid-processing modulation action of rosiglitazone and other agents of the same class, Dr. Watson said at the conference, presented by the Alzheimer's Association.

A larger trial aimed at replicating these findings is underway in Europe, he noted.

PHILADELPHIA – The diabetes drug rosiglitazone appears to preserve cognitive function in patients with mild cognitive impairment and Alzheimer's disease, G. Stennis Watson, Ph.D., reported at the Ninth International Conference on Alzheimer's Disease and Related Disorders.

The finding, from a small randomized clinical trial funded by GlaxoSmithKline, suggests that “there may be a therapeutic window … a novel approach to treating cognitive dysfunction,” study coauthor Dr. Suzanne Craft said at a press briefing.

Twenty subjects with either mild cognitive impairment or Alzheimer's disease were randomized to receive 4 mg/day of rosiglitazone for 24 weeks, while another 10 subjects with similar degrees of cognitive impairment were randomized to receive placebo. Tests of cognition were performed at 2, 4, and 6 months, said Dr. Watson of the University of Washington, Seattle.

On the eight-word delayed recall part of the Buschke Selective Reminding Test, subjects who received rosiglitazone remembered significantly more words than did the placebo subjects at 4 months (5.7 vs. 5.4) and 6 months (5.4 vs. 4.9), after adjustment for baseline performance. Similarly, the rosiglitazone group made fewer errors on the Stroop Color-Word Interference test, which measures selective attention. At 6 months, the rosiglitazone subjects made an average of 1.9 errors, compared with the expected 3.2 in the placebo group.

The effects are likely due to the drug's insulin-sensitizing and anti-inflammatory properties, and perhaps also to the amyloid-processing modulation action of rosiglitazone and other agents of the same class, Dr. Watson said at the conference, presented by the Alzheimer's Association.

A larger trial aimed at replicating these findings is underway in Europe, he noted.

PHILADELPHIA – The diabetes drug rosiglitazone appears to preserve cognitive function in patients with mild cognitive impairment and Alzheimer's disease, G. Stennis Watson, Ph.D., reported at the Ninth International Conference on Alzheimer's Disease and Related Disorders.

The finding, from a small randomized clinical trial funded by GlaxoSmithKline, suggests that “there may be a therapeutic window … a novel approach to treating cognitive dysfunction,” study coauthor Dr. Suzanne Craft said at a press briefing.

Twenty subjects with either mild cognitive impairment or Alzheimer's disease were randomized to receive 4 mg/day of rosiglitazone for 24 weeks, while another 10 subjects with similar degrees of cognitive impairment were randomized to receive placebo. Tests of cognition were performed at 2, 4, and 6 months, said Dr. Watson of the University of Washington, Seattle.

On the eight-word delayed recall part of the Buschke Selective Reminding Test, subjects who received rosiglitazone remembered significantly more words than did the placebo subjects at 4 months (5.7 vs. 5.4) and 6 months (5.4 vs. 4.9), after adjustment for baseline performance. Similarly, the rosiglitazone group made fewer errors on the Stroop Color-Word Interference test, which measures selective attention. At 6 months, the rosiglitazone subjects made an average of 1.9 errors, compared with the expected 3.2 in the placebo group.

The effects are likely due to the drug's insulin-sensitizing and anti-inflammatory properties, and perhaps also to the amyloid-processing modulation action of rosiglitazone and other agents of the same class, Dr. Watson said at the conference, presented by the Alzheimer's Association.

A larger trial aimed at replicating these findings is underway in Europe, he noted.

VIENNA — Preeclamptic women on magnesium sulfate treatment do not appear to be at increased risk for cognitive deficits, Judith Hibbard, M.D., reported at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

In fact, women who are being treated with magnesium sulfate (MgSO₄) for preeclampsia appear to have better attention and working memory capacity than do normotensive laboring women, said Dr. Hibbard, who is professor of ob.gyn. at the University of Illinois at Chicago.

Dr. Hibbard presented the paper for Sarosh Rana, M.D., of the University of Chicago.

These preliminary findings come from a study that was prompted by a news report of a nanny from Mexico who delivered and abandoned her baby on a Florida beach. She was arrested, but all charges were dropped when the physician at a local hospital stated that the mother had preeclampsia, and that associated mental changes could have prompted her temporary irrational behavior.

An initial literature search yielded a small amount of data suggesting that mild cognitive deficits may occur during normal pregnancy, as well as a few anecdotal reports of psychosis, but no previous formal studies looking specifically at cognition in preeclampsia.

Thus, the current study was initiated in which a battery of neurocognitive tests were administered twice to three groups of women: 15 with preeclampsia who were treated with MgSO₄, 15 women in preterm labor who received tocolytic MgSO₄, and 15 normal laboring women.

Tests assessing intelligence (IQ), auditory comprehension, attention, memory, pain, and distress were first performed prior to delivery (at least 2 hours after initiation of MgSO₄ in the preeclamptic and preterm groups and shortly after admission in the controls), and again after delivery (at least 12 hours after discontinuation of MgSO₄ in the two treatment groups).

Prior to delivery, there were no apparent differences in age, parity, IQ, education, auditory comprehension, or fatigue level among the three groups. Distress was greater among the preeclamptics, whereas pain was higher in the normal controls, Dr. Hibbard noted.

Immediate verbal memory was similar before and after delivery within the three groups. Delayed verbal memory, on the other hand, improved in all three groups following delivery, and significantly so in both the preeclamptics and preterm patients.

Digit span scores, which assess attention, did not differ significantly before and after delivery in any group, but were significantly better at both time points in the preeclamptic patients on MgSO₄ than they were in the other two groups. Out of a possible 30, the preeclamptics scored 18.8 post delivery, compared with 16.86 among the normal laboring women and 14.8 among the preterm patients, she said.

Similarly, whereas all three groups improved modestly post delivery on letter-number sequencing, which assesses attention and working memory, the preeclamptics also did better at both end points than did the other two groups.

Magnesium has been shown to have neuroprotective actions in cerebral ischemia and is a cerebral vasodilator for the ischemic—but not for the normally perfused—brain. This difference might explain the adverse cognitive effects of MgSO₄ on women in preterm labor and the absence of those effects in the preeclamptics in this study, Dr. Hibbard noted.

These preliminary results are part of a larger study that is looking at cognition among women with preeclampsia prior to the administration of magnesium, as well as among nonpregnant women, she said.

VIENNA — Preeclamptic women on magnesium sulfate treatment do not appear to be at increased risk for cognitive deficits, Judith Hibbard, M.D., reported at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

In fact, women who are being treated with magnesium sulfate (MgSO₄) for preeclampsia appear to have better attention and working memory capacity than do normotensive laboring women, said Dr. Hibbard, who is professor of ob.gyn. at the University of Illinois at Chicago.

Dr. Hibbard presented the paper for Sarosh Rana, M.D., of the University of Chicago.

These preliminary findings come from a study that was prompted by a news report of a nanny from Mexico who delivered and abandoned her baby on a Florida beach. She was arrested, but all charges were dropped when the physician at a local hospital stated that the mother had preeclampsia, and that associated mental changes could have prompted her temporary irrational behavior.

An initial literature search yielded a small amount of data suggesting that mild cognitive deficits may occur during normal pregnancy, as well as a few anecdotal reports of psychosis, but no previous formal studies looking specifically at cognition in preeclampsia.

Thus, the current study was initiated in which a battery of neurocognitive tests were administered twice to three groups of women: 15 with preeclampsia who were treated with MgSO₄, 15 women in preterm labor who received tocolytic MgSO₄, and 15 normal laboring women.

Tests assessing intelligence (IQ), auditory comprehension, attention, memory, pain, and distress were first performed prior to delivery (at least 2 hours after initiation of MgSO₄ in the preeclamptic and preterm groups and shortly after admission in the controls), and again after delivery (at least 12 hours after discontinuation of MgSO₄ in the two treatment groups).

Prior to delivery, there were no apparent differences in age, parity, IQ, education, auditory comprehension, or fatigue level among the three groups. Distress was greater among the preeclamptics, whereas pain was higher in the normal controls, Dr. Hibbard noted.

Immediate verbal memory was similar before and after delivery within the three groups. Delayed verbal memory, on the other hand, improved in all three groups following delivery, and significantly so in both the preeclamptics and preterm patients.

Digit span scores, which assess attention, did not differ significantly before and after delivery in any group, but were significantly better at both time points in the preeclamptic patients on MgSO₄ than they were in the other two groups. Out of a possible 30, the preeclamptics scored 18.8 post delivery, compared with 16.86 among the normal laboring women and 14.8 among the preterm patients, she said.

Similarly, whereas all three groups improved modestly post delivery on letter-number sequencing, which assesses attention and working memory, the preeclamptics also did better at both end points than did the other two groups.

Magnesium has been shown to have neuroprotective actions in cerebral ischemia and is a cerebral vasodilator for the ischemic—but not for the normally perfused—brain. This difference might explain the adverse cognitive effects of MgSO₄ on women in preterm labor and the absence of those effects in the preeclamptics in this study, Dr. Hibbard noted.

These preliminary results are part of a larger study that is looking at cognition among women with preeclampsia prior to the administration of magnesium, as well as among nonpregnant women, she said.

VIENNA — Preeclamptic women on magnesium sulfate treatment do not appear to be at increased risk for cognitive deficits, Judith Hibbard, M.D., reported at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

In fact, women who are being treated with magnesium sulfate (MgSO₄) for preeclampsia appear to have better attention and working memory capacity than do normotensive laboring women, said Dr. Hibbard, who is professor of ob.gyn. at the University of Illinois at Chicago.

Dr. Hibbard presented the paper for Sarosh Rana, M.D., of the University of Chicago.

These preliminary findings come from a study that was prompted by a news report of a nanny from Mexico who delivered and abandoned her baby on a Florida beach. She was arrested, but all charges were dropped when the physician at a local hospital stated that the mother had preeclampsia, and that associated mental changes could have prompted her temporary irrational behavior.

An initial literature search yielded a small amount of data suggesting that mild cognitive deficits may occur during normal pregnancy, as well as a few anecdotal reports of psychosis, but no previous formal studies looking specifically at cognition in preeclampsia.

Thus, the current study was initiated in which a battery of neurocognitive tests were administered twice to three groups of women: 15 with preeclampsia who were treated with MgSO₄, 15 women in preterm labor who received tocolytic MgSO₄, and 15 normal laboring women.

Tests assessing intelligence (IQ), auditory comprehension, attention, memory, pain, and distress were first performed prior to delivery (at least 2 hours after initiation of MgSO₄ in the preeclamptic and preterm groups and shortly after admission in the controls), and again after delivery (at least 12 hours after discontinuation of MgSO₄ in the two treatment groups).

Prior to delivery, there were no apparent differences in age, parity, IQ, education, auditory comprehension, or fatigue level among the three groups. Distress was greater among the preeclamptics, whereas pain was higher in the normal controls, Dr. Hibbard noted.

Immediate verbal memory was similar before and after delivery within the three groups. Delayed verbal memory, on the other hand, improved in all three groups following delivery, and significantly so in both the preeclamptics and preterm patients.

Digit span scores, which assess attention, did not differ significantly before and after delivery in any group, but were significantly better at both time points in the preeclamptic patients on MgSO₄ than they were in the other two groups. Out of a possible 30, the preeclamptics scored 18.8 post delivery, compared with 16.86 among the normal laboring women and 14.8 among the preterm patients, she said.

Similarly, whereas all three groups improved modestly post delivery on letter-number sequencing, which assesses attention and working memory, the preeclamptics also did better at both end points than did the other two groups.

Magnesium has been shown to have neuroprotective actions in cerebral ischemia and is a cerebral vasodilator for the ischemic—but not for the normally perfused—brain. This difference might explain the adverse cognitive effects of MgSO₄ on women in preterm labor and the absence of those effects in the preeclamptics in this study, Dr. Hibbard noted.

These preliminary results are part of a larger study that is looking at cognition among women with preeclampsia prior to the administration of magnesium, as well as among nonpregnant women, she said.

VIENNA — Both increasing severity and recurrence of gestational hypertension increase a woman's chances of developing ischemic heart disease later in life, Dr. Anna-Karin Wikström said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

Long-term measures to prevent hypertension should be undertaken in women who experience severe or recurrent hypertension during pregnancy, said Dr. Wikström of Uppsala University, Stockholm.

Data from three Swedish medical databases were analyzed for more than 400,000 women with first births since 1973 and for more than 200,000 who gave birth to two infants between 1973 and 1982. Only singleton births were included.

Women with chronic hypertension and/or diabetes were excluded from the study.

After adjustment for maternal age, socioeconomic status, and hospital category, the relative risk of developing ischemic heart disease (IHD) after 19-28 years' follow-up was 1.6 for the women who had gestational hypertension without proteinuria in their first pregnancies, compared with those who did not have hypertension in their first pregnancies. Among women with preeclampsia the relative risk was 1.9, and among those with severe preeclampsia it was 2.8. All the between-group differences were statistically significant, she said.

In the group with two children, the women who had any degree of hypertensive disease during their first pregnancy but not during the second had a 1.9 relative risk of IHD, compared with those who did not have hypertension in either pregnancy. The relative risk of IHD for women with hypertension in the second pregnancy but not the first was 2.4, and for those with hypertension in both pregnancies, 2.8. The difference between the first-pregnancy and both-pregnancy groups was statistically significant, she noted.

“We don't think that [this] information must be given to all women with gestational hypertensive disease, since it could create a lot of anxiety in a large group of women who will never go on to develop ischemic heart disease,” Dr. Wikström said.

Nevertheless, she added that giving such information “could be considered in women with a history of severe or recurrent preeclampsia, or gestation with coexisting, avoidable independent risk factors such as smoking and obesity.”

VIENNA — Both increasing severity and recurrence of gestational hypertension increase a woman's chances of developing ischemic heart disease later in life, Dr. Anna-Karin Wikström said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

Long-term measures to prevent hypertension should be undertaken in women who experience severe or recurrent hypertension during pregnancy, said Dr. Wikström of Uppsala University, Stockholm.

Data from three Swedish medical databases were analyzed for more than 400,000 women with first births since 1973 and for more than 200,000 who gave birth to two infants between 1973 and 1982. Only singleton births were included.

Women with chronic hypertension and/or diabetes were excluded from the study.

After adjustment for maternal age, socioeconomic status, and hospital category, the relative risk of developing ischemic heart disease (IHD) after 19-28 years' follow-up was 1.6 for the women who had gestational hypertension without proteinuria in their first pregnancies, compared with those who did not have hypertension in their first pregnancies. Among women with preeclampsia the relative risk was 1.9, and among those with severe preeclampsia it was 2.8. All the between-group differences were statistically significant, she said.

In the group with two children, the women who had any degree of hypertensive disease during their first pregnancy but not during the second had a 1.9 relative risk of IHD, compared with those who did not have hypertension in either pregnancy. The relative risk of IHD for women with hypertension in the second pregnancy but not the first was 2.4, and for those with hypertension in both pregnancies, 2.8. The difference between the first-pregnancy and both-pregnancy groups was statistically significant, she noted.

“We don't think that [this] information must be given to all women with gestational hypertensive disease, since it could create a lot of anxiety in a large group of women who will never go on to develop ischemic heart disease,” Dr. Wikström said.

Nevertheless, she added that giving such information “could be considered in women with a history of severe or recurrent preeclampsia, or gestation with coexisting, avoidable independent risk factors such as smoking and obesity.”

VIENNA — Both increasing severity and recurrence of gestational hypertension increase a woman's chances of developing ischemic heart disease later in life, Dr. Anna-Karin Wikström said at the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

Long-term measures to prevent hypertension should be undertaken in women who experience severe or recurrent hypertension during pregnancy, said Dr. Wikström of Uppsala University, Stockholm.

Data from three Swedish medical databases were analyzed for more than 400,000 women with first births since 1973 and for more than 200,000 who gave birth to two infants between 1973 and 1982. Only singleton births were included.

Women with chronic hypertension and/or diabetes were excluded from the study.

After adjustment for maternal age, socioeconomic status, and hospital category, the relative risk of developing ischemic heart disease (IHD) after 19-28 years' follow-up was 1.6 for the women who had gestational hypertension without proteinuria in their first pregnancies, compared with those who did not have hypertension in their first pregnancies. Among women with preeclampsia the relative risk was 1.9, and among those with severe preeclampsia it was 2.8. All the between-group differences were statistically significant, she said.

In the group with two children, the women who had any degree of hypertensive disease during their first pregnancy but not during the second had a 1.9 relative risk of IHD, compared with those who did not have hypertension in either pregnancy. The relative risk of IHD for women with hypertension in the second pregnancy but not the first was 2.4, and for those with hypertension in both pregnancies, 2.8. The difference between the first-pregnancy and both-pregnancy groups was statistically significant, she noted.

“We don't think that [this] information must be given to all women with gestational hypertensive disease, since it could create a lot of anxiety in a large group of women who will never go on to develop ischemic heart disease,” Dr. Wikström said.

Nevertheless, she added that giving such information “could be considered in women with a history of severe or recurrent preeclampsia, or gestation with coexisting, avoidable independent risk factors such as smoking and obesity.”

VIENNA — Obesity and excess prenatal weight gain increase the risk of preeclampsia among women from a diverse urban population, Terry J. Rosenberg, Ph.D., reported.

The findings suggest that the focus should shift from the treatment of preeclampsia to its prevention, said Dr. Rosenberg, who is the deputy director of research and evaluation, Medical Health and Research Association of New York City Inc. The association is an independent, nonprofit organization that works with the New York City Department of Health and Mental Hygiene in studying medically underserved populations.

Since many low-income women do not have regular health care providers, “There's a window of opportunity during pregnancy for ob.gyns. to provide the kind of advice that these women aren't likely to get from another physician. … Providing encouragement for a healthy diet and exercise during the perinatal period will carry over to better health throughout the lifetime of these women,” she said during the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

Among 330,216 singleton births during 1999-2001 from New York City's birth certificate database, 6% (20,702) of the mothers had a prepregnancy weight of more than 199 pounds. This weight was used as the definition of obesity, since height data were not included in the database.

Excess prenatal weight gain, which was defined as more than 40 pounds, was recorded for 18% (60,695) of the women in the study.

Preeclampsia, which was diagnosed by the physician, was recorded for 2% of the study population (7,011).

One-third of the mothers (33%) were Hispanic, 29% were white, 26% were black, and 12% were Asian.

One-third were foreign-born.

Obesity rates were highest among the black women (12.7%), followed by the Hispanic women (5.2%), and the whites (4.8%), with Asians far lower (0.8%), she said.

Excess weight gain was recorded for 21% of the Hispanic women, 20% of the black women, 17% of the whites, and 11% of the Asians.

Preeclampsia was diagnosed in 2.9% of the black women and 2.6% of the Hispanic women, at least double the rates among white (1.3%) and Asian (1.2%) women, Dr. Rosenberg reported during her presentation at the meeting.

After adjustment for significant predictors of preeclampsia—which included age older than 35, black or Hispanic ethnicity, low socioeconomic status, and chronic diabetes and/or hypertension—the risk for preeclampsia was 1.8 times greater for women who weighed 200-299 pounds, compared with those women weighing 100-149 pounds, the investigators found.

The risk was elevated 2.6-fold among women weighing at least 300 pounds.

Moreover, preeclampsia was 1.5 times as common among the women who gained more than 40 pounds during pregnancy, compared with those who gained less weight.

Those elevated risks did not differ significantly after 4,036 women with chronic diabetes and/or hypertension were removed from the analysis, Dr. Rosenberg noted.

VIENNA — Obesity and excess prenatal weight gain increase the risk of preeclampsia among women from a diverse urban population, Terry J. Rosenberg, Ph.D., reported.

The findings suggest that the focus should shift from the treatment of preeclampsia to its prevention, said Dr. Rosenberg, who is the deputy director of research and evaluation, Medical Health and Research Association of New York City Inc. The association is an independent, nonprofit organization that works with the New York City Department of Health and Mental Hygiene in studying medically underserved populations.

Since many low-income women do not have regular health care providers, “There's a window of opportunity during pregnancy for ob.gyns. to provide the kind of advice that these women aren't likely to get from another physician. … Providing encouragement for a healthy diet and exercise during the perinatal period will carry over to better health throughout the lifetime of these women,” she said during the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

Among 330,216 singleton births during 1999-2001 from New York City's birth certificate database, 6% (20,702) of the mothers had a prepregnancy weight of more than 199 pounds. This weight was used as the definition of obesity, since height data were not included in the database.

Excess prenatal weight gain, which was defined as more than 40 pounds, was recorded for 18% (60,695) of the women in the study.

Preeclampsia, which was diagnosed by the physician, was recorded for 2% of the study population (7,011).

One-third of the mothers (33%) were Hispanic, 29% were white, 26% were black, and 12% were Asian.

One-third were foreign-born.

Obesity rates were highest among the black women (12.7%), followed by the Hispanic women (5.2%), and the whites (4.8%), with Asians far lower (0.8%), she said.

Excess weight gain was recorded for 21% of the Hispanic women, 20% of the black women, 17% of the whites, and 11% of the Asians.

Preeclampsia was diagnosed in 2.9% of the black women and 2.6% of the Hispanic women, at least double the rates among white (1.3%) and Asian (1.2%) women, Dr. Rosenberg reported during her presentation at the meeting.

After adjustment for significant predictors of preeclampsia—which included age older than 35, black or Hispanic ethnicity, low socioeconomic status, and chronic diabetes and/or hypertension—the risk for preeclampsia was 1.8 times greater for women who weighed 200-299 pounds, compared with those women weighing 100-149 pounds, the investigators found.

The risk was elevated 2.6-fold among women weighing at least 300 pounds.

Moreover, preeclampsia was 1.5 times as common among the women who gained more than 40 pounds during pregnancy, compared with those who gained less weight.

Those elevated risks did not differ significantly after 4,036 women with chronic diabetes and/or hypertension were removed from the analysis, Dr. Rosenberg noted.

VIENNA — Obesity and excess prenatal weight gain increase the risk of preeclampsia among women from a diverse urban population, Terry J. Rosenberg, Ph.D., reported.

The findings suggest that the focus should shift from the treatment of preeclampsia to its prevention, said Dr. Rosenberg, who is the deputy director of research and evaluation, Medical Health and Research Association of New York City Inc. The association is an independent, nonprofit organization that works with the New York City Department of Health and Mental Hygiene in studying medically underserved populations.

Since many low-income women do not have regular health care providers, “There's a window of opportunity during pregnancy for ob.gyns. to provide the kind of advice that these women aren't likely to get from another physician. … Providing encouragement for a healthy diet and exercise during the perinatal period will carry over to better health throughout the lifetime of these women,” she said during the 14th World Congress of the International Society for the Study of Hypertension in Pregnancy.

Among 330,216 singleton births during 1999-2001 from New York City's birth certificate database, 6% (20,702) of the mothers had a prepregnancy weight of more than 199 pounds. This weight was used as the definition of obesity, since height data were not included in the database.

Excess prenatal weight gain, which was defined as more than 40 pounds, was recorded for 18% (60,695) of the women in the study.

Preeclampsia, which was diagnosed by the physician, was recorded for 2% of the study population (7,011).

One-third of the mothers (33%) were Hispanic, 29% were white, 26% were black, and 12% were Asian.

One-third were foreign-born.

Obesity rates were highest among the black women (12.7%), followed by the Hispanic women (5.2%), and the whites (4.8%), with Asians far lower (0.8%), she said.

Excess weight gain was recorded for 21% of the Hispanic women, 20% of the black women, 17% of the whites, and 11% of the Asians.

Preeclampsia was diagnosed in 2.9% of the black women and 2.6% of the Hispanic women, at least double the rates among white (1.3%) and Asian (1.2%) women, Dr. Rosenberg reported during her presentation at the meeting.

After adjustment for significant predictors of preeclampsia—which included age older than 35, black or Hispanic ethnicity, low socioeconomic status, and chronic diabetes and/or hypertension—the risk for preeclampsia was 1.8 times greater for women who weighed 200-299 pounds, compared with those women weighing 100-149 pounds, the investigators found.

The risk was elevated 2.6-fold among women weighing at least 300 pounds.

Moreover, preeclampsia was 1.5 times as common among the women who gained more than 40 pounds during pregnancy, compared with those who gained less weight.

Those elevated risks did not differ significantly after 4,036 women with chronic diabetes and/or hypertension were removed from the analysis, Dr. Rosenberg noted.

WASHINGTON — Methicillin-resistant Staphylococcus aureus has been transmitted via breast milk, Dawn Terashita Gastelum, M.D., reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The two reported cases, which resulted in MRSA outbreaks in neonatal intensive care units at two Los Angeles hospitals, suggest that hospital NICUs should consider screening mothers and family members for skin lesions at the time of delivery and obtaining breast milk cultures before infant feedings, said Dr. Terashita Gastelum of the Los Angeles County Department of Health Services.

The first case was in a premature (1,180 g at birth) quadruplet born to an Algerian mother who developed mastitis the day after delivery and was treated with dicloxacillin. Her breast milk was collected 3 days later and fed to the quadruplets. Twelve days after that, the baby girl died of MRSA sepsis.

The bacterium subsequently was found in nasopharyngeal cultures of the mother and her three surviving infants, another infant in the NICU, and the mother's frozen postpartum breast milk samples. Molecular fingerprinting was identical for the four infants and the breast milk, but the mother's nasopharyngeal isolate was different.

“Since the mother was actually colonized by a different strain, it is unlikely that the infants obtained the MRSA during birth or through skin-to-skin contact with the mother. The breast milk is the only known source,” Dr. Terashita Gastelum told this newspaper.

And, though it is possible to be colonized with two different strains of MRSA, it's rare. On the other hand, “it is easy to imagine that the macerated skin of the nipple on a postpartum woman is more susceptible to infection from any organism,” she said at the conference, sponsored by the American Society for Microbiology.

The second case was an 1,199-g male infant born to an African American mother, who was fed her breast milk the day of birth and developed MRSA sepsis 8 days later. This mother had no sign of mastitis, but MRSA was cultured from her breast milk collected on the day of delivery. Four other infants from the NICU were also positive: two colonized and two infected. Isolates from the breast milk and the five cases were identical.

WASHINGTON — Methicillin-resistant Staphylococcus aureus has been transmitted via breast milk, Dawn Terashita Gastelum, M.D., reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The two reported cases, which resulted in MRSA outbreaks in neonatal intensive care units at two Los Angeles hospitals, suggest that hospital NICUs should consider screening mothers and family members for skin lesions at the time of delivery and obtaining breast milk cultures before infant feedings, said Dr. Terashita Gastelum of the Los Angeles County Department of Health Services.

The first case was in a premature (1,180 g at birth) quadruplet born to an Algerian mother who developed mastitis the day after delivery and was treated with dicloxacillin. Her breast milk was collected 3 days later and fed to the quadruplets. Twelve days after that, the baby girl died of MRSA sepsis.

The bacterium subsequently was found in nasopharyngeal cultures of the mother and her three surviving infants, another infant in the NICU, and the mother's frozen postpartum breast milk samples. Molecular fingerprinting was identical for the four infants and the breast milk, but the mother's nasopharyngeal isolate was different.

“Since the mother was actually colonized by a different strain, it is unlikely that the infants obtained the MRSA during birth or through skin-to-skin contact with the mother. The breast milk is the only known source,” Dr. Terashita Gastelum told this newspaper.

And, though it is possible to be colonized with two different strains of MRSA, it's rare. On the other hand, “it is easy to imagine that the macerated skin of the nipple on a postpartum woman is more susceptible to infection from any organism,” she said at the conference, sponsored by the American Society for Microbiology.

The second case was an 1,199-g male infant born to an African American mother, who was fed her breast milk the day of birth and developed MRSA sepsis 8 days later. This mother had no sign of mastitis, but MRSA was cultured from her breast milk collected on the day of delivery. Four other infants from the NICU were also positive: two colonized and two infected. Isolates from the breast milk and the five cases were identical.

WASHINGTON — Methicillin-resistant Staphylococcus aureus has been transmitted via breast milk, Dawn Terashita Gastelum, M.D., reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The two reported cases, which resulted in MRSA outbreaks in neonatal intensive care units at two Los Angeles hospitals, suggest that hospital NICUs should consider screening mothers and family members for skin lesions at the time of delivery and obtaining breast milk cultures before infant feedings, said Dr. Terashita Gastelum of the Los Angeles County Department of Health Services.

The first case was in a premature (1,180 g at birth) quadruplet born to an Algerian mother who developed mastitis the day after delivery and was treated with dicloxacillin. Her breast milk was collected 3 days later and fed to the quadruplets. Twelve days after that, the baby girl died of MRSA sepsis.

The bacterium subsequently was found in nasopharyngeal cultures of the mother and her three surviving infants, another infant in the NICU, and the mother's frozen postpartum breast milk samples. Molecular fingerprinting was identical for the four infants and the breast milk, but the mother's nasopharyngeal isolate was different.

“Since the mother was actually colonized by a different strain, it is unlikely that the infants obtained the MRSA during birth or through skin-to-skin contact with the mother. The breast milk is the only known source,” Dr. Terashita Gastelum told this newspaper.

And, though it is possible to be colonized with two different strains of MRSA, it's rare. On the other hand, “it is easy to imagine that the macerated skin of the nipple on a postpartum woman is more susceptible to infection from any organism,” she said at the conference, sponsored by the American Society for Microbiology.

The second case was an 1,199-g male infant born to an African American mother, who was fed her breast milk the day of birth and developed MRSA sepsis 8 days later. This mother had no sign of mastitis, but MRSA was cultured from her breast milk collected on the day of delivery. Four other infants from the NICU were also positive: two colonized and two infected. Isolates from the breast milk and the five cases were identical.

WASHINGTON — Tigecycline, a novel broad-spectrum antibiotic, appears effective in treating a variety of serious infections, including those caused by resistant organisms, Evan Loh, M.D., said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Wyeth's tigecycline, the first of the glycylcycline class, is a modification of the minocycline molecule designed specifically to overcome two major bacterial resistance mechanisms. It has activity against gram-positive, gram-negative, atypical, anaerobic, and antibiotic-resistant bacteria. Phase III data thus far demonstrate efficacy in the treatment both complicated intraabdominal infections and skin/skin structure infections, said Dr. Loh, vice president, cardiovascular/infectious disease, Wyeth Research, Collegeville, Pa.

“This agent offers a broad spectrum of activity that offers an exciting opportunity for physicians to consider as empiric therapy when individuals with serious infections present in the hospital setting,” he said in a symposium at the meeting.

In late-breaker poster presentations, Nathalie Dartois, M.D., of Wyeth Research in Paris reported data from two phase III clinical trials. Tigecycline monotherapy was compared with the combination imipenem/cilastatin (IMI/CIS) regimen (Primaxin) in 817 adult patients with a wide variety of complicated intraabdominal infections, including appendicitis with perforation and abscess (41%), cholecystitis with evidence of perforation or empyema (22%), postoperative intraabdominal abscess (11%), and intestinal perforation with abscess or fecal contamination (9%). The patients were predominantly white (88%) and male (59%), with a mean age of 49 years.

Of the total 523 microbiologically evaluable cases, 265 were treated with tigecycline in an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours in 100 mL saline over 30 minutes, followed 6 hours later by 100 mL normal saline placebo infused over 30 minutes for an average duration of 7.7 days. The other 258 patients received IMI/CIS every 6 hours in a volume of 100 mL normal saline for a mean duration of 7.8 days.

Clinical cure, assessed at 12–44 days after the last dose, was achieved in 91% of the tigecycline subjects and 90% of the IMI/CIS group, Dr. Dartois reported.

Safety profiles were also similar between the two regimens, with adverse events reported by a total of 60% of the tigecycline and 59% of IMI/CIS subjects. Nausea was the most common, reported by 18% of the tigecycline group and 13% with IMI/CIS. Vomiting occurred in 13% and 9%, respectively. The findings demonstrate “noninferiority” to the combination regimen, she said.

In the other trial, tigecycline was compared with combination vancomycin/aztreonam (V/A) in 543 adults with skin and skin structure infections, including 324 with deep soft tissue infections, 308 with cellulitis (many had both), 157 with major abscesses, 44 with infected ulcers, and 17 with burns.

Tigecycline was given in an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours in 250 mL normal saline over 60 minutes, then 100 mL normal saline placebo over 60 minutes. The V/A group received an initial 1-g intravenous vancomycin dose in 250 mL normal saline over 60 minutes, followed by 2 g aztreonam in 100 mL normal saline over 60 minutes every 12 hours.

Clinical cure at 14–90 days after the last dose was achieved in 90% of 223 tigecycline patients (ranging from 83% for the ulcers to 100% among the burns), compared with 94% of the 213 treated with V/A (92% of soft tissue infections to 100% ulcers and burns). Among the total 312 patients for whom results were microbiologically evaluable, the eradication rate was 85% for tigecycline and 93% for V/A, she said.

Adverse events were reported by 52% with tigecycline and 44% for V/A. Nausea and vomiting were significantly more frequent with tigecycline than V/A (25% and 12% vs. 5% and 2%), while rash was more common with V/A (4% vs. 1%).

WASHINGTON — Tigecycline, a novel broad-spectrum antibiotic, appears effective in treating a variety of serious infections, including those caused by resistant organisms, Evan Loh, M.D., said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Wyeth's tigecycline, the first of the glycylcycline class, is a modification of the minocycline molecule designed specifically to overcome two major bacterial resistance mechanisms. It has activity against gram-positive, gram-negative, atypical, anaerobic, and antibiotic-resistant bacteria. Phase III data thus far demonstrate efficacy in the treatment both complicated intraabdominal infections and skin/skin structure infections, said Dr. Loh, vice president, cardiovascular/infectious disease, Wyeth Research, Collegeville, Pa.

“This agent offers a broad spectrum of activity that offers an exciting opportunity for physicians to consider as empiric therapy when individuals with serious infections present in the hospital setting,” he said in a symposium at the meeting.

In late-breaker poster presentations, Nathalie Dartois, M.D., of Wyeth Research in Paris reported data from two phase III clinical trials. Tigecycline monotherapy was compared with the combination imipenem/cilastatin (IMI/CIS) regimen (Primaxin) in 817 adult patients with a wide variety of complicated intraabdominal infections, including appendicitis with perforation and abscess (41%), cholecystitis with evidence of perforation or empyema (22%), postoperative intraabdominal abscess (11%), and intestinal perforation with abscess or fecal contamination (9%). The patients were predominantly white (88%) and male (59%), with a mean age of 49 years.

Of the total 523 microbiologically evaluable cases, 265 were treated with tigecycline in an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours in 100 mL saline over 30 minutes, followed 6 hours later by 100 mL normal saline placebo infused over 30 minutes for an average duration of 7.7 days. The other 258 patients received IMI/CIS every 6 hours in a volume of 100 mL normal saline for a mean duration of 7.8 days.

Clinical cure, assessed at 12–44 days after the last dose, was achieved in 91% of the tigecycline subjects and 90% of the IMI/CIS group, Dr. Dartois reported.

Safety profiles were also similar between the two regimens, with adverse events reported by a total of 60% of the tigecycline and 59% of IMI/CIS subjects. Nausea was the most common, reported by 18% of the tigecycline group and 13% with IMI/CIS. Vomiting occurred in 13% and 9%, respectively. The findings demonstrate “noninferiority” to the combination regimen, she said.

In the other trial, tigecycline was compared with combination vancomycin/aztreonam (V/A) in 543 adults with skin and skin structure infections, including 324 with deep soft tissue infections, 308 with cellulitis (many had both), 157 with major abscesses, 44 with infected ulcers, and 17 with burns.

Tigecycline was given in an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours in 250 mL normal saline over 60 minutes, then 100 mL normal saline placebo over 60 minutes. The V/A group received an initial 1-g intravenous vancomycin dose in 250 mL normal saline over 60 minutes, followed by 2 g aztreonam in 100 mL normal saline over 60 minutes every 12 hours.

Clinical cure at 14–90 days after the last dose was achieved in 90% of 223 tigecycline patients (ranging from 83% for the ulcers to 100% among the burns), compared with 94% of the 213 treated with V/A (92% of soft tissue infections to 100% ulcers and burns). Among the total 312 patients for whom results were microbiologically evaluable, the eradication rate was 85% for tigecycline and 93% for V/A, she said.

Adverse events were reported by 52% with tigecycline and 44% for V/A. Nausea and vomiting were significantly more frequent with tigecycline than V/A (25% and 12% vs. 5% and 2%), while rash was more common with V/A (4% vs. 1%).

WASHINGTON — Tigecycline, a novel broad-spectrum antibiotic, appears effective in treating a variety of serious infections, including those caused by resistant organisms, Evan Loh, M.D., said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Wyeth's tigecycline, the first of the glycylcycline class, is a modification of the minocycline molecule designed specifically to overcome two major bacterial resistance mechanisms. It has activity against gram-positive, gram-negative, atypical, anaerobic, and antibiotic-resistant bacteria. Phase III data thus far demonstrate efficacy in the treatment both complicated intraabdominal infections and skin/skin structure infections, said Dr. Loh, vice president, cardiovascular/infectious disease, Wyeth Research, Collegeville, Pa.

“This agent offers a broad spectrum of activity that offers an exciting opportunity for physicians to consider as empiric therapy when individuals with serious infections present in the hospital setting,” he said in a symposium at the meeting.

In late-breaker poster presentations, Nathalie Dartois, M.D., of Wyeth Research in Paris reported data from two phase III clinical trials. Tigecycline monotherapy was compared with the combination imipenem/cilastatin (IMI/CIS) regimen (Primaxin) in 817 adult patients with a wide variety of complicated intraabdominal infections, including appendicitis with perforation and abscess (41%), cholecystitis with evidence of perforation or empyema (22%), postoperative intraabdominal abscess (11%), and intestinal perforation with abscess or fecal contamination (9%). The patients were predominantly white (88%) and male (59%), with a mean age of 49 years.

Of the total 523 microbiologically evaluable cases, 265 were treated with tigecycline in an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours in 100 mL saline over 30 minutes, followed 6 hours later by 100 mL normal saline placebo infused over 30 minutes for an average duration of 7.7 days. The other 258 patients received IMI/CIS every 6 hours in a volume of 100 mL normal saline for a mean duration of 7.8 days.

Clinical cure, assessed at 12–44 days after the last dose, was achieved in 91% of the tigecycline subjects and 90% of the IMI/CIS group, Dr. Dartois reported.

Safety profiles were also similar between the two regimens, with adverse events reported by a total of 60% of the tigecycline and 59% of IMI/CIS subjects. Nausea was the most common, reported by 18% of the tigecycline group and 13% with IMI/CIS. Vomiting occurred in 13% and 9%, respectively. The findings demonstrate “noninferiority” to the combination regimen, she said.

In the other trial, tigecycline was compared with combination vancomycin/aztreonam (V/A) in 543 adults with skin and skin structure infections, including 324 with deep soft tissue infections, 308 with cellulitis (many had both), 157 with major abscesses, 44 with infected ulcers, and 17 with burns.

Tigecycline was given in an initial intravenous dose of 100 mg, followed by 50 mg every 12 hours in 250 mL normal saline over 60 minutes, then 100 mL normal saline placebo over 60 minutes. The V/A group received an initial 1-g intravenous vancomycin dose in 250 mL normal saline over 60 minutes, followed by 2 g aztreonam in 100 mL normal saline over 60 minutes every 12 hours.

Clinical cure at 14–90 days after the last dose was achieved in 90% of 223 tigecycline patients (ranging from 83% for the ulcers to 100% among the burns), compared with 94% of the 213 treated with V/A (92% of soft tissue infections to 100% ulcers and burns). Among the total 312 patients for whom results were microbiologically evaluable, the eradication rate was 85% for tigecycline and 93% for V/A, she said.

Adverse events were reported by 52% with tigecycline and 44% for V/A. Nausea and vomiting were significantly more frequent with tigecycline than V/A (25% and 12% vs. 5% and 2%), while rash was more common with V/A (4% vs. 1%).

WASHINGTON — GlaxoSmithKline's rotavirus vaccine is not associated with increased risk of intussusception, Miguel O'Ryan, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, sponsored by the American Society for Microbiology.

Unlike Wyeth's rhesus-human rotavirus reassortant-tetravalent RotaShield, which was withdrawn in 1999 due to an increased risk of intussusception, GlaxoSmithKline's Rotarix is a live attenuated monovalent human strain-derived vaccine. It is licensed in Mexico and in early 2005 it should be available in some Latin American countries. The company also will seek licensure in the United States, a spokesperson said.

Short-term safety and immunogenicity for Rotarix were established in phase II trials (Pediatr. Infect. Dis. J. 2004;23:S179–82 and Vaccine 2004;22:2836–42).

The current phase III data involve 63,225 healthy infants from 18 sites in 11 Latin American countries and in Finland (40% were from Mexico and Peru). They were randomized to receive a dose of vaccine or placebo at 2 and 4 months of age.

Active hospital surveillance for intussusception yielded six cases within 30 days of receiving the vaccine and seven cases within 30 days of placebo injection. Intussusception developed in an additional three vaccine and nine placebo recipients after more than 30 days. None of these differences were significant, said Dr. O'Ryan of the University of Chile, Santiago.

Unlike with RotaShield, in which most of the intussusception cases were clustered during the first week after dose 1, no such temporal clustering was seen with Rotarix. None of the 13 infants with intussusception in this study died. Surgery was required for four of the vaccine subjects and five in the placebo group, also not significantly different, he said.

The calculated risk for intussusception following Rotarix was -2.23/10,000, far lower than the 1/10,000 estimate for RotaShield (N. Engl. J. Med. 2001;344:564–72).

Dr. O'Ryan noted that although rotavirus is a far greater threat to infants in the developing world, the disease still results in high hospitalization rates in the developed world.

WASHINGTON — GlaxoSmithKline's rotavirus vaccine is not associated with increased risk of intussusception, Miguel O'Ryan, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, sponsored by the American Society for Microbiology.

Unlike Wyeth's rhesus-human rotavirus reassortant-tetravalent RotaShield, which was withdrawn in 1999 due to an increased risk of intussusception, GlaxoSmithKline's Rotarix is a live attenuated monovalent human strain-derived vaccine. It is licensed in Mexico and in early 2005 it should be available in some Latin American countries. The company also will seek licensure in the United States, a spokesperson said.

Short-term safety and immunogenicity for Rotarix were established in phase II trials (Pediatr. Infect. Dis. J. 2004;23:S179–82 and Vaccine 2004;22:2836–42).

The current phase III data involve 63,225 healthy infants from 18 sites in 11 Latin American countries and in Finland (40% were from Mexico and Peru). They were randomized to receive a dose of vaccine or placebo at 2 and 4 months of age.

Active hospital surveillance for intussusception yielded six cases within 30 days of receiving the vaccine and seven cases within 30 days of placebo injection. Intussusception developed in an additional three vaccine and nine placebo recipients after more than 30 days. None of these differences were significant, said Dr. O'Ryan of the University of Chile, Santiago.

Unlike with RotaShield, in which most of the intussusception cases were clustered during the first week after dose 1, no such temporal clustering was seen with Rotarix. None of the 13 infants with intussusception in this study died. Surgery was required for four of the vaccine subjects and five in the placebo group, also not significantly different, he said.

The calculated risk for intussusception following Rotarix was -2.23/10,000, far lower than the 1/10,000 estimate for RotaShield (N. Engl. J. Med. 2001;344:564–72).

Dr. O'Ryan noted that although rotavirus is a far greater threat to infants in the developing world, the disease still results in high hospitalization rates in the developed world.

WASHINGTON — GlaxoSmithKline's rotavirus vaccine is not associated with increased risk of intussusception, Miguel O'Ryan, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, sponsored by the American Society for Microbiology.

Unlike Wyeth's rhesus-human rotavirus reassortant-tetravalent RotaShield, which was withdrawn in 1999 due to an increased risk of intussusception, GlaxoSmithKline's Rotarix is a live attenuated monovalent human strain-derived vaccine. It is licensed in Mexico and in early 2005 it should be available in some Latin American countries. The company also will seek licensure in the United States, a spokesperson said.

Short-term safety and immunogenicity for Rotarix were established in phase II trials (Pediatr. Infect. Dis. J. 2004;23:S179–82 and Vaccine 2004;22:2836–42).

The current phase III data involve 63,225 healthy infants from 18 sites in 11 Latin American countries and in Finland (40% were from Mexico and Peru). They were randomized to receive a dose of vaccine or placebo at 2 and 4 months of age.

Active hospital surveillance for intussusception yielded six cases within 30 days of receiving the vaccine and seven cases within 30 days of placebo injection. Intussusception developed in an additional three vaccine and nine placebo recipients after more than 30 days. None of these differences were significant, said Dr. O'Ryan of the University of Chile, Santiago.

Unlike with RotaShield, in which most of the intussusception cases were clustered during the first week after dose 1, no such temporal clustering was seen with Rotarix. None of the 13 infants with intussusception in this study died. Surgery was required for four of the vaccine subjects and five in the placebo group, also not significantly different, he said.

The calculated risk for intussusception following Rotarix was -2.23/10,000, far lower than the 1/10,000 estimate for RotaShield (N. Engl. J. Med. 2001;344:564–72).

Dr. O'Ryan noted that although rotavirus is a far greater threat to infants in the developing world, the disease still results in high hospitalization rates in the developed world.

WASHINGTON — The safety profile of Aventis Pasteur's reduced-antigen tetanus-diphtheria acellular pertussis vaccine in adolescents is similar to that of the currently-licensed tetanus-diphtheria vaccine, Michael E. Pichichero, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Adacel (reduced-antigen tetanus-diphtheria acellular pertussis or Tdap) is licensed in Canada for booster immunization of adolescents and adults. It is under review by the Food and Drug Administration for use in individuals 11–64 years.

Two randomized multicenter U.S. trials included 2,990 adolescents aged 11–17 who received Tdap and 792 given tetanus-diphtheria toxoid (Td), said Dr. Pichichero, a pediatric infectious diseases specialist in Rochester, N.Y.

Immediate reactions (within 30 minutes) were reported at comparably low frequencies in both the Tdap and Td groups (0.5%-0.6%). Most reactions were mild and resolved within a day. Also comparable were the frequency, intensity, and mean duration of fever of 38° C or greater and injection site erythema and/or swelling.

Injection site pain was slightly but significantly more frequent in the Tdap group (79.2% vs. 71.0%), but this pain was usually of mild intensity and its mean duration did not differ significantly between the two groups, Dr. Pichichero said.

Postvaccination limb circumference measurements within 2 weeks of vaccination were similar between the two groups (increases of more than 3 cm occurred in roughly 5% of each group), and no study subjects had whole arm swelling. Headache, generalized body ache, and tiredness were the three most commonly reported solicited systemic events, all in less than 30% of each group.

WASHINGTON — The safety profile of Aventis Pasteur's reduced-antigen tetanus-diphtheria acellular pertussis vaccine in adolescents is similar to that of the currently-licensed tetanus-diphtheria vaccine, Michael E. Pichichero, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Adacel (reduced-antigen tetanus-diphtheria acellular pertussis or Tdap) is licensed in Canada for booster immunization of adolescents and adults. It is under review by the Food and Drug Administration for use in individuals 11–64 years.

Two randomized multicenter U.S. trials included 2,990 adolescents aged 11–17 who received Tdap and 792 given tetanus-diphtheria toxoid (Td), said Dr. Pichichero, a pediatric infectious diseases specialist in Rochester, N.Y.

Immediate reactions (within 30 minutes) were reported at comparably low frequencies in both the Tdap and Td groups (0.5%-0.6%). Most reactions were mild and resolved within a day. Also comparable were the frequency, intensity, and mean duration of fever of 38° C or greater and injection site erythema and/or swelling.

Injection site pain was slightly but significantly more frequent in the Tdap group (79.2% vs. 71.0%), but this pain was usually of mild intensity and its mean duration did not differ significantly between the two groups, Dr. Pichichero said.

Postvaccination limb circumference measurements within 2 weeks of vaccination were similar between the two groups (increases of more than 3 cm occurred in roughly 5% of each group), and no study subjects had whole arm swelling. Headache, generalized body ache, and tiredness were the three most commonly reported solicited systemic events, all in less than 30% of each group.

WASHINGTON — The safety profile of Aventis Pasteur's reduced-antigen tetanus-diphtheria acellular pertussis vaccine in adolescents is similar to that of the currently-licensed tetanus-diphtheria vaccine, Michael E. Pichichero, M.D., reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Adacel (reduced-antigen tetanus-diphtheria acellular pertussis or Tdap) is licensed in Canada for booster immunization of adolescents and adults. It is under review by the Food and Drug Administration for use in individuals 11–64 years.

Two randomized multicenter U.S. trials included 2,990 adolescents aged 11–17 who received Tdap and 792 given tetanus-diphtheria toxoid (Td), said Dr. Pichichero, a pediatric infectious diseases specialist in Rochester, N.Y.

Immediate reactions (within 30 minutes) were reported at comparably low frequencies in both the Tdap and Td groups (0.5%-0.6%). Most reactions were mild and resolved within a day. Also comparable were the frequency, intensity, and mean duration of fever of 38° C or greater and injection site erythema and/or swelling.

Injection site pain was slightly but significantly more frequent in the Tdap group (79.2% vs. 71.0%), but this pain was usually of mild intensity and its mean duration did not differ significantly between the two groups, Dr. Pichichero said.

Postvaccination limb circumference measurements within 2 weeks of vaccination were similar between the two groups (increases of more than 3 cm occurred in roughly 5% of each group), and no study subjects had whole arm swelling. Headache, generalized body ache, and tiredness were the three most commonly reported solicited systemic events, all in less than 30% of each group.