Kate Johnson

Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain, but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.

“The conclusion [of the AAN report] is that these injections are not overwhelmingly therapeutic, and I would say that is fair—they don't cure this problem—but they help certain patients, and I think when all is said and done, you have a better chance of helping someone [with epidural steroid injections] than harming them,” Dr. David Borenstein, a Washington rheumatologist who specializes in low back pain, said during an interview.

“When it comes down to the clinical situation, I think what's important is the risk benefit ratio,” said Dr. Borenstein, also of George Washington University, Washington.

The guidelines were drafted by the academy's (AAN's) Therapeutics and Technology Assessment Subcommittee and are based on a literature review (Neurology 2007;68:723–9).

From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.

Dr. Armon and colleagues reported that all four studies were consistent regarding their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”

“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.

People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient, said Dr. Borenstein, during the interview.

Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.

The authors noted that current data on the use of epidural steroid injections to treat cervical radicular pain are inadequate to make recommendations.

Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain, but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.

“The conclusion [of the AAN report] is that these injections are not overwhelmingly therapeutic, and I would say that is fair—they don't cure this problem—but they help certain patients, and I think when all is said and done, you have a better chance of helping someone [with epidural steroid injections] than harming them,” Dr. David Borenstein, a Washington rheumatologist who specializes in low back pain, said during an interview.

“When it comes down to the clinical situation, I think what's important is the risk benefit ratio,” said Dr. Borenstein, also of George Washington University, Washington.

The guidelines were drafted by the academy's (AAN's) Therapeutics and Technology Assessment Subcommittee and are based on a literature review (Neurology 2007;68:723–9).

From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.

Dr. Armon and colleagues reported that all four studies were consistent regarding their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”

“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.

People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient, said Dr. Borenstein, during the interview.

Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.

The authors noted that current data on the use of epidural steroid injections to treat cervical radicular pain are inadequate to make recommendations.

Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain, but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.

“The conclusion [of the AAN report] is that these injections are not overwhelmingly therapeutic, and I would say that is fair—they don't cure this problem—but they help certain patients, and I think when all is said and done, you have a better chance of helping someone [with epidural steroid injections] than harming them,” Dr. David Borenstein, a Washington rheumatologist who specializes in low back pain, said during an interview.

“When it comes down to the clinical situation, I think what's important is the risk benefit ratio,” said Dr. Borenstein, also of George Washington University, Washington.

The guidelines were drafted by the academy's (AAN's) Therapeutics and Technology Assessment Subcommittee and are based on a literature review (Neurology 2007;68:723–9).

From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.

Dr. Armon and colleagues reported that all four studies were consistent regarding their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”

“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.

People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient, said Dr. Borenstein, during the interview.

Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.

The authors noted that current data on the use of epidural steroid injections to treat cervical radicular pain are inadequate to make recommendations.

The number of U.S. children receiving preventive dental care has risen, but minority children from low-income families remain the least likely group of children to receive it, according to a study.

The report was published shortly after a Maryland boy on Medicaid died because of complications ultimately related to lack of preventive dental care.

Among those children at high risk, having a personal doctor and being enrolled in the State Children's Health Insurance Program (for a subgroup of children) were factors associated with receiving preventive dental care, according to the study.

“We still have a long way to go before we can say that all U.S. children are receiving the preventive dental care that they need,” wrote Dr. Charlotte W. Lewis of the University of Washington, Seattle, and her colleagues (Pediatrics 2007;119:544–53). They suggested that increasing the availability of dental insurance should be a priority in addressing this issue.

The study included data from 2003 on 102,353 children involved in the National Survey of Children's Health, and was weighted to represent 72.7 million children nationally. It found that in 2003, 72% of all children and 62.5% of low-income children (those at or below 200% of the federal poverty level [FPL]) reported a preventive dental care visit in the previous year. Almost 23% of children lacked dental insurance, compared with almost 9% who lacked health insurance.

The numbers of children receiving preventive dental care are higher than previously reported, and exceed the Healthy People 2010 goal of 57% of low-income children receiving a preventive dental care visit in the previous year, according to the authors.

But children who are at highest risk for dental problems are still those who are least likely to receive preventive care, they wrote.

“Certain groups continue to be underrepresented,” the researchers noted. “These include children who are young, who are black or multiracial, lack dental insurance, lack a personal doctor, are under 400% of the FPL … live in nonmetropolitan areas or states, or are foreign born.” After the researchers controlled for other variables, Hispanic and white children had a similar likelihood of receiving care, but black children had lower odds that persisted even after adjustment for income and insurance status, Dr. Lewis and her associates reported.

The picture painted by the study is a familiar one for Laurie Norris, a lawyer at the Baltimore-based Public Justice Center who tried between September 2006 and January 2007 to help the family of a 12-year-old Maryland boy who died in February after an infection from an abscessed tooth spread to his brain. There is “terrible access” to dental care for underprivileged children in Maryland, Ms. Norris said in an interview. “I made 26 calls and was unable to find a dentist contracted to the family's dental plan (Medicaid) in their geographic area.”

In examining factors influencing access to dental care, the study showed that income eligibility for State Children's Health Insurance Program (SCHIP) policies was associated with preventive dental health visits by “near-poor” children. (Near-poor was defined as 1− to 5-year-old children living at 133%–199% of the FPL, or children older than 5 years living at 100%–199% of the FPL.) Near-poor children in states with the broadest income eligibility for SCHIP dental care had a 24% higher likelihood of a preventive dental visit compared with children in states with limited or no eligibility for SCHIP dental services, reported the authors. Yet, “even in the best states, near-poor children lag substantially behind their higher income counterparts.”

Near-poor children were of primary interest “because they were the intended target of SCHIP/Medicaid expansions,” they noted.

The findings bear consideration “as we evaluate current SCHIP performance and contemplate potential revisions in anticipation of SCHIP legislative renewal in 2007,” Dr. Lewis and her associates noted.

There are “layers of barriers” built into the Medicaid and SCHIP systems in Maryland, and probably many other states, said Ms. Norris. But she is not convinced that access problems stem from government underfunding.

“I think it could be a structural problem. The system is too complex for parents to navigate and there aren't enough dentists in the system,” she said.

“The state is paying money to managed care programs to provide care, but that care is not being provided. The list of providers in the network looks good on paper, but when you go looking for them they are just not there. The money is padding the profits of the private plans,” she contended.

Although reasons for poor access to preventive dental care may be debated, the study identified that one positive influence on access to dental care was having a personal doctor.

“This is the first time to our knowledge that such an association has been recognized for the U.S. pediatric population as a whole,” wrote Dr. Lewis and her associates.

They noted several possible explanations for this, including the fact that families with a regular doctor “may have values and attributes that also lead them to seek preventive dental care,” or that physicians play an important role in referring patients and reinforcing the importance of dental care.

“By whatever mechanism,” they wrote, “there exists a link between having a personal doctor and receiving preventive dental care that deserves additional attention and study.”

The number of U.S. children receiving preventive dental care has risen, but minority children from low-income families remain the least likely group of children to receive it, according to a study.

The report was published shortly after a Maryland boy on Medicaid died because of complications ultimately related to lack of preventive dental care.

Among those children at high risk, having a personal doctor and being enrolled in the State Children's Health Insurance Program (for a subgroup of children) were factors associated with receiving preventive dental care, according to the study.

“We still have a long way to go before we can say that all U.S. children are receiving the preventive dental care that they need,” wrote Dr. Charlotte W. Lewis of the University of Washington, Seattle, and her colleagues (Pediatrics 2007;119:544–53). They suggested that increasing the availability of dental insurance should be a priority in addressing this issue.

The study included data from 2003 on 102,353 children involved in the National Survey of Children's Health, and was weighted to represent 72.7 million children nationally. It found that in 2003, 72% of all children and 62.5% of low-income children (those at or below 200% of the federal poverty level [FPL]) reported a preventive dental care visit in the previous year. Almost 23% of children lacked dental insurance, compared with almost 9% who lacked health insurance.

The numbers of children receiving preventive dental care are higher than previously reported, and exceed the Healthy People 2010 goal of 57% of low-income children receiving a preventive dental care visit in the previous year, according to the authors.

But children who are at highest risk for dental problems are still those who are least likely to receive preventive care, they wrote.

“Certain groups continue to be underrepresented,” the researchers noted. “These include children who are young, who are black or multiracial, lack dental insurance, lack a personal doctor, are under 400% of the FPL … live in nonmetropolitan areas or states, or are foreign born.” After the researchers controlled for other variables, Hispanic and white children had a similar likelihood of receiving care, but black children had lower odds that persisted even after adjustment for income and insurance status, Dr. Lewis and her associates reported.

The picture painted by the study is a familiar one for Laurie Norris, a lawyer at the Baltimore-based Public Justice Center who tried between September 2006 and January 2007 to help the family of a 12-year-old Maryland boy who died in February after an infection from an abscessed tooth spread to his brain. There is “terrible access” to dental care for underprivileged children in Maryland, Ms. Norris said in an interview. “I made 26 calls and was unable to find a dentist contracted to the family's dental plan (Medicaid) in their geographic area.”

In examining factors influencing access to dental care, the study showed that income eligibility for State Children's Health Insurance Program (SCHIP) policies was associated with preventive dental health visits by “near-poor” children. (Near-poor was defined as 1− to 5-year-old children living at 133%–199% of the FPL, or children older than 5 years living at 100%–199% of the FPL.) Near-poor children in states with the broadest income eligibility for SCHIP dental care had a 24% higher likelihood of a preventive dental visit compared with children in states with limited or no eligibility for SCHIP dental services, reported the authors. Yet, “even in the best states, near-poor children lag substantially behind their higher income counterparts.”

Near-poor children were of primary interest “because they were the intended target of SCHIP/Medicaid expansions,” they noted.

The findings bear consideration “as we evaluate current SCHIP performance and contemplate potential revisions in anticipation of SCHIP legislative renewal in 2007,” Dr. Lewis and her associates noted.

There are “layers of barriers” built into the Medicaid and SCHIP systems in Maryland, and probably many other states, said Ms. Norris. But she is not convinced that access problems stem from government underfunding.

“I think it could be a structural problem. The system is too complex for parents to navigate and there aren't enough dentists in the system,” she said.

“The state is paying money to managed care programs to provide care, but that care is not being provided. The list of providers in the network looks good on paper, but when you go looking for them they are just not there. The money is padding the profits of the private plans,” she contended.

Although reasons for poor access to preventive dental care may be debated, the study identified that one positive influence on access to dental care was having a personal doctor.

“This is the first time to our knowledge that such an association has been recognized for the U.S. pediatric population as a whole,” wrote Dr. Lewis and her associates.

They noted several possible explanations for this, including the fact that families with a regular doctor “may have values and attributes that also lead them to seek preventive dental care,” or that physicians play an important role in referring patients and reinforcing the importance of dental care.

“By whatever mechanism,” they wrote, “there exists a link between having a personal doctor and receiving preventive dental care that deserves additional attention and study.”

The number of U.S. children receiving preventive dental care has risen, but minority children from low-income families remain the least likely group of children to receive it, according to a study.

The report was published shortly after a Maryland boy on Medicaid died because of complications ultimately related to lack of preventive dental care.

Among those children at high risk, having a personal doctor and being enrolled in the State Children's Health Insurance Program (for a subgroup of children) were factors associated with receiving preventive dental care, according to the study.

“We still have a long way to go before we can say that all U.S. children are receiving the preventive dental care that they need,” wrote Dr. Charlotte W. Lewis of the University of Washington, Seattle, and her colleagues (Pediatrics 2007;119:544–53). They suggested that increasing the availability of dental insurance should be a priority in addressing this issue.

The study included data from 2003 on 102,353 children involved in the National Survey of Children's Health, and was weighted to represent 72.7 million children nationally. It found that in 2003, 72% of all children and 62.5% of low-income children (those at or below 200% of the federal poverty level [FPL]) reported a preventive dental care visit in the previous year. Almost 23% of children lacked dental insurance, compared with almost 9% who lacked health insurance.

The numbers of children receiving preventive dental care are higher than previously reported, and exceed the Healthy People 2010 goal of 57% of low-income children receiving a preventive dental care visit in the previous year, according to the authors.

But children who are at highest risk for dental problems are still those who are least likely to receive preventive care, they wrote.

“Certain groups continue to be underrepresented,” the researchers noted. “These include children who are young, who are black or multiracial, lack dental insurance, lack a personal doctor, are under 400% of the FPL … live in nonmetropolitan areas or states, or are foreign born.” After the researchers controlled for other variables, Hispanic and white children had a similar likelihood of receiving care, but black children had lower odds that persisted even after adjustment for income and insurance status, Dr. Lewis and her associates reported.

The picture painted by the study is a familiar one for Laurie Norris, a lawyer at the Baltimore-based Public Justice Center who tried between September 2006 and January 2007 to help the family of a 12-year-old Maryland boy who died in February after an infection from an abscessed tooth spread to his brain. There is “terrible access” to dental care for underprivileged children in Maryland, Ms. Norris said in an interview. “I made 26 calls and was unable to find a dentist contracted to the family's dental plan (Medicaid) in their geographic area.”

In examining factors influencing access to dental care, the study showed that income eligibility for State Children's Health Insurance Program (SCHIP) policies was associated with preventive dental health visits by “near-poor” children. (Near-poor was defined as 1− to 5-year-old children living at 133%–199% of the FPL, or children older than 5 years living at 100%–199% of the FPL.) Near-poor children in states with the broadest income eligibility for SCHIP dental care had a 24% higher likelihood of a preventive dental visit compared with children in states with limited or no eligibility for SCHIP dental services, reported the authors. Yet, “even in the best states, near-poor children lag substantially behind their higher income counterparts.”

Near-poor children were of primary interest “because they were the intended target of SCHIP/Medicaid expansions,” they noted.

The findings bear consideration “as we evaluate current SCHIP performance and contemplate potential revisions in anticipation of SCHIP legislative renewal in 2007,” Dr. Lewis and her associates noted.

There are “layers of barriers” built into the Medicaid and SCHIP systems in Maryland, and probably many other states, said Ms. Norris. But she is not convinced that access problems stem from government underfunding.

“I think it could be a structural problem. The system is too complex for parents to navigate and there aren't enough dentists in the system,” she said.

“The state is paying money to managed care programs to provide care, but that care is not being provided. The list of providers in the network looks good on paper, but when you go looking for them they are just not there. The money is padding the profits of the private plans,” she contended.

Although reasons for poor access to preventive dental care may be debated, the study identified that one positive influence on access to dental care was having a personal doctor.

“This is the first time to our knowledge that such an association has been recognized for the U.S. pediatric population as a whole,” wrote Dr. Lewis and her associates.

They noted several possible explanations for this, including the fact that families with a regular doctor “may have values and attributes that also lead them to seek preventive dental care,” or that physicians play an important role in referring patients and reinforcing the importance of dental care.

“By whatever mechanism,” they wrote, “there exists a link between having a personal doctor and receiving preventive dental care that deserves additional attention and study.”

The risks of prolonged acute otitis media in children who are not initially treated with antibiotics are two times higher if the patients are aged younger than 2 years and have acute bilateral infection, compared with older children who have unilateral infection, according to a meta-analysis.

“Clinicians can use these features … to inform parents more explicitly about the expected course of their child's AOM [acute otitis media] and to explain which features should prompt parents to contact their clinician for reexamination of the child,” wrote Maroeska M. Rovers, Ph.D., of the Julius Center for Health Sciences and Primary Care, and Wilhelmina Children's Hospital, University Medical Center Utrecht, the Netherlands, and colleagues (Pediatrics 2007;119; 579–85).

The meta-analysis included six randomized, controlled trials of children aged 6 months to 12 years with AOM who were randomized to antibiotic therapy or observation (either placebo or no treatment). Only the 824 patients in the observation arms were included in the analysis. The primary outcome was a prolonged infection defined as fever and/or pain at 3–7 days, and the predictors analyzed were age, gender, season, having been breast-fed or not, presence or absence of recurrent AOM, and baseline symptoms of fever, pain, bilateral AOM, otorrhea, and appearance of tympanic membrane (bulging, redness, perforation).

Of the 824 children, 303 (37%) had fever and/or pain at 3–7 days.

The absolute risks of pain and/or fever at follow-up were highest for children aged under 2 years with bilateral infection (55%) and lowest for those aged 2 years or older with unilateral infection (25%).

The risks of prolonged acute otitis media in children who are not initially treated with antibiotics are two times higher if the patients are aged younger than 2 years and have acute bilateral infection, compared with older children who have unilateral infection, according to a meta-analysis.

“Clinicians can use these features … to inform parents more explicitly about the expected course of their child's AOM [acute otitis media] and to explain which features should prompt parents to contact their clinician for reexamination of the child,” wrote Maroeska M. Rovers, Ph.D., of the Julius Center for Health Sciences and Primary Care, and Wilhelmina Children's Hospital, University Medical Center Utrecht, the Netherlands, and colleagues (Pediatrics 2007;119; 579–85).

The meta-analysis included six randomized, controlled trials of children aged 6 months to 12 years with AOM who were randomized to antibiotic therapy or observation (either placebo or no treatment). Only the 824 patients in the observation arms were included in the analysis. The primary outcome was a prolonged infection defined as fever and/or pain at 3–7 days, and the predictors analyzed were age, gender, season, having been breast-fed or not, presence or absence of recurrent AOM, and baseline symptoms of fever, pain, bilateral AOM, otorrhea, and appearance of tympanic membrane (bulging, redness, perforation).

Of the 824 children, 303 (37%) had fever and/or pain at 3–7 days.

The absolute risks of pain and/or fever at follow-up were highest for children aged under 2 years with bilateral infection (55%) and lowest for those aged 2 years or older with unilateral infection (25%).

The risks of prolonged acute otitis media in children who are not initially treated with antibiotics are two times higher if the patients are aged younger than 2 years and have acute bilateral infection, compared with older children who have unilateral infection, according to a meta-analysis.

“Clinicians can use these features … to inform parents more explicitly about the expected course of their child's AOM [acute otitis media] and to explain which features should prompt parents to contact their clinician for reexamination of the child,” wrote Maroeska M. Rovers, Ph.D., of the Julius Center for Health Sciences and Primary Care, and Wilhelmina Children's Hospital, University Medical Center Utrecht, the Netherlands, and colleagues (Pediatrics 2007;119; 579–85).

The meta-analysis included six randomized, controlled trials of children aged 6 months to 12 years with AOM who were randomized to antibiotic therapy or observation (either placebo or no treatment). Only the 824 patients in the observation arms were included in the analysis. The primary outcome was a prolonged infection defined as fever and/or pain at 3–7 days, and the predictors analyzed were age, gender, season, having been breast-fed or not, presence or absence of recurrent AOM, and baseline symptoms of fever, pain, bilateral AOM, otorrhea, and appearance of tympanic membrane (bulging, redness, perforation).

Of the 824 children, 303 (37%) had fever and/or pain at 3–7 days.

The absolute risks of pain and/or fever at follow-up were highest for children aged under 2 years with bilateral infection (55%) and lowest for those aged 2 years or older with unilateral infection (25%).

Preterm infants vaccinated against measles, mumps, rubella, and varicella at age 15 months mount adequate antibody responses similar to those of term infants, according to study findings.

“These findings support the prevailing recommendations for immunization of the preterm infant at the chronological age appropriate for a term infant,” concluded Dr. Carl T. D'Angio of the University of Rochester (N.Y.) and his colleagues (Pediatrics 2007;119;574–9).

They noted that whereas few data previously have existed on these particular vaccines in preterm infants, limited data on other vaccines—such as inactivated influenza, Haemophilus influenzae type b booster, tetanus, diphtheria, and polio—have suggested diminished responses in preterm compared with term infants. “The relatively robust responses in preterm infants in this study may be explained in part by the specific vaccine antigens studied,” they noted. “Live viral vaccines, such as MMR [measles, mumps, rubella] and varicella, often are highly immunogenic.”

The study included 16 term infants, aged 37 weeks or older, and 16 preterm infants younger than 29 weeks. All infants were immunized with MMR and varicella vaccines between the ages of 14.4 and 16 months. Blood specimens were obtained before and again 3–6 weeks after immunization. Measles antibody was measured by plaque reduction neutralization assay; mumps and rubella immunoglobulin G (IgG) titers were measured by enzyme-linked fluorescent immunoassay; and varicella IgG was measured using a glycoprotein enzyme-linked immunosorbent assay.

Before vaccination, all patients in both groups were seronegative for measles-neutralizing antibody, and all had measles titers of more than 120 mIU/mL after vaccination, reported the authors. Varicella titers were similar in both groups before and after vaccination; mumps and rubella titers were similar in both groups after vaccination, but lower in preterm than in term infants before vaccination. “This is consistent with lower transplacental antibody transfer in the preterm infants, because the most likely source of detectable prevaccine antibodies would be maternal,” they explained.

Preterm infants vaccinated against measles, mumps, rubella, and varicella at age 15 months mount adequate antibody responses similar to those of term infants, according to study findings.

“These findings support the prevailing recommendations for immunization of the preterm infant at the chronological age appropriate for a term infant,” concluded Dr. Carl T. D'Angio of the University of Rochester (N.Y.) and his colleagues (Pediatrics 2007;119;574–9).

They noted that whereas few data previously have existed on these particular vaccines in preterm infants, limited data on other vaccines—such as inactivated influenza, Haemophilus influenzae type b booster, tetanus, diphtheria, and polio—have suggested diminished responses in preterm compared with term infants. “The relatively robust responses in preterm infants in this study may be explained in part by the specific vaccine antigens studied,” they noted. “Live viral vaccines, such as MMR [measles, mumps, rubella] and varicella, often are highly immunogenic.”

The study included 16 term infants, aged 37 weeks or older, and 16 preterm infants younger than 29 weeks. All infants were immunized with MMR and varicella vaccines between the ages of 14.4 and 16 months. Blood specimens were obtained before and again 3–6 weeks after immunization. Measles antibody was measured by plaque reduction neutralization assay; mumps and rubella immunoglobulin G (IgG) titers were measured by enzyme-linked fluorescent immunoassay; and varicella IgG was measured using a glycoprotein enzyme-linked immunosorbent assay.

Before vaccination, all patients in both groups were seronegative for measles-neutralizing antibody, and all had measles titers of more than 120 mIU/mL after vaccination, reported the authors. Varicella titers were similar in both groups before and after vaccination; mumps and rubella titers were similar in both groups after vaccination, but lower in preterm than in term infants before vaccination. “This is consistent with lower transplacental antibody transfer in the preterm infants, because the most likely source of detectable prevaccine antibodies would be maternal,” they explained.

Preterm infants vaccinated against measles, mumps, rubella, and varicella at age 15 months mount adequate antibody responses similar to those of term infants, according to study findings.

“These findings support the prevailing recommendations for immunization of the preterm infant at the chronological age appropriate for a term infant,” concluded Dr. Carl T. D'Angio of the University of Rochester (N.Y.) and his colleagues (Pediatrics 2007;119;574–9).

They noted that whereas few data previously have existed on these particular vaccines in preterm infants, limited data on other vaccines—such as inactivated influenza, Haemophilus influenzae type b booster, tetanus, diphtheria, and polio—have suggested diminished responses in preterm compared with term infants. “The relatively robust responses in preterm infants in this study may be explained in part by the specific vaccine antigens studied,” they noted. “Live viral vaccines, such as MMR [measles, mumps, rubella] and varicella, often are highly immunogenic.”

The study included 16 term infants, aged 37 weeks or older, and 16 preterm infants younger than 29 weeks. All infants were immunized with MMR and varicella vaccines between the ages of 14.4 and 16 months. Blood specimens were obtained before and again 3–6 weeks after immunization. Measles antibody was measured by plaque reduction neutralization assay; mumps and rubella immunoglobulin G (IgG) titers were measured by enzyme-linked fluorescent immunoassay; and varicella IgG was measured using a glycoprotein enzyme-linked immunosorbent assay.

Before vaccination, all patients in both groups were seronegative for measles-neutralizing antibody, and all had measles titers of more than 120 mIU/mL after vaccination, reported the authors. Varicella titers were similar in both groups before and after vaccination; mumps and rubella titers were similar in both groups after vaccination, but lower in preterm than in term infants before vaccination. “This is consistent with lower transplacental antibody transfer in the preterm infants, because the most likely source of detectable prevaccine antibodies would be maternal,” they explained.

The first rapid test for viral meningitis has been cleared for marketing by the Food and Drug Administration.

The Xpert EV test (Cepheid, Sunnyvale, Calif.)—which was released in Europe last summer—can help identify viral meningitis within 2.5 hours instead of the current 3–7 days, thus helping physicians to distinguish quickly between the viral and bacterial forms of the infection, according to the FDA.

“Since bacterial meningitis can be deadly within as little as 2 days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard,” said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, in a written statement. By using the rapid test, physicians can reduce this unnecessary antibiotic treatment, he noted.

The Xpert EV test uses reverse-transcription real-time polymerase chain reaction to detect enterovirus, which is responsible for 85%–95% of viral meningitis, in cerebrospinal fluid (CSF). However, the test should not be used in isolation, said Dr. Steven Gutman, director of the FDA's Office of In Vitro Diagnostics. “It is not intended that this test would be the sole determinant. It is an adjunctive test.” he said in an interview.

Indeed, according to the company, the test is designed to be used in conjunction “with standard CSF tests [such as] bacterial Gram stain, bacterial culture, CSF glucose, CSF-blood glucose ratio, CSF protein concentrations, and CSF leukocyte counts.” It “fills a clinical testing void,” because it is a fully automated test, thereby allowing “round-the-clock” testing, Cepheid said in a written statement.

The first rapid test for viral meningitis has been cleared for marketing by the Food and Drug Administration.

The Xpert EV test (Cepheid, Sunnyvale, Calif.)—which was released in Europe last summer—can help identify viral meningitis within 2.5 hours instead of the current 3–7 days, thus helping physicians to distinguish quickly between the viral and bacterial forms of the infection, according to the FDA.

“Since bacterial meningitis can be deadly within as little as 2 days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard,” said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, in a written statement. By using the rapid test, physicians can reduce this unnecessary antibiotic treatment, he noted.

The Xpert EV test uses reverse-transcription real-time polymerase chain reaction to detect enterovirus, which is responsible for 85%–95% of viral meningitis, in cerebrospinal fluid (CSF). However, the test should not be used in isolation, said Dr. Steven Gutman, director of the FDA's Office of In Vitro Diagnostics. “It is not intended that this test would be the sole determinant. It is an adjunctive test.” he said in an interview.

Indeed, according to the company, the test is designed to be used in conjunction “with standard CSF tests [such as] bacterial Gram stain, bacterial culture, CSF glucose, CSF-blood glucose ratio, CSF protein concentrations, and CSF leukocyte counts.” It “fills a clinical testing void,” because it is a fully automated test, thereby allowing “round-the-clock” testing, Cepheid said in a written statement.

The first rapid test for viral meningitis has been cleared for marketing by the Food and Drug Administration.

The Xpert EV test (Cepheid, Sunnyvale, Calif.)—which was released in Europe last summer—can help identify viral meningitis within 2.5 hours instead of the current 3–7 days, thus helping physicians to distinguish quickly between the viral and bacterial forms of the infection, according to the FDA.

“Since bacterial meningitis can be deadly within as little as 2 days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard,” said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, in a written statement. By using the rapid test, physicians can reduce this unnecessary antibiotic treatment, he noted.

The Xpert EV test uses reverse-transcription real-time polymerase chain reaction to detect enterovirus, which is responsible for 85%–95% of viral meningitis, in cerebrospinal fluid (CSF). However, the test should not be used in isolation, said Dr. Steven Gutman, director of the FDA's Office of In Vitro Diagnostics. “It is not intended that this test would be the sole determinant. It is an adjunctive test.” he said in an interview.

Indeed, according to the company, the test is designed to be used in conjunction “with standard CSF tests [such as] bacterial Gram stain, bacterial culture, CSF glucose, CSF-blood glucose ratio, CSF protein concentrations, and CSF leukocyte counts.” It “fills a clinical testing void,” because it is a fully automated test, thereby allowing “round-the-clock” testing, Cepheid said in a written statement.

HOUSTON — Women with Crohn's disease can sometimes present with knifelike vulvar ulcers that are very specific to the disorder and may be its only manifestation, according to several experts who spoke at a conference on vulvovaginal diseases jointly sponsored by Baylor College of Medicine and the Methodist Hospital.

“There are three things in the vulvar or perianal area that might make you think of unrecognized Crohn's: knifelike ulcerations, vulvar edema that has no other cause, or fistula around the anus,” said Dr. Libby Edwards, a dermatologist in private practice in Charlotte, N.C. “It has been said that vulvar Crohn's is rare, but it is not. It's uncommon but it's not rare. I see it several times a year, and most gynecologists will see it without necessarily recognizing what it is,” she said in an interview.

While for some patients, vulvar signs may be the first presentation of Crohn's, this tends to be the exception, said Dr. Hope K. Haefner, professor of obstetrics and gynecology at the University of Michigan and director of the university's Center for Vulvar Diseases in Ann Arbor.

“There is the rare patient who doesn't have any gastrointestinal symptoms and might develop them later, but usually the majority already have a diagnosis of gastrointestinal Crohn's and are seeking gynecologic care for their vulvar symptoms,” she said in an interview. In her opinion, perianal fistulae may be the most common of the three gynecologic manifestations of Crohn's. “I see them every couple of months, in children and in the elderly—there's a big age range,” she said.

Vulvar and perianal Crohn's is a marker for severe disease that needs to be aggressively treated systemically, said Dr. Edwards, also of the department of dermatology at the University of North Carolina at Chapel Hill. “First of all, if [these patients] don't have an aggressive gastroenterologist, they really need one,” she said, adding that aggressive systemic treatment for Crohn's might relieve some vulvar symptoms. But, she said, patients also need local vulvar care. “These patients get secondary infections, and when they do, they need oral antibiotics—maybe even on a long-term basis if they have open, draining sores.” In addition, both oral antibiotics and immunosuppressive therapy for Crohn's can make patients susceptible to yeast infections, which may require weekly antifungal therapy, she said.

HOUSTON — Women with Crohn's disease can sometimes present with knifelike vulvar ulcers that are very specific to the disorder and may be its only manifestation, according to several experts who spoke at a conference on vulvovaginal diseases jointly sponsored by Baylor College of Medicine and the Methodist Hospital.

“There are three things in the vulvar or perianal area that might make you think of unrecognized Crohn's: knifelike ulcerations, vulvar edema that has no other cause, or fistula around the anus,” said Dr. Libby Edwards, a dermatologist in private practice in Charlotte, N.C. “It has been said that vulvar Crohn's is rare, but it is not. It's uncommon but it's not rare. I see it several times a year, and most gynecologists will see it without necessarily recognizing what it is,” she said in an interview.

While for some patients, vulvar signs may be the first presentation of Crohn's, this tends to be the exception, said Dr. Hope K. Haefner, professor of obstetrics and gynecology at the University of Michigan and director of the university's Center for Vulvar Diseases in Ann Arbor.

“There is the rare patient who doesn't have any gastrointestinal symptoms and might develop them later, but usually the majority already have a diagnosis of gastrointestinal Crohn's and are seeking gynecologic care for their vulvar symptoms,” she said in an interview. In her opinion, perianal fistulae may be the most common of the three gynecologic manifestations of Crohn's. “I see them every couple of months, in children and in the elderly—there's a big age range,” she said.

Vulvar and perianal Crohn's is a marker for severe disease that needs to be aggressively treated systemically, said Dr. Edwards, also of the department of dermatology at the University of North Carolina at Chapel Hill. “First of all, if [these patients] don't have an aggressive gastroenterologist, they really need one,” she said, adding that aggressive systemic treatment for Crohn's might relieve some vulvar symptoms. But, she said, patients also need local vulvar care. “These patients get secondary infections, and when they do, they need oral antibiotics—maybe even on a long-term basis if they have open, draining sores.” In addition, both oral antibiotics and immunosuppressive therapy for Crohn's can make patients susceptible to yeast infections, which may require weekly antifungal therapy, she said.

HOUSTON — Women with Crohn's disease can sometimes present with knifelike vulvar ulcers that are very specific to the disorder and may be its only manifestation, according to several experts who spoke at a conference on vulvovaginal diseases jointly sponsored by Baylor College of Medicine and the Methodist Hospital.

“There are three things in the vulvar or perianal area that might make you think of unrecognized Crohn's: knifelike ulcerations, vulvar edema that has no other cause, or fistula around the anus,” said Dr. Libby Edwards, a dermatologist in private practice in Charlotte, N.C. “It has been said that vulvar Crohn's is rare, but it is not. It's uncommon but it's not rare. I see it several times a year, and most gynecologists will see it without necessarily recognizing what it is,” she said in an interview.

While for some patients, vulvar signs may be the first presentation of Crohn's, this tends to be the exception, said Dr. Hope K. Haefner, professor of obstetrics and gynecology at the University of Michigan and director of the university's Center for Vulvar Diseases in Ann Arbor.

“There is the rare patient who doesn't have any gastrointestinal symptoms and might develop them later, but usually the majority already have a diagnosis of gastrointestinal Crohn's and are seeking gynecologic care for their vulvar symptoms,” she said in an interview. In her opinion, perianal fistulae may be the most common of the three gynecologic manifestations of Crohn's. “I see them every couple of months, in children and in the elderly—there's a big age range,” she said.

Vulvar and perianal Crohn's is a marker for severe disease that needs to be aggressively treated systemically, said Dr. Edwards, also of the department of dermatology at the University of North Carolina at Chapel Hill. “First of all, if [these patients] don't have an aggressive gastroenterologist, they really need one,” she said, adding that aggressive systemic treatment for Crohn's might relieve some vulvar symptoms. But, she said, patients also need local vulvar care. “These patients get secondary infections, and when they do, they need oral antibiotics—maybe even on a long-term basis if they have open, draining sores.” In addition, both oral antibiotics and immunosuppressive therapy for Crohn's can make patients susceptible to yeast infections, which may require weekly antifungal therapy, she said.

Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.

The guidelines were drafted by the AAN's Therapeutics and Technology Assessment Subcommittee, based on a literature review (Neurology 2007;68:723–9).

From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.

Dr. Armon and colleagues said all four studies were consistent in their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”

“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.

Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.

“I think the risk-benefit ratio [is important],” Dr. David Borenstein, clinical professor of rheumatology at George Washington University and a rheumatologist specializing in low back pain, said in an interview. “People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient.”

“Epidural steroid injections are likely overused,” said Dr. J. D. Bartleson, a neurologist at the spine center of the Mayo Clinic in Rochester, Minn. “There is bias that they are extremely helpful, which is not borne out by the data,” he said in an interview. “I hope neurologists … will gain a better understanding of the modest help that epidural injections can provide.”

Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.

The guidelines were drafted by the AAN's Therapeutics and Technology Assessment Subcommittee, based on a literature review (Neurology 2007;68:723–9).

From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.

Dr. Armon and colleagues said all four studies were consistent in their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”

“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.

Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.

“I think the risk-benefit ratio [is important],” Dr. David Borenstein, clinical professor of rheumatology at George Washington University and a rheumatologist specializing in low back pain, said in an interview. “People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient.”

“Epidural steroid injections are likely overused,” said Dr. J. D. Bartleson, a neurologist at the spine center of the Mayo Clinic in Rochester, Minn. “There is bias that they are extremely helpful, which is not borne out by the data,” he said in an interview. “I hope neurologists … will gain a better understanding of the modest help that epidural injections can provide.”

Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.

The guidelines were drafted by the AAN's Therapeutics and Technology Assessment Subcommittee, based on a literature review (Neurology 2007;68:723–9).

From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.

Dr. Armon and colleagues said all four studies were consistent in their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”

“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.

Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.

“I think the risk-benefit ratio [is important],” Dr. David Borenstein, clinical professor of rheumatology at George Washington University and a rheumatologist specializing in low back pain, said in an interview. “People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient.”

“Epidural steroid injections are likely overused,” said Dr. J. D. Bartleson, a neurologist at the spine center of the Mayo Clinic in Rochester, Minn. “There is bias that they are extremely helpful, which is not borne out by the data,” he said in an interview. “I hope neurologists … will gain a better understanding of the modest help that epidural injections can provide.”

NEW YORK — Symptomatic celiac disease is a clear indication for treatment with a gluten-free diet, but debate about the necessity of diagnosing and treating asymptomatic disease was lively at an international symposium on celiac disease.

“If we are going to diagnose this disease [in asymptomatic people], we have to be certain it will be of benefit,” said Dr. Richard Logan of the University of Nottingham (England).

Experts believe that diagnosed, symptomatic celiac disease represents only the tip of the iceberg of gluten sensitivity, while below the waterline is a spectrum of asymptomatic disease, which includes people with positive serology and histology (silent disease), as well as those with positive serology but negative histology (latent disease).

Such asymptomatic patients are often diagnosed during family screening, because it is now recognized that genetic predisposition plays an important role in the development of the disorder; almost all celiac patients carry the DQ2 or DQ8 genes.

But the uncertain clinical benefit of labeling asymptomatic individuals and prescribing them a lifelong gluten-free diet should be carefully weighed against the potential psychological and economic risks, warned several experts at the meeting, which was cosponsored by the AGA Institute.

Reducing Long-Term Risk

A gluten-free diet can dramatically reduce or eliminate symptoms, and this treatment has also been considered protective against the increased risks of malignancy and osteoporosis that have been associated with celiac disease—even its asymptomatic form. However, new research suggests that these long-term risks might be lower than previously believed, said Dr. Joe West of the University of Nottingham (England).

His study of almost 5,000 treated celiac patients and more than 23,000 controls revealed a 30% increase in overall malignancies among the celiac patients (BMJ 2004;329:716–9), but a closer analysis revealed a detection bias in that most cancers were diagnosed in the first year after the celiac diagnosis.

After controlling for this phenomenon, the difference in overall cancer rate between the two groups was no longer significant. However, further analysis of individual cancers did reveal a fivefold increase in non-Hodgkin's lymphoma among the celiac patients, and a 40-fold increase in small bowel lymphoma (Aliment. Pharmacol. Ther. 2004;20:769–75). Interestingly, breast cancers were 70% less common in the celiac population. “This is a pretty robust and intriguing finding for which I have no explanation,” Dr. West said.

His research also found a 30% increase in osteoporosis among celiac patients, with a twofold increase in hip fracture; however, the absolute risk remained small. These results were restricted to diagnosed celiac patients who were being treated with a gluten-free diet, and therefore their relevance for undiagnosed, untreated individuals is not clear, he said. “One way to look at it is to say that in an untreated group the risks could be much higher. The other way of looking at it is to say that people with undetected celiac may have less severe disease and therefore perhaps less risk,” he said.

Another argument for screening and treating asymptomatic celiac disease comes from evidence that it might progress to overt disease with continued gluten exposure, other experts said. Early treatment with a gluten-free diet could halt the progression from latent to silent and then to symptomatic disease, they suggested, although this is still widely debated.

The Psychological Toll

But the psychological price of a lifelong gluten-free diet is often underappreciated by physicians who prescribe it, Dr. Logan said. A recent survey of patients diagnosed with celiac disease revealed that one-third felt the gluten-free diet greatly reduced their enjoyment of food, and a quarter were not entirely pleased to have been diagnosed, he said. Despite experiencing relief of symptoms, many celiac patients (particularly women) on a gluten-free diet report a reduced quality of life, according to research by Dr. Claes Hallert of Linköping (Sweden) University.

“We used to say celiac was a very treatable disorder, but that is not entirely true,” he said in an interview. “Many patients react psychologically to the restrictive diet—there are social problems, societal problems, problems at work, problems with travel—and this may lead to depression.”

In a study of 40 celiac patients, his research group identified 195 situational dilemmas faced by patients dealing with a gluten-free diet. Specific emotions that were identified included isolation, shame, fear of gluten, and worry about inconveniencing others. Patients also reported unwanted visibility, neglect, disclosure avoidance, and risk-taking, as well as restrictions on food choice and extra work involved in food preparation (J. Hum. Nutr. Diet. 2005;18:171–80).

Such barriers might be important contributors to noncompliance with the diet, suggested Dr. Carolina Ciacci, whose research showed that anger is the predominant emotion in roughly 40% of diagnosed patients (Dig. Dis. Sci. 2002;47:2082–7). Between 45% and 75% of patients report strict adherence to the diet, she said.

NEW YORK — Symptomatic celiac disease is a clear indication for treatment with a gluten-free diet, but debate about the necessity of diagnosing and treating asymptomatic disease was lively at an international symposium on celiac disease.

“If we are going to diagnose this disease [in asymptomatic people], we have to be certain it will be of benefit,” said Dr. Richard Logan of the University of Nottingham (England).

Experts believe that diagnosed, symptomatic celiac disease represents only the tip of the iceberg of gluten sensitivity, while below the waterline is a spectrum of asymptomatic disease, which includes people with positive serology and histology (silent disease), as well as those with positive serology but negative histology (latent disease).

Such asymptomatic patients are often diagnosed during family screening, because it is now recognized that genetic predisposition plays an important role in the development of the disorder; almost all celiac patients carry the DQ2 or DQ8 genes.

But the uncertain clinical benefit of labeling asymptomatic individuals and prescribing them a lifelong gluten-free diet should be carefully weighed against the potential psychological and economic risks, warned several experts at the meeting, which was cosponsored by the AGA Institute.

Reducing Long-Term Risk

A gluten-free diet can dramatically reduce or eliminate symptoms, and this treatment has also been considered protective against the increased risks of malignancy and osteoporosis that have been associated with celiac disease—even its asymptomatic form. However, new research suggests that these long-term risks might be lower than previously believed, said Dr. Joe West of the University of Nottingham (England).

His study of almost 5,000 treated celiac patients and more than 23,000 controls revealed a 30% increase in overall malignancies among the celiac patients (BMJ 2004;329:716–9), but a closer analysis revealed a detection bias in that most cancers were diagnosed in the first year after the celiac diagnosis.

After controlling for this phenomenon, the difference in overall cancer rate between the two groups was no longer significant. However, further analysis of individual cancers did reveal a fivefold increase in non-Hodgkin's lymphoma among the celiac patients, and a 40-fold increase in small bowel lymphoma (Aliment. Pharmacol. Ther. 2004;20:769–75). Interestingly, breast cancers were 70% less common in the celiac population. “This is a pretty robust and intriguing finding for which I have no explanation,” Dr. West said.

His research also found a 30% increase in osteoporosis among celiac patients, with a twofold increase in hip fracture; however, the absolute risk remained small. These results were restricted to diagnosed celiac patients who were being treated with a gluten-free diet, and therefore their relevance for undiagnosed, untreated individuals is not clear, he said. “One way to look at it is to say that in an untreated group the risks could be much higher. The other way of looking at it is to say that people with undetected celiac may have less severe disease and therefore perhaps less risk,” he said.

Another argument for screening and treating asymptomatic celiac disease comes from evidence that it might progress to overt disease with continued gluten exposure, other experts said. Early treatment with a gluten-free diet could halt the progression from latent to silent and then to symptomatic disease, they suggested, although this is still widely debated.

The Psychological Toll

But the psychological price of a lifelong gluten-free diet is often underappreciated by physicians who prescribe it, Dr. Logan said. A recent survey of patients diagnosed with celiac disease revealed that one-third felt the gluten-free diet greatly reduced their enjoyment of food, and a quarter were not entirely pleased to have been diagnosed, he said. Despite experiencing relief of symptoms, many celiac patients (particularly women) on a gluten-free diet report a reduced quality of life, according to research by Dr. Claes Hallert of Linköping (Sweden) University.

“We used to say celiac was a very treatable disorder, but that is not entirely true,” he said in an interview. “Many patients react psychologically to the restrictive diet—there are social problems, societal problems, problems at work, problems with travel—and this may lead to depression.”

In a study of 40 celiac patients, his research group identified 195 situational dilemmas faced by patients dealing with a gluten-free diet. Specific emotions that were identified included isolation, shame, fear of gluten, and worry about inconveniencing others. Patients also reported unwanted visibility, neglect, disclosure avoidance, and risk-taking, as well as restrictions on food choice and extra work involved in food preparation (J. Hum. Nutr. Diet. 2005;18:171–80).

Such barriers might be important contributors to noncompliance with the diet, suggested Dr. Carolina Ciacci, whose research showed that anger is the predominant emotion in roughly 40% of diagnosed patients (Dig. Dis. Sci. 2002;47:2082–7). Between 45% and 75% of patients report strict adherence to the diet, she said.

NEW YORK — Symptomatic celiac disease is a clear indication for treatment with a gluten-free diet, but debate about the necessity of diagnosing and treating asymptomatic disease was lively at an international symposium on celiac disease.

“If we are going to diagnose this disease [in asymptomatic people], we have to be certain it will be of benefit,” said Dr. Richard Logan of the University of Nottingham (England).

Experts believe that diagnosed, symptomatic celiac disease represents only the tip of the iceberg of gluten sensitivity, while below the waterline is a spectrum of asymptomatic disease, which includes people with positive serology and histology (silent disease), as well as those with positive serology but negative histology (latent disease).

Such asymptomatic patients are often diagnosed during family screening, because it is now recognized that genetic predisposition plays an important role in the development of the disorder; almost all celiac patients carry the DQ2 or DQ8 genes.

But the uncertain clinical benefit of labeling asymptomatic individuals and prescribing them a lifelong gluten-free diet should be carefully weighed against the potential psychological and economic risks, warned several experts at the meeting, which was cosponsored by the AGA Institute.

Reducing Long-Term Risk

A gluten-free diet can dramatically reduce or eliminate symptoms, and this treatment has also been considered protective against the increased risks of malignancy and osteoporosis that have been associated with celiac disease—even its asymptomatic form. However, new research suggests that these long-term risks might be lower than previously believed, said Dr. Joe West of the University of Nottingham (England).

His study of almost 5,000 treated celiac patients and more than 23,000 controls revealed a 30% increase in overall malignancies among the celiac patients (BMJ 2004;329:716–9), but a closer analysis revealed a detection bias in that most cancers were diagnosed in the first year after the celiac diagnosis.

After controlling for this phenomenon, the difference in overall cancer rate between the two groups was no longer significant. However, further analysis of individual cancers did reveal a fivefold increase in non-Hodgkin's lymphoma among the celiac patients, and a 40-fold increase in small bowel lymphoma (Aliment. Pharmacol. Ther. 2004;20:769–75). Interestingly, breast cancers were 70% less common in the celiac population. “This is a pretty robust and intriguing finding for which I have no explanation,” Dr. West said.

His research also found a 30% increase in osteoporosis among celiac patients, with a twofold increase in hip fracture; however, the absolute risk remained small. These results were restricted to diagnosed celiac patients who were being treated with a gluten-free diet, and therefore their relevance for undiagnosed, untreated individuals is not clear, he said. “One way to look at it is to say that in an untreated group the risks could be much higher. The other way of looking at it is to say that people with undetected celiac may have less severe disease and therefore perhaps less risk,” he said.

Another argument for screening and treating asymptomatic celiac disease comes from evidence that it might progress to overt disease with continued gluten exposure, other experts said. Early treatment with a gluten-free diet could halt the progression from latent to silent and then to symptomatic disease, they suggested, although this is still widely debated.

The Psychological Toll

But the psychological price of a lifelong gluten-free diet is often underappreciated by physicians who prescribe it, Dr. Logan said. A recent survey of patients diagnosed with celiac disease revealed that one-third felt the gluten-free diet greatly reduced their enjoyment of food, and a quarter were not entirely pleased to have been diagnosed, he said. Despite experiencing relief of symptoms, many celiac patients (particularly women) on a gluten-free diet report a reduced quality of life, according to research by Dr. Claes Hallert of Linköping (Sweden) University.

“We used to say celiac was a very treatable disorder, but that is not entirely true,” he said in an interview. “Many patients react psychologically to the restrictive diet—there are social problems, societal problems, problems at work, problems with travel—and this may lead to depression.”

In a study of 40 celiac patients, his research group identified 195 situational dilemmas faced by patients dealing with a gluten-free diet. Specific emotions that were identified included isolation, shame, fear of gluten, and worry about inconveniencing others. Patients also reported unwanted visibility, neglect, disclosure avoidance, and risk-taking, as well as restrictions on food choice and extra work involved in food preparation (J. Hum. Nutr. Diet. 2005;18:171–80).

Such barriers might be important contributors to noncompliance with the diet, suggested Dr. Carolina Ciacci, whose research showed that anger is the predominant emotion in roughly 40% of diagnosed patients (Dig. Dis. Sci. 2002;47:2082–7). Between 45% and 75% of patients report strict adherence to the diet, she said.

Physicians need a stronger message about the cardiac risks of treating chronic pain with anti-inflammatory drugs, both traditional NSAIDs and cyclooxygenase-2 inhibitors, according to Dr. Elliott M. Antman and his colleagues.

“We believe that some physicians have been prescribing COX-2 inhibitors as the first line of treatment. … For chronic pain in patients with known heart disease or who are at risk for heart disease, these drugs should be the last line of treatment,” they said in a statement.

“I wish I could say to you that everybody has got the message correctly and is now modifying the way they practice, but unfortunately we don't believe that is the case,” Dr. Antman, lead author of the statement, said in an interview. He added that this approach should be adopted even for patients with no known heart risks, and that caution should be extended to all NSAIDs. “The regulatory authorities have now put black box warnings on all NSAIDs, except aspirin, and even today many physicians are not aware [the warnings] exist.”

The American Heart Association statement updates the 2005 statement and reflects this new information, said Dr. Antman, professor of medicine at Harvard Medical School, Boston. But the document, coauthored by six cardiologists, might not sit so comfortably with physicians who treat chronic pain on a regular basis.

“The point they're making, which I agree with, is that you have to be cautious. But that doesn't mean we can't use these medications judiciously and appropriately. They're looking at it from the cardiologist's view when it's the rheumatologists who are sitting with the patient who is in pain,” said Dr. Roland Moskowitz, a rheumatologist and professor of medicine at Case Western Reserve University, Cleveland, in an interview.

The AHA document outlines a stepped-care approach to the pharmacologic treatment of musculoskeletal pain in patients with known cardiovascular disease or risk factors, starting with agents with the lowest cardiac risk. “When acetaminophen, aspirin, and perhaps even narcotic medications (for acute pain) are not effective, tolerated, or appropriate, it may be reasonable to consider an NSAID as the next step; however, this should be coupled with the realization that effective pain relief may come at the cost of a small but real increase in risk for cardiovascular or cerebrovascular complications,” wrote Dr. Antman and his colleagues (Circulation 2007 Feb. 26 [Epub doi:10.1161/CIRCULATIONAHA.106.181424]).

They noted that “if symptoms are not adequately controlled by a nonselective NSAID, subsequent steps involve prescription of drugs with increasing degrees of COX-2 inhibitory activity, ultimately concluding with the COX-2 selective NSAIDs.”

Dr. Moskowitz said that most rheumatologists are already well aware of NSAIDs' cardiac risks, but they must also consider gastrointestinal risks and pain control: “You could be very nihilistic and say to the patient 'there's nothing I can give you that's safe' and let them walk out with pain, but that doesn't make sense. [Physicians] are frightening people away from using these things when they need to use them.”

The American College of Rheumatology's NSAID guidelines have not yet been updated to reflect recent concerns about cardiovascular risk (Arthritis Rheum. 2000;43:1905–15). But the Osteoarthritis Research Society International's guidelines committee, of which Dr. Moskowitz is cochair, is expected to release its recommendations on osteoarthritis management soon. Dr. Moskowitz doesn't expect these guidelines to be as targeted as the AHA statement: “There are no absolute algorithms. … At low doses, some COX-2 selective inhibitors may have no greater cardiovascular risk than other NSAIDs.”

Dr. Antman and his colleagues disclosed no potential conflicts of interest. Dr. Moskowitz has served as a consultant for Pfizer Inc., Novartis, Merck & Co., GlaxoSmithKline Inc., and Sanofi Aventis.

In patients with known heart disease or at risk for heart disease, COX-2 inhibitors should be the last line of treatment. DR. ANTMAN

Physicians need a stronger message about the cardiac risks of treating chronic pain with anti-inflammatory drugs, both traditional NSAIDs and cyclooxygenase-2 inhibitors, according to Dr. Elliott M. Antman and his colleagues.

“We believe that some physicians have been prescribing COX-2 inhibitors as the first line of treatment. … For chronic pain in patients with known heart disease or who are at risk for heart disease, these drugs should be the last line of treatment,” they said in a statement.

“I wish I could say to you that everybody has got the message correctly and is now modifying the way they practice, but unfortunately we don't believe that is the case,” Dr. Antman, lead author of the statement, said in an interview. He added that this approach should be adopted even for patients with no known heart risks, and that caution should be extended to all NSAIDs. “The regulatory authorities have now put black box warnings on all NSAIDs, except aspirin, and even today many physicians are not aware [the warnings] exist.”

The American Heart Association statement updates the 2005 statement and reflects this new information, said Dr. Antman, professor of medicine at Harvard Medical School, Boston. But the document, coauthored by six cardiologists, might not sit so comfortably with physicians who treat chronic pain on a regular basis.

“The point they're making, which I agree with, is that you have to be cautious. But that doesn't mean we can't use these medications judiciously and appropriately. They're looking at it from the cardiologist's view when it's the rheumatologists who are sitting with the patient who is in pain,” said Dr. Roland Moskowitz, a rheumatologist and professor of medicine at Case Western Reserve University, Cleveland, in an interview.

The AHA document outlines a stepped-care approach to the pharmacologic treatment of musculoskeletal pain in patients with known cardiovascular disease or risk factors, starting with agents with the lowest cardiac risk. “When acetaminophen, aspirin, and perhaps even narcotic medications (for acute pain) are not effective, tolerated, or appropriate, it may be reasonable to consider an NSAID as the next step; however, this should be coupled with the realization that effective pain relief may come at the cost of a small but real increase in risk for cardiovascular or cerebrovascular complications,” wrote Dr. Antman and his colleagues (Circulation 2007 Feb. 26 [Epub doi:10.1161/CIRCULATIONAHA.106.181424]).

They noted that “if symptoms are not adequately controlled by a nonselective NSAID, subsequent steps involve prescription of drugs with increasing degrees of COX-2 inhibitory activity, ultimately concluding with the COX-2 selective NSAIDs.”

Dr. Moskowitz said that most rheumatologists are already well aware of NSAIDs' cardiac risks, but they must also consider gastrointestinal risks and pain control: “You could be very nihilistic and say to the patient 'there's nothing I can give you that's safe' and let them walk out with pain, but that doesn't make sense. [Physicians] are frightening people away from using these things when they need to use them.”

The American College of Rheumatology's NSAID guidelines have not yet been updated to reflect recent concerns about cardiovascular risk (Arthritis Rheum. 2000;43:1905–15). But the Osteoarthritis Research Society International's guidelines committee, of which Dr. Moskowitz is cochair, is expected to release its recommendations on osteoarthritis management soon. Dr. Moskowitz doesn't expect these guidelines to be as targeted as the AHA statement: “There are no absolute algorithms. … At low doses, some COX-2 selective inhibitors may have no greater cardiovascular risk than other NSAIDs.”

Dr. Antman and his colleagues disclosed no potential conflicts of interest. Dr. Moskowitz has served as a consultant for Pfizer Inc., Novartis, Merck & Co., GlaxoSmithKline Inc., and Sanofi Aventis.

In patients with known heart disease or at risk for heart disease, COX-2 inhibitors should be the last line of treatment. DR. ANTMAN

Physicians need a stronger message about the cardiac risks of treating chronic pain with anti-inflammatory drugs, both traditional NSAIDs and cyclooxygenase-2 inhibitors, according to Dr. Elliott M. Antman and his colleagues.

“We believe that some physicians have been prescribing COX-2 inhibitors as the first line of treatment. … For chronic pain in patients with known heart disease or who are at risk for heart disease, these drugs should be the last line of treatment,” they said in a statement.

“I wish I could say to you that everybody has got the message correctly and is now modifying the way they practice, but unfortunately we don't believe that is the case,” Dr. Antman, lead author of the statement, said in an interview. He added that this approach should be adopted even for patients with no known heart risks, and that caution should be extended to all NSAIDs. “The regulatory authorities have now put black box warnings on all NSAIDs, except aspirin, and even today many physicians are not aware [the warnings] exist.”

The American Heart Association statement updates the 2005 statement and reflects this new information, said Dr. Antman, professor of medicine at Harvard Medical School, Boston. But the document, coauthored by six cardiologists, might not sit so comfortably with physicians who treat chronic pain on a regular basis.

“The point they're making, which I agree with, is that you have to be cautious. But that doesn't mean we can't use these medications judiciously and appropriately. They're looking at it from the cardiologist's view when it's the rheumatologists who are sitting with the patient who is in pain,” said Dr. Roland Moskowitz, a rheumatologist and professor of medicine at Case Western Reserve University, Cleveland, in an interview.

The AHA document outlines a stepped-care approach to the pharmacologic treatment of musculoskeletal pain in patients with known cardiovascular disease or risk factors, starting with agents with the lowest cardiac risk. “When acetaminophen, aspirin, and perhaps even narcotic medications (for acute pain) are not effective, tolerated, or appropriate, it may be reasonable to consider an NSAID as the next step; however, this should be coupled with the realization that effective pain relief may come at the cost of a small but real increase in risk for cardiovascular or cerebrovascular complications,” wrote Dr. Antman and his colleagues (Circulation 2007 Feb. 26 [Epub doi:10.1161/CIRCULATIONAHA.106.181424]).

They noted that “if symptoms are not adequately controlled by a nonselective NSAID, subsequent steps involve prescription of drugs with increasing degrees of COX-2 inhibitory activity, ultimately concluding with the COX-2 selective NSAIDs.”

Dr. Moskowitz said that most rheumatologists are already well aware of NSAIDs' cardiac risks, but they must also consider gastrointestinal risks and pain control: “You could be very nihilistic and say to the patient 'there's nothing I can give you that's safe' and let them walk out with pain, but that doesn't make sense. [Physicians] are frightening people away from using these things when they need to use them.”

The American College of Rheumatology's NSAID guidelines have not yet been updated to reflect recent concerns about cardiovascular risk (Arthritis Rheum. 2000;43:1905–15). But the Osteoarthritis Research Society International's guidelines committee, of which Dr. Moskowitz is cochair, is expected to release its recommendations on osteoarthritis management soon. Dr. Moskowitz doesn't expect these guidelines to be as targeted as the AHA statement: “There are no absolute algorithms. … At low doses, some COX-2 selective inhibitors may have no greater cardiovascular risk than other NSAIDs.”

Dr. Antman and his colleagues disclosed no potential conflicts of interest. Dr. Moskowitz has served as a consultant for Pfizer Inc., Novartis, Merck & Co., GlaxoSmithKline Inc., and Sanofi Aventis.

In patients with known heart disease or at risk for heart disease, COX-2 inhibitors should be the last line of treatment. DR. ANTMAN

Diabetologists and cardiologists are joining forces to address the issue of cardiovascular disease in patients with diabetes.

In North America, new joint guidelines from the American Heart Association (AHA) and the American Diabetes Association (ADA) focus on the primary prevention of cardiovascular disease in patients with diabetes (Circulation 2007;115:114–26; Diabetes Care 2007;30:162–72).

“People with … diabetes are at increased risk for [cardiovascular disease] and have worse outcomes after surviving a CVD event,” wrote coauthor Dr. John Buse, director of the diabetes care center at the University of North Carolina, Chapel Hill, and his colleagues. And in Europe, the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC) have issued guidelines on diabetes, prediabetes, and cardiovascular diseases (Eur. Heart J. 2007;28:88–136).

The North American and European documents focus on different aspects of the diabetes-cardiovascular disease dyad, making them potentially complementary documents. In both documents, special attention is placed on the early stages of disease, but the European document focuses on the role of prediabetes in early cardiovascular dysfunction, while the North American document emphasizes primary prevention of cardiovascular disease in patients with overt diabetes.

The joint ADA/AHA guidelines “encourage more aggressive prevention and treatment of risk factors that lead to heart disease” in people with diabetes, according to a statement from the two organizations.

“Patients with diabetes have twice the risk of incident myocardial infarction and stroke as that of the general population,” they say. “Furthermore, large numbers of people with diabetes do not survive their first event, and if they do survive, their [mortality] over the subsequent months to years is generally greater than that of the general population. As many as 80% of patients with type 2 diabetes will develop and possibly die of macrovascular disease.”

While continuing to encourage lifestyle changes—such as weight loss, improved nutrition, and physical activity—the joint statement also emphasizes the importance of medical interventions to manage lipids, blood pressure, and blood glucose in this population.

The importance of the ADA/AHA document is not so much its content, but rather “that these two organizations are agreeing to a joint statement on primary prevention of cardiovascular disease in diabetes,” commented Dr. Daniel Einhorn, medical director of the Scripps Whittier Institute for Diabetes, an endocrinologist at the University of California, San Diego, and a spokesperson for the American Association of Clinical Endocrinologists.

Cooperation between the ADA and AHA is, for both organizations, a hurdle crossed after some much publicized disagreement last year, Dr. Buse acknowledged in an interview. “This paper was an effort to get together and hammer out where the common ground is in the few areas where there were fairly nuanced differences in approach.”

The main issue of contention between the ADA and AHA has been the debate over whether metabolic syndrome exists.

In the joint statement, they have agreed to disagree: “The AHA and the [National Heart, Lung, and Blood Institute] have issued a statement on management of the metabolic syndrome and maintain that with regard to risk for CVD, the metabolic syndrome and type 2 diabetes can coexist in one person. The ADA, in contrast, contends that once type 2 diabetes is present, the metabolic syndrome no longer pertains because CVD risk factors characteristic of the metabolic syndrome are largely subsumed in the type 2 diabetes syndrome,” they wrote.

The full text of the guidelines can be viewed at http://care.diabetesjournals.org/cgi/content/full/30/1/162

It was an effort to hammer out the common ground in the few areas in which there were fairly nuanced differences. DR. BUSE

Diabetologists and cardiologists are joining forces to address the issue of cardiovascular disease in patients with diabetes.

In North America, new joint guidelines from the American Heart Association (AHA) and the American Diabetes Association (ADA) focus on the primary prevention of cardiovascular disease in patients with diabetes (Circulation 2007;115:114–26; Diabetes Care 2007;30:162–72).

“People with … diabetes are at increased risk for [cardiovascular disease] and have worse outcomes after surviving a CVD event,” wrote coauthor Dr. John Buse, director of the diabetes care center at the University of North Carolina, Chapel Hill, and his colleagues. And in Europe, the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC) have issued guidelines on diabetes, prediabetes, and cardiovascular diseases (Eur. Heart J. 2007;28:88–136).

The North American and European documents focus on different aspects of the diabetes-cardiovascular disease dyad, making them potentially complementary documents. In both documents, special attention is placed on the early stages of disease, but the European document focuses on the role of prediabetes in early cardiovascular dysfunction, while the North American document emphasizes primary prevention of cardiovascular disease in patients with overt diabetes.

The joint ADA/AHA guidelines “encourage more aggressive prevention and treatment of risk factors that lead to heart disease” in people with diabetes, according to a statement from the two organizations.

“Patients with diabetes have twice the risk of incident myocardial infarction and stroke as that of the general population,” they say. “Furthermore, large numbers of people with diabetes do not survive their first event, and if they do survive, their [mortality] over the subsequent months to years is generally greater than that of the general population. As many as 80% of patients with type 2 diabetes will develop and possibly die of macrovascular disease.”

While continuing to encourage lifestyle changes—such as weight loss, improved nutrition, and physical activity—the joint statement also emphasizes the importance of medical interventions to manage lipids, blood pressure, and blood glucose in this population.

The importance of the ADA/AHA document is not so much its content, but rather “that these two organizations are agreeing to a joint statement on primary prevention of cardiovascular disease in diabetes,” commented Dr. Daniel Einhorn, medical director of the Scripps Whittier Institute for Diabetes, an endocrinologist at the University of California, San Diego, and a spokesperson for the American Association of Clinical Endocrinologists.

Cooperation between the ADA and AHA is, for both organizations, a hurdle crossed after some much publicized disagreement last year, Dr. Buse acknowledged in an interview. “This paper was an effort to get together and hammer out where the common ground is in the few areas where there were fairly nuanced differences in approach.”

The main issue of contention between the ADA and AHA has been the debate over whether metabolic syndrome exists.

In the joint statement, they have agreed to disagree: “The AHA and the [National Heart, Lung, and Blood Institute] have issued a statement on management of the metabolic syndrome and maintain that with regard to risk for CVD, the metabolic syndrome and type 2 diabetes can coexist in one person. The ADA, in contrast, contends that once type 2 diabetes is present, the metabolic syndrome no longer pertains because CVD risk factors characteristic of the metabolic syndrome are largely subsumed in the type 2 diabetes syndrome,” they wrote.

The full text of the guidelines can be viewed at http://care.diabetesjournals.org/cgi/content/full/30/1/162

It was an effort to hammer out the common ground in the few areas in which there were fairly nuanced differences. DR. BUSE

Diabetologists and cardiologists are joining forces to address the issue of cardiovascular disease in patients with diabetes.

In North America, new joint guidelines from the American Heart Association (AHA) and the American Diabetes Association (ADA) focus on the primary prevention of cardiovascular disease in patients with diabetes (Circulation 2007;115:114–26; Diabetes Care 2007;30:162–72).

“People with … diabetes are at increased risk for [cardiovascular disease] and have worse outcomes after surviving a CVD event,” wrote coauthor Dr. John Buse, director of the diabetes care center at the University of North Carolina, Chapel Hill, and his colleagues. And in Europe, the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC) have issued guidelines on diabetes, prediabetes, and cardiovascular diseases (Eur. Heart J. 2007;28:88–136).

The North American and European documents focus on different aspects of the diabetes-cardiovascular disease dyad, making them potentially complementary documents. In both documents, special attention is placed on the early stages of disease, but the European document focuses on the role of prediabetes in early cardiovascular dysfunction, while the North American document emphasizes primary prevention of cardiovascular disease in patients with overt diabetes.

The joint ADA/AHA guidelines “encourage more aggressive prevention and treatment of risk factors that lead to heart disease” in people with diabetes, according to a statement from the two organizations.

“Patients with diabetes have twice the risk of incident myocardial infarction and stroke as that of the general population,” they say. “Furthermore, large numbers of people with diabetes do not survive their first event, and if they do survive, their [mortality] over the subsequent months to years is generally greater than that of the general population. As many as 80% of patients with type 2 diabetes will develop and possibly die of macrovascular disease.”

While continuing to encourage lifestyle changes—such as weight loss, improved nutrition, and physical activity—the joint statement also emphasizes the importance of medical interventions to manage lipids, blood pressure, and blood glucose in this population.

The importance of the ADA/AHA document is not so much its content, but rather “that these two organizations are agreeing to a joint statement on primary prevention of cardiovascular disease in diabetes,” commented Dr. Daniel Einhorn, medical director of the Scripps Whittier Institute for Diabetes, an endocrinologist at the University of California, San Diego, and a spokesperson for the American Association of Clinical Endocrinologists.

Cooperation between the ADA and AHA is, for both organizations, a hurdle crossed after some much publicized disagreement last year, Dr. Buse acknowledged in an interview. “This paper was an effort to get together and hammer out where the common ground is in the few areas where there were fairly nuanced differences in approach.”

The main issue of contention between the ADA and AHA has been the debate over whether metabolic syndrome exists.

In the joint statement, they have agreed to disagree: “The AHA and the [National Heart, Lung, and Blood Institute] have issued a statement on management of the metabolic syndrome and maintain that with regard to risk for CVD, the metabolic syndrome and type 2 diabetes can coexist in one person. The ADA, in contrast, contends that once type 2 diabetes is present, the metabolic syndrome no longer pertains because CVD risk factors characteristic of the metabolic syndrome are largely subsumed in the type 2 diabetes syndrome,” they wrote.

The full text of the guidelines can be viewed at http://care.diabetesjournals.org/cgi/content/full/30/1/162

It was an effort to hammer out the common ground in the few areas in which there were fairly nuanced differences. DR. BUSE