Sharon Worcester

NEW YORK — Patient-centered management and early, aggressive treatment of hypertension is necessary in patients with diabetes to address the sevenfold mortality increase in this patient population, according to an updated guidance from the American Society of Hypertension.

The new recommendations were addressed during an October press briefing sponsored by the society and published in the Journal of Clinical Hypertension (J. Clin. Hypertens. 2008;10:707).

Physicians need to take a more integrated, individualized approach to treating hypertension in patients with diabetes by “treating the intricacies of each patient profile, rather than focusing on the disease in isolation,” according to a statement by ASH.

The guidance does not alter the fundamental treatment of blood pressure goals for this patient population, but it does emphasize that early detection of risk factors unique to each patient is needed and that earlier, more-aggressive treatment should be implemented, including the identification and reduction of proteinuria.

Once high blood pressure is identified, initiation of ACE inhibitors or angiotensin receptor blocker therapy, along with either thiazide-like diuretics or calcium antagonists is needed to maintain a target blood pressure of 130/80 mm Hg. More frequent patient follow-up also is needed, according to the guidance document.

Specifically, follow-up visits after each medication adjustment should occur within 2–3 weeks rather than 4–8 weeks as was previously recommended, and immediate referral to a specialist is necessary if repeated attempts to achieve blood pressure goals fail, according to the guidance.

Previous studies show that, compared with conventional treatment, aggressive blood pressure control is associated with far fewer cardiovascular events in diabetes patients, Dr. George Bakris, of the University of Chicago, said during the briefing. Yet physicians are not being as aggressive as necessary to get blood pressure under control. They also need to empower patients to take control, and they need to focus on the goal of reducing morbidity.

Patients who make the necessary lifestyle changes and who comply with aggressive therapy will prolong their lives and improve their quality of life by reducing morbidity, he said.

Physicians need to emphasize that the need for treatment is not transient but is lifelong. That said, obese patients who lose weight can successfully reduce their antihypertensive pill burden, he noted.

“These patients require an integrated therapeutic intervention that, in addition to blood pressure control, should include glycemic and lipid control and antiplatelet therapy,” Dr. Bakris noted in an ASH statement. All risk factors must be attacked simultaneously to manage the profile of each patient more vigilantly, he added.

The challenges of identifying and treating hypertension are not limited to adults.

Nearly a third of obese teens also have high blood pressure, Dr. Bonita Falkner, a nephrologist at Thomas Jefferson University, Philadelphia, said during the briefing.

Obesity has become such a significant problem among adolescents that the prevalence of premature heart disease in young adults is expected to more than triple from 5% to 16% when currently obese adolescents reach age 35, she added.

Dr. Henry Black, president of ASH, said at the briefing that immediate action is needed to address the problem of childhood obesity and the associated risks.

Overall, about 3.5% of children have hypertension and another 3.5% have prehypertension. It is likely that these children have—or will develop—blood pressure levels that require therapy and that they will become hypertensive young adults, said Dr. Falkner, an author on pediatric hypertension guidelines published in 2004.

Additional clinical research involving adolescents is needed to define the disease pathway, to improve detection and treatment methods, and to determine the most beneficial time point for interventions, she said.

For now, she recommended that:

▸ Blood pressure be measured as part of routine health care beginning at age 3 years.

▸ Blood pressure be measured as part of a medical exam in those younger than 3 years with chronic disease or unexplained symptoms.

▸ An appropriate evaluation be conducted in those with detected and verified hypertension.

NEW YORK — Patient-centered management and early, aggressive treatment of hypertension is necessary in patients with diabetes to address the sevenfold mortality increase in this patient population, according to an updated guidance from the American Society of Hypertension.

The new recommendations were addressed during an October press briefing sponsored by the society and published in the Journal of Clinical Hypertension (J. Clin. Hypertens. 2008;10:707).

Physicians need to take a more integrated, individualized approach to treating hypertension in patients with diabetes by “treating the intricacies of each patient profile, rather than focusing on the disease in isolation,” according to a statement by ASH.

The guidance does not alter the fundamental treatment of blood pressure goals for this patient population, but it does emphasize that early detection of risk factors unique to each patient is needed and that earlier, more-aggressive treatment should be implemented, including the identification and reduction of proteinuria.

Once high blood pressure is identified, initiation of ACE inhibitors or angiotensin receptor blocker therapy, along with either thiazide-like diuretics or calcium antagonists is needed to maintain a target blood pressure of 130/80 mm Hg. More frequent patient follow-up also is needed, according to the guidance document.

Specifically, follow-up visits after each medication adjustment should occur within 2–3 weeks rather than 4–8 weeks as was previously recommended, and immediate referral to a specialist is necessary if repeated attempts to achieve blood pressure goals fail, according to the guidance.

Previous studies show that, compared with conventional treatment, aggressive blood pressure control is associated with far fewer cardiovascular events in diabetes patients, Dr. George Bakris, of the University of Chicago, said during the briefing. Yet physicians are not being as aggressive as necessary to get blood pressure under control. They also need to empower patients to take control, and they need to focus on the goal of reducing morbidity.

Patients who make the necessary lifestyle changes and who comply with aggressive therapy will prolong their lives and improve their quality of life by reducing morbidity, he said.

Physicians need to emphasize that the need for treatment is not transient but is lifelong. That said, obese patients who lose weight can successfully reduce their antihypertensive pill burden, he noted.

“These patients require an integrated therapeutic intervention that, in addition to blood pressure control, should include glycemic and lipid control and antiplatelet therapy,” Dr. Bakris noted in an ASH statement. All risk factors must be attacked simultaneously to manage the profile of each patient more vigilantly, he added.

The challenges of identifying and treating hypertension are not limited to adults.

Nearly a third of obese teens also have high blood pressure, Dr. Bonita Falkner, a nephrologist at Thomas Jefferson University, Philadelphia, said during the briefing.

Obesity has become such a significant problem among adolescents that the prevalence of premature heart disease in young adults is expected to more than triple from 5% to 16% when currently obese adolescents reach age 35, she added.

Dr. Henry Black, president of ASH, said at the briefing that immediate action is needed to address the problem of childhood obesity and the associated risks.

Overall, about 3.5% of children have hypertension and another 3.5% have prehypertension. It is likely that these children have—or will develop—blood pressure levels that require therapy and that they will become hypertensive young adults, said Dr. Falkner, an author on pediatric hypertension guidelines published in 2004.

Additional clinical research involving adolescents is needed to define the disease pathway, to improve detection and treatment methods, and to determine the most beneficial time point for interventions, she said.

For now, she recommended that:

▸ Blood pressure be measured as part of routine health care beginning at age 3 years.

▸ Blood pressure be measured as part of a medical exam in those younger than 3 years with chronic disease or unexplained symptoms.

▸ An appropriate evaluation be conducted in those with detected and verified hypertension.

NEW YORK — Patient-centered management and early, aggressive treatment of hypertension is necessary in patients with diabetes to address the sevenfold mortality increase in this patient population, according to an updated guidance from the American Society of Hypertension.

The new recommendations were addressed during an October press briefing sponsored by the society and published in the Journal of Clinical Hypertension (J. Clin. Hypertens. 2008;10:707).

Physicians need to take a more integrated, individualized approach to treating hypertension in patients with diabetes by “treating the intricacies of each patient profile, rather than focusing on the disease in isolation,” according to a statement by ASH.

The guidance does not alter the fundamental treatment of blood pressure goals for this patient population, but it does emphasize that early detection of risk factors unique to each patient is needed and that earlier, more-aggressive treatment should be implemented, including the identification and reduction of proteinuria.

Once high blood pressure is identified, initiation of ACE inhibitors or angiotensin receptor blocker therapy, along with either thiazide-like diuretics or calcium antagonists is needed to maintain a target blood pressure of 130/80 mm Hg. More frequent patient follow-up also is needed, according to the guidance document.

Specifically, follow-up visits after each medication adjustment should occur within 2–3 weeks rather than 4–8 weeks as was previously recommended, and immediate referral to a specialist is necessary if repeated attempts to achieve blood pressure goals fail, according to the guidance.

Previous studies show that, compared with conventional treatment, aggressive blood pressure control is associated with far fewer cardiovascular events in diabetes patients, Dr. George Bakris, of the University of Chicago, said during the briefing. Yet physicians are not being as aggressive as necessary to get blood pressure under control. They also need to empower patients to take control, and they need to focus on the goal of reducing morbidity.

Patients who make the necessary lifestyle changes and who comply with aggressive therapy will prolong their lives and improve their quality of life by reducing morbidity, he said.

Physicians need to emphasize that the need for treatment is not transient but is lifelong. That said, obese patients who lose weight can successfully reduce their antihypertensive pill burden, he noted.

“These patients require an integrated therapeutic intervention that, in addition to blood pressure control, should include glycemic and lipid control and antiplatelet therapy,” Dr. Bakris noted in an ASH statement. All risk factors must be attacked simultaneously to manage the profile of each patient more vigilantly, he added.

The challenges of identifying and treating hypertension are not limited to adults.

Nearly a third of obese teens also have high blood pressure, Dr. Bonita Falkner, a nephrologist at Thomas Jefferson University, Philadelphia, said during the briefing.

Obesity has become such a significant problem among adolescents that the prevalence of premature heart disease in young adults is expected to more than triple from 5% to 16% when currently obese adolescents reach age 35, she added.

Dr. Henry Black, president of ASH, said at the briefing that immediate action is needed to address the problem of childhood obesity and the associated risks.

Overall, about 3.5% of children have hypertension and another 3.5% have prehypertension. It is likely that these children have—or will develop—blood pressure levels that require therapy and that they will become hypertensive young adults, said Dr. Falkner, an author on pediatric hypertension guidelines published in 2004.

Additional clinical research involving adolescents is needed to define the disease pathway, to improve detection and treatment methods, and to determine the most beneficial time point for interventions, she said.

For now, she recommended that:

▸ Blood pressure be measured as part of routine health care beginning at age 3 years.

▸ Blood pressure be measured as part of a medical exam in those younger than 3 years with chronic disease or unexplained symptoms.

▸ An appropriate evaluation be conducted in those with detected and verified hypertension.

NEW YORK — Patient-centered management and early, aggressive treatment of hypertension is necessary in patients with diabetes to address the sevenfold mortality increase in this patient population, according to an updated guidance from the American Society of Hypertension.

Physicians need to take a more integrated, individualized approach to treating hypertension in patients with diabetes by “treating the intricacies of each patient profile, rather than focusing on the disease in isolation,” according to a statement by ASH.

The new recommendations were addressed in a press briefing and published in a position paper in the Journal of Clinical Hypertension (2008;10:707).

The guidance does not alter the fundamental treatment of blood pressure goals for this patient population, but it does emphasize that early detection of risk factors unique to each patient is needed and that earlier, more-aggressive treatment should be implemented, including the identification and reduction of proteinuria.

Once high blood pressure is identified, initiation of ACE inhibitors or angiotensin receptor blocker therapy along with either thiazide-like diuretics or calcium antagonists is needed to maintain a target blood pressure of 130/80 mm Hg. More frequent patient follow-up also is needed, according to the guidance.

Previous studies show that, compared with conventional treatment, aggressive blood pressure control is associated with far fewer cardiovascular events in diabetic patients, Dr. George Bakris, professor of medicine at the University of Chicago, said during the briefing. Yet physicians are not being as aggressive as necessary to get blood pressure under control. Physicians also need to empower patients to take control, and they need to focus on the goal of reducing morbidity.

Physicians need to emphasize that the need for treatment is not transient but is lifelong. That said, obese patients who lose weight can successfully reduce their antihypertensive pill burden, he noted.

“These patients require an integrated therapeutic intervention that, in addition to blood pressure control, should include glycemic and lipid control and antiplatelet therapy,” Dr. Bakris noted in an ASH statement. It is imperative that all risk factors be attacked simultaneously to manage the profile of each patient more vigilantly, he added.

The challenges of identifying and treating hypertension are not limited to adults.

Nearly a third of obese teens also have high blood pressure, Dr. Bonita Falkner, a nephrologist at Thomas Jefferson University, Philadelphia, said during the briefing.

Overall, about 3.5% of children have hypertension and another 3.5% have prehypertension. It is likely that these children have—or will develop—blood pressure levels that require therapy and that they will become hypertensive young adults, said Dr. Falkner.

Additional clinical research involving adolescents is needed to define the disease pathway and to improve detection and treatment methods, she said. But for now, she recommended that blood pressure be measured as part of routine health care beginning at age 3 years, and in those younger than 3 years with chronic disease or unexplained symptoms, and that an appropriate evaluation be conducted in those with detected and verified hypertension.

NEW YORK — Patient-centered management and early, aggressive treatment of hypertension is necessary in patients with diabetes to address the sevenfold mortality increase in this patient population, according to an updated guidance from the American Society of Hypertension.

Physicians need to take a more integrated, individualized approach to treating hypertension in patients with diabetes by “treating the intricacies of each patient profile, rather than focusing on the disease in isolation,” according to a statement by ASH.

The new recommendations were addressed in a press briefing and published in a position paper in the Journal of Clinical Hypertension (2008;10:707).

The guidance does not alter the fundamental treatment of blood pressure goals for this patient population, but it does emphasize that early detection of risk factors unique to each patient is needed and that earlier, more-aggressive treatment should be implemented, including the identification and reduction of proteinuria.

Once high blood pressure is identified, initiation of ACE inhibitors or angiotensin receptor blocker therapy along with either thiazide-like diuretics or calcium antagonists is needed to maintain a target blood pressure of 130/80 mm Hg. More frequent patient follow-up also is needed, according to the guidance.

Previous studies show that, compared with conventional treatment, aggressive blood pressure control is associated with far fewer cardiovascular events in diabetic patients, Dr. George Bakris, professor of medicine at the University of Chicago, said during the briefing. Yet physicians are not being as aggressive as necessary to get blood pressure under control. Physicians also need to empower patients to take control, and they need to focus on the goal of reducing morbidity.

Physicians need to emphasize that the need for treatment is not transient but is lifelong. That said, obese patients who lose weight can successfully reduce their antihypertensive pill burden, he noted.

“These patients require an integrated therapeutic intervention that, in addition to blood pressure control, should include glycemic and lipid control and antiplatelet therapy,” Dr. Bakris noted in an ASH statement. It is imperative that all risk factors be attacked simultaneously to manage the profile of each patient more vigilantly, he added.

The challenges of identifying and treating hypertension are not limited to adults.

Nearly a third of obese teens also have high blood pressure, Dr. Bonita Falkner, a nephrologist at Thomas Jefferson University, Philadelphia, said during the briefing.

Overall, about 3.5% of children have hypertension and another 3.5% have prehypertension. It is likely that these children have—or will develop—blood pressure levels that require therapy and that they will become hypertensive young adults, said Dr. Falkner.

Additional clinical research involving adolescents is needed to define the disease pathway and to improve detection and treatment methods, she said. But for now, she recommended that blood pressure be measured as part of routine health care beginning at age 3 years, and in those younger than 3 years with chronic disease or unexplained symptoms, and that an appropriate evaluation be conducted in those with detected and verified hypertension.

NEW YORK — Patient-centered management and early, aggressive treatment of hypertension is necessary in patients with diabetes to address the sevenfold mortality increase in this patient population, according to an updated guidance from the American Society of Hypertension.

Physicians need to take a more integrated, individualized approach to treating hypertension in patients with diabetes by “treating the intricacies of each patient profile, rather than focusing on the disease in isolation,” according to a statement by ASH.

The new recommendations were addressed in a press briefing and published in a position paper in the Journal of Clinical Hypertension (2008;10:707).

The guidance does not alter the fundamental treatment of blood pressure goals for this patient population, but it does emphasize that early detection of risk factors unique to each patient is needed and that earlier, more-aggressive treatment should be implemented, including the identification and reduction of proteinuria.

Once high blood pressure is identified, initiation of ACE inhibitors or angiotensin receptor blocker therapy along with either thiazide-like diuretics or calcium antagonists is needed to maintain a target blood pressure of 130/80 mm Hg. More frequent patient follow-up also is needed, according to the guidance.

Previous studies show that, compared with conventional treatment, aggressive blood pressure control is associated with far fewer cardiovascular events in diabetic patients, Dr. George Bakris, professor of medicine at the University of Chicago, said during the briefing. Yet physicians are not being as aggressive as necessary to get blood pressure under control. Physicians also need to empower patients to take control, and they need to focus on the goal of reducing morbidity.

Physicians need to emphasize that the need for treatment is not transient but is lifelong. That said, obese patients who lose weight can successfully reduce their antihypertensive pill burden, he noted.

“These patients require an integrated therapeutic intervention that, in addition to blood pressure control, should include glycemic and lipid control and antiplatelet therapy,” Dr. Bakris noted in an ASH statement. It is imperative that all risk factors be attacked simultaneously to manage the profile of each patient more vigilantly, he added.

The challenges of identifying and treating hypertension are not limited to adults.

Nearly a third of obese teens also have high blood pressure, Dr. Bonita Falkner, a nephrologist at Thomas Jefferson University, Philadelphia, said during the briefing.

Overall, about 3.5% of children have hypertension and another 3.5% have prehypertension. It is likely that these children have—or will develop—blood pressure levels that require therapy and that they will become hypertensive young adults, said Dr. Falkner.

Additional clinical research involving adolescents is needed to define the disease pathway and to improve detection and treatment methods, she said. But for now, she recommended that blood pressure be measured as part of routine health care beginning at age 3 years, and in those younger than 3 years with chronic disease or unexplained symptoms, and that an appropriate evaluation be conducted in those with detected and verified hypertension.

Free drug samples not only do little to equalize medication access in the pediatric population, but they also may pose safety concerns in young patients, results of a recent study show.

The practice of providing free drug samples to children in nonurgent situations should be carefully reconsidered—and perhaps abandoned, the investigators concluded (Pediatrics 2008;122;736–42).

Study author Dr. Sarah L. Cutrona of Harvard Medical School, Boston, and her colleagues said the findings, which were based on nationally representative longitudinal survey data from 10,295 United States residents under age 18 years from the Agency for Healthcare Research and Quality 2004 Medical Expenditure Panel Survey, show that free drug samples tend to go to children with the best access to health care, not to those with the greatest financial need.

About 5% of the children in the survey received at least one free drug sample in 2004, and 10% of the children who received a prescription medication received a free drug sample that year.

On multivariate analyses, routine health care access, defined for the study as three or more provider visits in 2004, was found to be associated with the receipt of free samples, but insurance status and family income was not found to play a role in determining which children received samples.

That is, poor children, defined as those from families with incomes less than 200% of the federal poverty level, were no more likely to receive free samples than were those from families with incomes of 400% of the poverty level or greater (3.8% vs. 5.9%; odds ratio, 0.78), and those who were uninsured for part or all of the year were no more likely to receive samples than were those who were insured for the entire year, (4.5% vs. 5.1%; OR, 1.05).

In addition, Hispanic and nonwhite children were much less likely to receive free samples, compared with non-Hispanic white children (2.4% and 3.5%, respectively, vs. 6.2%; OR, 0.51 and 0.72, respectively).

Factors indicative of health care access also were associated with free sample receipt. For example, among those who received more free samples were those who had more visits to medical or dental providers (OR, 1.77 for two vs. one visit; OR, 3.25 for three or more vs. one visit), those who used office-based primary care vs. those with no usual site of care (OR, 1.52), and those who received more medications in 2004 were more likely to receive free samples (OR, 1.06 for incremental increase of one drug).

The high prevalence of drug sample use among pediatric patients also is of concern because the 15 most frequently distributed sample drugs in 2004 included two schedule II controlled medications (Strattera and Adderall). In addition, these two drugs, along with two others (Elidel and Advair) required a new or revised black box warning between 2004 and 2007. Elidel, for example, added a warning against use of the drug in children under age 2 years, yet the survey data indicate that nearly 38,200 children under age 2 years received free samples of this medication.

Although the findings suggest that doctors make a sincere effort to provide free samples to needy children who arrive in the office, system-wide barriers to health care access appear to prevent the most disadvantaged children from benefiting from these efforts, Dr Cutrona and her associates said.

For example, the findings—like those from a recently published national physician survey—indicate that physicians who practice in hospital or clinic settings, and who thus treat greater proportions of poor and uninsured patients, are much less likely than those in group or solo practices to receive free samples to provide to patients.

“If, as our study indicates, free samples fail to improve equality of medication access on a national scale, then their continued presence in family medicine and pediatric practices across the country may be difficult to justify,” Dr. Cutrona and her associates commented.

The study—the first to look at free drug sample practices in the pediatric population—is an interesting and helpful study that draws attention to the widespread practice, Dr. David Fassler, clinical professor of psychiatry at the University of Vermont, Burlington, said in an interview.

“The authors raise legitimate questions about the potential safety of current practices with respect to free samples. In particular, they report that controlled substances and treatments not generally considered “first line” were included in the list of medications most commonly distributed as free samples.

“Of particular concern, they also note that a significant number of very young children (under 2 years of age) received samples of medications which are specifically contraindicated for this age group,” Dr. Fassler said.

However, based on the methodology employed, the study raises more questions than it answers, he said.

“For example, did the kids actually take the medication received as a free sample?

“Did the families subsequently receive a prescription for ongoing treatment?

“Does the availability of free samples influence a physician's overall prescription pattern?

“The authors have opened an interesting avenue of inquiry. I expect these and other questions will be addressed in subsequent studies,” he added.

The authors stated they had no financial relationships relevant to this study.

Dr. Fassler said he had no conflicts of interest with respect to this issue.

'Does the availability of free samples influence a physician's overall prescription pattern?' DR. FASSLER

Free drug samples not only do little to equalize medication access in the pediatric population, but they also may pose safety concerns in young patients, results of a recent study show.

The practice of providing free drug samples to children in nonurgent situations should be carefully reconsidered—and perhaps abandoned, the investigators concluded (Pediatrics 2008;122;736–42).

Study author Dr. Sarah L. Cutrona of Harvard Medical School, Boston, and her colleagues said the findings, which were based on nationally representative longitudinal survey data from 10,295 United States residents under age 18 years from the Agency for Healthcare Research and Quality 2004 Medical Expenditure Panel Survey, show that free drug samples tend to go to children with the best access to health care, not to those with the greatest financial need.

About 5% of the children in the survey received at least one free drug sample in 2004, and 10% of the children who received a prescription medication received a free drug sample that year.

On multivariate analyses, routine health care access, defined for the study as three or more provider visits in 2004, was found to be associated with the receipt of free samples, but insurance status and family income was not found to play a role in determining which children received samples.

That is, poor children, defined as those from families with incomes less than 200% of the federal poverty level, were no more likely to receive free samples than were those from families with incomes of 400% of the poverty level or greater (3.8% vs. 5.9%; odds ratio, 0.78), and those who were uninsured for part or all of the year were no more likely to receive samples than were those who were insured for the entire year, (4.5% vs. 5.1%; OR, 1.05).

In addition, Hispanic and nonwhite children were much less likely to receive free samples, compared with non-Hispanic white children (2.4% and 3.5%, respectively, vs. 6.2%; OR, 0.51 and 0.72, respectively).

Factors indicative of health care access also were associated with free sample receipt. For example, among those who received more free samples were those who had more visits to medical or dental providers (OR, 1.77 for two vs. one visit; OR, 3.25 for three or more vs. one visit), those who used office-based primary care vs. those with no usual site of care (OR, 1.52), and those who received more medications in 2004 were more likely to receive free samples (OR, 1.06 for incremental increase of one drug).

The high prevalence of drug sample use among pediatric patients also is of concern because the 15 most frequently distributed sample drugs in 2004 included two schedule II controlled medications (Strattera and Adderall). In addition, these two drugs, along with two others (Elidel and Advair) required a new or revised black box warning between 2004 and 2007. Elidel, for example, added a warning against use of the drug in children under age 2 years, yet the survey data indicate that nearly 38,200 children under age 2 years received free samples of this medication.

Although the findings suggest that doctors make a sincere effort to provide free samples to needy children who arrive in the office, system-wide barriers to health care access appear to prevent the most disadvantaged children from benefiting from these efforts, Dr Cutrona and her associates said.

For example, the findings—like those from a recently published national physician survey—indicate that physicians who practice in hospital or clinic settings, and who thus treat greater proportions of poor and uninsured patients, are much less likely than those in group or solo practices to receive free samples to provide to patients.

“If, as our study indicates, free samples fail to improve equality of medication access on a national scale, then their continued presence in family medicine and pediatric practices across the country may be difficult to justify,” Dr. Cutrona and her associates commented.

The study—the first to look at free drug sample practices in the pediatric population—is an interesting and helpful study that draws attention to the widespread practice, Dr. David Fassler, clinical professor of psychiatry at the University of Vermont, Burlington, said in an interview.

“The authors raise legitimate questions about the potential safety of current practices with respect to free samples. In particular, they report that controlled substances and treatments not generally considered “first line” were included in the list of medications most commonly distributed as free samples.

“Of particular concern, they also note that a significant number of very young children (under 2 years of age) received samples of medications which are specifically contraindicated for this age group,” Dr. Fassler said.

However, based on the methodology employed, the study raises more questions than it answers, he said.

“For example, did the kids actually take the medication received as a free sample?

“Did the families subsequently receive a prescription for ongoing treatment?

“Does the availability of free samples influence a physician's overall prescription pattern?

“The authors have opened an interesting avenue of inquiry. I expect these and other questions will be addressed in subsequent studies,” he added.

The authors stated they had no financial relationships relevant to this study.

Dr. Fassler said he had no conflicts of interest with respect to this issue.

'Does the availability of free samples influence a physician's overall prescription pattern?' DR. FASSLER

Free drug samples not only do little to equalize medication access in the pediatric population, but they also may pose safety concerns in young patients, results of a recent study show.

The practice of providing free drug samples to children in nonurgent situations should be carefully reconsidered—and perhaps abandoned, the investigators concluded (Pediatrics 2008;122;736–42).

Study author Dr. Sarah L. Cutrona of Harvard Medical School, Boston, and her colleagues said the findings, which were based on nationally representative longitudinal survey data from 10,295 United States residents under age 18 years from the Agency for Healthcare Research and Quality 2004 Medical Expenditure Panel Survey, show that free drug samples tend to go to children with the best access to health care, not to those with the greatest financial need.

About 5% of the children in the survey received at least one free drug sample in 2004, and 10% of the children who received a prescription medication received a free drug sample that year.

On multivariate analyses, routine health care access, defined for the study as three or more provider visits in 2004, was found to be associated with the receipt of free samples, but insurance status and family income was not found to play a role in determining which children received samples.

That is, poor children, defined as those from families with incomes less than 200% of the federal poverty level, were no more likely to receive free samples than were those from families with incomes of 400% of the poverty level or greater (3.8% vs. 5.9%; odds ratio, 0.78), and those who were uninsured for part or all of the year were no more likely to receive samples than were those who were insured for the entire year, (4.5% vs. 5.1%; OR, 1.05).

In addition, Hispanic and nonwhite children were much less likely to receive free samples, compared with non-Hispanic white children (2.4% and 3.5%, respectively, vs. 6.2%; OR, 0.51 and 0.72, respectively).

Factors indicative of health care access also were associated with free sample receipt. For example, among those who received more free samples were those who had more visits to medical or dental providers (OR, 1.77 for two vs. one visit; OR, 3.25 for three or more vs. one visit), those who used office-based primary care vs. those with no usual site of care (OR, 1.52), and those who received more medications in 2004 were more likely to receive free samples (OR, 1.06 for incremental increase of one drug).

The high prevalence of drug sample use among pediatric patients also is of concern because the 15 most frequently distributed sample drugs in 2004 included two schedule II controlled medications (Strattera and Adderall). In addition, these two drugs, along with two others (Elidel and Advair) required a new or revised black box warning between 2004 and 2007. Elidel, for example, added a warning against use of the drug in children under age 2 years, yet the survey data indicate that nearly 38,200 children under age 2 years received free samples of this medication.

Although the findings suggest that doctors make a sincere effort to provide free samples to needy children who arrive in the office, system-wide barriers to health care access appear to prevent the most disadvantaged children from benefiting from these efforts, Dr Cutrona and her associates said.

For example, the findings—like those from a recently published national physician survey—indicate that physicians who practice in hospital or clinic settings, and who thus treat greater proportions of poor and uninsured patients, are much less likely than those in group or solo practices to receive free samples to provide to patients.

“If, as our study indicates, free samples fail to improve equality of medication access on a national scale, then their continued presence in family medicine and pediatric practices across the country may be difficult to justify,” Dr. Cutrona and her associates commented.

The study—the first to look at free drug sample practices in the pediatric population—is an interesting and helpful study that draws attention to the widespread practice, Dr. David Fassler, clinical professor of psychiatry at the University of Vermont, Burlington, said in an interview.

“The authors raise legitimate questions about the potential safety of current practices with respect to free samples. In particular, they report that controlled substances and treatments not generally considered “first line” were included in the list of medications most commonly distributed as free samples.

“Of particular concern, they also note that a significant number of very young children (under 2 years of age) received samples of medications which are specifically contraindicated for this age group,” Dr. Fassler said.

However, based on the methodology employed, the study raises more questions than it answers, he said.

“For example, did the kids actually take the medication received as a free sample?

“Did the families subsequently receive a prescription for ongoing treatment?

“Does the availability of free samples influence a physician's overall prescription pattern?

“The authors have opened an interesting avenue of inquiry. I expect these and other questions will be addressed in subsequent studies,” he added.

The authors stated they had no financial relationships relevant to this study.

Dr. Fassler said he had no conflicts of interest with respect to this issue.

'Does the availability of free samples influence a physician's overall prescription pattern?' DR. FASSLER

ATLANTA — Postlicensure safety monitoring by three national vaccine safety systems indicates that, in the more than 2 years since the human papillomavirus vaccine Gardasil was licensed, serious adverse events have been rare and have not been specifically linked with the product.

More than 20 million doses of Gardasil, manufactured by Merck & Co., had been distributed and are under passive surveillance, and more than 375,000 doses are under active surveillance as of Aug. 31, the Centers for Disease Control and Prevention officials reported at the fall meeting of the CDC's Advisory Committee on Immunization Practices.

Of the more than 10,300 adverse events reported thus far to the Vaccine Adverse Event Reporting System (VAERS), 94% have been nonserious. Most of the adverse event reports to VAERS were consistent with prelicensure trial data. Among the adverse events reported are syncope, dizziness, nausea, Guillain Barré syndrome, venous thromboembolism, and death, said Dr. Angela Calugar of the CDC.

About 51 reports, 3 of which were serious, have been made per 100,000 doses given. About half of all reports are in those aged 11–18 years, and 25% are in those aged 19–26 years, Dr. Calugar said, noting that this likely reflects the proportion of patients in these age groups who are receiving HPV vaccine.

Serious adverse events—including syncope, venous thromboembolism (VTE), and Guillain Barré syndrome—occurred mostly in individuals with other contributing factors. For example, of 18 reports of VTE, 14 were in patients who also used hormonal contraceptives, which are known to increase VTE risk, she noted.

As for the 17 deaths reported in association with HPV vaccination, no clusters based on patient age, timing of vaccination, or other factors were identified that might hint at a causal relationship, she said.

Furthermore, the Clinical Immunization Safety Assessment (CISA) Network—a collaboration of six U.S. academic centers that conduct research on adverse events associated with immunizations—has found insufficient evidence to support a causal relationship between HPV vaccination and the reported serious adverse events, reported Dr. Barbara Slade, also of the CDC.

Likewise, findings of the Vaccine Safety Datalink project—which was established in 1990 to improve the evaluation of vaccine safety through active surveillance and epidemiologic studies—showed that among more than 375,000 doses administered and monitored, no statistically significant risk for any prespecified adverse event (Guillain Barré syndrome, seizures, syncope, anaphylaxis, other allergic reactions, appendicitis, stroke, and VTE) occurred after vaccination in either youth (ages 9–18 years) or adults (ages 19–26 years), Julianne Gee of the CDC reported.

ATLANTA — Postlicensure safety monitoring by three national vaccine safety systems indicates that, in the more than 2 years since the human papillomavirus vaccine Gardasil was licensed, serious adverse events have been rare and have not been specifically linked with the product.

More than 20 million doses of Gardasil, manufactured by Merck & Co., had been distributed and are under passive surveillance, and more than 375,000 doses are under active surveillance as of Aug. 31, the Centers for Disease Control and Prevention officials reported at the fall meeting of the CDC's Advisory Committee on Immunization Practices.

Of the more than 10,300 adverse events reported thus far to the Vaccine Adverse Event Reporting System (VAERS), 94% have been nonserious. Most of the adverse event reports to VAERS were consistent with prelicensure trial data. Among the adverse events reported are syncope, dizziness, nausea, Guillain Barré syndrome, venous thromboembolism, and death, said Dr. Angela Calugar of the CDC.

About 51 reports, 3 of which were serious, have been made per 100,000 doses given. About half of all reports are in those aged 11–18 years, and 25% are in those aged 19–26 years, Dr. Calugar said, noting that this likely reflects the proportion of patients in these age groups who are receiving HPV vaccine.

Serious adverse events—including syncope, venous thromboembolism (VTE), and Guillain Barré syndrome—occurred mostly in individuals with other contributing factors. For example, of 18 reports of VTE, 14 were in patients who also used hormonal contraceptives, which are known to increase VTE risk, she noted.

As for the 17 deaths reported in association with HPV vaccination, no clusters based on patient age, timing of vaccination, or other factors were identified that might hint at a causal relationship, she said.

Furthermore, the Clinical Immunization Safety Assessment (CISA) Network—a collaboration of six U.S. academic centers that conduct research on adverse events associated with immunizations—has found insufficient evidence to support a causal relationship between HPV vaccination and the reported serious adverse events, reported Dr. Barbara Slade, also of the CDC.

Likewise, findings of the Vaccine Safety Datalink project—which was established in 1990 to improve the evaluation of vaccine safety through active surveillance and epidemiologic studies—showed that among more than 375,000 doses administered and monitored, no statistically significant risk for any prespecified adverse event (Guillain Barré syndrome, seizures, syncope, anaphylaxis, other allergic reactions, appendicitis, stroke, and VTE) occurred after vaccination in either youth (ages 9–18 years) or adults (ages 19–26 years), Julianne Gee of the CDC reported.

ATLANTA — Postlicensure safety monitoring by three national vaccine safety systems indicates that, in the more than 2 years since the human papillomavirus vaccine Gardasil was licensed, serious adverse events have been rare and have not been specifically linked with the product.

More than 20 million doses of Gardasil, manufactured by Merck & Co., had been distributed and are under passive surveillance, and more than 375,000 doses are under active surveillance as of Aug. 31, the Centers for Disease Control and Prevention officials reported at the fall meeting of the CDC's Advisory Committee on Immunization Practices.

Of the more than 10,300 adverse events reported thus far to the Vaccine Adverse Event Reporting System (VAERS), 94% have been nonserious. Most of the adverse event reports to VAERS were consistent with prelicensure trial data. Among the adverse events reported are syncope, dizziness, nausea, Guillain Barré syndrome, venous thromboembolism, and death, said Dr. Angela Calugar of the CDC.

About 51 reports, 3 of which were serious, have been made per 100,000 doses given. About half of all reports are in those aged 11–18 years, and 25% are in those aged 19–26 years, Dr. Calugar said, noting that this likely reflects the proportion of patients in these age groups who are receiving HPV vaccine.

Serious adverse events—including syncope, venous thromboembolism (VTE), and Guillain Barré syndrome—occurred mostly in individuals with other contributing factors. For example, of 18 reports of VTE, 14 were in patients who also used hormonal contraceptives, which are known to increase VTE risk, she noted.

As for the 17 deaths reported in association with HPV vaccination, no clusters based on patient age, timing of vaccination, or other factors were identified that might hint at a causal relationship, she said.

Furthermore, the Clinical Immunization Safety Assessment (CISA) Network—a collaboration of six U.S. academic centers that conduct research on adverse events associated with immunizations—has found insufficient evidence to support a causal relationship between HPV vaccination and the reported serious adverse events, reported Dr. Barbara Slade, also of the CDC.

Likewise, findings of the Vaccine Safety Datalink project—which was established in 1990 to improve the evaluation of vaccine safety through active surveillance and epidemiologic studies—showed that among more than 375,000 doses administered and monitored, no statistically significant risk for any prespecified adverse event (Guillain Barré syndrome, seizures, syncope, anaphylaxis, other allergic reactions, appendicitis, stroke, and VTE) occurred after vaccination in either youth (ages 9–18 years) or adults (ages 19–26 years), Julianne Gee of the CDC reported.

ATLANTA — Vaccination with 23-valent pneumococcal polysaccharide vaccine should be given 5 years after vaccination with 7-valent pneumococcal conjugate vaccine in high-risk children, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices agreed at its fall meeting.

The purpose of the vote was to clarify existing recommendations, which called for an interval of 3–5 years between vaccinations in this population, despite a lack of data on revaccination safety and the best timing for revaccination, according to Dr. Pekka Nuorti of the CDC, who presented the recommendation on behalf of the Pneumococcal Vaccines Workgroup.

“The [3- to 5-year interval] recommendation causes confusion among providers as to which time period is recommended,” he said, noting that the suggestion that a 3-year interval might be warranted in some children was based on data from studies conducted several years ago that indicated some children had rapid declines in antibodies following initial vaccination.

However, those studies predated the availability of more sensitive and specific assays, he said.

The one-time, 5-year revaccination interval approved by the ACIP applies to those aged 2 years and older who are immunocompromised, have sickle cell disease, or have functional or anatomic asplenia.

These individuals are at highest risk for serious pneumococcal infection and may have a rapid decline in pneumococcal antibody levels after initial vaccination.

The 23-valent pneumococcal polysaccharide vaccine (PPV23) has been shown to provide excellent booster response in healthy children to the seven serotypes found in both the 7-valent pneumococcal conjugate vaccine (PCV7) and in PPV23. The intent of revaccination with PPV23 in high-risk children is to target the 16 serotypes included in PPV23 to better protect those who were previously vaccinated with PCV7.

The work group based its recommendation in part on the possibility that immunologic responses to PPV23 are improved in older children and also on the possibility that a longer interval between doses may reduce immunologic hyperresponsiveness, said Dr. Nuorti.

In other PPV23-related business, the committee also addressed revaccination in American Indians and Alaska Natives, who may have high rates of invasive pneumococcal disease. Vaccination is routine in those aged 24–59 months with medical conditions that are PPV23 indications, and existing language allows for revaccination in those who were previously vaccinated with PCV7, but the burden of the decision to revaccinate was put on individual practitioners who rarely employed this approach.

The new wording, upon CDC approval of the committee's recommendation, will advise against routine use of PPV23 in those aged 24–59 months who were previously vaccinated with PCV7, because the current consensus is that anticipated benefits of revaccination do not outweigh potential risks. The change however, will, allow for consideration of revaccination in special situations—namely in areas in which public health authorities deem the risk for invasive pneumococcal disease is increased.

ATLANTA — Vaccination with 23-valent pneumococcal polysaccharide vaccine should be given 5 years after vaccination with 7-valent pneumococcal conjugate vaccine in high-risk children, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices agreed at its fall meeting.

The purpose of the vote was to clarify existing recommendations, which called for an interval of 3–5 years between vaccinations in this population, despite a lack of data on revaccination safety and the best timing for revaccination, according to Dr. Pekka Nuorti of the CDC, who presented the recommendation on behalf of the Pneumococcal Vaccines Workgroup.

“The [3- to 5-year interval] recommendation causes confusion among providers as to which time period is recommended,” he said, noting that the suggestion that a 3-year interval might be warranted in some children was based on data from studies conducted several years ago that indicated some children had rapid declines in antibodies following initial vaccination.

However, those studies predated the availability of more sensitive and specific assays, he said.

The one-time, 5-year revaccination interval approved by the ACIP applies to those aged 2 years and older who are immunocompromised, have sickle cell disease, or have functional or anatomic asplenia.

These individuals are at highest risk for serious pneumococcal infection and may have a rapid decline in pneumococcal antibody levels after initial vaccination.

The 23-valent pneumococcal polysaccharide vaccine (PPV23) has been shown to provide excellent booster response in healthy children to the seven serotypes found in both the 7-valent pneumococcal conjugate vaccine (PCV7) and in PPV23. The intent of revaccination with PPV23 in high-risk children is to target the 16 serotypes included in PPV23 to better protect those who were previously vaccinated with PCV7.

The work group based its recommendation in part on the possibility that immunologic responses to PPV23 are improved in older children and also on the possibility that a longer interval between doses may reduce immunologic hyperresponsiveness, said Dr. Nuorti.

In other PPV23-related business, the committee also addressed revaccination in American Indians and Alaska Natives, who may have high rates of invasive pneumococcal disease. Vaccination is routine in those aged 24–59 months with medical conditions that are PPV23 indications, and existing language allows for revaccination in those who were previously vaccinated with PCV7, but the burden of the decision to revaccinate was put on individual practitioners who rarely employed this approach.

The new wording, upon CDC approval of the committee's recommendation, will advise against routine use of PPV23 in those aged 24–59 months who were previously vaccinated with PCV7, because the current consensus is that anticipated benefits of revaccination do not outweigh potential risks. The change however, will, allow for consideration of revaccination in special situations—namely in areas in which public health authorities deem the risk for invasive pneumococcal disease is increased.

ATLANTA — Vaccination with 23-valent pneumococcal polysaccharide vaccine should be given 5 years after vaccination with 7-valent pneumococcal conjugate vaccine in high-risk children, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices agreed at its fall meeting.

The purpose of the vote was to clarify existing recommendations, which called for an interval of 3–5 years between vaccinations in this population, despite a lack of data on revaccination safety and the best timing for revaccination, according to Dr. Pekka Nuorti of the CDC, who presented the recommendation on behalf of the Pneumococcal Vaccines Workgroup.

“The [3- to 5-year interval] recommendation causes confusion among providers as to which time period is recommended,” he said, noting that the suggestion that a 3-year interval might be warranted in some children was based on data from studies conducted several years ago that indicated some children had rapid declines in antibodies following initial vaccination.

However, those studies predated the availability of more sensitive and specific assays, he said.

The one-time, 5-year revaccination interval approved by the ACIP applies to those aged 2 years and older who are immunocompromised, have sickle cell disease, or have functional or anatomic asplenia.

These individuals are at highest risk for serious pneumococcal infection and may have a rapid decline in pneumococcal antibody levels after initial vaccination.

The 23-valent pneumococcal polysaccharide vaccine (PPV23) has been shown to provide excellent booster response in healthy children to the seven serotypes found in both the 7-valent pneumococcal conjugate vaccine (PCV7) and in PPV23. The intent of revaccination with PPV23 in high-risk children is to target the 16 serotypes included in PPV23 to better protect those who were previously vaccinated with PCV7.

The work group based its recommendation in part on the possibility that immunologic responses to PPV23 are improved in older children and also on the possibility that a longer interval between doses may reduce immunologic hyperresponsiveness, said Dr. Nuorti.

In other PPV23-related business, the committee also addressed revaccination in American Indians and Alaska Natives, who may have high rates of invasive pneumococcal disease. Vaccination is routine in those aged 24–59 months with medical conditions that are PPV23 indications, and existing language allows for revaccination in those who were previously vaccinated with PCV7, but the burden of the decision to revaccinate was put on individual practitioners who rarely employed this approach.

The new wording, upon CDC approval of the committee's recommendation, will advise against routine use of PPV23 in those aged 24–59 months who were previously vaccinated with PCV7, because the current consensus is that anticipated benefits of revaccination do not outweigh potential risks. The change however, will, allow for consideration of revaccination in special situations—namely in areas in which public health authorities deem the risk for invasive pneumococcal disease is increased.

ATLANTA — Influenza vaccination rates remain low among children aged 6–23 months, despite a recommendation made 3 years ago by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices that children younger than age 2 years be vaccinated.

At the committee's fall meeting, Dr. Anthony Fiore reported that the latest data show complete coverage of only about 21% in the under-2 age group.

“We still have a long way to go,” said Dr. Fiore of the CDC.

The findings, which are from the 2007 National Immunization Survey and which are based on the 2006–2007 influenza season, were published recently in Morbidity and Mortality Weekly Report.

Data emerging from the 2007–2008 season appear similar to those from 2006–2007, Dr. Fiore noted.

Because children younger than age 2 years are at the greatest risk for influenza-related hospitalizations, ACIP in 2002 encouraged vaccination of this population, and in 2004 strengthened that stand by recommending vaccination.

According to the MMWR report, 32% of children aged 6–23 months received one or more doses of vaccine during the 2006–2007 flu season, and only 21% were fully vaccinated.

Two doses given 4 weeks apart are recommended in children younger than age 9 years who are being vaccinated for the first time (MMWR 2008;57:1039–43).

Of note, there was substantial variability in vaccination coverage among states, according to the survey results.

For example, only about 9% of children were fully vaccinated in Mississippi, and nearly 48% were vaccinated in Rhode Island.

In most states, there was no significant increase in the percentage of children who were fully vaccinated, compared with the previous flu season.

“The findings underscore the need to increase interest in and access to influenza vaccination for more children in the United States.

Further study is needed to identify knowledge deficits or logistical barriers that might contribute to continued low influenza vaccination coverage among young children,” the article states.

Additionally, in an editorial note, the authors state that health care providers can help improve vaccination coverage among young children by routinely informing parents about “the substantial burden of influenza illness among young children and about the benefits and safety of preventing influenza with vaccination.”

Proven strategies for reducing missed opportunities for vaccination also include having standing orders to offer vaccine to all patients throughout the flu season, holding vaccination-only clinics, and using reminder/recall systems, they noted.

ATLANTA — Influenza vaccination rates remain low among children aged 6–23 months, despite a recommendation made 3 years ago by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices that children younger than age 2 years be vaccinated.

At the committee's fall meeting, Dr. Anthony Fiore reported that the latest data show complete coverage of only about 21% in the under-2 age group.

“We still have a long way to go,” said Dr. Fiore of the CDC.

The findings, which are from the 2007 National Immunization Survey and which are based on the 2006–2007 influenza season, were published recently in Morbidity and Mortality Weekly Report.

Data emerging from the 2007–2008 season appear similar to those from 2006–2007, Dr. Fiore noted.

Because children younger than age 2 years are at the greatest risk for influenza-related hospitalizations, ACIP in 2002 encouraged vaccination of this population, and in 2004 strengthened that stand by recommending vaccination.

According to the MMWR report, 32% of children aged 6–23 months received one or more doses of vaccine during the 2006–2007 flu season, and only 21% were fully vaccinated.

Two doses given 4 weeks apart are recommended in children younger than age 9 years who are being vaccinated for the first time (MMWR 2008;57:1039–43).

Of note, there was substantial variability in vaccination coverage among states, according to the survey results.

For example, only about 9% of children were fully vaccinated in Mississippi, and nearly 48% were vaccinated in Rhode Island.

In most states, there was no significant increase in the percentage of children who were fully vaccinated, compared with the previous flu season.

“The findings underscore the need to increase interest in and access to influenza vaccination for more children in the United States.

Further study is needed to identify knowledge deficits or logistical barriers that might contribute to continued low influenza vaccination coverage among young children,” the article states.

Additionally, in an editorial note, the authors state that health care providers can help improve vaccination coverage among young children by routinely informing parents about “the substantial burden of influenza illness among young children and about the benefits and safety of preventing influenza with vaccination.”

Proven strategies for reducing missed opportunities for vaccination also include having standing orders to offer vaccine to all patients throughout the flu season, holding vaccination-only clinics, and using reminder/recall systems, they noted.

ATLANTA — Influenza vaccination rates remain low among children aged 6–23 months, despite a recommendation made 3 years ago by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices that children younger than age 2 years be vaccinated.

At the committee's fall meeting, Dr. Anthony Fiore reported that the latest data show complete coverage of only about 21% in the under-2 age group.

“We still have a long way to go,” said Dr. Fiore of the CDC.

The findings, which are from the 2007 National Immunization Survey and which are based on the 2006–2007 influenza season, were published recently in Morbidity and Mortality Weekly Report.

Data emerging from the 2007–2008 season appear similar to those from 2006–2007, Dr. Fiore noted.

Because children younger than age 2 years are at the greatest risk for influenza-related hospitalizations, ACIP in 2002 encouraged vaccination of this population, and in 2004 strengthened that stand by recommending vaccination.

According to the MMWR report, 32% of children aged 6–23 months received one or more doses of vaccine during the 2006–2007 flu season, and only 21% were fully vaccinated.

Two doses given 4 weeks apart are recommended in children younger than age 9 years who are being vaccinated for the first time (MMWR 2008;57:1039–43).

Of note, there was substantial variability in vaccination coverage among states, according to the survey results.

For example, only about 9% of children were fully vaccinated in Mississippi, and nearly 48% were vaccinated in Rhode Island.

In most states, there was no significant increase in the percentage of children who were fully vaccinated, compared with the previous flu season.

“The findings underscore the need to increase interest in and access to influenza vaccination for more children in the United States.

Further study is needed to identify knowledge deficits or logistical barriers that might contribute to continued low influenza vaccination coverage among young children,” the article states.

Additionally, in an editorial note, the authors state that health care providers can help improve vaccination coverage among young children by routinely informing parents about “the substantial burden of influenza illness among young children and about the benefits and safety of preventing influenza with vaccination.”

Proven strategies for reducing missed opportunities for vaccination also include having standing orders to offer vaccine to all patients throughout the flu season, holding vaccination-only clinics, and using reminder/recall systems, they noted.

Rhinitis was a strong predictor of adult-onset asthma, according to findings from an 8-year population-based study in Europe.

In the European Community Respiratory Health Survey, data from 6,461 participants showed that allergic rhinitis was associated with an increased risk of adult-onset asthma (adjusted relative risk of 3.53), as was nonallergic rhinitis, although to a lesser degree (adjusted relative risk of 2.71), Dr. Rafea Shaaban of Bichat Teaching Hospital, Paris, and colleagues reported.

The subjects were aged 20–44 years without asthma at baseline. They were categorized into four groups: a control group including 3,163 subjects with no atopy and no rhinitis, an atopy-only group including 704 subjects with atopy but no rhinitis, a nonallergic rhinitis group including 1,377 subjects with rhinitis but no atopy, and an allergic rhinitis group including 1,217 subjects with atopy and rhinitis.

A total of 140 subjects developed asthma during the 8.8-year study period, for a cumulative incidence of 2.2%. The incidence in the groups was 1.1%, 1.9%, 3.1%, and 4.0%, respectively. The differences were statistically significant, but only allergic rhinitis in those identified by a skin-prick test as having dust mite sensitization was found to be associated with increased risk of asthma independently of other allergens (Lancet 2008;372:1049-57).

A possible explanation for the dust mite link, the investigators said, is that patients with allergic rhinitis in response to mites are likely to have nasal symptoms over a longer period of time, because mites are a perennial indoor allergen. That theory is consistent with the findings of at least one other study showing that early exposure to dust mite allergen is associated with an increased risk of childhood asthma.

Sensitization to allergens in addition to mites was associated with additional small increases in asthma risk. For example, in those sensitized to dust mites, sensitization to cats increased asthma risk from 4.6% to 6.4%, and sensitization to grass increased the risk to 7.6%. Sensitization to birch increased the risk to 9.1%.

Those increases did not reach statistical significance, but that may be because of the small number of patients with those sensitivities, the researchers suggested.

Although prior epidemiologic and clinical studies have shown a close relationship between asthma and allergic rhinitis, the nature of the link between the two has remained unclear. The current study, however, provides new evidence that rhinitis is predictive of asthma development, the investigators said, along with support of hypotheses suggesting that rhinitis might be a cause of asthma.

In addition, the current findings suggest that bronchial hyperresponsiveness (BHR) is “an intermediate factor in the process leading from allergic rhinitis to asthma,” the authors noted. Not only is allergic rhinitis shown in this and prior studies to be a risk factor for BHR in nonasthmatic adults, they said, but there is now substantial evidence that asymptomatic BHR frequently precedes—and can be considered a risk factor for—symptomatic asthma.

Because the association between asthma and allergic rhinitis in the current study decreased substantially after controlling for BHR, it is likely that part of the effect of allergic rhinitis on development of asthma is mediated through the development of BHR. “This observation is important, because BHR is thought to be a dynamic process, and can be decreased by anti-inflammatory therapy,” the researchers said.

Interventional studies to assess the effects of rhinitis treatment on reducing the incidence of asthma—an effect that has been observed in clinical trials—are necessary to verify this effect, they concluded.

In an accompanying editorial, Dr. Erika von Mutius of University Children's Hospital in Munich wrote, “the idea that allergic rhinitis could cause asthma raises the possibility of preventing asthma by preventing atopic sensitization, which could in turn prevent allergic rhinitis.”

The long-term preventive effect that immunotherapy might have is unknown, although it can improve nasal symptom scores, reduce airway responsiveness, and thus cut asthma burden in patients with allergic rhinitis (Lancet 2008;372:1012-4). But, “even if immunotreatments work, the fairly low population-attributable risk might diminish the overall effect of this therapeutic approach,” she warned.

Rhinitis was a strong predictor of adult-onset asthma, according to findings from an 8-year population-based study in Europe.

In the European Community Respiratory Health Survey, data from 6,461 participants showed that allergic rhinitis was associated with an increased risk of adult-onset asthma (adjusted relative risk of 3.53), as was nonallergic rhinitis, although to a lesser degree (adjusted relative risk of 2.71), Dr. Rafea Shaaban of Bichat Teaching Hospital, Paris, and colleagues reported.

The subjects were aged 20–44 years without asthma at baseline. They were categorized into four groups: a control group including 3,163 subjects with no atopy and no rhinitis, an atopy-only group including 704 subjects with atopy but no rhinitis, a nonallergic rhinitis group including 1,377 subjects with rhinitis but no atopy, and an allergic rhinitis group including 1,217 subjects with atopy and rhinitis.

A total of 140 subjects developed asthma during the 8.8-year study period, for a cumulative incidence of 2.2%. The incidence in the groups was 1.1%, 1.9%, 3.1%, and 4.0%, respectively. The differences were statistically significant, but only allergic rhinitis in those identified by a skin-prick test as having dust mite sensitization was found to be associated with increased risk of asthma independently of other allergens (Lancet 2008;372:1049-57).

A possible explanation for the dust mite link, the investigators said, is that patients with allergic rhinitis in response to mites are likely to have nasal symptoms over a longer period of time, because mites are a perennial indoor allergen. That theory is consistent with the findings of at least one other study showing that early exposure to dust mite allergen is associated with an increased risk of childhood asthma.

Sensitization to allergens in addition to mites was associated with additional small increases in asthma risk. For example, in those sensitized to dust mites, sensitization to cats increased asthma risk from 4.6% to 6.4%, and sensitization to grass increased the risk to 7.6%. Sensitization to birch increased the risk to 9.1%.

Those increases did not reach statistical significance, but that may be because of the small number of patients with those sensitivities, the researchers suggested.

Although prior epidemiologic and clinical studies have shown a close relationship between asthma and allergic rhinitis, the nature of the link between the two has remained unclear. The current study, however, provides new evidence that rhinitis is predictive of asthma development, the investigators said, along with support of hypotheses suggesting that rhinitis might be a cause of asthma.

In addition, the current findings suggest that bronchial hyperresponsiveness (BHR) is “an intermediate factor in the process leading from allergic rhinitis to asthma,” the authors noted. Not only is allergic rhinitis shown in this and prior studies to be a risk factor for BHR in nonasthmatic adults, they said, but there is now substantial evidence that asymptomatic BHR frequently precedes—and can be considered a risk factor for—symptomatic asthma.

Because the association between asthma and allergic rhinitis in the current study decreased substantially after controlling for BHR, it is likely that part of the effect of allergic rhinitis on development of asthma is mediated through the development of BHR. “This observation is important, because BHR is thought to be a dynamic process, and can be decreased by anti-inflammatory therapy,” the researchers said.

Interventional studies to assess the effects of rhinitis treatment on reducing the incidence of asthma—an effect that has been observed in clinical trials—are necessary to verify this effect, they concluded.

In an accompanying editorial, Dr. Erika von Mutius of University Children's Hospital in Munich wrote, “the idea that allergic rhinitis could cause asthma raises the possibility of preventing asthma by preventing atopic sensitization, which could in turn prevent allergic rhinitis.”

The long-term preventive effect that immunotherapy might have is unknown, although it can improve nasal symptom scores, reduce airway responsiveness, and thus cut asthma burden in patients with allergic rhinitis (Lancet 2008;372:1012-4). But, “even if immunotreatments work, the fairly low population-attributable risk might diminish the overall effect of this therapeutic approach,” she warned.

Rhinitis was a strong predictor of adult-onset asthma, according to findings from an 8-year population-based study in Europe.

In the European Community Respiratory Health Survey, data from 6,461 participants showed that allergic rhinitis was associated with an increased risk of adult-onset asthma (adjusted relative risk of 3.53), as was nonallergic rhinitis, although to a lesser degree (adjusted relative risk of 2.71), Dr. Rafea Shaaban of Bichat Teaching Hospital, Paris, and colleagues reported.

The subjects were aged 20–44 years without asthma at baseline. They were categorized into four groups: a control group including 3,163 subjects with no atopy and no rhinitis, an atopy-only group including 704 subjects with atopy but no rhinitis, a nonallergic rhinitis group including 1,377 subjects with rhinitis but no atopy, and an allergic rhinitis group including 1,217 subjects with atopy and rhinitis.

A total of 140 subjects developed asthma during the 8.8-year study period, for a cumulative incidence of 2.2%. The incidence in the groups was 1.1%, 1.9%, 3.1%, and 4.0%, respectively. The differences were statistically significant, but only allergic rhinitis in those identified by a skin-prick test as having dust mite sensitization was found to be associated with increased risk of asthma independently of other allergens (Lancet 2008;372:1049-57).

A possible explanation for the dust mite link, the investigators said, is that patients with allergic rhinitis in response to mites are likely to have nasal symptoms over a longer period of time, because mites are a perennial indoor allergen. That theory is consistent with the findings of at least one other study showing that early exposure to dust mite allergen is associated with an increased risk of childhood asthma.

Sensitization to allergens in addition to mites was associated with additional small increases in asthma risk. For example, in those sensitized to dust mites, sensitization to cats increased asthma risk from 4.6% to 6.4%, and sensitization to grass increased the risk to 7.6%. Sensitization to birch increased the risk to 9.1%.

Those increases did not reach statistical significance, but that may be because of the small number of patients with those sensitivities, the researchers suggested.

Although prior epidemiologic and clinical studies have shown a close relationship between asthma and allergic rhinitis, the nature of the link between the two has remained unclear. The current study, however, provides new evidence that rhinitis is predictive of asthma development, the investigators said, along with support of hypotheses suggesting that rhinitis might be a cause of asthma.

In addition, the current findings suggest that bronchial hyperresponsiveness (BHR) is “an intermediate factor in the process leading from allergic rhinitis to asthma,” the authors noted. Not only is allergic rhinitis shown in this and prior studies to be a risk factor for BHR in nonasthmatic adults, they said, but there is now substantial evidence that asymptomatic BHR frequently precedes—and can be considered a risk factor for—symptomatic asthma.

Because the association between asthma and allergic rhinitis in the current study decreased substantially after controlling for BHR, it is likely that part of the effect of allergic rhinitis on development of asthma is mediated through the development of BHR. “This observation is important, because BHR is thought to be a dynamic process, and can be decreased by anti-inflammatory therapy,” the researchers said.

Interventional studies to assess the effects of rhinitis treatment on reducing the incidence of asthma—an effect that has been observed in clinical trials—are necessary to verify this effect, they concluded.

In an accompanying editorial, Dr. Erika von Mutius of University Children's Hospital in Munich wrote, “the idea that allergic rhinitis could cause asthma raises the possibility of preventing asthma by preventing atopic sensitization, which could in turn prevent allergic rhinitis.”

The long-term preventive effect that immunotherapy might have is unknown, although it can improve nasal symptom scores, reduce airway responsiveness, and thus cut asthma burden in patients with allergic rhinitis (Lancet 2008;372:1012-4). But, “even if immunotreatments work, the fairly low population-attributable risk might diminish the overall effect of this therapeutic approach,” she warned.

Identifying and treating the potentially life-threatening problem of gastrointestinal complications in patients who use the combination of antiplatelet therapy and NSAIDs are the focus of a new scientific statement by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

Practical clinical guidance for reducing the risk of ulceration and related bleeding—including the use of gastroprotection, either with protein pump inhibitor therapy or treatment of Helicobacter pylori infection—was included in the consensus document.

Ulcerations and gastrointestinal bleeding are recognizable risks in individuals who use antiplatelet agents and NSAIDs, with these patients having up to a fourfold increased risk of such complications, compared with those who are not using the medications, according to Dr. Deepak L. Bhatt, document cochair, and his colleagues on the consensus document writing committee (J. Am. Coll. Cardiol. 2008 [doi:10.1016/j.jacc.2008.08.002]).

Considering that NSAIDs, including aspirin, are the most widely used class of medication in the United States, and that more Americans are surviving and living with heart disease in addition to conditions that require them to take NSAIDs (such as arthritis, inflammation, and related musculoskeletal pain), the management of GI risk will become an increasingly important part of cardiovascular care, according to an American College of Cardiology (ACC) statement on the consensus document.

“Doctors are uncertain about how best to prevent bleeding complications in patients receiving antiplatelet therapy and NSAIDs, which are both commonly used, and can cause erosions in the stomach lining,” Dr. Bhatt, chief of cardiology at VA Boston Healthcare System, noted in the statement. “These recommendations represent the collective expertise of leading cardiologists and gastroenterologists, as well as an extensive review of the literature, and provide specialists with practical measures to manage competing risks and help improve patient safety.”

In addition, Dr. David Johnson, the immediate past president of the American College of Gastroenterology and professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, stressed the importance of “proactive assessment” of individual risk, and of the need for improved communication between cardiologists, gastroenterologists, and primary care physicians to improve patient safety.

Likewise, patients must be informed of the importance of disclosing all medication information to ensure that appropriate measures can be taken to reduce risk, he noted.

The organizations made recommendations for the following clinical scenarios:

▸ GI complications of aspirin and of combined aspirin and nonaspirin NSAIDs. Gastroprotective therapy should be prescribed for at-risk patients who use low-dose aspirin, and for those using any NSAIDs in conjunction with cardiac-dose aspirin. Because the risk of upper-gastrointestinal events increases with aspirin dose escalation, doses greater than 81 mg should not be routinely prescribed for chronic phase therapy.

▸ GI effects of combined aspirin and anticoagulate therapy. There is a “clinically meaningful and significantly increased risk of major extracranial bleeding events, a large proportion from the upper GI tract” in those on this combination, and the combination should be used with an “established vascular, arrhythmic, or valvular indication.” Concomitant proton pump inhibitor (PPI) therapy is advised.

▸ GI effects of clopidogrel and clopidogrel plus anticoagulant therapy. Clopidogrel should not be substituted for aspirin as a strategy to reduce recurrent ulcer bleeding in high-risk patients, because it is inferior to the combination of aspirin plus PPIs. Also, the combination of clopidogrel and warfarin therapy is associated with an increased incidence of major bleeding, compared with monotherapy; this combination should be considered only when the benefits are likely to outweigh the risks. An international normalized ratio of 2.0–2.5 is recommended when warfarin is added to aspirin or to aspirin and clopidogrel.

▸ Treatment and prevention of aspirin and NSAID-related gastroduodenal injury. PPIs should be used for both the prevention and the treatment of NSAID- and aspirin-associated GI injury.

▸ H. pylori testing and eradication. Before initiating chronic antiplatelet therapy in patients with a history of ulcer disease, test for and eradicate H. pylori.

▸ Discontinuation of antiplatelet therapy because of bleeding. The decision to discontinue aspirin therapy in the setting of acute ulcer bleeding should be individualized based on cardiac risk and GI risk assessments to discern potential thrombotic and hemorrhagic complications.

▸ Endoscopy in patients on mono or dual antiplatelet therapy. High-risk cardiovascular patients who are on dual therapy may benefit from endoscopic therapy. Collaboration between the cardiologist and endoscopist is important to asses the risk of bleeding against the risk of thrombosis in regard to the timing of antiplatelet therapy cessation.

The consensus document is considered to be part of “an ongoing dialogue” and will be updated “as more definitive data are accrued,” according to the ACC statement.

Identifying and treating the potentially life-threatening problem of gastrointestinal complications in patients who use the combination of antiplatelet therapy and NSAIDs are the focus of a new scientific statement by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

Practical clinical guidance for reducing the risk of ulceration and related bleeding—including the use of gastroprotection, either with protein pump inhibitor therapy or treatment of Helicobacter pylori infection—was included in the consensus document.

Ulcerations and gastrointestinal bleeding are recognizable risks in individuals who use antiplatelet agents and NSAIDs, with these patients having up to a fourfold increased risk of such complications, compared with those who are not using the medications, according to Dr. Deepak L. Bhatt, document cochair, and his colleagues on the consensus document writing committee (J. Am. Coll. Cardiol. 2008 [doi:10.1016/j.jacc.2008.08.002]).

Considering that NSAIDs, including aspirin, are the most widely used class of medication in the United States, and that more Americans are surviving and living with heart disease in addition to conditions that require them to take NSAIDs (such as arthritis, inflammation, and related musculoskeletal pain), the management of GI risk will become an increasingly important part of cardiovascular care, according to an American College of Cardiology (ACC) statement on the consensus document.

“Doctors are uncertain about how best to prevent bleeding complications in patients receiving antiplatelet therapy and NSAIDs, which are both commonly used, and can cause erosions in the stomach lining,” Dr. Bhatt, chief of cardiology at VA Boston Healthcare System, noted in the statement. “These recommendations represent the collective expertise of leading cardiologists and gastroenterologists, as well as an extensive review of the literature, and provide specialists with practical measures to manage competing risks and help improve patient safety.”

In addition, Dr. David Johnson, the immediate past president of the American College of Gastroenterology and professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, stressed the importance of “proactive assessment” of individual risk, and of the need for improved communication between cardiologists, gastroenterologists, and primary care physicians to improve patient safety.

Likewise, patients must be informed of the importance of disclosing all medication information to ensure that appropriate measures can be taken to reduce risk, he noted.

The organizations made recommendations for the following clinical scenarios:

▸ GI complications of aspirin and of combined aspirin and nonaspirin NSAIDs. Gastroprotective therapy should be prescribed for at-risk patients who use low-dose aspirin, and for those using any NSAIDs in conjunction with cardiac-dose aspirin. Because the risk of upper-gastrointestinal events increases with aspirin dose escalation, doses greater than 81 mg should not be routinely prescribed for chronic phase therapy.

▸ GI effects of combined aspirin and anticoagulate therapy. There is a “clinically meaningful and significantly increased risk of major extracranial bleeding events, a large proportion from the upper GI tract” in those on this combination, and the combination should be used with an “established vascular, arrhythmic, or valvular indication.” Concomitant proton pump inhibitor (PPI) therapy is advised.

▸ GI effects of clopidogrel and clopidogrel plus anticoagulant therapy. Clopidogrel should not be substituted for aspirin as a strategy to reduce recurrent ulcer bleeding in high-risk patients, because it is inferior to the combination of aspirin plus PPIs. Also, the combination of clopidogrel and warfarin therapy is associated with an increased incidence of major bleeding, compared with monotherapy; this combination should be considered only when the benefits are likely to outweigh the risks. An international normalized ratio of 2.0–2.5 is recommended when warfarin is added to aspirin or to aspirin and clopidogrel.

▸ Treatment and prevention of aspirin and NSAID-related gastroduodenal injury. PPIs should be used for both the prevention and the treatment of NSAID- and aspirin-associated GI injury.

▸ H. pylori testing and eradication. Before initiating chronic antiplatelet therapy in patients with a history of ulcer disease, test for and eradicate H. pylori.

▸ Discontinuation of antiplatelet therapy because of bleeding. The decision to discontinue aspirin therapy in the setting of acute ulcer bleeding should be individualized based on cardiac risk and GI risk assessments to discern potential thrombotic and hemorrhagic complications.

▸ Endoscopy in patients on mono or dual antiplatelet therapy. High-risk cardiovascular patients who are on dual therapy may benefit from endoscopic therapy. Collaboration between the cardiologist and endoscopist is important to asses the risk of bleeding against the risk of thrombosis in regard to the timing of antiplatelet therapy cessation.

The consensus document is considered to be part of “an ongoing dialogue” and will be updated “as more definitive data are accrued,” according to the ACC statement.

Identifying and treating the potentially life-threatening problem of gastrointestinal complications in patients who use the combination of antiplatelet therapy and NSAIDs are the focus of a new scientific statement by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

Practical clinical guidance for reducing the risk of ulceration and related bleeding—including the use of gastroprotection, either with protein pump inhibitor therapy or treatment of Helicobacter pylori infection—was included in the consensus document.

Ulcerations and gastrointestinal bleeding are recognizable risks in individuals who use antiplatelet agents and NSAIDs, with these patients having up to a fourfold increased risk of such complications, compared with those who are not using the medications, according to Dr. Deepak L. Bhatt, document cochair, and his colleagues on the consensus document writing committee (J. Am. Coll. Cardiol. 2008 [doi:10.1016/j.jacc.2008.08.002]).

Considering that NSAIDs, including aspirin, are the most widely used class of medication in the United States, and that more Americans are surviving and living with heart disease in addition to conditions that require them to take NSAIDs (such as arthritis, inflammation, and related musculoskeletal pain), the management of GI risk will become an increasingly important part of cardiovascular care, according to an American College of Cardiology (ACC) statement on the consensus document.

“Doctors are uncertain about how best to prevent bleeding complications in patients receiving antiplatelet therapy and NSAIDs, which are both commonly used, and can cause erosions in the stomach lining,” Dr. Bhatt, chief of cardiology at VA Boston Healthcare System, noted in the statement. “These recommendations represent the collective expertise of leading cardiologists and gastroenterologists, as well as an extensive review of the literature, and provide specialists with practical measures to manage competing risks and help improve patient safety.”

In addition, Dr. David Johnson, the immediate past president of the American College of Gastroenterology and professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, stressed the importance of “proactive assessment” of individual risk, and of the need for improved communication between cardiologists, gastroenterologists, and primary care physicians to improve patient safety.

Likewise, patients must be informed of the importance of disclosing all medication information to ensure that appropriate measures can be taken to reduce risk, he noted.

The organizations made recommendations for the following clinical scenarios:

▸ GI complications of aspirin and of combined aspirin and nonaspirin NSAIDs. Gastroprotective therapy should be prescribed for at-risk patients who use low-dose aspirin, and for those using any NSAIDs in conjunction with cardiac-dose aspirin. Because the risk of upper-gastrointestinal events increases with aspirin dose escalation, doses greater than 81 mg should not be routinely prescribed for chronic phase therapy.

▸ GI effects of combined aspirin and anticoagulate therapy. There is a “clinically meaningful and significantly increased risk of major extracranial bleeding events, a large proportion from the upper GI tract” in those on this combination, and the combination should be used with an “established vascular, arrhythmic, or valvular indication.” Concomitant proton pump inhibitor (PPI) therapy is advised.

▸ GI effects of clopidogrel and clopidogrel plus anticoagulant therapy. Clopidogrel should not be substituted for aspirin as a strategy to reduce recurrent ulcer bleeding in high-risk patients, because it is inferior to the combination of aspirin plus PPIs. Also, the combination of clopidogrel and warfarin therapy is associated with an increased incidence of major bleeding, compared with monotherapy; this combination should be considered only when the benefits are likely to outweigh the risks. An international normalized ratio of 2.0–2.5 is recommended when warfarin is added to aspirin or to aspirin and clopidogrel.

▸ Treatment and prevention of aspirin and NSAID-related gastroduodenal injury. PPIs should be used for both the prevention and the treatment of NSAID- and aspirin-associated GI injury.

▸ H. pylori testing and eradication. Before initiating chronic antiplatelet therapy in patients with a history of ulcer disease, test for and eradicate H. pylori.

▸ Discontinuation of antiplatelet therapy because of bleeding. The decision to discontinue aspirin therapy in the setting of acute ulcer bleeding should be individualized based on cardiac risk and GI risk assessments to discern potential thrombotic and hemorrhagic complications.

▸ Endoscopy in patients on mono or dual antiplatelet therapy. High-risk cardiovascular patients who are on dual therapy may benefit from endoscopic therapy. Collaboration between the cardiologist and endoscopist is important to asses the risk of bleeding against the risk of thrombosis in regard to the timing of antiplatelet therapy cessation.

The consensus document is considered to be part of “an ongoing dialogue” and will be updated “as more definitive data are accrued,” according to the ACC statement.

NEW ORLEANS – Anger control appears to have beneficial effects on cardiovascular disease risk in African Americans, and conversely, the expression of anger and hostility may be linked with increased levels of an inflammatory marker of cardiovascular disease in this population.

In a study presented at a meeting sponsored by the International Society on Hypertension in Blacks, an unwillingness to express anger outwardly was significantly negatively associated with LDL cholesterol levels and significantly positively associated with HDL cholesterol levels in a convenience sample of 174 normotensive African American adults.

Anger in the participants was assessed using the 20-item Spielberger Anger Expression scale, and plasma cholesterol and triglyceride levels were measured. Items 1 and 8 of the scale, which assessed anger control (“I control my temper” and “I keep my cool,” respectively), were the “highest endorsed” items on the scale, but only item 15 (“I am angrier than I am willing to admit”) was significantly associated with cholesterol levels, Mildred A. Pointer, Ph.D., of North Carolina Central University, Durham, reported in a poster at the meeting.

Avoiding the outward expression of anger may serve as a survival technique in African Americans as they navigate through life, Dr. Pointer suggested, but it also appears to provide protection against cardiovascular disease by improving the ratio of “good” (HDL) cholesterol to “bad” (LDL) cholesterol, she said.

In a separate study, Den'ee T. Mwendwa, Ph.D., of Howard University, Washington, reported that trait depression and anger/hostility both were significantly positively correlated with C-reactive protein (CRP) levels in a study of 155 African American adults.

The purpose of the study–which is part of an ongoing project to identify biologic and psychosocial predictors of renal health outcomes–was to determine whether trait depression and anger/hostility were associated with increases in CRP levels in a community-based sample of middle-aged African Americans, and it followed previous findings suggesting that depression and anger/hostility traits are associated with cardiovascular disease and stroke, Dr. Mwendwa noted in a poster.

Researchers have suggested that chronic inflammation can result from changes in the immune system that are triggered by negative mood states, and the findings of the current study appear to support this theory. Participants underwent neuropsychological and psychosocial evaluation, and CRP levels were used as a measure of inflammation.

The findings suggest that regular screening for anger and depression would be beneficial in African Americans, Dr. Mwendwa concluded.

NEW ORLEANS – Anger control appears to have beneficial effects on cardiovascular disease risk in African Americans, and conversely, the expression of anger and hostility may be linked with increased levels of an inflammatory marker of cardiovascular disease in this population.

In a study presented at a meeting sponsored by the International Society on Hypertension in Blacks, an unwillingness to express anger outwardly was significantly negatively associated with LDL cholesterol levels and significantly positively associated with HDL cholesterol levels in a convenience sample of 174 normotensive African American adults.

Anger in the participants was assessed using the 20-item Spielberger Anger Expression scale, and plasma cholesterol and triglyceride levels were measured. Items 1 and 8 of the scale, which assessed anger control (“I control my temper” and “I keep my cool,” respectively), were the “highest endorsed” items on the scale, but only item 15 (“I am angrier than I am willing to admit”) was significantly associated with cholesterol levels, Mildred A. Pointer, Ph.D., of North Carolina Central University, Durham, reported in a poster at the meeting.

Avoiding the outward expression of anger may serve as a survival technique in African Americans as they navigate through life, Dr. Pointer suggested, but it also appears to provide protection against cardiovascular disease by improving the ratio of “good” (HDL) cholesterol to “bad” (LDL) cholesterol, she said.

In a separate study, Den'ee T. Mwendwa, Ph.D., of Howard University, Washington, reported that trait depression and anger/hostility both were significantly positively correlated with C-reactive protein (CRP) levels in a study of 155 African American adults.

The purpose of the study–which is part of an ongoing project to identify biologic and psychosocial predictors of renal health outcomes–was to determine whether trait depression and anger/hostility were associated with increases in CRP levels in a community-based sample of middle-aged African Americans, and it followed previous findings suggesting that depression and anger/hostility traits are associated with cardiovascular disease and stroke, Dr. Mwendwa noted in a poster.

Researchers have suggested that chronic inflammation can result from changes in the immune system that are triggered by negative mood states, and the findings of the current study appear to support this theory. Participants underwent neuropsychological and psychosocial evaluation, and CRP levels were used as a measure of inflammation.

The findings suggest that regular screening for anger and depression would be beneficial in African Americans, Dr. Mwendwa concluded.

NEW ORLEANS – Anger control appears to have beneficial effects on cardiovascular disease risk in African Americans, and conversely, the expression of anger and hostility may be linked with increased levels of an inflammatory marker of cardiovascular disease in this population.

In a study presented at a meeting sponsored by the International Society on Hypertension in Blacks, an unwillingness to express anger outwardly was significantly negatively associated with LDL cholesterol levels and significantly positively associated with HDL cholesterol levels in a convenience sample of 174 normotensive African American adults.

Anger in the participants was assessed using the 20-item Spielberger Anger Expression scale, and plasma cholesterol and triglyceride levels were measured. Items 1 and 8 of the scale, which assessed anger control (“I control my temper” and “I keep my cool,” respectively), were the “highest endorsed” items on the scale, but only item 15 (“I am angrier than I am willing to admit”) was significantly associated with cholesterol levels, Mildred A. Pointer, Ph.D., of North Carolina Central University, Durham, reported in a poster at the meeting.

Avoiding the outward expression of anger may serve as a survival technique in African Americans as they navigate through life, Dr. Pointer suggested, but it also appears to provide protection against cardiovascular disease by improving the ratio of “good” (HDL) cholesterol to “bad” (LDL) cholesterol, she said.

In a separate study, Den'ee T. Mwendwa, Ph.D., of Howard University, Washington, reported that trait depression and anger/hostility both were significantly positively correlated with C-reactive protein (CRP) levels in a study of 155 African American adults.

The purpose of the study–which is part of an ongoing project to identify biologic and psychosocial predictors of renal health outcomes–was to determine whether trait depression and anger/hostility were associated with increases in CRP levels in a community-based sample of middle-aged African Americans, and it followed previous findings suggesting that depression and anger/hostility traits are associated with cardiovascular disease and stroke, Dr. Mwendwa noted in a poster.

Researchers have suggested that chronic inflammation can result from changes in the immune system that are triggered by negative mood states, and the findings of the current study appear to support this theory. Participants underwent neuropsychological and psychosocial evaluation, and CRP levels were used as a measure of inflammation.

The findings suggest that regular screening for anger and depression would be beneficial in African Americans, Dr. Mwendwa concluded.

Praying significantly improves quality of life in nursing home residents with dementia and agitation, findings from a controlled study of 28 nursing home residents suggest.

Residents assigned to the intervention group participated with the researcher in a prayer exercise that included about 5 minutes of prayer on 5 out of 7 days for 4 consecutive weeks; the control group did not participate in the program. For the intervention, residents picked a prayer or the researcher provided one of two nondenominational prayers.

Both quantitative and qualitative analyses indicated that the residents in the prayer group had more improvement in quality of life, said Lena G. Smith, Ph.D., of the University of New Mexico, Albuquerque. She completed the study as part of a dissertation and has presented the findings at conferences including the Alzheimer's Association Dementia Care Conference in Garden Grove, Calif.

Quantitative measures included the Quality of Life in Late-Stage Dementia (QUALID) scale and the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). Using multivariate analysis of covariance, Dr. Smith found a significant difference between the two groups (P = .003), and subsequent univariate analysis showed it was the QUALID scale that contributed to the significance seen on multivariate analysis (P = .002). “This indicates that the difference between the two groups was in quality of life,” Dr. Smith said in an interview.

She applied qualitative analysis to data derived from information logged during the study period, such as verbal comments, gestures, and facial expressions observed during prayer time. Four major themes of behavior and responses emerged as attributable to the impact of the prayer exercise emerged. Supporting the quantitative findings, the themes were gratitude, reverence, satisfaction, and familiarity.

For example, more than 70% of residents in the intervention group expressed direct verbal gratitude, and many showed reverence by bowing their heads, crossing themselves, or placing their hands in a prayer position.

The nursing home residents who participated in the study had moderate to late-stage dementia (Mini-Mental State Exam scores averaged 8 out of 30).

Dementia affects at least 15% of people over age 65 years, and behavior disturbances can occur in up to 80% of nursing home patients with Alzheimer's disease. The findings are important because they provide an intervention for agitation and quality of life other than medication, Dr. Smith said.

Furthermore, surveys show that prayer is important for many Americans, with 75% reporting that they pray for wellness and up to 96% expressing a belief in God. In addition, most Americans say they believe in the healing power of prayer, and at least one study reported religion as “very important” to 75% of people aged 75 years and older, Dr. Smith noted.

Positive Change IsSeen in Behaviors

Gratitude, reverence, satisfaction, and familiarity were four themes that emerged from qualitative analysis in Dr. Smith's study.

Gratitude was expressed verbally by a number of residents in the intervention group. Examples of some of their responses included, “Thank you for that,” “That was so pretty,” “God bless you, darling,” and “That was sweet.”

Nonverbal expressions of gratitude included hugs, hand squeezes, smiles, and tears.

Reverence was shown by participants in the intervention group by closed eyes, bowed heads, head nodding during the prayer, and by holding of hands in a traditional prayer position.

Overall, 63% of participants had a positive change in behaviors and demeanor during prayer, she noted. Familiarity was demonstrated by increased conversation and recognition. Residents often would say, “See you tomorrow” or “I'm glad you came back.”

Praying significantly improves quality of life in nursing home residents with dementia and agitation, findings from a controlled study of 28 nursing home residents suggest.

Residents assigned to the intervention group participated with the researcher in a prayer exercise that included about 5 minutes of prayer on 5 out of 7 days for 4 consecutive weeks; the control group did not participate in the program. For the intervention, residents picked a prayer or the researcher provided one of two nondenominational prayers.

Both quantitative and qualitative analyses indicated that the residents in the prayer group had more improvement in quality of life, said Lena G. Smith, Ph.D., of the University of New Mexico, Albuquerque. She completed the study as part of a dissertation and has presented the findings at conferences including the Alzheimer's Association Dementia Care Conference in Garden Grove, Calif.

Quantitative measures included the Quality of Life in Late-Stage Dementia (QUALID) scale and the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). Using multivariate analysis of covariance, Dr. Smith found a significant difference between the two groups (P = .003), and subsequent univariate analysis showed it was the QUALID scale that contributed to the significance seen on multivariate analysis (P = .002). “This indicates that the difference between the two groups was in quality of life,” Dr. Smith said in an interview.

She applied qualitative analysis to data derived from information logged during the study period, such as verbal comments, gestures, and facial expressions observed during prayer time. Four major themes of behavior and responses emerged as attributable to the impact of the prayer exercise emerged. Supporting the quantitative findings, the themes were gratitude, reverence, satisfaction, and familiarity.

For example, more than 70% of residents in the intervention group expressed direct verbal gratitude, and many showed reverence by bowing their heads, crossing themselves, or placing their hands in a prayer position.

The nursing home residents who participated in the study had moderate to late-stage dementia (Mini-Mental State Exam scores averaged 8 out of 30).

Dementia affects at least 15% of people over age 65 years, and behavior disturbances can occur in up to 80% of nursing home patients with Alzheimer's disease. The findings are important because they provide an intervention for agitation and quality of life other than medication, Dr. Smith said.

Furthermore, surveys show that prayer is important for many Americans, with 75% reporting that they pray for wellness and up to 96% expressing a belief in God. In addition, most Americans say they believe in the healing power of prayer, and at least one study reported religion as “very important” to 75% of people aged 75 years and older, Dr. Smith noted.

Positive Change IsSeen in Behaviors

Gratitude, reverence, satisfaction, and familiarity were four themes that emerged from qualitative analysis in Dr. Smith's study.

Gratitude was expressed verbally by a number of residents in the intervention group. Examples of some of their responses included, “Thank you for that,” “That was so pretty,” “God bless you, darling,” and “That was sweet.”

Nonverbal expressions of gratitude included hugs, hand squeezes, smiles, and tears.

Reverence was shown by participants in the intervention group by closed eyes, bowed heads, head nodding during the prayer, and by holding of hands in a traditional prayer position.

Overall, 63% of participants had a positive change in behaviors and demeanor during prayer, she noted. Familiarity was demonstrated by increased conversation and recognition. Residents often would say, “See you tomorrow” or “I'm glad you came back.”

Praying significantly improves quality of life in nursing home residents with dementia and agitation, findings from a controlled study of 28 nursing home residents suggest.

Residents assigned to the intervention group participated with the researcher in a prayer exercise that included about 5 minutes of prayer on 5 out of 7 days for 4 consecutive weeks; the control group did not participate in the program. For the intervention, residents picked a prayer or the researcher provided one of two nondenominational prayers.

Both quantitative and qualitative analyses indicated that the residents in the prayer group had more improvement in quality of life, said Lena G. Smith, Ph.D., of the University of New Mexico, Albuquerque. She completed the study as part of a dissertation and has presented the findings at conferences including the Alzheimer's Association Dementia Care Conference in Garden Grove, Calif.

Quantitative measures included the Quality of Life in Late-Stage Dementia (QUALID) scale and the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). Using multivariate analysis of covariance, Dr. Smith found a significant difference between the two groups (P = .003), and subsequent univariate analysis showed it was the QUALID scale that contributed to the significance seen on multivariate analysis (P = .002). “This indicates that the difference between the two groups was in quality of life,” Dr. Smith said in an interview.

She applied qualitative analysis to data derived from information logged during the study period, such as verbal comments, gestures, and facial expressions observed during prayer time. Four major themes of behavior and responses emerged as attributable to the impact of the prayer exercise emerged. Supporting the quantitative findings, the themes were gratitude, reverence, satisfaction, and familiarity.

For example, more than 70% of residents in the intervention group expressed direct verbal gratitude, and many showed reverence by bowing their heads, crossing themselves, or placing their hands in a prayer position.

The nursing home residents who participated in the study had moderate to late-stage dementia (Mini-Mental State Exam scores averaged 8 out of 30).

Dementia affects at least 15% of people over age 65 years, and behavior disturbances can occur in up to 80% of nursing home patients with Alzheimer's disease. The findings are important because they provide an intervention for agitation and quality of life other than medication, Dr. Smith said.

Furthermore, surveys show that prayer is important for many Americans, with 75% reporting that they pray for wellness and up to 96% expressing a belief in God. In addition, most Americans say they believe in the healing power of prayer, and at least one study reported religion as “very important” to 75% of people aged 75 years and older, Dr. Smith noted.

Positive Change IsSeen in Behaviors

Gratitude, reverence, satisfaction, and familiarity were four themes that emerged from qualitative analysis in Dr. Smith's study.

Gratitude was expressed verbally by a number of residents in the intervention group. Examples of some of their responses included, “Thank you for that,” “That was so pretty,” “God bless you, darling,” and “That was sweet.”

Nonverbal expressions of gratitude included hugs, hand squeezes, smiles, and tears.

Reverence was shown by participants in the intervention group by closed eyes, bowed heads, head nodding during the prayer, and by holding of hands in a traditional prayer position.

Overall, 63% of participants had a positive change in behaviors and demeanor during prayer, she noted. Familiarity was demonstrated by increased conversation and recognition. Residents often would say, “See you tomorrow” or “I'm glad you came back.”