Miriam E. Tucker

New travel medicine guidelines issued by the Infectious Diseases Society of America clearly illustrate that the field has expanded far beyond simply giving a few exotic immunizations.

“An awareness has developed among practitioners that prevention of illness in travelers includes not only the provision of vaccines and chemoprophylaxis but also a discussion of topics such as personal behavior and safety during travel, prevention of altitude illness, and access to medical care in the event of illness,” said guideline lead author Dr. David R. Hill and his associates (Clin. Infect. Dis. 2006; 43:1499–1539).

The comprehensive 40-page document comprises a standard for the practice of travel medicine as well as specific recommendations for pretravel risk assessment, immunizations (including updates of routinely recommended vaccines such as hepatitis A and B, and influenza), diarrhea and malaria prophylaxis, guidance on personal safety, and posttravel medical care.

Although most travel medicine should be provided in specialized travel clinics by professionals who have training in the field, primary care physicians should be able to advise travelers who are in good health and who will be visiting low-risk destinations with standard planned activities, according to the document.

“Each section has merit to both the specialist and the generalist. … Many generalists have been doing some travel medicine for their patients but not really understood how pretravel risk assessment and provision of advice, immunizations, and prophylaxis fits into the larger picture of travel medicine,” Dr. Hill, director of the National Travel Health Network and Centre Hospital for Tropical Diseases, London, said in an interview.

The field of travel medicine has developed rapidly in recent decades, for several reasons. The number of travelers crossing international borders grew from 457 million in 1990 to 763 million in 2004. This increase in global travel has led both to more frequent illness during travel and to importation of disease back to the United States, with potential transmission to susceptible individuals living here.

“The failure of health care professionals to accurately advise the traveler of health risks and the failure of the traveler to either seek or follow pretravel advice may lead to excess morbidity and mortality from diseases such as malaria,” the authors noted.

At a minimum, all travelers should be informed about vaccine-preventable illness, avoidance of insects, use of malaria chemoprophylaxis, prevention and self-treatment of traveler's diarrhea, personal behavior and safety, the importance of obtaining travel and evacuation insurance policies, and access to medical care during travel. Additional information should be tailored to the particular itinerary, they advised.

Primary care physicians should be able to provide pretravel services to healthy patients, other than young infants or very elderly individuals, who will be visiting relatively low-risk areas like the Caribbean or a Mexican resort.

However, “as soon as the traveler has complex health conditions, or one is considering administering specialty vaccines—e.g., Japanese encephalitis and yellow fever, or malaria prevention to someone with a seizure disorder—then the level of expertise needs to be greater,” Dr. Hill explained.

But, he added, “this does not stop a generalist from seeking additional education and training in the field so that they can advise the more complex traveler. Indeed, we would encourage them to do so.”

Both the International Society of Travel Medicine (www.istm.orgwww.astmh.org

New travel medicine guidelines issued by the Infectious Diseases Society of America clearly illustrate that the field has expanded far beyond simply giving a few exotic immunizations.

“An awareness has developed among practitioners that prevention of illness in travelers includes not only the provision of vaccines and chemoprophylaxis but also a discussion of topics such as personal behavior and safety during travel, prevention of altitude illness, and access to medical care in the event of illness,” said guideline lead author Dr. David R. Hill and his associates (Clin. Infect. Dis. 2006; 43:1499–1539).

The comprehensive 40-page document comprises a standard for the practice of travel medicine as well as specific recommendations for pretravel risk assessment, immunizations (including updates of routinely recommended vaccines such as hepatitis A and B, and influenza), diarrhea and malaria prophylaxis, guidance on personal safety, and posttravel medical care.

Although most travel medicine should be provided in specialized travel clinics by professionals who have training in the field, primary care physicians should be able to advise travelers who are in good health and who will be visiting low-risk destinations with standard planned activities, according to the document.

“Each section has merit to both the specialist and the generalist. … Many generalists have been doing some travel medicine for their patients but not really understood how pretravel risk assessment and provision of advice, immunizations, and prophylaxis fits into the larger picture of travel medicine,” Dr. Hill, director of the National Travel Health Network and Centre Hospital for Tropical Diseases, London, said in an interview.

The field of travel medicine has developed rapidly in recent decades, for several reasons. The number of travelers crossing international borders grew from 457 million in 1990 to 763 million in 2004. This increase in global travel has led both to more frequent illness during travel and to importation of disease back to the United States, with potential transmission to susceptible individuals living here.

“The failure of health care professionals to accurately advise the traveler of health risks and the failure of the traveler to either seek or follow pretravel advice may lead to excess morbidity and mortality from diseases such as malaria,” the authors noted.

At a minimum, all travelers should be informed about vaccine-preventable illness, avoidance of insects, use of malaria chemoprophylaxis, prevention and self-treatment of traveler's diarrhea, personal behavior and safety, the importance of obtaining travel and evacuation insurance policies, and access to medical care during travel. Additional information should be tailored to the particular itinerary, they advised.

Primary care physicians should be able to provide pretravel services to healthy patients, other than young infants or very elderly individuals, who will be visiting relatively low-risk areas like the Caribbean or a Mexican resort.

However, “as soon as the traveler has complex health conditions, or one is considering administering specialty vaccines—e.g., Japanese encephalitis and yellow fever, or malaria prevention to someone with a seizure disorder—then the level of expertise needs to be greater,” Dr. Hill explained.

But, he added, “this does not stop a generalist from seeking additional education and training in the field so that they can advise the more complex traveler. Indeed, we would encourage them to do so.”

Both the International Society of Travel Medicine (www.istm.orgwww.astmh.org

New travel medicine guidelines issued by the Infectious Diseases Society of America clearly illustrate that the field has expanded far beyond simply giving a few exotic immunizations.

“An awareness has developed among practitioners that prevention of illness in travelers includes not only the provision of vaccines and chemoprophylaxis but also a discussion of topics such as personal behavior and safety during travel, prevention of altitude illness, and access to medical care in the event of illness,” said guideline lead author Dr. David R. Hill and his associates (Clin. Infect. Dis. 2006; 43:1499–1539).

The comprehensive 40-page document comprises a standard for the practice of travel medicine as well as specific recommendations for pretravel risk assessment, immunizations (including updates of routinely recommended vaccines such as hepatitis A and B, and influenza), diarrhea and malaria prophylaxis, guidance on personal safety, and posttravel medical care.

Although most travel medicine should be provided in specialized travel clinics by professionals who have training in the field, primary care physicians should be able to advise travelers who are in good health and who will be visiting low-risk destinations with standard planned activities, according to the document.

“Each section has merit to both the specialist and the generalist. … Many generalists have been doing some travel medicine for their patients but not really understood how pretravel risk assessment and provision of advice, immunizations, and prophylaxis fits into the larger picture of travel medicine,” Dr. Hill, director of the National Travel Health Network and Centre Hospital for Tropical Diseases, London, said in an interview.

The field of travel medicine has developed rapidly in recent decades, for several reasons. The number of travelers crossing international borders grew from 457 million in 1990 to 763 million in 2004. This increase in global travel has led both to more frequent illness during travel and to importation of disease back to the United States, with potential transmission to susceptible individuals living here.

“The failure of health care professionals to accurately advise the traveler of health risks and the failure of the traveler to either seek or follow pretravel advice may lead to excess morbidity and mortality from diseases such as malaria,” the authors noted.

At a minimum, all travelers should be informed about vaccine-preventable illness, avoidance of insects, use of malaria chemoprophylaxis, prevention and self-treatment of traveler's diarrhea, personal behavior and safety, the importance of obtaining travel and evacuation insurance policies, and access to medical care during travel. Additional information should be tailored to the particular itinerary, they advised.

Primary care physicians should be able to provide pretravel services to healthy patients, other than young infants or very elderly individuals, who will be visiting relatively low-risk areas like the Caribbean or a Mexican resort.

However, “as soon as the traveler has complex health conditions, or one is considering administering specialty vaccines—e.g., Japanese encephalitis and yellow fever, or malaria prevention to someone with a seizure disorder—then the level of expertise needs to be greater,” Dr. Hill explained.

But, he added, “this does not stop a generalist from seeking additional education and training in the field so that they can advise the more complex traveler. Indeed, we would encourage them to do so.”

Both the International Society of Travel Medicine (www.istm.orgwww.astmh.org

TORONTO — The risk for hip fractures appears to be elevated in elderly men and women with diabetes, Dr. Lorraine L. Lipscome reported in a poster at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Whereas previous studies have documented an association between type 1 diabetes and osteoporotic fractures, the data on patients with type 2 diabetes have conflicted. Those studies have mostly been small and limited to women. Moreover, bone density is typically normal or high in type 2 diabetes, whereas it is reduced in type 1, leading some to believe that people with type 2 diabetes are somehow “protected,” said Dr. Lipscome, of the University of Toronto.

In a retrospective cohort study using population-based Ontario health care databases from 1994 to 2003, researchers compared the risk of hip fractures between individuals older than 65 years of age with and without diabetes. After excluding those with prior hip fractures or hip replacements and those on oral corticosteroid treatment, the study population comprised 207,252 diabetics and 414,504 nondiabetics, with an overall mean age of 71.7 years. Information about diabetes type was not available, but it was presumed that most were type 2 because of the age group involved, Dr. Lipscome said in an interview.

After a mean of 6.1 years, the risk for hip fractures was significantly higher among those with diabetes, at 7.21 per 1,000 person-years, compared with 6.15 per 1,000 person-years among those without diabetes.

Compared with nondiabetics, those with diabetes had more comorbidity, were less likely to have had a bone mineral density test, and were more likely to be taking drugs that affected fall risk and bone density.

Women had a significantly higher risk for fracture than did men, but diabetes increased the risk in both genders, with hazard ratios of 1.22 for men and 1.19 for women. The increased risk remained significant (1.18 in men and 1.11 in women) after adjustment for age; comorbidity; prior stroke; visual impairment; neuropathy; amputation; treatment with nitrates, statins, anticonvulsants, inhaled corticosteroids, thiazides, or fall-promoting medications; history of a bone mineral density test; estrogen treatment in women; and income quintile in men, Dr. Lipscome reported.

Insulin use among the patients with diabetes increased the fracture risk, with hazard ratios of 1.34 in women and 1.64 in men, compared with those not using insulin.

Until the phenomenon is better understood, bone fracture risk assessment and enhanced prevention strategies are warranted in all patients with diabetes, she said.

TORONTO — The risk for hip fractures appears to be elevated in elderly men and women with diabetes, Dr. Lorraine L. Lipscome reported in a poster at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Whereas previous studies have documented an association between type 1 diabetes and osteoporotic fractures, the data on patients with type 2 diabetes have conflicted. Those studies have mostly been small and limited to women. Moreover, bone density is typically normal or high in type 2 diabetes, whereas it is reduced in type 1, leading some to believe that people with type 2 diabetes are somehow “protected,” said Dr. Lipscome, of the University of Toronto.

In a retrospective cohort study using population-based Ontario health care databases from 1994 to 2003, researchers compared the risk of hip fractures between individuals older than 65 years of age with and without diabetes. After excluding those with prior hip fractures or hip replacements and those on oral corticosteroid treatment, the study population comprised 207,252 diabetics and 414,504 nondiabetics, with an overall mean age of 71.7 years. Information about diabetes type was not available, but it was presumed that most were type 2 because of the age group involved, Dr. Lipscome said in an interview.

After a mean of 6.1 years, the risk for hip fractures was significantly higher among those with diabetes, at 7.21 per 1,000 person-years, compared with 6.15 per 1,000 person-years among those without diabetes.

Compared with nondiabetics, those with diabetes had more comorbidity, were less likely to have had a bone mineral density test, and were more likely to be taking drugs that affected fall risk and bone density.

Women had a significantly higher risk for fracture than did men, but diabetes increased the risk in both genders, with hazard ratios of 1.22 for men and 1.19 for women. The increased risk remained significant (1.18 in men and 1.11 in women) after adjustment for age; comorbidity; prior stroke; visual impairment; neuropathy; amputation; treatment with nitrates, statins, anticonvulsants, inhaled corticosteroids, thiazides, or fall-promoting medications; history of a bone mineral density test; estrogen treatment in women; and income quintile in men, Dr. Lipscome reported.

Insulin use among the patients with diabetes increased the fracture risk, with hazard ratios of 1.34 in women and 1.64 in men, compared with those not using insulin.

Until the phenomenon is better understood, bone fracture risk assessment and enhanced prevention strategies are warranted in all patients with diabetes, she said.

TORONTO — The risk for hip fractures appears to be elevated in elderly men and women with diabetes, Dr. Lorraine L. Lipscome reported in a poster at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Whereas previous studies have documented an association between type 1 diabetes and osteoporotic fractures, the data on patients with type 2 diabetes have conflicted. Those studies have mostly been small and limited to women. Moreover, bone density is typically normal or high in type 2 diabetes, whereas it is reduced in type 1, leading some to believe that people with type 2 diabetes are somehow “protected,” said Dr. Lipscome, of the University of Toronto.

In a retrospective cohort study using population-based Ontario health care databases from 1994 to 2003, researchers compared the risk of hip fractures between individuals older than 65 years of age with and without diabetes. After excluding those with prior hip fractures or hip replacements and those on oral corticosteroid treatment, the study population comprised 207,252 diabetics and 414,504 nondiabetics, with an overall mean age of 71.7 years. Information about diabetes type was not available, but it was presumed that most were type 2 because of the age group involved, Dr. Lipscome said in an interview.

After a mean of 6.1 years, the risk for hip fractures was significantly higher among those with diabetes, at 7.21 per 1,000 person-years, compared with 6.15 per 1,000 person-years among those without diabetes.

Compared with nondiabetics, those with diabetes had more comorbidity, were less likely to have had a bone mineral density test, and were more likely to be taking drugs that affected fall risk and bone density.

Women had a significantly higher risk for fracture than did men, but diabetes increased the risk in both genders, with hazard ratios of 1.22 for men and 1.19 for women. The increased risk remained significant (1.18 in men and 1.11 in women) after adjustment for age; comorbidity; prior stroke; visual impairment; neuropathy; amputation; treatment with nitrates, statins, anticonvulsants, inhaled corticosteroids, thiazides, or fall-promoting medications; history of a bone mineral density test; estrogen treatment in women; and income quintile in men, Dr. Lipscome reported.

Insulin use among the patients with diabetes increased the fracture risk, with hazard ratios of 1.34 in women and 1.64 in men, compared with those not using insulin.

Until the phenomenon is better understood, bone fracture risk assessment and enhanced prevention strategies are warranted in all patients with diabetes, she said.

TORONTO — Questionnaires are as accurate as laboratory tests in screening patients for type 2 diabetes, Dr. Kara A. Nerenberg and her associates reported in a poster at the annual joint meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

“Diabetes screening questionnaires are simple, cheap alternatives to lab tests as initial screening tests,” said Dr. Nerenberg and her associates of McMaster University, Hamilton, Ont.

A systematic review of data assessing the diagnostic performance of diabetes screening questionnaires yielded 10 studies of eight different questionnaires in 22 global populations with similar prevalences of type 2 diabetes. All of the questionnaires asked about age and obesity, while a majority also assessed hypertension, history of dysglycemia, activity/exercise, and diet.

Sensitivity of the questionnaires ranged from 0.67 (The Finnish DRS-Modified) to 0.82 (the Finnish DRS), and specificity from 0.58 (the Finnish DRS) to 0.74 (the Danish Risk Score). Both the Finnish and Danish scores performed consistently well in the different ethnic populations studied. Overall sensitivity of the questionnaires was 0.58, within the same range as the 0.40–0.60 with fasting plasma glucose and 0.69 for the oral glucose tolerance test.

The screening questionnaire could be filled out in the waiting room, which would allow the physician to discuss the results with the patient at the same visit, Dr. Nerenberg said in an interview.

TORONTO — Questionnaires are as accurate as laboratory tests in screening patients for type 2 diabetes, Dr. Kara A. Nerenberg and her associates reported in a poster at the annual joint meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

“Diabetes screening questionnaires are simple, cheap alternatives to lab tests as initial screening tests,” said Dr. Nerenberg and her associates of McMaster University, Hamilton, Ont.

A systematic review of data assessing the diagnostic performance of diabetes screening questionnaires yielded 10 studies of eight different questionnaires in 22 global populations with similar prevalences of type 2 diabetes. All of the questionnaires asked about age and obesity, while a majority also assessed hypertension, history of dysglycemia, activity/exercise, and diet.

Sensitivity of the questionnaires ranged from 0.67 (The Finnish DRS-Modified) to 0.82 (the Finnish DRS), and specificity from 0.58 (the Finnish DRS) to 0.74 (the Danish Risk Score). Both the Finnish and Danish scores performed consistently well in the different ethnic populations studied. Overall sensitivity of the questionnaires was 0.58, within the same range as the 0.40–0.60 with fasting plasma glucose and 0.69 for the oral glucose tolerance test.

The screening questionnaire could be filled out in the waiting room, which would allow the physician to discuss the results with the patient at the same visit, Dr. Nerenberg said in an interview.

TORONTO — Questionnaires are as accurate as laboratory tests in screening patients for type 2 diabetes, Dr. Kara A. Nerenberg and her associates reported in a poster at the annual joint meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

“Diabetes screening questionnaires are simple, cheap alternatives to lab tests as initial screening tests,” said Dr. Nerenberg and her associates of McMaster University, Hamilton, Ont.

A systematic review of data assessing the diagnostic performance of diabetes screening questionnaires yielded 10 studies of eight different questionnaires in 22 global populations with similar prevalences of type 2 diabetes. All of the questionnaires asked about age and obesity, while a majority also assessed hypertension, history of dysglycemia, activity/exercise, and diet.

Sensitivity of the questionnaires ranged from 0.67 (The Finnish DRS-Modified) to 0.82 (the Finnish DRS), and specificity from 0.58 (the Finnish DRS) to 0.74 (the Danish Risk Score). Both the Finnish and Danish scores performed consistently well in the different ethnic populations studied. Overall sensitivity of the questionnaires was 0.58, within the same range as the 0.40–0.60 with fasting plasma glucose and 0.69 for the oral glucose tolerance test.

The screening questionnaire could be filled out in the waiting room, which would allow the physician to discuss the results with the patient at the same visit, Dr. Nerenberg said in an interview.

COPENHAGEN — Self-treatment with a biofeedback device that guides breathing can significantly lower blood pressure among patients with type 2 diabetes, Dr. Moshe H. Schein reported at the annual meeting of the European Association for the Study of Diabetes.

The device, called RESPeRATE, is made by InterCure Ltd., Lod, Israel. It was approved for use by the Food and Drug Administration in 2002 for use in stress reduction and as adjunctive treatment for hypertension, together with other pharmacologic and nonpharmacologic interventions. It works by using melodic tones to guide the patient through progressively slower inhalation and exhalation.

Previous data have shown that the device-guided technique results in significant blood pressure reductions among hypertensive patients who use it at home on a daily basis (J. Hum. Hypertens. 2001;15:271–8).

In the new study, a total of 60 patients with type 2 diabetes who had blood pressures greater than 130/80 mm Hg were randomized to use of the device for 15 minutes a day along with usual treatment, or to usual treatment alone for 8 weeks. The group was 60% male, with a mean age of 64 years and a mean body mass index of 30 kg/m

At baseline, mean blood pressure was 149/82 mm Hg in the treatment group and 146/81 mm Hg in the control group, even though the majority of patients—78% of the treatment group and 89% of the controls—were taking blood pressure medication, said Dr. Schein, director of the Family Medicine Unit, Hadassah University Hospital, Jerusalem.

Systolic blood pressure dropped by 9.5 mm Hg in the group using the device, compared with an increase of 2.1 mm Hg among the controls, a significant difference between the two groups.

The change in pulse pressure also was significantly different at 2 months; it dropped by 5.9 mm Hg from a mean of 67 mm Hg at baseline in the guided-breathing group, and increased by 3.6 mm Hg from a mean of 66 mm Hg in the controls.

Diastolic blood pressure dropped slightly in both groups, by 3.5 mm Hg in the guided-breathing patients and by 1.5 mm Hg among the controls. That difference was not significant.

There was a dose-response relationship between use of the device and systolic blood pressure reduction: The longer the patient spent in the slow breathing exercise, the greater the drop. (Although patients had been instructed to perform the device-guided breathing exercise daily, they actually did it for a mean of 5.6 sessions per week. However, the duration of each session lasted 15.9 minutes, slightly longer than the instructed 15 minutes, and patients spent a mean of 40.4 minutes per week in slow breathing.)

Blood pressure control—defined as 130/80 mm Hg or below—was achieved by 8 of 30 (27%) in the device group, compared with just 2 of the 30 (7%) of the controls, Dr. Schein reported.

COPENHAGEN — Self-treatment with a biofeedback device that guides breathing can significantly lower blood pressure among patients with type 2 diabetes, Dr. Moshe H. Schein reported at the annual meeting of the European Association for the Study of Diabetes.

The device, called RESPeRATE, is made by InterCure Ltd., Lod, Israel. It was approved for use by the Food and Drug Administration in 2002 for use in stress reduction and as adjunctive treatment for hypertension, together with other pharmacologic and nonpharmacologic interventions. It works by using melodic tones to guide the patient through progressively slower inhalation and exhalation.

Previous data have shown that the device-guided technique results in significant blood pressure reductions among hypertensive patients who use it at home on a daily basis (J. Hum. Hypertens. 2001;15:271–8).

In the new study, a total of 60 patients with type 2 diabetes who had blood pressures greater than 130/80 mm Hg were randomized to use of the device for 15 minutes a day along with usual treatment, or to usual treatment alone for 8 weeks. The group was 60% male, with a mean age of 64 years and a mean body mass index of 30 kg/m

At baseline, mean blood pressure was 149/82 mm Hg in the treatment group and 146/81 mm Hg in the control group, even though the majority of patients—78% of the treatment group and 89% of the controls—were taking blood pressure medication, said Dr. Schein, director of the Family Medicine Unit, Hadassah University Hospital, Jerusalem.

Systolic blood pressure dropped by 9.5 mm Hg in the group using the device, compared with an increase of 2.1 mm Hg among the controls, a significant difference between the two groups.

The change in pulse pressure also was significantly different at 2 months; it dropped by 5.9 mm Hg from a mean of 67 mm Hg at baseline in the guided-breathing group, and increased by 3.6 mm Hg from a mean of 66 mm Hg in the controls.

Diastolic blood pressure dropped slightly in both groups, by 3.5 mm Hg in the guided-breathing patients and by 1.5 mm Hg among the controls. That difference was not significant.

There was a dose-response relationship between use of the device and systolic blood pressure reduction: The longer the patient spent in the slow breathing exercise, the greater the drop. (Although patients had been instructed to perform the device-guided breathing exercise daily, they actually did it for a mean of 5.6 sessions per week. However, the duration of each session lasted 15.9 minutes, slightly longer than the instructed 15 minutes, and patients spent a mean of 40.4 minutes per week in slow breathing.)

Blood pressure control—defined as 130/80 mm Hg or below—was achieved by 8 of 30 (27%) in the device group, compared with just 2 of the 30 (7%) of the controls, Dr. Schein reported.

COPENHAGEN — Self-treatment with a biofeedback device that guides breathing can significantly lower blood pressure among patients with type 2 diabetes, Dr. Moshe H. Schein reported at the annual meeting of the European Association for the Study of Diabetes.

The device, called RESPeRATE, is made by InterCure Ltd., Lod, Israel. It was approved for use by the Food and Drug Administration in 2002 for use in stress reduction and as adjunctive treatment for hypertension, together with other pharmacologic and nonpharmacologic interventions. It works by using melodic tones to guide the patient through progressively slower inhalation and exhalation.

Previous data have shown that the device-guided technique results in significant blood pressure reductions among hypertensive patients who use it at home on a daily basis (J. Hum. Hypertens. 2001;15:271–8).

In the new study, a total of 60 patients with type 2 diabetes who had blood pressures greater than 130/80 mm Hg were randomized to use of the device for 15 minutes a day along with usual treatment, or to usual treatment alone for 8 weeks. The group was 60% male, with a mean age of 64 years and a mean body mass index of 30 kg/m

At baseline, mean blood pressure was 149/82 mm Hg in the treatment group and 146/81 mm Hg in the control group, even though the majority of patients—78% of the treatment group and 89% of the controls—were taking blood pressure medication, said Dr. Schein, director of the Family Medicine Unit, Hadassah University Hospital, Jerusalem.

Systolic blood pressure dropped by 9.5 mm Hg in the group using the device, compared with an increase of 2.1 mm Hg among the controls, a significant difference between the two groups.

The change in pulse pressure also was significantly different at 2 months; it dropped by 5.9 mm Hg from a mean of 67 mm Hg at baseline in the guided-breathing group, and increased by 3.6 mm Hg from a mean of 66 mm Hg in the controls.

Diastolic blood pressure dropped slightly in both groups, by 3.5 mm Hg in the guided-breathing patients and by 1.5 mm Hg among the controls. That difference was not significant.

There was a dose-response relationship between use of the device and systolic blood pressure reduction: The longer the patient spent in the slow breathing exercise, the greater the drop. (Although patients had been instructed to perform the device-guided breathing exercise daily, they actually did it for a mean of 5.6 sessions per week. However, the duration of each session lasted 15.9 minutes, slightly longer than the instructed 15 minutes, and patients spent a mean of 40.4 minutes per week in slow breathing.)

Blood pressure control—defined as 130/80 mm Hg or below—was achieved by 8 of 30 (27%) in the device group, compared with just 2 of the 30 (7%) of the controls, Dr. Schein reported.

New travel medicine guidelines issued by the Infectious Diseases Society of America clearly illustrate that the field has expanded far beyond simply giving a few exotic immunizations.

“An awareness has developed among practitioners that prevention of illness in travelers includes not only the provision of vaccines and chemoprophylaxis, but also a discussion of topics such as personal behavior and safety during travel, prevention of altitude illness, and access to medical care in the event of illness,” guidelines author Dr. David R. Hill and his associates said (Clin. Infect. Dis. 2006;43:1499–539).

The comprehensive 40-page document comprises a standard for the practice of travel medicine as well as specific recommendations for pretravel risk assessment, immunizations (including updates of routinely recommended vaccines such as hepatitis A and B, and influenza), diarrhea and malaria prophylaxis, guidance on personal safety, and posttravel medical care.

While most travel medicine should be provided in specialized travel clinics by people who have training in the field, primary care physicians should be able to advise travelers who are in good health and who will be visiting low-risk destinations with standard planned activities, according to the document.

The guidelines are aimed at clinicians providing care to all travelers including children, coauthor Dr. Phillip R. Fischer said in an interview.

“The Centers for Disease Control and Prevention estimates that 1.9 million American children travel overseas each year. Trips often relate to family vacation, school-sponsored education, and humanitarian service. The guidelines list lots of resources for interested physicians who want to prepare to care for traveling children,” said Dr. Fischer, a travel medicine specialist who is professor of pediatrics and chair of the division of general pediatric and adolescent medicine at the Mayo Clinic, Rochester, Minn.

The field of travel medicine has developed dramatically over the last 25 years, for several reasons. The number of travelers crossing international borders grew from 457 million in 1990 to 763 million in 2004, according to the document. This increase in global travel has led both to more frequent illness during travel and to importation of disease back to the United States with potential transmission to susceptible individuals living here.

Indeed, Dr. Fischer noted, “Most U.S. cases of malaria occur in travelers who took no prophylactic medication, and many went overseas to visit friends and relatives. Pediatricians must be particularly vigilant to help ensure that children with relatives in other countries get appropriate advice and help prior to international trips.”

At a minimum, traveling families should be informed about vaccine-preventable illness, avoidance of insects, use of malaria chemoprophylaxis, prevention and self-treatment of traveler's diarrhea, personal behavior and safety, the importance of obtaining travel and evacuation insurance policies, and access to medical care during travel. Additional information should be tailored to the particular itinerary, the authors said.

In general, the guidelines advise that primary care physicians should be able to provide pretravel services to healthy patients visiting low-risk areas like the Caribbean or a Mexican resort. But “as soon as the traveler has complex health conditions, or one is considering administering specialty vaccines—e.g., Japanese encephalitis and yellow fever, or malaria prevention to someone with a seizure disorder—then the level of expertise needs to be greater,” Dr. Hill, director of the National Travel Health Network and Centre Hospital for Tropical Diseases, London, said in an interview.

Both the International Society of Travel Medicine (www.istm.orgwww.astmh.org

Pediatricians must help ensure that children get appropriate advice and help prior to international trips. DR. FISCHER

New travel medicine guidelines issued by the Infectious Diseases Society of America clearly illustrate that the field has expanded far beyond simply giving a few exotic immunizations.

“An awareness has developed among practitioners that prevention of illness in travelers includes not only the provision of vaccines and chemoprophylaxis, but also a discussion of topics such as personal behavior and safety during travel, prevention of altitude illness, and access to medical care in the event of illness,” guidelines author Dr. David R. Hill and his associates said (Clin. Infect. Dis. 2006;43:1499–539).

The comprehensive 40-page document comprises a standard for the practice of travel medicine as well as specific recommendations for pretravel risk assessment, immunizations (including updates of routinely recommended vaccines such as hepatitis A and B, and influenza), diarrhea and malaria prophylaxis, guidance on personal safety, and posttravel medical care.

While most travel medicine should be provided in specialized travel clinics by people who have training in the field, primary care physicians should be able to advise travelers who are in good health and who will be visiting low-risk destinations with standard planned activities, according to the document.

The guidelines are aimed at clinicians providing care to all travelers including children, coauthor Dr. Phillip R. Fischer said in an interview.

“The Centers for Disease Control and Prevention estimates that 1.9 million American children travel overseas each year. Trips often relate to family vacation, school-sponsored education, and humanitarian service. The guidelines list lots of resources for interested physicians who want to prepare to care for traveling children,” said Dr. Fischer, a travel medicine specialist who is professor of pediatrics and chair of the division of general pediatric and adolescent medicine at the Mayo Clinic, Rochester, Minn.

The field of travel medicine has developed dramatically over the last 25 years, for several reasons. The number of travelers crossing international borders grew from 457 million in 1990 to 763 million in 2004, according to the document. This increase in global travel has led both to more frequent illness during travel and to importation of disease back to the United States with potential transmission to susceptible individuals living here.

Indeed, Dr. Fischer noted, “Most U.S. cases of malaria occur in travelers who took no prophylactic medication, and many went overseas to visit friends and relatives. Pediatricians must be particularly vigilant to help ensure that children with relatives in other countries get appropriate advice and help prior to international trips.”

At a minimum, traveling families should be informed about vaccine-preventable illness, avoidance of insects, use of malaria chemoprophylaxis, prevention and self-treatment of traveler's diarrhea, personal behavior and safety, the importance of obtaining travel and evacuation insurance policies, and access to medical care during travel. Additional information should be tailored to the particular itinerary, the authors said.

In general, the guidelines advise that primary care physicians should be able to provide pretravel services to healthy patients visiting low-risk areas like the Caribbean or a Mexican resort. But “as soon as the traveler has complex health conditions, or one is considering administering specialty vaccines—e.g., Japanese encephalitis and yellow fever, or malaria prevention to someone with a seizure disorder—then the level of expertise needs to be greater,” Dr. Hill, director of the National Travel Health Network and Centre Hospital for Tropical Diseases, London, said in an interview.

Both the International Society of Travel Medicine (www.istm.orgwww.astmh.org

Pediatricians must help ensure that children get appropriate advice and help prior to international trips. DR. FISCHER

New travel medicine guidelines issued by the Infectious Diseases Society of America clearly illustrate that the field has expanded far beyond simply giving a few exotic immunizations.

“An awareness has developed among practitioners that prevention of illness in travelers includes not only the provision of vaccines and chemoprophylaxis, but also a discussion of topics such as personal behavior and safety during travel, prevention of altitude illness, and access to medical care in the event of illness,” guidelines author Dr. David R. Hill and his associates said (Clin. Infect. Dis. 2006;43:1499–539).

The comprehensive 40-page document comprises a standard for the practice of travel medicine as well as specific recommendations for pretravel risk assessment, immunizations (including updates of routinely recommended vaccines such as hepatitis A and B, and influenza), diarrhea and malaria prophylaxis, guidance on personal safety, and posttravel medical care.

While most travel medicine should be provided in specialized travel clinics by people who have training in the field, primary care physicians should be able to advise travelers who are in good health and who will be visiting low-risk destinations with standard planned activities, according to the document.

The guidelines are aimed at clinicians providing care to all travelers including children, coauthor Dr. Phillip R. Fischer said in an interview.

“The Centers for Disease Control and Prevention estimates that 1.9 million American children travel overseas each year. Trips often relate to family vacation, school-sponsored education, and humanitarian service. The guidelines list lots of resources for interested physicians who want to prepare to care for traveling children,” said Dr. Fischer, a travel medicine specialist who is professor of pediatrics and chair of the division of general pediatric and adolescent medicine at the Mayo Clinic, Rochester, Minn.

The field of travel medicine has developed dramatically over the last 25 years, for several reasons. The number of travelers crossing international borders grew from 457 million in 1990 to 763 million in 2004, according to the document. This increase in global travel has led both to more frequent illness during travel and to importation of disease back to the United States with potential transmission to susceptible individuals living here.

Indeed, Dr. Fischer noted, “Most U.S. cases of malaria occur in travelers who took no prophylactic medication, and many went overseas to visit friends and relatives. Pediatricians must be particularly vigilant to help ensure that children with relatives in other countries get appropriate advice and help prior to international trips.”

At a minimum, traveling families should be informed about vaccine-preventable illness, avoidance of insects, use of malaria chemoprophylaxis, prevention and self-treatment of traveler's diarrhea, personal behavior and safety, the importance of obtaining travel and evacuation insurance policies, and access to medical care during travel. Additional information should be tailored to the particular itinerary, the authors said.

In general, the guidelines advise that primary care physicians should be able to provide pretravel services to healthy patients visiting low-risk areas like the Caribbean or a Mexican resort. But “as soon as the traveler has complex health conditions, or one is considering administering specialty vaccines—e.g., Japanese encephalitis and yellow fever, or malaria prevention to someone with a seizure disorder—then the level of expertise needs to be greater,” Dr. Hill, director of the National Travel Health Network and Centre Hospital for Tropical Diseases, London, said in an interview.

Both the International Society of Travel Medicine (www.istm.orgwww.astmh.org

Pediatricians must help ensure that children get appropriate advice and help prior to international trips. DR. FISCHER

COPENHAGEN — A combination of ezetimibe and simvastatin provides additional lipid-modifying benefits compared with rosuvastatin monotherapy among patients with type 2 diabetes or with metabolic syndrome without diabetes, Dr. Alberico L. Catapano reported at the annual meeting of the European Association for the Study of Diabetes.

“Overall, ezetimibe/simvastatin, a single-tablet, dual-cholesterol inhibitor, offers an effective and well-tolerated lipid-modifying option for the treatment of hypercholesterolemia in patients with type 2 diabetes and metabolic syndrome,” said Dr. Catapano, of the department of pharmacological sciences at the University of Milan.

In a post-hoc analysis of data from a multicenter, double-blind, randomized, 6-week study sponsored by Merck & Co., 375 patients with type 2 diabetes, 840 with metabolic syndrome but without diabetes, 1,722 with neither condition, and 22 who could not be placed in a category because of missing data were randomized to one of six treatment groups: ezetimibe/simvastatin (E/S) in doses of 10 mg/20 mg (respectively), 10 mg/40 mg, or 10 mg/80 mg; or rosuvastatin (R) in doses of 10, 20, or 40 mg. All had hypercholesterolemia, defined as an LDL-cholesterol level of 145–249 mg/dL (3.7–6.4 mmol/L) with triglycerides at or below 350 mg/dL (4 mmol/L).

Among the whole cohort of 2,959 patients, significant reductions in LDL cholesterol from baseline were seen among the E/S group at the usual starting, next highest, and maximum dosing levels. (See chart.)

Across all doses, the difference in LDL-cholesterol reduction between E/S and R was significant for the whole cohort (55.8% vs. 51.6%). Consistent with that, LDL-cholesterol lowering was also greater with E/S in the type 2 diabetes patients (58.5% vs. 54.2%), nondiabetics with metabolic syndrome (55% vs. 51.8%), and those with neither (55.6% vs. 51%), Dr. Catapano reported.

Overall, 95.3% of the E/S group, compared with 92.1% of the R group, attained the recommended LDL-cholesterol goals of less than 100 mg/dL (2.6 mmol/L) for the diabetics, 130 mg/dL (3.4 mmol/L) for the nondiabetics with metabolic syndrome, or 160 mg/dL (4.1 mmol/L) for the group with neither. A total of 88.2% of the E/S patients versus 81.9% of the R patients achieved an LDL-cholesterol level of less than 100 mg/dL (2.6 mmol/L), whereas 45.3% vs. 29.5% reached an LDL-cholesterol level of less than 70 mg/dL (1.8 mmol/L). All of these differences were significant, he said.

Reductions in total cholesterol, non-HDL cholesterol, apolipoprotein B, and triglycerides were also significantly greater with E/S; there were no significant differences between the two treatments in HDL cholesterol, or high-sensitivity C-reactive protein.

Both drugs showed similar rates of adverse events (8.1% E/S vs. 7.4% R) and discontinuations because of adverse events (2.2% for both drugs). Proteinuria was higher at baseline in the R group and among those with diabetes, he noted.

ELSEVIER GLOBAL MEDICAL NEWS

COPENHAGEN — A combination of ezetimibe and simvastatin provides additional lipid-modifying benefits compared with rosuvastatin monotherapy among patients with type 2 diabetes or with metabolic syndrome without diabetes, Dr. Alberico L. Catapano reported at the annual meeting of the European Association for the Study of Diabetes.

“Overall, ezetimibe/simvastatin, a single-tablet, dual-cholesterol inhibitor, offers an effective and well-tolerated lipid-modifying option for the treatment of hypercholesterolemia in patients with type 2 diabetes and metabolic syndrome,” said Dr. Catapano, of the department of pharmacological sciences at the University of Milan.

In a post-hoc analysis of data from a multicenter, double-blind, randomized, 6-week study sponsored by Merck & Co., 375 patients with type 2 diabetes, 840 with metabolic syndrome but without diabetes, 1,722 with neither condition, and 22 who could not be placed in a category because of missing data were randomized to one of six treatment groups: ezetimibe/simvastatin (E/S) in doses of 10 mg/20 mg (respectively), 10 mg/40 mg, or 10 mg/80 mg; or rosuvastatin (R) in doses of 10, 20, or 40 mg. All had hypercholesterolemia, defined as an LDL-cholesterol level of 145–249 mg/dL (3.7–6.4 mmol/L) with triglycerides at or below 350 mg/dL (4 mmol/L).

Among the whole cohort of 2,959 patients, significant reductions in LDL cholesterol from baseline were seen among the E/S group at the usual starting, next highest, and maximum dosing levels. (See chart.)

Across all doses, the difference in LDL-cholesterol reduction between E/S and R was significant for the whole cohort (55.8% vs. 51.6%). Consistent with that, LDL-cholesterol lowering was also greater with E/S in the type 2 diabetes patients (58.5% vs. 54.2%), nondiabetics with metabolic syndrome (55% vs. 51.8%), and those with neither (55.6% vs. 51%), Dr. Catapano reported.

Overall, 95.3% of the E/S group, compared with 92.1% of the R group, attained the recommended LDL-cholesterol goals of less than 100 mg/dL (2.6 mmol/L) for the diabetics, 130 mg/dL (3.4 mmol/L) for the nondiabetics with metabolic syndrome, or 160 mg/dL (4.1 mmol/L) for the group with neither. A total of 88.2% of the E/S patients versus 81.9% of the R patients achieved an LDL-cholesterol level of less than 100 mg/dL (2.6 mmol/L), whereas 45.3% vs. 29.5% reached an LDL-cholesterol level of less than 70 mg/dL (1.8 mmol/L). All of these differences were significant, he said.

Reductions in total cholesterol, non-HDL cholesterol, apolipoprotein B, and triglycerides were also significantly greater with E/S; there were no significant differences between the two treatments in HDL cholesterol, or high-sensitivity C-reactive protein.

Both drugs showed similar rates of adverse events (8.1% E/S vs. 7.4% R) and discontinuations because of adverse events (2.2% for both drugs). Proteinuria was higher at baseline in the R group and among those with diabetes, he noted.

ELSEVIER GLOBAL MEDICAL NEWS

COPENHAGEN — A combination of ezetimibe and simvastatin provides additional lipid-modifying benefits compared with rosuvastatin monotherapy among patients with type 2 diabetes or with metabolic syndrome without diabetes, Dr. Alberico L. Catapano reported at the annual meeting of the European Association for the Study of Diabetes.

“Overall, ezetimibe/simvastatin, a single-tablet, dual-cholesterol inhibitor, offers an effective and well-tolerated lipid-modifying option for the treatment of hypercholesterolemia in patients with type 2 diabetes and metabolic syndrome,” said Dr. Catapano, of the department of pharmacological sciences at the University of Milan.

In a post-hoc analysis of data from a multicenter, double-blind, randomized, 6-week study sponsored by Merck & Co., 375 patients with type 2 diabetes, 840 with metabolic syndrome but without diabetes, 1,722 with neither condition, and 22 who could not be placed in a category because of missing data were randomized to one of six treatment groups: ezetimibe/simvastatin (E/S) in doses of 10 mg/20 mg (respectively), 10 mg/40 mg, or 10 mg/80 mg; or rosuvastatin (R) in doses of 10, 20, or 40 mg. All had hypercholesterolemia, defined as an LDL-cholesterol level of 145–249 mg/dL (3.7–6.4 mmol/L) with triglycerides at or below 350 mg/dL (4 mmol/L).

Among the whole cohort of 2,959 patients, significant reductions in LDL cholesterol from baseline were seen among the E/S group at the usual starting, next highest, and maximum dosing levels. (See chart.)

Across all doses, the difference in LDL-cholesterol reduction between E/S and R was significant for the whole cohort (55.8% vs. 51.6%). Consistent with that, LDL-cholesterol lowering was also greater with E/S in the type 2 diabetes patients (58.5% vs. 54.2%), nondiabetics with metabolic syndrome (55% vs. 51.8%), and those with neither (55.6% vs. 51%), Dr. Catapano reported.

Overall, 95.3% of the E/S group, compared with 92.1% of the R group, attained the recommended LDL-cholesterol goals of less than 100 mg/dL (2.6 mmol/L) for the diabetics, 130 mg/dL (3.4 mmol/L) for the nondiabetics with metabolic syndrome, or 160 mg/dL (4.1 mmol/L) for the group with neither. A total of 88.2% of the E/S patients versus 81.9% of the R patients achieved an LDL-cholesterol level of less than 100 mg/dL (2.6 mmol/L), whereas 45.3% vs. 29.5% reached an LDL-cholesterol level of less than 70 mg/dL (1.8 mmol/L). All of these differences were significant, he said.

Reductions in total cholesterol, non-HDL cholesterol, apolipoprotein B, and triglycerides were also significantly greater with E/S; there were no significant differences between the two treatments in HDL cholesterol, or high-sensitivity C-reactive protein.

Both drugs showed similar rates of adverse events (8.1% E/S vs. 7.4% R) and discontinuations because of adverse events (2.2% for both drugs). Proteinuria was higher at baseline in the R group and among those with diabetes, he noted.

ELSEVIER GLOBAL MEDICAL NEWS

COPENHAGEN — Self-treatment with a biofeedback device that guides breathing can significantly lower blood pressure among patients with type 2 diabetes, Dr. Moshe H. Schein reported at the annual meeting of the European Association for the Study of Diabetes.

The device, called RESPeRATE, is made by InterCure Ltd., Lod, Israel. It was approved by the U.S. Food and Drug Administration in 2002 for use in stress reduction and as adjunctive treatment for hypertension, together with other pharmacologic and nonpharmacologic interventions. It works by using melodic tones to guide the patient through progressively slower inhalation and exhalation.

Previous data have shown that the device-guided technique results in significant blood pressure reductions among hypertensive patients who use it at home on a daily basis (J. Hum. Hypertens. 2001;15:271–8).

In the new study, a total of 60 patients with type 2 diabetes who had blood pressures greater than 130/80 mm Hg were randomized to use of the device for 15 minutes a day along with usual treatment, or to usual treatment alone for 8 weeks. The group was 60% male, with a mean age of 64 years and a mean body mass index of 30 kg/m

At baseline, mean blood pressure was 149/82 mm Hg in the treatment group and 146/81 mm Hg in the control group, even though the majority—78% of the treatment group and 89% of the controls—were taking blood pressure medication, said Dr. Schein, director of the Family Medicine Unit, Hadassah University Hospital, Jerusalem.

Systolic blood pressure dropped by 9.5 mm Hg in the group using the device, compared with an increase of 2.1 mm Hg among the controls, a significant difference between the two groups. The change in pulse pressure also was significantly different at 2 months; it dropped by 5.9 mm Hg from a mean of 67 mm Hg at baseline in the guided-breathing group, and increased by 3.6 mm Hg from a mean of 66 mm Hg in the controls.

Diastolic blood pressure dropped slightly in both groups, by 3.5 mm Hg in the guided-breathing patients and by 1.5 mm Hg among the controls. That difference was not significant.

There was a dose-response relationship between use of the device and systolic blood pressure reduction: The longer the patient spent in the slow breathing exercise, the greater the drop. (Although patients had been instructed to perform the device-guided breathing exercise daily, they actually did it for a mean of 5.6 sessions per week. However, each session lasted 15.9 minutes, slightly longer than the instructed 15 minutes, and patients spent a mean of 40.4 minutes per week in slow breathing. Blood pressure control, defined as 130/80 mm Hg or below, was achieved by 8 of 30 (27%) in the device group, compared with 2 of the 30 (7%) controls.

COPENHAGEN — Self-treatment with a biofeedback device that guides breathing can significantly lower blood pressure among patients with type 2 diabetes, Dr. Moshe H. Schein reported at the annual meeting of the European Association for the Study of Diabetes.

The device, called RESPeRATE, is made by InterCure Ltd., Lod, Israel. It was approved by the U.S. Food and Drug Administration in 2002 for use in stress reduction and as adjunctive treatment for hypertension, together with other pharmacologic and nonpharmacologic interventions. It works by using melodic tones to guide the patient through progressively slower inhalation and exhalation.

Previous data have shown that the device-guided technique results in significant blood pressure reductions among hypertensive patients who use it at home on a daily basis (J. Hum. Hypertens. 2001;15:271–8).

In the new study, a total of 60 patients with type 2 diabetes who had blood pressures greater than 130/80 mm Hg were randomized to use of the device for 15 minutes a day along with usual treatment, or to usual treatment alone for 8 weeks. The group was 60% male, with a mean age of 64 years and a mean body mass index of 30 kg/m

At baseline, mean blood pressure was 149/82 mm Hg in the treatment group and 146/81 mm Hg in the control group, even though the majority—78% of the treatment group and 89% of the controls—were taking blood pressure medication, said Dr. Schein, director of the Family Medicine Unit, Hadassah University Hospital, Jerusalem.

Systolic blood pressure dropped by 9.5 mm Hg in the group using the device, compared with an increase of 2.1 mm Hg among the controls, a significant difference between the two groups. The change in pulse pressure also was significantly different at 2 months; it dropped by 5.9 mm Hg from a mean of 67 mm Hg at baseline in the guided-breathing group, and increased by 3.6 mm Hg from a mean of 66 mm Hg in the controls.

Diastolic blood pressure dropped slightly in both groups, by 3.5 mm Hg in the guided-breathing patients and by 1.5 mm Hg among the controls. That difference was not significant.

There was a dose-response relationship between use of the device and systolic blood pressure reduction: The longer the patient spent in the slow breathing exercise, the greater the drop. (Although patients had been instructed to perform the device-guided breathing exercise daily, they actually did it for a mean of 5.6 sessions per week. However, each session lasted 15.9 minutes, slightly longer than the instructed 15 minutes, and patients spent a mean of 40.4 minutes per week in slow breathing. Blood pressure control, defined as 130/80 mm Hg or below, was achieved by 8 of 30 (27%) in the device group, compared with 2 of the 30 (7%) controls.

COPENHAGEN — Self-treatment with a biofeedback device that guides breathing can significantly lower blood pressure among patients with type 2 diabetes, Dr. Moshe H. Schein reported at the annual meeting of the European Association for the Study of Diabetes.

The device, called RESPeRATE, is made by InterCure Ltd., Lod, Israel. It was approved by the U.S. Food and Drug Administration in 2002 for use in stress reduction and as adjunctive treatment for hypertension, together with other pharmacologic and nonpharmacologic interventions. It works by using melodic tones to guide the patient through progressively slower inhalation and exhalation.

Previous data have shown that the device-guided technique results in significant blood pressure reductions among hypertensive patients who use it at home on a daily basis (J. Hum. Hypertens. 2001;15:271–8).

In the new study, a total of 60 patients with type 2 diabetes who had blood pressures greater than 130/80 mm Hg were randomized to use of the device for 15 minutes a day along with usual treatment, or to usual treatment alone for 8 weeks. The group was 60% male, with a mean age of 64 years and a mean body mass index of 30 kg/m

At baseline, mean blood pressure was 149/82 mm Hg in the treatment group and 146/81 mm Hg in the control group, even though the majority—78% of the treatment group and 89% of the controls—were taking blood pressure medication, said Dr. Schein, director of the Family Medicine Unit, Hadassah University Hospital, Jerusalem.

Systolic blood pressure dropped by 9.5 mm Hg in the group using the device, compared with an increase of 2.1 mm Hg among the controls, a significant difference between the two groups. The change in pulse pressure also was significantly different at 2 months; it dropped by 5.9 mm Hg from a mean of 67 mm Hg at baseline in the guided-breathing group, and increased by 3.6 mm Hg from a mean of 66 mm Hg in the controls.

Diastolic blood pressure dropped slightly in both groups, by 3.5 mm Hg in the guided-breathing patients and by 1.5 mm Hg among the controls. That difference was not significant.

There was a dose-response relationship between use of the device and systolic blood pressure reduction: The longer the patient spent in the slow breathing exercise, the greater the drop. (Although patients had been instructed to perform the device-guided breathing exercise daily, they actually did it for a mean of 5.6 sessions per week. However, each session lasted 15.9 minutes, slightly longer than the instructed 15 minutes, and patients spent a mean of 40.4 minutes per week in slow breathing. Blood pressure control, defined as 130/80 mm Hg or below, was achieved by 8 of 30 (27%) in the device group, compared with 2 of the 30 (7%) controls.

COPENHAGEN — Metformin in a chewing gum? It could happen.

The optimism comes from an analysis presented in a poster by Dr. Gerald Bernstein at the annual meeting of the European Association for the Study of Diabetes, showing that a chewing gum formulation of the glucose-lowering drug displays a similar pharmacokinetic profile to that of conventional tablets.

If further study proves that the metformin gum is as effective and safe as the pills but without the gastrointestinal side effects, it could hold particular promise in treating a wide range of patients, including both adults and children with type 2 diabetes or polycystic ovary syndrome who can't tolerate metformin's side effects, or who can't swallow the pills.

“Metformin is a great drug, but some people can't take it because of the gastrointestinal side effects. Maybe we can bypass that by buccal absorption,” Dr. Bernstein, vice president of medical affairs, Generex Biotechnology, Toronto, said in an interview.

Plasma metformin concentrations were measured in 10 healthy volunteers for 12 hours after ingestion of an 850-mg metformin tablet, for 24 hours following about 5–6 minutes of chewing a 429-mg dose of metformin gum (two pieces containing 214.5 mg each), and for 24 hours after swallowing a 429-mg metformin tablet. The two different metformin tablet dosages showed an expected doubling in area under the curve of parts per million. When the identical dosages of gum and tablet were compared, the curves were similar during 24 hours.

Generex, which is also developing an oral insulin spray, funded the study. The company plans to begin clinical trials of metformin gum in patients with type 2 diabetes in the next few months.

COPENHAGEN — Metformin in a chewing gum? It could happen.

The optimism comes from an analysis presented in a poster by Dr. Gerald Bernstein at the annual meeting of the European Association for the Study of Diabetes, showing that a chewing gum formulation of the glucose-lowering drug displays a similar pharmacokinetic profile to that of conventional tablets.

If further study proves that the metformin gum is as effective and safe as the pills but without the gastrointestinal side effects, it could hold particular promise in treating a wide range of patients, including both adults and children with type 2 diabetes or polycystic ovary syndrome who can't tolerate metformin's side effects, or who can't swallow the pills.

“Metformin is a great drug, but some people can't take it because of the gastrointestinal side effects. Maybe we can bypass that by buccal absorption,” Dr. Bernstein, vice president of medical affairs, Generex Biotechnology, Toronto, said in an interview.

Plasma metformin concentrations were measured in 10 healthy volunteers for 12 hours after ingestion of an 850-mg metformin tablet, for 24 hours following about 5–6 minutes of chewing a 429-mg dose of metformin gum (two pieces containing 214.5 mg each), and for 24 hours after swallowing a 429-mg metformin tablet. The two different metformin tablet dosages showed an expected doubling in area under the curve of parts per million. When the identical dosages of gum and tablet were compared, the curves were similar during 24 hours.

Generex, which is also developing an oral insulin spray, funded the study. The company plans to begin clinical trials of metformin gum in patients with type 2 diabetes in the next few months.

COPENHAGEN — Metformin in a chewing gum? It could happen.

The optimism comes from an analysis presented in a poster by Dr. Gerald Bernstein at the annual meeting of the European Association for the Study of Diabetes, showing that a chewing gum formulation of the glucose-lowering drug displays a similar pharmacokinetic profile to that of conventional tablets.

If further study proves that the metformin gum is as effective and safe as the pills but without the gastrointestinal side effects, it could hold particular promise in treating a wide range of patients, including both adults and children with type 2 diabetes or polycystic ovary syndrome who can't tolerate metformin's side effects, or who can't swallow the pills.

“Metformin is a great drug, but some people can't take it because of the gastrointestinal side effects. Maybe we can bypass that by buccal absorption,” Dr. Bernstein, vice president of medical affairs, Generex Biotechnology, Toronto, said in an interview.

Plasma metformin concentrations were measured in 10 healthy volunteers for 12 hours after ingestion of an 850-mg metformin tablet, for 24 hours following about 5–6 minutes of chewing a 429-mg dose of metformin gum (two pieces containing 214.5 mg each), and for 24 hours after swallowing a 429-mg metformin tablet. The two different metformin tablet dosages showed an expected doubling in area under the curve of parts per million. When the identical dosages of gum and tablet were compared, the curves were similar during 24 hours.

Generex, which is also developing an oral insulin spray, funded the study. The company plans to begin clinical trials of metformin gum in patients with type 2 diabetes in the next few months.

TORONTO — Postpartum testing in women who had gestational diabetes during pregnancy should include both an oral glucose-tolerance test and a lipid profile, Genevieve Dubé and her colleagues advised in a poster presented at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Data from a retrospective analysis of 223 women with gestational diabetes mellitus (GDM) during pregnancy revealed that postpartum glucose-tolerance abnormalities were common, affecting one-fourth of all women. Moreover, “isolated fasting glucose testing would have failed to identify most cases of postpartum dysglycemia,” noted Ms. Dubé, a dietician, and her colleagues at the Centre Régional du Diabète de Laval (Que.). The data also suggested that a lipid profile should be part of the assessment, because many of the women with previous GDM—including those with normal postpartum oral glucose-tolerance test (OGTT) results—have altered lipids suggestive of features of the cardiometabolic syndrome, they said.

The 223 women had received prenatal care between June 2004 and April 2005 at Laval's diabetic pregnancy clinic, where a program of routine postnatal GDM follow-up has been in place since 2002. The group had a mean age of 31 years and a mean body mass index of 28.3 kg/m

Of the 164 who underwent the OGTT, some form of impaired glucose tolerance was detected in 25% (41 patients), including frank type 2 diabetes in 4% (7 patients), isolated impaired glucose tolerance in 16% (26 patients), isolated impaired fasting glucose in 2% (3 patients), and both impaired glucose tolerance and impaired fasting glucose in 3% (5 patients).

Whatever fasting blood glucose (FBG) cutoff was used, more than half of dysglycemic women would have been missed if screening included only FBG. Among the 41 women with abnormal 2-hour OGTT results, just 49% had FBG values at or above 5.6 mmol/L, 41.5% had FBG levels of 5.8 mmol/L or higher, and 32% had FBG levels of 6.1 mmol/L or higher.

The need for insulin therapy and a first-trimester FBG above 6.1 mmol/L were the only risk factors that significantly predicted postpartum abnormal OGTT, with odds ratios of 1.89 and 3.41, respectively. Maternal age, BMI, parity, macrosomia, and nonwhite race were not predictive. Among the 165 women who underwent postpartum lipid tests, 70% had at least one abnormality, defined as a triglyceride level of 1.7 mmol/L or higher, HDL cholesterol level at or lower than 1.3 mmol/L, or a total cholesterol/HDL cholesterol ratio of 5.0 or greater. Cardiometabolic risk factors were not limited to those with abnormal OGTT results and diabetes. Two-thirds of the 123 women with normal postpartum glucose tolerance had at least one lipid abnormality; 23% had triglyceride levels of 1.7 mmol/L or higher, and 23% had HDL cholesterol of 1.3 mmol/L or lower. Only when those two abnormalities were combined was there a significant correlation with OGTT results.

Although it may be good to bring women in for postpartum testing while they're breast-feeding in order to avoid loss to follow-up, lactation can mask some lipid and glucose abnormalities, she noted.

TORONTO — Postpartum testing in women who had gestational diabetes during pregnancy should include both an oral glucose-tolerance test and a lipid profile, Genevieve Dubé and her colleagues advised in a poster presented at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Data from a retrospective analysis of 223 women with gestational diabetes mellitus (GDM) during pregnancy revealed that postpartum glucose-tolerance abnormalities were common, affecting one-fourth of all women. Moreover, “isolated fasting glucose testing would have failed to identify most cases of postpartum dysglycemia,” noted Ms. Dubé, a dietician, and her colleagues at the Centre Régional du Diabète de Laval (Que.). The data also suggested that a lipid profile should be part of the assessment, because many of the women with previous GDM—including those with normal postpartum oral glucose-tolerance test (OGTT) results—have altered lipids suggestive of features of the cardiometabolic syndrome, they said.

The 223 women had received prenatal care between June 2004 and April 2005 at Laval's diabetic pregnancy clinic, where a program of routine postnatal GDM follow-up has been in place since 2002. The group had a mean age of 31 years and a mean body mass index of 28.3 kg/m

Of the 164 who underwent the OGTT, some form of impaired glucose tolerance was detected in 25% (41 patients), including frank type 2 diabetes in 4% (7 patients), isolated impaired glucose tolerance in 16% (26 patients), isolated impaired fasting glucose in 2% (3 patients), and both impaired glucose tolerance and impaired fasting glucose in 3% (5 patients).

Whatever fasting blood glucose (FBG) cutoff was used, more than half of dysglycemic women would have been missed if screening included only FBG. Among the 41 women with abnormal 2-hour OGTT results, just 49% had FBG values at or above 5.6 mmol/L, 41.5% had FBG levels of 5.8 mmol/L or higher, and 32% had FBG levels of 6.1 mmol/L or higher.

The need for insulin therapy and a first-trimester FBG above 6.1 mmol/L were the only risk factors that significantly predicted postpartum abnormal OGTT, with odds ratios of 1.89 and 3.41, respectively. Maternal age, BMI, parity, macrosomia, and nonwhite race were not predictive. Among the 165 women who underwent postpartum lipid tests, 70% had at least one abnormality, defined as a triglyceride level of 1.7 mmol/L or higher, HDL cholesterol level at or lower than 1.3 mmol/L, or a total cholesterol/HDL cholesterol ratio of 5.0 or greater. Cardiometabolic risk factors were not limited to those with abnormal OGTT results and diabetes. Two-thirds of the 123 women with normal postpartum glucose tolerance had at least one lipid abnormality; 23% had triglyceride levels of 1.7 mmol/L or higher, and 23% had HDL cholesterol of 1.3 mmol/L or lower. Only when those two abnormalities were combined was there a significant correlation with OGTT results.

Although it may be good to bring women in for postpartum testing while they're breast-feeding in order to avoid loss to follow-up, lactation can mask some lipid and glucose abnormalities, she noted.

TORONTO — Postpartum testing in women who had gestational diabetes during pregnancy should include both an oral glucose-tolerance test and a lipid profile, Genevieve Dubé and her colleagues advised in a poster presented at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Data from a retrospective analysis of 223 women with gestational diabetes mellitus (GDM) during pregnancy revealed that postpartum glucose-tolerance abnormalities were common, affecting one-fourth of all women. Moreover, “isolated fasting glucose testing would have failed to identify most cases of postpartum dysglycemia,” noted Ms. Dubé, a dietician, and her colleagues at the Centre Régional du Diabète de Laval (Que.). The data also suggested that a lipid profile should be part of the assessment, because many of the women with previous GDM—including those with normal postpartum oral glucose-tolerance test (OGTT) results—have altered lipids suggestive of features of the cardiometabolic syndrome, they said.

The 223 women had received prenatal care between June 2004 and April 2005 at Laval's diabetic pregnancy clinic, where a program of routine postnatal GDM follow-up has been in place since 2002. The group had a mean age of 31 years and a mean body mass index of 28.3 kg/m

Of the 164 who underwent the OGTT, some form of impaired glucose tolerance was detected in 25% (41 patients), including frank type 2 diabetes in 4% (7 patients), isolated impaired glucose tolerance in 16% (26 patients), isolated impaired fasting glucose in 2% (3 patients), and both impaired glucose tolerance and impaired fasting glucose in 3% (5 patients).

Whatever fasting blood glucose (FBG) cutoff was used, more than half of dysglycemic women would have been missed if screening included only FBG. Among the 41 women with abnormal 2-hour OGTT results, just 49% had FBG values at or above 5.6 mmol/L, 41.5% had FBG levels of 5.8 mmol/L or higher, and 32% had FBG levels of 6.1 mmol/L or higher.

The need for insulin therapy and a first-trimester FBG above 6.1 mmol/L were the only risk factors that significantly predicted postpartum abnormal OGTT, with odds ratios of 1.89 and 3.41, respectively. Maternal age, BMI, parity, macrosomia, and nonwhite race were not predictive. Among the 165 women who underwent postpartum lipid tests, 70% had at least one abnormality, defined as a triglyceride level of 1.7 mmol/L or higher, HDL cholesterol level at or lower than 1.3 mmol/L, or a total cholesterol/HDL cholesterol ratio of 5.0 or greater. Cardiometabolic risk factors were not limited to those with abnormal OGTT results and diabetes. Two-thirds of the 123 women with normal postpartum glucose tolerance had at least one lipid abnormality; 23% had triglyceride levels of 1.7 mmol/L or higher, and 23% had HDL cholesterol of 1.3 mmol/L or lower. Only when those two abnormalities were combined was there a significant correlation with OGTT results.

Although it may be good to bring women in for postpartum testing while they're breast-feeding in order to avoid loss to follow-up, lactation can mask some lipid and glucose abnormalities, she noted.

TORONTO — A formulation of insulin that is sprayed in the mouth and absorbed buccally appears to control glucose as well as injected insulin when used before a meal, Dr. Gerald Bernstein reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The product, Generex Oral-lyn, is made by Toronto-based Generex Biotechnology. When sprayed into the mouth using the company's “RapidMist” device, the insulin is absorbed into the buccal epithelium and is dispersed directly into the vascular system, thereby avoiding the problem of digestion that would occur if insulin were swallowed. The product has been approved for use in Ecuador for patients with type 1 and type 2 diabetes, according to a company statement.

Dr. Bernstein, the company's vice president for medical affairs, presented a 3-month interim analysis of a 6-month study conducted by Dr. Jaime Guevara-Aguirre and his associates at the Institute of Endocrinology IEMYR in Quito, Ecuador. A total of 24 adolescents (mean age 15 years) and 5 young adults (21 years) with type 1 diabetes were first stabilized for 6 weeks with basal twice-daily glargine and premeal injections of regular insulin. For the next 6 weeks, they took Oral-lyn immediately before and immediately after lunch instead of the injected regular insulin, while continuing to inject the glargine twice daily and the regular insulin before breakfast and dinner.

At baseline, the group had a mean hemoglobin A_1c of 9.9% and mean glucose of 236.6 mg/dL. After stabilization, their mean A_1c level dropped to 8.4% and mean glucose—measured by the patients six times each day—dropped to 140.4 mg/dL.

After 3 weeks of substituting Oral-lyn for regular insulin at lunch, the mean A_1c was 8.5%, and mean glucose was 143.3 mg/dL. Three weeks later (study week 12), the mean A_1c was down to 8.0%, Dr. Bernstein reported.

Doses of the glargine and the prelunch Oral-lyn were split in this study because previous data on each had shown that doing so improves efficacy. However, in practice, patients could take the entire dose of Oral-lyn prior to the meal, since the timing of its action is similar to that of currently available short-acting analogs: It begins working within 5 minutes, peaks at 30 minutes, and is cleared from the bloodstream by 2 hours, he explained.

A larger study is now underway comparing glargine plus either regular insulin or Oral-lyn given before each meal.

Generex Biotechnology plans to file a submission for approval in Canada and Europe concurrently within the next 12–15 months. Submission to the Food and Drug Administration is expected to follow and may fall within an 18-month time frame, according to a company spokesperson.

TORONTO — A formulation of insulin that is sprayed in the mouth and absorbed buccally appears to control glucose as well as injected insulin when used before a meal, Dr. Gerald Bernstein reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The product, Generex Oral-lyn, is made by Toronto-based Generex Biotechnology. When sprayed into the mouth using the company's “RapidMist” device, the insulin is absorbed into the buccal epithelium and is dispersed directly into the vascular system, thereby avoiding the problem of digestion that would occur if insulin were swallowed. The product has been approved for use in Ecuador for patients with type 1 and type 2 diabetes, according to a company statement.

Dr. Bernstein, the company's vice president for medical affairs, presented a 3-month interim analysis of a 6-month study conducted by Dr. Jaime Guevara-Aguirre and his associates at the Institute of Endocrinology IEMYR in Quito, Ecuador. A total of 24 adolescents (mean age 15 years) and 5 young adults (21 years) with type 1 diabetes were first stabilized for 6 weeks with basal twice-daily glargine and premeal injections of regular insulin. For the next 6 weeks, they took Oral-lyn immediately before and immediately after lunch instead of the injected regular insulin, while continuing to inject the glargine twice daily and the regular insulin before breakfast and dinner.

At baseline, the group had a mean hemoglobin A_1c of 9.9% and mean glucose of 236.6 mg/dL. After stabilization, their mean A_1c level dropped to 8.4% and mean glucose—measured by the patients six times each day—dropped to 140.4 mg/dL.

After 3 weeks of substituting Oral-lyn for regular insulin at lunch, the mean A_1c was 8.5%, and mean glucose was 143.3 mg/dL. Three weeks later (study week 12), the mean A_1c was down to 8.0%, Dr. Bernstein reported.

Doses of the glargine and the prelunch Oral-lyn were split in this study because previous data on each had shown that doing so improves efficacy. However, in practice, patients could take the entire dose of Oral-lyn prior to the meal, since the timing of its action is similar to that of currently available short-acting analogs: It begins working within 5 minutes, peaks at 30 minutes, and is cleared from the bloodstream by 2 hours, he explained.

A larger study is now underway comparing glargine plus either regular insulin or Oral-lyn given before each meal.

Generex Biotechnology plans to file a submission for approval in Canada and Europe concurrently within the next 12–15 months. Submission to the Food and Drug Administration is expected to follow and may fall within an 18-month time frame, according to a company spokesperson.

TORONTO — A formulation of insulin that is sprayed in the mouth and absorbed buccally appears to control glucose as well as injected insulin when used before a meal, Dr. Gerald Bernstein reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The product, Generex Oral-lyn, is made by Toronto-based Generex Biotechnology. When sprayed into the mouth using the company's “RapidMist” device, the insulin is absorbed into the buccal epithelium and is dispersed directly into the vascular system, thereby avoiding the problem of digestion that would occur if insulin were swallowed. The product has been approved for use in Ecuador for patients with type 1 and type 2 diabetes, according to a company statement.

Dr. Bernstein, the company's vice president for medical affairs, presented a 3-month interim analysis of a 6-month study conducted by Dr. Jaime Guevara-Aguirre and his associates at the Institute of Endocrinology IEMYR in Quito, Ecuador. A total of 24 adolescents (mean age 15 years) and 5 young adults (21 years) with type 1 diabetes were first stabilized for 6 weeks with basal twice-daily glargine and premeal injections of regular insulin. For the next 6 weeks, they took Oral-lyn immediately before and immediately after lunch instead of the injected regular insulin, while continuing to inject the glargine twice daily and the regular insulin before breakfast and dinner.

At baseline, the group had a mean hemoglobin A_1c of 9.9% and mean glucose of 236.6 mg/dL. After stabilization, their mean A_1c level dropped to 8.4% and mean glucose—measured by the patients six times each day—dropped to 140.4 mg/dL.

After 3 weeks of substituting Oral-lyn for regular insulin at lunch, the mean A_1c was 8.5%, and mean glucose was 143.3 mg/dL. Three weeks later (study week 12), the mean A_1c was down to 8.0%, Dr. Bernstein reported.

Doses of the glargine and the prelunch Oral-lyn were split in this study because previous data on each had shown that doing so improves efficacy. However, in practice, patients could take the entire dose of Oral-lyn prior to the meal, since the timing of its action is similar to that of currently available short-acting analogs: It begins working within 5 minutes, peaks at 30 minutes, and is cleared from the bloodstream by 2 hours, he explained.

A larger study is now underway comparing glargine plus either regular insulin or Oral-lyn given before each meal.

Generex Biotechnology plans to file a submission for approval in Canada and Europe concurrently within the next 12–15 months. Submission to the Food and Drug Administration is expected to follow and may fall within an 18-month time frame, according to a company spokesperson.