Michele G. Sullivan

Posttraumatic stress disorder appears to have a significant relationship with the development of metabolic syndrome, Pia S. Heppner, Ph.D., and her colleagues have reported.

Their observational study of 253 male and female veterans found that the risk for metabolic syndrome increased by 1% for each point scored on the Clinician Administered PTSD Scale (CAPS). The association between the disorders remained robust even after controlling for multiple demographic and medical factors, wrote Dr. Heppner of the Veterans Affairs San Diego Health Care System research service and her coauthors.

“The importance of the association becomes apparent when one considers the fact that metabolic syndrome has been shown to predict cardiovascular disease-related morbidity and mortality,” they wrote in BioMed Central Medicine (doi:10.1186/1741–7015–7–1).

The study subjects were mostly male (92%) and white (76%). Their mean age was 51 years; most of them (71%) had served in Vietnam. According to both the CAPS scale and DSM-IV diagnostic criteria, PTSD of at least moderate criteria was present in 55%, while another 24% expressed symptoms at a subthreshold level. An additional 64% had a current or past history of depression.

The overall prevalence of metabolic syndrome was 40%. Among those with PTSD only, 34% met the criteria for metabolic syndrome; the prevalence among those with major depressive disorder (MDD) was 29%. Prevalence was significantly higher in those with both disorders (46%).

A logistic regression analysis controlled for age, sex, race, education, drug and alcohol use/abuse, nicotine use, and a current or past diagnosis of MDD. The total CAPS score was a significant predictor of metabolic syndrome, but MDD was not, they wrote.

Dr. Heppner and her colleagues said that their findings are in line with previous studies in populations vulnerable to PTSD. For example, one study found that metabolic syndrome was three times more likely in police officers with severe PTSD symptoms, compared with officers in the “lowest PTSD severity category” (Int. J. Emerg. Mental Health 2006;8:227–37). Still, the current study “extends the current knowledge of PTSD and diminished health status.”

The study's cross-sectional design prevented Dr. Heppner and her colleagues from fully establishing a causal relationship between PTSD and metabolic syndrome. “Prospective studies are clearly needed in this area to fully examine the long-term health risk related to PTSD,” they wrote.

Posttraumatic stress disorder appears to have a significant relationship with the development of metabolic syndrome, Pia S. Heppner, Ph.D., and her colleagues have reported.

Their observational study of 253 male and female veterans found that the risk for metabolic syndrome increased by 1% for each point scored on the Clinician Administered PTSD Scale (CAPS). The association between the disorders remained robust even after controlling for multiple demographic and medical factors, wrote Dr. Heppner of the Veterans Affairs San Diego Health Care System research service and her coauthors.

“The importance of the association becomes apparent when one considers the fact that metabolic syndrome has been shown to predict cardiovascular disease-related morbidity and mortality,” they wrote in BioMed Central Medicine (doi:10.1186/1741–7015–7–1).

The study subjects were mostly male (92%) and white (76%). Their mean age was 51 years; most of them (71%) had served in Vietnam. According to both the CAPS scale and DSM-IV diagnostic criteria, PTSD of at least moderate criteria was present in 55%, while another 24% expressed symptoms at a subthreshold level. An additional 64% had a current or past history of depression.

The overall prevalence of metabolic syndrome was 40%. Among those with PTSD only, 34% met the criteria for metabolic syndrome; the prevalence among those with major depressive disorder (MDD) was 29%. Prevalence was significantly higher in those with both disorders (46%).

A logistic regression analysis controlled for age, sex, race, education, drug and alcohol use/abuse, nicotine use, and a current or past diagnosis of MDD. The total CAPS score was a significant predictor of metabolic syndrome, but MDD was not, they wrote.

Dr. Heppner and her colleagues said that their findings are in line with previous studies in populations vulnerable to PTSD. For example, one study found that metabolic syndrome was three times more likely in police officers with severe PTSD symptoms, compared with officers in the “lowest PTSD severity category” (Int. J. Emerg. Mental Health 2006;8:227–37). Still, the current study “extends the current knowledge of PTSD and diminished health status.”

The study's cross-sectional design prevented Dr. Heppner and her colleagues from fully establishing a causal relationship between PTSD and metabolic syndrome. “Prospective studies are clearly needed in this area to fully examine the long-term health risk related to PTSD,” they wrote.

Posttraumatic stress disorder appears to have a significant relationship with the development of metabolic syndrome, Pia S. Heppner, Ph.D., and her colleagues have reported.

Their observational study of 253 male and female veterans found that the risk for metabolic syndrome increased by 1% for each point scored on the Clinician Administered PTSD Scale (CAPS). The association between the disorders remained robust even after controlling for multiple demographic and medical factors, wrote Dr. Heppner of the Veterans Affairs San Diego Health Care System research service and her coauthors.

“The importance of the association becomes apparent when one considers the fact that metabolic syndrome has been shown to predict cardiovascular disease-related morbidity and mortality,” they wrote in BioMed Central Medicine (doi:10.1186/1741–7015–7–1).

The study subjects were mostly male (92%) and white (76%). Their mean age was 51 years; most of them (71%) had served in Vietnam. According to both the CAPS scale and DSM-IV diagnostic criteria, PTSD of at least moderate criteria was present in 55%, while another 24% expressed symptoms at a subthreshold level. An additional 64% had a current or past history of depression.

The overall prevalence of metabolic syndrome was 40%. Among those with PTSD only, 34% met the criteria for metabolic syndrome; the prevalence among those with major depressive disorder (MDD) was 29%. Prevalence was significantly higher in those with both disorders (46%).

A logistic regression analysis controlled for age, sex, race, education, drug and alcohol use/abuse, nicotine use, and a current or past diagnosis of MDD. The total CAPS score was a significant predictor of metabolic syndrome, but MDD was not, they wrote.

Dr. Heppner and her colleagues said that their findings are in line with previous studies in populations vulnerable to PTSD. For example, one study found that metabolic syndrome was three times more likely in police officers with severe PTSD symptoms, compared with officers in the “lowest PTSD severity category” (Int. J. Emerg. Mental Health 2006;8:227–37). Still, the current study “extends the current knowledge of PTSD and diminished health status.”

The study's cross-sectional design prevented Dr. Heppner and her colleagues from fully establishing a causal relationship between PTSD and metabolic syndrome. “Prospective studies are clearly needed in this area to fully examine the long-term health risk related to PTSD,” they wrote.

Within a decade, the United States won't have enough gastroenterologists to meet the demand for colorectal cancer screenings, given its burgeoning elderly population, a new study has found.

If the national screening rates remain stable, the country could be short 1,050 gastroenterologists (GIs) by 2020 because of the aging of the population, according to a study by the Lewin Group, a health care policy research and management consulting firm.

If screening rates increase by just 10% during the next decade, the shortfall will be as high as 1,550 gastroenterologists by 2020, said Tim Dall, the Lewin Group's vice president and the study's lead author.

“This shortage is absolutely going to impact our national ability to provide colorectal cancer screening,” Mr. Dall said in a teleconference sponsored by Olympus America Inc., one of the world's largest manufacturers of gastrointestinal endoscopes.

The shortage of GIs could also affect primary care physicians who perform colonoscopies because, Mr. Dall said, “if they're doing these screenings, then they are not providing other services that are also in high demand.”

“The confluence of an aging population, improvements in technology, fluxes in the economic milieu, and changes in disease prevalence/impact will act in concert to place new unprecedented pressure on GI service delivery,” said Dr. Patrick I. Okolo III, chief of endoscopy, division of gastroenterology, Johns Hopkins University, Baltimore. “A comprehensive, focused national approach to broaden the number and quality of physicians trained in gastroenterology will be necessary.”

Olympus commissioned the study to gather data to support its legislative push for a federally funded gastroenterology fellowship program, said F. Mark Gumz, president and CEO of Olympus America. The “GI Bill for GIs” would make up to $50 million available for fellowships over a 5-year period, with the goal of training 130 new gastroenterologists each year. “We have called for this federal legislation before, and now, with this new research, we are redoubling our efforts,” Mr. Gumz said at the teleconference.

Despite its name, the bill is not aimed at veterans, a company spokesperson pointed out. “Olympus refers to its proposed legislation as the GI Bill for GIs because of the service component in our proposal. Just as the GI Bill for soldiers provides education in exchange for service to the nation, our proposed GI Bill for GIs requires participants to provide service to their community, in the form of practicing in an underserved area. This is not intended to be simply a free scholarship.”

Although the bill has not been formally introduced, Mr. Gumz said Olympus has had preliminary discussions with Sen. Arlen Spector (R-Pa.) and Rep. Charlie Dent (R-Pa.).

The current supply of U.S. gastroenterologists who are active in patient care now hovers near 10,400, Mr. Dall said. Supply is projected to grow by just 10% (to about 11,460) by 2020. Even if there were no increase in the demand for screening, the supply of GIs would still be 250 short by 2020.

But national population estimates strongly suggest that demand for services will grow significantly. As the percentage of older patients increases, so will the need for routine screening. And, noted Mr. Dall, a proportion of these newly screened patients will have findings that place them in a higher-risk surveillance group, requiring more frequent screening.

Emerging technology could slightly affect the study's projections, he said. “We calculated a modest effect of a shift in screening modalities that could be performed by other clinicians, such as virtual colonoscopy. We found this would have little impact on demand, because many of these screens will show positive findings and result in referrals to GIs.”

The study concluded that training ?an additional 130 GIs each year starting in 2011 would make up the shortfall, increasing the supply by 1,550 GIs by 2020—a goal Olympus would like to see met by the national fellowship program.

Within a decade, the United States won't have enough gastroenterologists to meet the demand for colorectal cancer screenings, given its burgeoning elderly population, a new study has found.

If the national screening rates remain stable, the country could be short 1,050 gastroenterologists (GIs) by 2020 because of the aging of the population, according to a study by the Lewin Group, a health care policy research and management consulting firm.

If screening rates increase by just 10% during the next decade, the shortfall will be as high as 1,550 gastroenterologists by 2020, said Tim Dall, the Lewin Group's vice president and the study's lead author.

“This shortage is absolutely going to impact our national ability to provide colorectal cancer screening,” Mr. Dall said in a teleconference sponsored by Olympus America Inc., one of the world's largest manufacturers of gastrointestinal endoscopes.

The shortage of GIs could also affect primary care physicians who perform colonoscopies because, Mr. Dall said, “if they're doing these screenings, then they are not providing other services that are also in high demand.”

“The confluence of an aging population, improvements in technology, fluxes in the economic milieu, and changes in disease prevalence/impact will act in concert to place new unprecedented pressure on GI service delivery,” said Dr. Patrick I. Okolo III, chief of endoscopy, division of gastroenterology, Johns Hopkins University, Baltimore. “A comprehensive, focused national approach to broaden the number and quality of physicians trained in gastroenterology will be necessary.”

Olympus commissioned the study to gather data to support its legislative push for a federally funded gastroenterology fellowship program, said F. Mark Gumz, president and CEO of Olympus America. The “GI Bill for GIs” would make up to $50 million available for fellowships over a 5-year period, with the goal of training 130 new gastroenterologists each year. “We have called for this federal legislation before, and now, with this new research, we are redoubling our efforts,” Mr. Gumz said at the teleconference.

Despite its name, the bill is not aimed at veterans, a company spokesperson pointed out. “Olympus refers to its proposed legislation as the GI Bill for GIs because of the service component in our proposal. Just as the GI Bill for soldiers provides education in exchange for service to the nation, our proposed GI Bill for GIs requires participants to provide service to their community, in the form of practicing in an underserved area. This is not intended to be simply a free scholarship.”

Although the bill has not been formally introduced, Mr. Gumz said Olympus has had preliminary discussions with Sen. Arlen Spector (R-Pa.) and Rep. Charlie Dent (R-Pa.).

The current supply of U.S. gastroenterologists who are active in patient care now hovers near 10,400, Mr. Dall said. Supply is projected to grow by just 10% (to about 11,460) by 2020. Even if there were no increase in the demand for screening, the supply of GIs would still be 250 short by 2020.

But national population estimates strongly suggest that demand for services will grow significantly. As the percentage of older patients increases, so will the need for routine screening. And, noted Mr. Dall, a proportion of these newly screened patients will have findings that place them in a higher-risk surveillance group, requiring more frequent screening.

Emerging technology could slightly affect the study's projections, he said. “We calculated a modest effect of a shift in screening modalities that could be performed by other clinicians, such as virtual colonoscopy. We found this would have little impact on demand, because many of these screens will show positive findings and result in referrals to GIs.”

The study concluded that training ?an additional 130 GIs each year starting in 2011 would make up the shortfall, increasing the supply by 1,550 GIs by 2020—a goal Olympus would like to see met by the national fellowship program.

Within a decade, the United States won't have enough gastroenterologists to meet the demand for colorectal cancer screenings, given its burgeoning elderly population, a new study has found.

If the national screening rates remain stable, the country could be short 1,050 gastroenterologists (GIs) by 2020 because of the aging of the population, according to a study by the Lewin Group, a health care policy research and management consulting firm.

If screening rates increase by just 10% during the next decade, the shortfall will be as high as 1,550 gastroenterologists by 2020, said Tim Dall, the Lewin Group's vice president and the study's lead author.

“This shortage is absolutely going to impact our national ability to provide colorectal cancer screening,” Mr. Dall said in a teleconference sponsored by Olympus America Inc., one of the world's largest manufacturers of gastrointestinal endoscopes.

The shortage of GIs could also affect primary care physicians who perform colonoscopies because, Mr. Dall said, “if they're doing these screenings, then they are not providing other services that are also in high demand.”

“The confluence of an aging population, improvements in technology, fluxes in the economic milieu, and changes in disease prevalence/impact will act in concert to place new unprecedented pressure on GI service delivery,” said Dr. Patrick I. Okolo III, chief of endoscopy, division of gastroenterology, Johns Hopkins University, Baltimore. “A comprehensive, focused national approach to broaden the number and quality of physicians trained in gastroenterology will be necessary.”

Olympus commissioned the study to gather data to support its legislative push for a federally funded gastroenterology fellowship program, said F. Mark Gumz, president and CEO of Olympus America. The “GI Bill for GIs” would make up to $50 million available for fellowships over a 5-year period, with the goal of training 130 new gastroenterologists each year. “We have called for this federal legislation before, and now, with this new research, we are redoubling our efforts,” Mr. Gumz said at the teleconference.

Despite its name, the bill is not aimed at veterans, a company spokesperson pointed out. “Olympus refers to its proposed legislation as the GI Bill for GIs because of the service component in our proposal. Just as the GI Bill for soldiers provides education in exchange for service to the nation, our proposed GI Bill for GIs requires participants to provide service to their community, in the form of practicing in an underserved area. This is not intended to be simply a free scholarship.”

Although the bill has not been formally introduced, Mr. Gumz said Olympus has had preliminary discussions with Sen. Arlen Spector (R-Pa.) and Rep. Charlie Dent (R-Pa.).

The current supply of U.S. gastroenterologists who are active in patient care now hovers near 10,400, Mr. Dall said. Supply is projected to grow by just 10% (to about 11,460) by 2020. Even if there were no increase in the demand for screening, the supply of GIs would still be 250 short by 2020.

But national population estimates strongly suggest that demand for services will grow significantly. As the percentage of older patients increases, so will the need for routine screening. And, noted Mr. Dall, a proportion of these newly screened patients will have findings that place them in a higher-risk surveillance group, requiring more frequent screening.

Emerging technology could slightly affect the study's projections, he said. “We calculated a modest effect of a shift in screening modalities that could be performed by other clinicians, such as virtual colonoscopy. We found this would have little impact on demand, because many of these screens will show positive findings and result in referrals to GIs.”

The study concluded that training ?an additional 130 GIs each year starting in 2011 would make up the shortfall, increasing the supply by 1,550 GIs by 2020—a goal Olympus would like to see met by the national fellowship program.

Antipsychotics appear to significantly increase the risk of death in patients with Alzheimer's disease, especially if taken for more than 12 months, a randomized controlled trial has determined.

Nursing home patients with Alzheimer's disease (AD) who continued taking the drugs for 1 year were 7% more likely to die than were those who discontinued them, and the mortality difference escalated over the 4-year study. By the end of the trial, just 26% of those taking the drugs were still alive, compared with 53% of those taking a placebo, wrote Dr. Clive Ballard of King's College, London, and his associates (Lancet 2009 Jan. 9 [doi:10. 1016/S1474-4422[08] 70295-3]).

The authors did support a limited use of the drugs, particularly in patients with severe dementia-related aggression, geriatrician Karl Steinberg, who is in a group practice in Oceanside, Calif., noted in an interview. But their risks must be carefully considered.

The conclusions seem to support the Omnibus Budget Reconciliation Act of 1987, which mandated gradual dose reductions of antipsychotics in nursing home residents, he added. “This is looking like an increasingly sound idea. We need to keep in mind that the patients for whom we prescribe these medications are suffering from significant dementia and already nearing the end of life, where quality of life should be a major concern.”

The trial comprised 165 nursing home residents with AD (mean age 89). At baseline, all of the patients were taking an antipsychotic medication. Most (93%) were taking either risperidone or haloperidol; other agents included thioridazine, chlorpromaine, and trifluoperazine.

Patients were randomized to either continue treatment (83) or discontinue treatment by taking a placebo. Thirty-seven patients did not start treatment, leaving 64 in each treatment group. The 12-, 24-, 36-, and 42-month survival rates were analyzed in the group of those who began taking their study medication, regardless of whether they stopped at any time during the study.

After 12 months, those taking placebo were more likely to survive than were those taking an active agent (70% vs. 77%); the difference was statistically significant. The disparity was magnified as the trial continued. At 24 months, the cumulative survival rate was 71% in the placebo group vs. 46% in the active group; at 36 months, the rate was 59% vs. 30%; and at 42 months, it was 53% vs. 26%.

Death certificates were available for 78%. More deaths of a probable vascular nature occurred in the placebo group; there was no indication that antipsychotics contribute to cerebrovascular deaths.

The reasons for the biggest difference in mortality occurring after the first 12 months of the trial are unclear. “One possible explanation is that the most frail participants who had the most severe dementia … have a high mortality risk regardless of whichever treatment is assigned,” they noted. However, “the results are consistent in that patients allocated to discontinue antipsychotics seem to benefit from lower mortality during long-term follow-up than [do] those allocated to placebo.”

They noted that up to 60% of nursing home residents with dementia in Europe and North America receive antipsychotic medication, often for extended periods of time, despite data suggesting that the risks outweigh any possible benefit.

“There is clear evidence of a significant increase in adverse events, including parkinsonism, sedation, oedema, chest infections, accelerated cognitive decline, and cerebrovascular events in patients with Alzheimer's treated with antipsychotics,” they noted. Alternative treatments include psychological management, memantine, and antidepressants.

The results confirm those in other trials suggesting a link between the drugs and increased morbidity and mortality in dementia patients, said Dr. Marwan Sabbagh in an interview. “This risk was the impetus for the black box warning issued by the FDA for risk associated with antipsychotic use specifically in dementia.”

“What makes this more compelling is that … this is objective evidence in a randomized, placebo-controlled study that [AD] subjects taking antipsychotics had demonstrable increases in mortality,” said Dr. Sabbagh, chief medical-scientific officer and director of clinical research at the Sun Health Research Institute, Sun City, Ariz.

The study was funded by the U.K. Alzheimer's Research Trust. Dr. Ballard noted financial relationships with many companies that manufacture antipsychotics and Alzheimer's medications.

Antipsychotics appear to significantly increase the risk of death in patients with Alzheimer's disease, especially if taken for more than 12 months, a randomized controlled trial has determined.

Nursing home patients with Alzheimer's disease (AD) who continued taking the drugs for 1 year were 7% more likely to die than were those who discontinued them, and the mortality difference escalated over the 4-year study. By the end of the trial, just 26% of those taking the drugs were still alive, compared with 53% of those taking a placebo, wrote Dr. Clive Ballard of King's College, London, and his associates (Lancet 2009 Jan. 9 [doi:10. 1016/S1474-4422[08] 70295-3]).

The authors did support a limited use of the drugs, particularly in patients with severe dementia-related aggression, geriatrician Karl Steinberg, who is in a group practice in Oceanside, Calif., noted in an interview. But their risks must be carefully considered.

The conclusions seem to support the Omnibus Budget Reconciliation Act of 1987, which mandated gradual dose reductions of antipsychotics in nursing home residents, he added. “This is looking like an increasingly sound idea. We need to keep in mind that the patients for whom we prescribe these medications are suffering from significant dementia and already nearing the end of life, where quality of life should be a major concern.”

The trial comprised 165 nursing home residents with AD (mean age 89). At baseline, all of the patients were taking an antipsychotic medication. Most (93%) were taking either risperidone or haloperidol; other agents included thioridazine, chlorpromaine, and trifluoperazine.

Patients were randomized to either continue treatment (83) or discontinue treatment by taking a placebo. Thirty-seven patients did not start treatment, leaving 64 in each treatment group. The 12-, 24-, 36-, and 42-month survival rates were analyzed in the group of those who began taking their study medication, regardless of whether they stopped at any time during the study.

After 12 months, those taking placebo were more likely to survive than were those taking an active agent (70% vs. 77%); the difference was statistically significant. The disparity was magnified as the trial continued. At 24 months, the cumulative survival rate was 71% in the placebo group vs. 46% in the active group; at 36 months, the rate was 59% vs. 30%; and at 42 months, it was 53% vs. 26%.

Death certificates were available for 78%. More deaths of a probable vascular nature occurred in the placebo group; there was no indication that antipsychotics contribute to cerebrovascular deaths.

The reasons for the biggest difference in mortality occurring after the first 12 months of the trial are unclear. “One possible explanation is that the most frail participants who had the most severe dementia … have a high mortality risk regardless of whichever treatment is assigned,” they noted. However, “the results are consistent in that patients allocated to discontinue antipsychotics seem to benefit from lower mortality during long-term follow-up than [do] those allocated to placebo.”

They noted that up to 60% of nursing home residents with dementia in Europe and North America receive antipsychotic medication, often for extended periods of time, despite data suggesting that the risks outweigh any possible benefit.

“There is clear evidence of a significant increase in adverse events, including parkinsonism, sedation, oedema, chest infections, accelerated cognitive decline, and cerebrovascular events in patients with Alzheimer's treated with antipsychotics,” they noted. Alternative treatments include psychological management, memantine, and antidepressants.

The results confirm those in other trials suggesting a link between the drugs and increased morbidity and mortality in dementia patients, said Dr. Marwan Sabbagh in an interview. “This risk was the impetus for the black box warning issued by the FDA for risk associated with antipsychotic use specifically in dementia.”

“What makes this more compelling is that … this is objective evidence in a randomized, placebo-controlled study that [AD] subjects taking antipsychotics had demonstrable increases in mortality,” said Dr. Sabbagh, chief medical-scientific officer and director of clinical research at the Sun Health Research Institute, Sun City, Ariz.

The study was funded by the U.K. Alzheimer's Research Trust. Dr. Ballard noted financial relationships with many companies that manufacture antipsychotics and Alzheimer's medications.

Antipsychotics appear to significantly increase the risk of death in patients with Alzheimer's disease, especially if taken for more than 12 months, a randomized controlled trial has determined.

Nursing home patients with Alzheimer's disease (AD) who continued taking the drugs for 1 year were 7% more likely to die than were those who discontinued them, and the mortality difference escalated over the 4-year study. By the end of the trial, just 26% of those taking the drugs were still alive, compared with 53% of those taking a placebo, wrote Dr. Clive Ballard of King's College, London, and his associates (Lancet 2009 Jan. 9 [doi:10. 1016/S1474-4422[08] 70295-3]).

The authors did support a limited use of the drugs, particularly in patients with severe dementia-related aggression, geriatrician Karl Steinberg, who is in a group practice in Oceanside, Calif., noted in an interview. But their risks must be carefully considered.

The conclusions seem to support the Omnibus Budget Reconciliation Act of 1987, which mandated gradual dose reductions of antipsychotics in nursing home residents, he added. “This is looking like an increasingly sound idea. We need to keep in mind that the patients for whom we prescribe these medications are suffering from significant dementia and already nearing the end of life, where quality of life should be a major concern.”

The trial comprised 165 nursing home residents with AD (mean age 89). At baseline, all of the patients were taking an antipsychotic medication. Most (93%) were taking either risperidone or haloperidol; other agents included thioridazine, chlorpromaine, and trifluoperazine.

Patients were randomized to either continue treatment (83) or discontinue treatment by taking a placebo. Thirty-seven patients did not start treatment, leaving 64 in each treatment group. The 12-, 24-, 36-, and 42-month survival rates were analyzed in the group of those who began taking their study medication, regardless of whether they stopped at any time during the study.

After 12 months, those taking placebo were more likely to survive than were those taking an active agent (70% vs. 77%); the difference was statistically significant. The disparity was magnified as the trial continued. At 24 months, the cumulative survival rate was 71% in the placebo group vs. 46% in the active group; at 36 months, the rate was 59% vs. 30%; and at 42 months, it was 53% vs. 26%.

Death certificates were available for 78%. More deaths of a probable vascular nature occurred in the placebo group; there was no indication that antipsychotics contribute to cerebrovascular deaths.

The reasons for the biggest difference in mortality occurring after the first 12 months of the trial are unclear. “One possible explanation is that the most frail participants who had the most severe dementia … have a high mortality risk regardless of whichever treatment is assigned,” they noted. However, “the results are consistent in that patients allocated to discontinue antipsychotics seem to benefit from lower mortality during long-term follow-up than [do] those allocated to placebo.”

They noted that up to 60% of nursing home residents with dementia in Europe and North America receive antipsychotic medication, often for extended periods of time, despite data suggesting that the risks outweigh any possible benefit.

“There is clear evidence of a significant increase in adverse events, including parkinsonism, sedation, oedema, chest infections, accelerated cognitive decline, and cerebrovascular events in patients with Alzheimer's treated with antipsychotics,” they noted. Alternative treatments include psychological management, memantine, and antidepressants.

The results confirm those in other trials suggesting a link between the drugs and increased morbidity and mortality in dementia patients, said Dr. Marwan Sabbagh in an interview. “This risk was the impetus for the black box warning issued by the FDA for risk associated with antipsychotic use specifically in dementia.”

“What makes this more compelling is that … this is objective evidence in a randomized, placebo-controlled study that [AD] subjects taking antipsychotics had demonstrable increases in mortality,” said Dr. Sabbagh, chief medical-scientific officer and director of clinical research at the Sun Health Research Institute, Sun City, Ariz.

The study was funded by the U.K. Alzheimer's Research Trust. Dr. Ballard noted financial relationships with many companies that manufacture antipsychotics and Alzheimer's medications.

Prolonged empirical antibiotic therapy is associated with an increased risk of necrotizing enterocolitis and death in extremely low-birth-weight infants, results of a retrospective study found.

Although the study couldn't prove causality, it did link antibiotics use with a 46% increased risk of death among these already vulnerable newborns, Dr. C. Michael Cotten and his colleagues reported (Pediatrics 2009;123:58–66).

Dr. Cotten of Duke University, Durham, N.C., and the coauthors did not propose any changes to clinical practice. However, they said, broad-spectrum antibiotic treatment in the absence of proven sepsis “may not be benign.”

The real problem, Dr. Richard Polin said in an interview, is how to identify which infants actually do have a bacterial infection and need the antibiotics therapy.

“It's very difficult to diagnose sepsis in these babies,” said Dr. Polin, director of neonatology at the Morgan Stanley Children's Hospital of New York-Presbyterian Hospital. “There is no test to identify them, other than a positive blood culture, and that is an imperfect test because the volume of blood needed for a reliable diagnosis isn't always available. If we did develop a sensitive assay that would allow us to differentiate septic from nonseptic babies, we could keep them on antibiotics for shorter times. But until that happens, the best advice is to stop antibiotics as early as possible if you are reasonably sure that the infant is not septic.”

The study examined the rates of necrotizing enterocolitis (NEC), death, and the combination of both in a group of 4,039 extremely low-birth-weight (ELBW) babies who received initial empirical antibiotic treatment during the first few days of life, despite a sterile blood culture. Most (2,147; 53%) received prolonged therapy, defined as at least 5 days of treatment. The most commonly prescribed regimen was a combination of ampicillin and gentamicin (83% of the study population).

Overall, 11% of the group (440) developed NEC; of these, 46% had NEC of Bell stage 2a, 2b, or 3a, and 54% had NEC of Bell stage 3b. Sixteen percent of the study group (658) died after postnatal day 5, while 23% (919) developed the composite outcome of NEC or death. Compared with infants who developed neither outcome, significantly more of those with the composite outcome had received prolonged antibiotic therapy (61% vs. 51%).

After adjusting for Apgar score, race, and gestational age, the investigators found a 4% increase in the combined risk of NEC or death with each additional day of initial empirical antibiotic treatment.

The increase was more striking when the results were examined separately, with about a 7% increase in the risk of NEC alone and a 16% increase in the risk of death alone for each additional treatment day.

The number needed to harm with prolonged antibiotic treatment for death alone was 21; for NEC alone, 54; and for the combination outcome, 22. Changing the definition of “prolonged” therapy from 5 or more days to 4 or more days did not change the risks, the authors commented. Sicker infants were at even higher risk. When the analysis considered only the newborns who were intubated for the first 7 postnatal days, the number needed to harm with prolonged empirical antibiotic therapy was 14 for NEC or death, 16 for death alone, and 25 for NEC alone.

Dr. Cotten and associates speculated that the link between antibiotic use and poor outcomes may be related to interference with the natural process of gut colonization.

“This colonization, at least in animal models, seems to contribute to physiologic development of the intestine, immunologic development, and absorbance of nutrients,” they said.

They also noted that antibiotics may suppress normal flora, allowing competing organisms, like yeasts and fungi, the chance to overgrow.

Prolonged empirical antibiotic therapy is associated with an increased risk of necrotizing enterocolitis and death in extremely low-birth-weight infants, results of a retrospective study found.

Although the study couldn't prove causality, it did link antibiotics use with a 46% increased risk of death among these already vulnerable newborns, Dr. C. Michael Cotten and his colleagues reported (Pediatrics 2009;123:58–66).

Dr. Cotten of Duke University, Durham, N.C., and the coauthors did not propose any changes to clinical practice. However, they said, broad-spectrum antibiotic treatment in the absence of proven sepsis “may not be benign.”

The real problem, Dr. Richard Polin said in an interview, is how to identify which infants actually do have a bacterial infection and need the antibiotics therapy.

“It's very difficult to diagnose sepsis in these babies,” said Dr. Polin, director of neonatology at the Morgan Stanley Children's Hospital of New York-Presbyterian Hospital. “There is no test to identify them, other than a positive blood culture, and that is an imperfect test because the volume of blood needed for a reliable diagnosis isn't always available. If we did develop a sensitive assay that would allow us to differentiate septic from nonseptic babies, we could keep them on antibiotics for shorter times. But until that happens, the best advice is to stop antibiotics as early as possible if you are reasonably sure that the infant is not septic.”

The study examined the rates of necrotizing enterocolitis (NEC), death, and the combination of both in a group of 4,039 extremely low-birth-weight (ELBW) babies who received initial empirical antibiotic treatment during the first few days of life, despite a sterile blood culture. Most (2,147; 53%) received prolonged therapy, defined as at least 5 days of treatment. The most commonly prescribed regimen was a combination of ampicillin and gentamicin (83% of the study population).

Overall, 11% of the group (440) developed NEC; of these, 46% had NEC of Bell stage 2a, 2b, or 3a, and 54% had NEC of Bell stage 3b. Sixteen percent of the study group (658) died after postnatal day 5, while 23% (919) developed the composite outcome of NEC or death. Compared with infants who developed neither outcome, significantly more of those with the composite outcome had received prolonged antibiotic therapy (61% vs. 51%).

After adjusting for Apgar score, race, and gestational age, the investigators found a 4% increase in the combined risk of NEC or death with each additional day of initial empirical antibiotic treatment.

The increase was more striking when the results were examined separately, with about a 7% increase in the risk of NEC alone and a 16% increase in the risk of death alone for each additional treatment day.

The number needed to harm with prolonged antibiotic treatment for death alone was 21; for NEC alone, 54; and for the combination outcome, 22. Changing the definition of “prolonged” therapy from 5 or more days to 4 or more days did not change the risks, the authors commented. Sicker infants were at even higher risk. When the analysis considered only the newborns who were intubated for the first 7 postnatal days, the number needed to harm with prolonged empirical antibiotic therapy was 14 for NEC or death, 16 for death alone, and 25 for NEC alone.

Dr. Cotten and associates speculated that the link between antibiotic use and poor outcomes may be related to interference with the natural process of gut colonization.

“This colonization, at least in animal models, seems to contribute to physiologic development of the intestine, immunologic development, and absorbance of nutrients,” they said.

They also noted that antibiotics may suppress normal flora, allowing competing organisms, like yeasts and fungi, the chance to overgrow.

Prolonged empirical antibiotic therapy is associated with an increased risk of necrotizing enterocolitis and death in extremely low-birth-weight infants, results of a retrospective study found.

Although the study couldn't prove causality, it did link antibiotics use with a 46% increased risk of death among these already vulnerable newborns, Dr. C. Michael Cotten and his colleagues reported (Pediatrics 2009;123:58–66).

Dr. Cotten of Duke University, Durham, N.C., and the coauthors did not propose any changes to clinical practice. However, they said, broad-spectrum antibiotic treatment in the absence of proven sepsis “may not be benign.”

The real problem, Dr. Richard Polin said in an interview, is how to identify which infants actually do have a bacterial infection and need the antibiotics therapy.

“It's very difficult to diagnose sepsis in these babies,” said Dr. Polin, director of neonatology at the Morgan Stanley Children's Hospital of New York-Presbyterian Hospital. “There is no test to identify them, other than a positive blood culture, and that is an imperfect test because the volume of blood needed for a reliable diagnosis isn't always available. If we did develop a sensitive assay that would allow us to differentiate septic from nonseptic babies, we could keep them on antibiotics for shorter times. But until that happens, the best advice is to stop antibiotics as early as possible if you are reasonably sure that the infant is not septic.”

The study examined the rates of necrotizing enterocolitis (NEC), death, and the combination of both in a group of 4,039 extremely low-birth-weight (ELBW) babies who received initial empirical antibiotic treatment during the first few days of life, despite a sterile blood culture. Most (2,147; 53%) received prolonged therapy, defined as at least 5 days of treatment. The most commonly prescribed regimen was a combination of ampicillin and gentamicin (83% of the study population).

Overall, 11% of the group (440) developed NEC; of these, 46% had NEC of Bell stage 2a, 2b, or 3a, and 54% had NEC of Bell stage 3b. Sixteen percent of the study group (658) died after postnatal day 5, while 23% (919) developed the composite outcome of NEC or death. Compared with infants who developed neither outcome, significantly more of those with the composite outcome had received prolonged antibiotic therapy (61% vs. 51%).

After adjusting for Apgar score, race, and gestational age, the investigators found a 4% increase in the combined risk of NEC or death with each additional day of initial empirical antibiotic treatment.

The increase was more striking when the results were examined separately, with about a 7% increase in the risk of NEC alone and a 16% increase in the risk of death alone for each additional treatment day.

The number needed to harm with prolonged antibiotic treatment for death alone was 21; for NEC alone, 54; and for the combination outcome, 22. Changing the definition of “prolonged” therapy from 5 or more days to 4 or more days did not change the risks, the authors commented. Sicker infants were at even higher risk. When the analysis considered only the newborns who were intubated for the first 7 postnatal days, the number needed to harm with prolonged empirical antibiotic therapy was 14 for NEC or death, 16 for death alone, and 25 for NEC alone.

Dr. Cotten and associates speculated that the link between antibiotic use and poor outcomes may be related to interference with the natural process of gut colonization.

“This colonization, at least in animal models, seems to contribute to physiologic development of the intestine, immunologic development, and absorbance of nutrients,” they said.

They also noted that antibiotics may suppress normal flora, allowing competing organisms, like yeasts and fungi, the chance to overgrow.

Variants in genes that control the cytochrome P450 pathway can reduce the beneficial effects of clopidogrel, significantly increasing the rate of cardiovascular death, heart attack, stroke, and stent thrombosis in persons who carry the polymorphisms.

The variants “were associated with adverse clinical outcomes … more than 50% greater, and a rate of stent thrombosis that was greater by a factor of 3 than the rate in noncarriers,” Dr. Jessica L. Mega and her associates reported (N. Engl. J. Med. 2009;360:354-62).

The cytochrome P450 pathway transforms clopidogrel into an active metabolite. Genetic variants that reduce the pathway's enzymatic function also decrease this transformation, thus reducing exposure to the active metabolite, wrote Dr. Mega of Brigham and Women's Hospital, Boston, and her colleagues. The reduced-function variant is common, occurring in about 30% of whites, 40% of blacks, and 55% of East Asians.

The two-pronged study analyzed the alleles' pharmacokinetic effects in healthy patients who were included in several drug studies, and its clinical effects in patients who received clopidogrel during the TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel [Clopidogrel]-Thrombolysis in Myocardial Infarction 38) study.

The pharmacokinetic study measured plasma concentrations of clopidogrel's active metabolite in 162 subjects, and sorted the results according to five genes known to affect the enzymatic pathway. Carriers of at least one of the reduced-function alleles of the CYP2C19 gene had a 32% reduction in the active metabolite, compared with noncarriers, and exhibited a 9% decrease in pharmacodynamic response. The reduced response was seen after a loading dose and during maintenance therapy.

The clinical outcomes analysis included data on 1,477 patients who had been assigned to clopidogrel treatment in TRITON-TIMI 38, and who had provided DNA samples. At least one reduced-function CYP2C19 allele was present in 27% of the study population.

Overall, carriers were 50% more likely than noncarriers to experience one of the study's primary outcomes. On individual outcomes, carriers were nearly five times more likely to die from cardiovascular causes, 38% more likely to have had a nonfatal heart attack, and four times more likely to have had a nonfatal stroke.

Carriers were also three times more likely to experience stent thrombosis than were noncarriers. The CYP2C19*2 allele was present in 95% of patients who were classified as having a reduced-function allele.

Variants in genes that control the cytochrome P450 pathway can reduce the beneficial effects of clopidogrel, significantly increasing the rate of cardiovascular death, heart attack, stroke, and stent thrombosis in persons who carry the polymorphisms.

The variants “were associated with adverse clinical outcomes … more than 50% greater, and a rate of stent thrombosis that was greater by a factor of 3 than the rate in noncarriers,” Dr. Jessica L. Mega and her associates reported (N. Engl. J. Med. 2009;360:354-62).

The cytochrome P450 pathway transforms clopidogrel into an active metabolite. Genetic variants that reduce the pathway's enzymatic function also decrease this transformation, thus reducing exposure to the active metabolite, wrote Dr. Mega of Brigham and Women's Hospital, Boston, and her colleagues. The reduced-function variant is common, occurring in about 30% of whites, 40% of blacks, and 55% of East Asians.

The two-pronged study analyzed the alleles' pharmacokinetic effects in healthy patients who were included in several drug studies, and its clinical effects in patients who received clopidogrel during the TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel [Clopidogrel]-Thrombolysis in Myocardial Infarction 38) study.

The pharmacokinetic study measured plasma concentrations of clopidogrel's active metabolite in 162 subjects, and sorted the results according to five genes known to affect the enzymatic pathway. Carriers of at least one of the reduced-function alleles of the CYP2C19 gene had a 32% reduction in the active metabolite, compared with noncarriers, and exhibited a 9% decrease in pharmacodynamic response. The reduced response was seen after a loading dose and during maintenance therapy.

The clinical outcomes analysis included data on 1,477 patients who had been assigned to clopidogrel treatment in TRITON-TIMI 38, and who had provided DNA samples. At least one reduced-function CYP2C19 allele was present in 27% of the study population.

Overall, carriers were 50% more likely than noncarriers to experience one of the study's primary outcomes. On individual outcomes, carriers were nearly five times more likely to die from cardiovascular causes, 38% more likely to have had a nonfatal heart attack, and four times more likely to have had a nonfatal stroke.

Carriers were also three times more likely to experience stent thrombosis than were noncarriers. The CYP2C19*2 allele was present in 95% of patients who were classified as having a reduced-function allele.

Variants in genes that control the cytochrome P450 pathway can reduce the beneficial effects of clopidogrel, significantly increasing the rate of cardiovascular death, heart attack, stroke, and stent thrombosis in persons who carry the polymorphisms.

The variants “were associated with adverse clinical outcomes … more than 50% greater, and a rate of stent thrombosis that was greater by a factor of 3 than the rate in noncarriers,” Dr. Jessica L. Mega and her associates reported (N. Engl. J. Med. 2009;360:354-62).

The cytochrome P450 pathway transforms clopidogrel into an active metabolite. Genetic variants that reduce the pathway's enzymatic function also decrease this transformation, thus reducing exposure to the active metabolite, wrote Dr. Mega of Brigham and Women's Hospital, Boston, and her colleagues. The reduced-function variant is common, occurring in about 30% of whites, 40% of blacks, and 55% of East Asians.

The two-pronged study analyzed the alleles' pharmacokinetic effects in healthy patients who were included in several drug studies, and its clinical effects in patients who received clopidogrel during the TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel [Clopidogrel]-Thrombolysis in Myocardial Infarction 38) study.

The pharmacokinetic study measured plasma concentrations of clopidogrel's active metabolite in 162 subjects, and sorted the results according to five genes known to affect the enzymatic pathway. Carriers of at least one of the reduced-function alleles of the CYP2C19 gene had a 32% reduction in the active metabolite, compared with noncarriers, and exhibited a 9% decrease in pharmacodynamic response. The reduced response was seen after a loading dose and during maintenance therapy.

The clinical outcomes analysis included data on 1,477 patients who had been assigned to clopidogrel treatment in TRITON-TIMI 38, and who had provided DNA samples. At least one reduced-function CYP2C19 allele was present in 27% of the study population.

Overall, carriers were 50% more likely than noncarriers to experience one of the study's primary outcomes. On individual outcomes, carriers were nearly five times more likely to die from cardiovascular causes, 38% more likely to have had a nonfatal heart attack, and four times more likely to have had a nonfatal stroke.

Carriers were also three times more likely to experience stent thrombosis than were noncarriers. The CYP2C19*2 allele was present in 95% of patients who were classified as having a reduced-function allele.

Within a decade, the United States won't have enough gastroenterologists to meet the demand for colorectal cancer screenings, given its burgeoning elderly population, a new study has found.

If the national screening rates remain stable for the various age and gender groups, the country could be short 1,050 gastroenterologists (GIs) by 2020 because of the aging of the population, the study found. The data were released today by the Lewin Group, a health care policy research and management consulting firm.

But if screening rates increase by just 10%, the shortfall will be as high as 1,550 gastroenterologists by 2020, said Tim Dall, the Lewin Group's vice president and lead author of the study.

“This shortage is absolutely going to impact our national ability to provide colorectal cancer screening,” Mr. Dall said in a teleconference sponsored by Olympus America Inc., which is one of the world's largest manufacturers of gastrointestinal endoscopes.

The shortage of gastroenterologists could also affect primary care physicians who perform colonoscopies, because, Mr. Dall said, “If they're doing these screenings, then they are not providing other services that are also in high demand.”

“The confluence of an aging population, improvements in technology, fluxes in the economic milieu, and changes in disease prevalence/impact will act in concert to place new unprecedented pressure on GI service delivery,” commented Dr. Patrick I. Okolo III, chief of endoscopy, division of gastroenterology at Johns Hopkins University, Baltimore. “A comprehensive, focused national approach to broaden the number and quality of physicians trained in gastroenterology will be necessary to obviate this divide,” he added.

Olympus commissioned the study to gather data that support its legislative push for a federally funded gastroenterology fellowship program, said F. Mark Gumz, president and CEO of Olympus America. The “GI Bill for GIs” would make up to $50 million available for fellowships over a 5-year period, with the goal of training 130 new gastroenterologists each year. “We have called for this federal legislation before, and now, with this new research, we are redoubling our efforts,” Mr. Gumz said at the teleconference.

Despite its name, the bill is not aimed at veterans, a company spokesperson pointed out. “Olympus refers to its proposed legislation as the GI Bill for GIs because of the service component in our proposal. Just as the GI Bill for soldiers provides education in exchange for service to the nation, our proposed GI Bill for GIs requires participants to provide service to their community, in the form of practicing in an underserved area. This is not intended to be simply a free scholarship.”

Although the bill has not been formally introduced, Mr. Gumz said Olympus America, located in Center Valley, Pa., has had preliminary discussions with Sen. Arlen Spector (R-Pa.) and Rep. Charlie Dent (R-Pa.).

The Lewin study was based on two complex microsimulation models that the company had previously developed: the national colorectal cancer screening guidelines, developed for the Centers for Disease Control and Prevention and the American Cancer Society; and the Physician Supply and Demand Model, developed as the basis of government workforce studies.

The current supply of U.S. gastroenterologists who are active in patient care now hovers near 10,400, Mr. Dall said. Supply is projected to grow by just 10% (to about 11,460) by 2020. Even if there were no increase in the demand for screening, the supply of GIs would still be 250 short by 2020.

But national population estimates suggest that demand for services will grow significantly. As the percentage of older patients increases, so will the need for routine screening. A certain proportion of these newly screened patients will have findings that place them in a higher-risk surveillance group, requiring more frequent screening, Dr. Dall noted.

Within a decade, the United States won't have enough gastroenterologists to meet the demand for colorectal cancer screenings, given its burgeoning elderly population, a new study has found.

If the national screening rates remain stable for the various age and gender groups, the country could be short 1,050 gastroenterologists (GIs) by 2020 because of the aging of the population, the study found. The data were released today by the Lewin Group, a health care policy research and management consulting firm.

But if screening rates increase by just 10%, the shortfall will be as high as 1,550 gastroenterologists by 2020, said Tim Dall, the Lewin Group's vice president and lead author of the study.

“This shortage is absolutely going to impact our national ability to provide colorectal cancer screening,” Mr. Dall said in a teleconference sponsored by Olympus America Inc., which is one of the world's largest manufacturers of gastrointestinal endoscopes.

The shortage of gastroenterologists could also affect primary care physicians who perform colonoscopies, because, Mr. Dall said, “If they're doing these screenings, then they are not providing other services that are also in high demand.”

“The confluence of an aging population, improvements in technology, fluxes in the economic milieu, and changes in disease prevalence/impact will act in concert to place new unprecedented pressure on GI service delivery,” commented Dr. Patrick I. Okolo III, chief of endoscopy, division of gastroenterology at Johns Hopkins University, Baltimore. “A comprehensive, focused national approach to broaden the number and quality of physicians trained in gastroenterology will be necessary to obviate this divide,” he added.

Olympus commissioned the study to gather data that support its legislative push for a federally funded gastroenterology fellowship program, said F. Mark Gumz, president and CEO of Olympus America. The “GI Bill for GIs” would make up to $50 million available for fellowships over a 5-year period, with the goal of training 130 new gastroenterologists each year. “We have called for this federal legislation before, and now, with this new research, we are redoubling our efforts,” Mr. Gumz said at the teleconference.

Despite its name, the bill is not aimed at veterans, a company spokesperson pointed out. “Olympus refers to its proposed legislation as the GI Bill for GIs because of the service component in our proposal. Just as the GI Bill for soldiers provides education in exchange for service to the nation, our proposed GI Bill for GIs requires participants to provide service to their community, in the form of practicing in an underserved area. This is not intended to be simply a free scholarship.”

Although the bill has not been formally introduced, Mr. Gumz said Olympus America, located in Center Valley, Pa., has had preliminary discussions with Sen. Arlen Spector (R-Pa.) and Rep. Charlie Dent (R-Pa.).

The Lewin study was based on two complex microsimulation models that the company had previously developed: the national colorectal cancer screening guidelines, developed for the Centers for Disease Control and Prevention and the American Cancer Society; and the Physician Supply and Demand Model, developed as the basis of government workforce studies.

The current supply of U.S. gastroenterologists who are active in patient care now hovers near 10,400, Mr. Dall said. Supply is projected to grow by just 10% (to about 11,460) by 2020. Even if there were no increase in the demand for screening, the supply of GIs would still be 250 short by 2020.

But national population estimates suggest that demand for services will grow significantly. As the percentage of older patients increases, so will the need for routine screening. A certain proportion of these newly screened patients will have findings that place them in a higher-risk surveillance group, requiring more frequent screening, Dr. Dall noted.

Within a decade, the United States won't have enough gastroenterologists to meet the demand for colorectal cancer screenings, given its burgeoning elderly population, a new study has found.

If the national screening rates remain stable for the various age and gender groups, the country could be short 1,050 gastroenterologists (GIs) by 2020 because of the aging of the population, the study found. The data were released today by the Lewin Group, a health care policy research and management consulting firm.

But if screening rates increase by just 10%, the shortfall will be as high as 1,550 gastroenterologists by 2020, said Tim Dall, the Lewin Group's vice president and lead author of the study.

“This shortage is absolutely going to impact our national ability to provide colorectal cancer screening,” Mr. Dall said in a teleconference sponsored by Olympus America Inc., which is one of the world's largest manufacturers of gastrointestinal endoscopes.

The shortage of gastroenterologists could also affect primary care physicians who perform colonoscopies, because, Mr. Dall said, “If they're doing these screenings, then they are not providing other services that are also in high demand.”

“The confluence of an aging population, improvements in technology, fluxes in the economic milieu, and changes in disease prevalence/impact will act in concert to place new unprecedented pressure on GI service delivery,” commented Dr. Patrick I. Okolo III, chief of endoscopy, division of gastroenterology at Johns Hopkins University, Baltimore. “A comprehensive, focused national approach to broaden the number and quality of physicians trained in gastroenterology will be necessary to obviate this divide,” he added.

Olympus commissioned the study to gather data that support its legislative push for a federally funded gastroenterology fellowship program, said F. Mark Gumz, president and CEO of Olympus America. The “GI Bill for GIs” would make up to $50 million available for fellowships over a 5-year period, with the goal of training 130 new gastroenterologists each year. “We have called for this federal legislation before, and now, with this new research, we are redoubling our efforts,” Mr. Gumz said at the teleconference.

Despite its name, the bill is not aimed at veterans, a company spokesperson pointed out. “Olympus refers to its proposed legislation as the GI Bill for GIs because of the service component in our proposal. Just as the GI Bill for soldiers provides education in exchange for service to the nation, our proposed GI Bill for GIs requires participants to provide service to their community, in the form of practicing in an underserved area. This is not intended to be simply a free scholarship.”

Although the bill has not been formally introduced, Mr. Gumz said Olympus America, located in Center Valley, Pa., has had preliminary discussions with Sen. Arlen Spector (R-Pa.) and Rep. Charlie Dent (R-Pa.).

The Lewin study was based on two complex microsimulation models that the company had previously developed: the national colorectal cancer screening guidelines, developed for the Centers for Disease Control and Prevention and the American Cancer Society; and the Physician Supply and Demand Model, developed as the basis of government workforce studies.

The current supply of U.S. gastroenterologists who are active in patient care now hovers near 10,400, Mr. Dall said. Supply is projected to grow by just 10% (to about 11,460) by 2020. Even if there were no increase in the demand for screening, the supply of GIs would still be 250 short by 2020.

But national population estimates suggest that demand for services will grow significantly. As the percentage of older patients increases, so will the need for routine screening. A certain proportion of these newly screened patients will have findings that place them in a higher-risk surveillance group, requiring more frequent screening, Dr. Dall noted.

Intensive glucose control isn't any more effective than standard therapy at reducing the rates of major cardiovascular events, death, or microvascular disease in patients with poorly controlled type 2 diabetes, a large prospective study has concluded.

In fact, patients assigned to intensive therapy were significantly more likely to experience hypoglycemia, dyspnea, and other serious adverse events, according to Dr. William Duckworth of the Phoenix Veterans Affairs Health Care Center and his colleagues.

Given these findings, the authors recommended that preventive efforts focus on factors more directly tied to cardiovascular health. “For now, appropriate management of hypertension, dyslipidemia, and other cardiovascular risk factors appears to be the most effective approach to preventing cardiovascular morbidity and mortality” in these patients, the investigators wrote (N. Engl. J. Med. 2009, 360[2]:129-39).

The Veterans Affairs Diabetes Trial (VADT) examined the effect of intensive glucose control in 1,791 military veterans (mean age, 60 years) who had poorly controlled type 2 diabetes. Patients were randomized to either standard or intensive glucose control therapy. In both groups, obese patients (those with a body mass index of 27 kg/m

The primary outcome was the time from randomization to a first major cardiovascular event, heart failure, surgery for vascular disease, or amputation for ischemic gangrene.

At 3 months, median HbA1c had decreased in both groups; by 6 months, it had stabilized at 8% in the standard therapy group and 7% in the intensive therapy group.

After a median follow-up of 6 years, the investigators found that those in the intensive therapy group were 12% less likely than those in the standard care group to have had a cardiovascular event (not a significant difference). Nor were there significant differences in any of the individual cardiovascular end points, or in the rate of cardiovascular deaths.

Intensive therapy did not significantly affect any of the outcomes associated with microvascular disease. There were no significant between-group differences in amputation. And although the investigators found a slight reduction in diabetic retinopathy in the intensive therapy group, it was nonsignificant.

Intensive therapy did not significantly improve renal function or slow its decline, and was associated with a nonsignificant increase in autonomic neuropathy.

Patients in the intensive therapy group had significantly more adverse events than did those in the standard therapy group. The most common was hypoglycemia (1,566 vs. 432 incidents per 100 patient-years). Significantly more patients in the intensive therapy group had at least one serious adverse event (24% vs. 18%).

Among these, dyspnea was the most commonly reported.

There were 95 deaths from any cause in the standard therapy group, and 102 in the intensive therapy group, which was not a significant difference.

The results of VADT agree with those of two other large trials–ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease)–that examined the effect of intensive glucose control, the authors said.

“Intensive glucose control did not reduce cardiovascular events [in these trials]. The ACCORD study was terminated at 3.5 years because of increased mortality in the intensive therapy group. The ADVANCE study showed a reduction in the progression of albuminuria, but there were no changes in the rates of severe nephropathy, retinopathy, or cardiovascular events.”

The American Association of Clinical Endocrinologists (AACE) presented its perspectives of the VADT findings on the AACE Web site (www.aace.com

The study was sponsored by the Department of Veterans Affairs, the American Diabetes Association, and the National Eye Institute, with additional funding from various pharmaceutical companies.

Dr. Duckworth and his coauthors reported numerous financial connections with those companies.

Patients assigned to intensive therapy were significantly more likely to experience adverse events. DR. DUCKWORTH

Intensive glucose control isn't any more effective than standard therapy at reducing the rates of major cardiovascular events, death, or microvascular disease in patients with poorly controlled type 2 diabetes, a large prospective study has concluded.

In fact, patients assigned to intensive therapy were significantly more likely to experience hypoglycemia, dyspnea, and other serious adverse events, according to Dr. William Duckworth of the Phoenix Veterans Affairs Health Care Center and his colleagues.

Given these findings, the authors recommended that preventive efforts focus on factors more directly tied to cardiovascular health. “For now, appropriate management of hypertension, dyslipidemia, and other cardiovascular risk factors appears to be the most effective approach to preventing cardiovascular morbidity and mortality” in these patients, the investigators wrote (N. Engl. J. Med. 2009, 360[2]:129-39).

The Veterans Affairs Diabetes Trial (VADT) examined the effect of intensive glucose control in 1,791 military veterans (mean age, 60 years) who had poorly controlled type 2 diabetes. Patients were randomized to either standard or intensive glucose control therapy. In both groups, obese patients (those with a body mass index of 27 kg/m

The primary outcome was the time from randomization to a first major cardiovascular event, heart failure, surgery for vascular disease, or amputation for ischemic gangrene.

At 3 months, median HbA1c had decreased in both groups; by 6 months, it had stabilized at 8% in the standard therapy group and 7% in the intensive therapy group.

After a median follow-up of 6 years, the investigators found that those in the intensive therapy group were 12% less likely than those in the standard care group to have had a cardiovascular event (not a significant difference). Nor were there significant differences in any of the individual cardiovascular end points, or in the rate of cardiovascular deaths.

Intensive therapy did not significantly affect any of the outcomes associated with microvascular disease. There were no significant between-group differences in amputation. And although the investigators found a slight reduction in diabetic retinopathy in the intensive therapy group, it was nonsignificant.

Intensive therapy did not significantly improve renal function or slow its decline, and was associated with a nonsignificant increase in autonomic neuropathy.

Patients in the intensive therapy group had significantly more adverse events than did those in the standard therapy group. The most common was hypoglycemia (1,566 vs. 432 incidents per 100 patient-years). Significantly more patients in the intensive therapy group had at least one serious adverse event (24% vs. 18%).

Among these, dyspnea was the most commonly reported.

There were 95 deaths from any cause in the standard therapy group, and 102 in the intensive therapy group, which was not a significant difference.

The results of VADT agree with those of two other large trials–ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease)–that examined the effect of intensive glucose control, the authors said.

“Intensive glucose control did not reduce cardiovascular events [in these trials]. The ACCORD study was terminated at 3.5 years because of increased mortality in the intensive therapy group. The ADVANCE study showed a reduction in the progression of albuminuria, but there were no changes in the rates of severe nephropathy, retinopathy, or cardiovascular events.”

The American Association of Clinical Endocrinologists (AACE) presented its perspectives of the VADT findings on the AACE Web site (www.aace.com

The study was sponsored by the Department of Veterans Affairs, the American Diabetes Association, and the National Eye Institute, with additional funding from various pharmaceutical companies.

Dr. Duckworth and his coauthors reported numerous financial connections with those companies.

Patients assigned to intensive therapy were significantly more likely to experience adverse events. DR. DUCKWORTH

Intensive glucose control isn't any more effective than standard therapy at reducing the rates of major cardiovascular events, death, or microvascular disease in patients with poorly controlled type 2 diabetes, a large prospective study has concluded.

In fact, patients assigned to intensive therapy were significantly more likely to experience hypoglycemia, dyspnea, and other serious adverse events, according to Dr. William Duckworth of the Phoenix Veterans Affairs Health Care Center and his colleagues.

Given these findings, the authors recommended that preventive efforts focus on factors more directly tied to cardiovascular health. “For now, appropriate management of hypertension, dyslipidemia, and other cardiovascular risk factors appears to be the most effective approach to preventing cardiovascular morbidity and mortality” in these patients, the investigators wrote (N. Engl. J. Med. 2009, 360[2]:129-39).

The Veterans Affairs Diabetes Trial (VADT) examined the effect of intensive glucose control in 1,791 military veterans (mean age, 60 years) who had poorly controlled type 2 diabetes. Patients were randomized to either standard or intensive glucose control therapy. In both groups, obese patients (those with a body mass index of 27 kg/m

The primary outcome was the time from randomization to a first major cardiovascular event, heart failure, surgery for vascular disease, or amputation for ischemic gangrene.

At 3 months, median HbA1c had decreased in both groups; by 6 months, it had stabilized at 8% in the standard therapy group and 7% in the intensive therapy group.

After a median follow-up of 6 years, the investigators found that those in the intensive therapy group were 12% less likely than those in the standard care group to have had a cardiovascular event (not a significant difference). Nor were there significant differences in any of the individual cardiovascular end points, or in the rate of cardiovascular deaths.

Intensive therapy did not significantly affect any of the outcomes associated with microvascular disease. There were no significant between-group differences in amputation. And although the investigators found a slight reduction in diabetic retinopathy in the intensive therapy group, it was nonsignificant.

Intensive therapy did not significantly improve renal function or slow its decline, and was associated with a nonsignificant increase in autonomic neuropathy.

Patients in the intensive therapy group had significantly more adverse events than did those in the standard therapy group. The most common was hypoglycemia (1,566 vs. 432 incidents per 100 patient-years). Significantly more patients in the intensive therapy group had at least one serious adverse event (24% vs. 18%).

Among these, dyspnea was the most commonly reported.

There were 95 deaths from any cause in the standard therapy group, and 102 in the intensive therapy group, which was not a significant difference.

The results of VADT agree with those of two other large trials–ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease)–that examined the effect of intensive glucose control, the authors said.

“Intensive glucose control did not reduce cardiovascular events [in these trials]. The ACCORD study was terminated at 3.5 years because of increased mortality in the intensive therapy group. The ADVANCE study showed a reduction in the progression of albuminuria, but there were no changes in the rates of severe nephropathy, retinopathy, or cardiovascular events.”

The American Association of Clinical Endocrinologists (AACE) presented its perspectives of the VADT findings on the AACE Web site (www.aace.com

The study was sponsored by the Department of Veterans Affairs, the American Diabetes Association, and the National Eye Institute, with additional funding from various pharmaceutical companies.

Dr. Duckworth and his coauthors reported numerous financial connections with those companies.

Patients assigned to intensive therapy were significantly more likely to experience adverse events. DR. DUCKWORTH

Antipsychotics appeared to increase the risk of death in patients with Alzheimer's disease, especially if taken for more than 12 months, in a randomized controlled trial.

Nursing home patients with Alzheimer's who continued taking the drugs for 1 year were 7% more likely to die than were those who discontinued them, and the mortality difference escalated over the 4-year study. By the end of the trial, just 26% of those taking the drugs were still alive, compared with 53% of those taking a placebo, Dr. Clive Ballard of King's College, London, and his associates wrote in the Lancet (doi:10.1016/S1474–4422[08]70295–3

The authors did support a limited use of the drugs, particularly in patients with severe dementia-related aggression, geriatrician Karl Steinberg noted in an interview. But the risks must be carefully considered.

“The authors make it clear that in some clinical situations, the benefits of treatment seem to outweigh the risks, but it's important to obtain informed consent when we choose to utilize them,” said Dr. Steinberg, who is in a group practice in Oceanside, Calif.

The findings seem to support the Omnibus Budget Reconciliation Act of 1987, which mandated gradual dose reductions of antipsychotics in nursing home residents, he added. “We need to keep in mind that the patients for whom we prescribe these medications are suffering from significant dementia and already nearing the end of life, where quality of life should be a major concern.”

The trial comprised 165 nursing home residents with Alzheimer's disease (mean age 89 years). At baseline, all patients were taking an antipsychotic medication. Most (93%) were taking either risperidone or haloperidol; other agents included thioridazine, chlorpromazine, and trifluoperazine.

Patients were randomized to either continue treatment (83) or discontinue treatment by taking a placebo. Because 37 patients did not start treatment, 64 were left in each treatment group. The 12-, 24-, 36-, and 42-month survival rates were analyzed among those who began taking their study medication, regardless of whether they stopped at any time during the study.

After 12 months, those on placebo were 7% more likely to survive than were those on an active agent (70% vs. 77%); the difference was statistically significant. The disparity grew as the trial continued. At 24 months, the cumulative survival rate was 71% in the placebo group vs. 46% in the active group; at 36 months, the rate was 59% vs. 30%; and at 42 months, it was 53% vs. 26%.

Death certificates were available for 78%. More deaths of a probable vascular nature occurred in the placebo group; there was no indication that antipsychotics contribute to cerebrovascular deaths. The reasons why the biggest difference in mortality occurred after the first 12 months of the trial are unclear, the researchers wrote.

They noted that up to 60% of nursing home residents with dementia in Europe and North America receive antipsychotic medication, despite studies suggesting that the risks outweigh any possible benefit.

“There is clear evidence of a significant increase in adverse events, including parkinsonism, sedation, oedema, chest infections, accelerated cognitive decline, and cerebrovascular events in patients with Alzheimer's treated with antipsychotics,” they noted. Alternative treatments include psychological management, memantine, and antidepressants, which “might be safer and effective for some neuropsychiatric symptoms.”

The results confirm other evidence of a link between the drugs and increased morbidity and mortality in dementia patients, Alzheimer's researcher Marwan Sabbagh said in an interview. “This risk was the impetus for the black box warning issued by the FDA for risk associated with antipsychotic use specifically in dementia,” said Dr. Sabbagh, director of clinical research at the Sun Health Research Institute, Sun City, Ariz.

“What makes this more compelling is that it is not simply an observational study. Rather, this is objective evidence in a randomized, placebo-controlled study that [Alzheimer's disease] subjects taking antipsychotics had demonstrable increases in mortality,” Dr. Sabbagh said. “This should compel practitioners to employ additional caution when administering this class of medication to demented individuals.”

The study was funded by the U.K. Alzheimer's Research Trust. Dr. Ballard noted financial relationships with many companies that manufacture antipsychotics and Alzheimer's medications.

Antipsychotics appeared to increase the risk of death in patients with Alzheimer's disease, especially if taken for more than 12 months, in a randomized controlled trial.

Nursing home patients with Alzheimer's who continued taking the drugs for 1 year were 7% more likely to die than were those who discontinued them, and the mortality difference escalated over the 4-year study. By the end of the trial, just 26% of those taking the drugs were still alive, compared with 53% of those taking a placebo, Dr. Clive Ballard of King's College, London, and his associates wrote in the Lancet (doi:10.1016/S1474–4422[08]70295–3

The authors did support a limited use of the drugs, particularly in patients with severe dementia-related aggression, geriatrician Karl Steinberg noted in an interview. But the risks must be carefully considered.

“The authors make it clear that in some clinical situations, the benefits of treatment seem to outweigh the risks, but it's important to obtain informed consent when we choose to utilize them,” said Dr. Steinberg, who is in a group practice in Oceanside, Calif.

The findings seem to support the Omnibus Budget Reconciliation Act of 1987, which mandated gradual dose reductions of antipsychotics in nursing home residents, he added. “We need to keep in mind that the patients for whom we prescribe these medications are suffering from significant dementia and already nearing the end of life, where quality of life should be a major concern.”

The trial comprised 165 nursing home residents with Alzheimer's disease (mean age 89 years). At baseline, all patients were taking an antipsychotic medication. Most (93%) were taking either risperidone or haloperidol; other agents included thioridazine, chlorpromazine, and trifluoperazine.

Patients were randomized to either continue treatment (83) or discontinue treatment by taking a placebo. Because 37 patients did not start treatment, 64 were left in each treatment group. The 12-, 24-, 36-, and 42-month survival rates were analyzed among those who began taking their study medication, regardless of whether they stopped at any time during the study.

After 12 months, those on placebo were 7% more likely to survive than were those on an active agent (70% vs. 77%); the difference was statistically significant. The disparity grew as the trial continued. At 24 months, the cumulative survival rate was 71% in the placebo group vs. 46% in the active group; at 36 months, the rate was 59% vs. 30%; and at 42 months, it was 53% vs. 26%.

Death certificates were available for 78%. More deaths of a probable vascular nature occurred in the placebo group; there was no indication that antipsychotics contribute to cerebrovascular deaths. The reasons why the biggest difference in mortality occurred after the first 12 months of the trial are unclear, the researchers wrote.

They noted that up to 60% of nursing home residents with dementia in Europe and North America receive antipsychotic medication, despite studies suggesting that the risks outweigh any possible benefit.

“There is clear evidence of a significant increase in adverse events, including parkinsonism, sedation, oedema, chest infections, accelerated cognitive decline, and cerebrovascular events in patients with Alzheimer's treated with antipsychotics,” they noted. Alternative treatments include psychological management, memantine, and antidepressants, which “might be safer and effective for some neuropsychiatric symptoms.”

The results confirm other evidence of a link between the drugs and increased morbidity and mortality in dementia patients, Alzheimer's researcher Marwan Sabbagh said in an interview. “This risk was the impetus for the black box warning issued by the FDA for risk associated with antipsychotic use specifically in dementia,” said Dr. Sabbagh, director of clinical research at the Sun Health Research Institute, Sun City, Ariz.

“What makes this more compelling is that it is not simply an observational study. Rather, this is objective evidence in a randomized, placebo-controlled study that [Alzheimer's disease] subjects taking antipsychotics had demonstrable increases in mortality,” Dr. Sabbagh said. “This should compel practitioners to employ additional caution when administering this class of medication to demented individuals.”

The study was funded by the U.K. Alzheimer's Research Trust. Dr. Ballard noted financial relationships with many companies that manufacture antipsychotics and Alzheimer's medications.

Antipsychotics appeared to increase the risk of death in patients with Alzheimer's disease, especially if taken for more than 12 months, in a randomized controlled trial.

Nursing home patients with Alzheimer's who continued taking the drugs for 1 year were 7% more likely to die than were those who discontinued them, and the mortality difference escalated over the 4-year study. By the end of the trial, just 26% of those taking the drugs were still alive, compared with 53% of those taking a placebo, Dr. Clive Ballard of King's College, London, and his associates wrote in the Lancet (doi:10.1016/S1474–4422[08]70295–3

The authors did support a limited use of the drugs, particularly in patients with severe dementia-related aggression, geriatrician Karl Steinberg noted in an interview. But the risks must be carefully considered.

“The authors make it clear that in some clinical situations, the benefits of treatment seem to outweigh the risks, but it's important to obtain informed consent when we choose to utilize them,” said Dr. Steinberg, who is in a group practice in Oceanside, Calif.

The findings seem to support the Omnibus Budget Reconciliation Act of 1987, which mandated gradual dose reductions of antipsychotics in nursing home residents, he added. “We need to keep in mind that the patients for whom we prescribe these medications are suffering from significant dementia and already nearing the end of life, where quality of life should be a major concern.”

The trial comprised 165 nursing home residents with Alzheimer's disease (mean age 89 years). At baseline, all patients were taking an antipsychotic medication. Most (93%) were taking either risperidone or haloperidol; other agents included thioridazine, chlorpromazine, and trifluoperazine.

Patients were randomized to either continue treatment (83) or discontinue treatment by taking a placebo. Because 37 patients did not start treatment, 64 were left in each treatment group. The 12-, 24-, 36-, and 42-month survival rates were analyzed among those who began taking their study medication, regardless of whether they stopped at any time during the study.

After 12 months, those on placebo were 7% more likely to survive than were those on an active agent (70% vs. 77%); the difference was statistically significant. The disparity grew as the trial continued. At 24 months, the cumulative survival rate was 71% in the placebo group vs. 46% in the active group; at 36 months, the rate was 59% vs. 30%; and at 42 months, it was 53% vs. 26%.

Death certificates were available for 78%. More deaths of a probable vascular nature occurred in the placebo group; there was no indication that antipsychotics contribute to cerebrovascular deaths. The reasons why the biggest difference in mortality occurred after the first 12 months of the trial are unclear, the researchers wrote.

They noted that up to 60% of nursing home residents with dementia in Europe and North America receive antipsychotic medication, despite studies suggesting that the risks outweigh any possible benefit.

“There is clear evidence of a significant increase in adverse events, including parkinsonism, sedation, oedema, chest infections, accelerated cognitive decline, and cerebrovascular events in patients with Alzheimer's treated with antipsychotics,” they noted. Alternative treatments include psychological management, memantine, and antidepressants, which “might be safer and effective for some neuropsychiatric symptoms.”

The results confirm other evidence of a link between the drugs and increased morbidity and mortality in dementia patients, Alzheimer's researcher Marwan Sabbagh said in an interview. “This risk was the impetus for the black box warning issued by the FDA for risk associated with antipsychotic use specifically in dementia,” said Dr. Sabbagh, director of clinical research at the Sun Health Research Institute, Sun City, Ariz.

“What makes this more compelling is that it is not simply an observational study. Rather, this is objective evidence in a randomized, placebo-controlled study that [Alzheimer's disease] subjects taking antipsychotics had demonstrable increases in mortality,” Dr. Sabbagh said. “This should compel practitioners to employ additional caution when administering this class of medication to demented individuals.”

The study was funded by the U.K. Alzheimer's Research Trust. Dr. Ballard noted financial relationships with many companies that manufacture antipsychotics and Alzheimer's medications.

Weaning or reducing diabetes medications in elderly nursing home residents is possible and may reduce the risk of hypoglycemic events that can cause cognitive impairment, cardiac arrhythmias, and even death, a small Swedish study has concluded.

Blood glucose remained stable in the intervention patients by 3 and 6 months. Glucose levels also decreased slightly in patients in a comparator group that continued antidiabetes medications during the study period, Dr. Peter Sjoblom of the Soderkoping (Sweden) Primary Health Care Center and colleagues reported.

They noted the effect of diabetes medication continuation, or withdrawal/reduction in 98 patients (mean age 84 years). Patients with hemoglobin A1c (HbA_1c) levels at 6% or higher at baseline (66) stayed on their medication, whereas those with HbA_1c levels below 6% (32) were placed in the intervention group. Of these, 10 took oral antidiabetic drugs, 17 needed insulin injections, and 5 were on a combination regimen (Diab. Res. Clin. Pract. 2008;82:197–202).

Before intervention, the frequency of hypoglycemia was assessed by measuring the interventions groups' glucose levels 4 times each day for 3 days. There were 31 episodes of hypoglycemia (mean blood glucose level of 72 mg/dL or lower), of which about half (17) were at night.

Frequency varied with the antidiabetic regimen: 40% of patients on oral drugs alone had at least one hypoglycemic event, as did 75% of those on injected insulin and 100% of those on combination regimens.

After the baseline glucose measurements, oral drugs were withdrawn, as was insulin in patients taking 20 U/day or less. Insulin was cut by half in those taking more than 20 U/day.

At 3 months, 24 patients (76%) had been successfully weaned from their medication. Hyperglycemia (plasma glucose of at least 16 mmol/L) occurred in four patients; their medications were restored. Two patients were withdrawn from the trial due to relatives' concern, and two died from causes unrelated to diabetes.

The study was funded by local and regional governmental grants.

The authors said they had no conflicts of interest.

Weaning or reducing diabetes medications in elderly nursing home residents is possible and may reduce the risk of hypoglycemic events that can cause cognitive impairment, cardiac arrhythmias, and even death, a small Swedish study has concluded.

Blood glucose remained stable in the intervention patients by 3 and 6 months. Glucose levels also decreased slightly in patients in a comparator group that continued antidiabetes medications during the study period, Dr. Peter Sjoblom of the Soderkoping (Sweden) Primary Health Care Center and colleagues reported.

They noted the effect of diabetes medication continuation, or withdrawal/reduction in 98 patients (mean age 84 years). Patients with hemoglobin A1c (HbA_1c) levels at 6% or higher at baseline (66) stayed on their medication, whereas those with HbA_1c levels below 6% (32) were placed in the intervention group. Of these, 10 took oral antidiabetic drugs, 17 needed insulin injections, and 5 were on a combination regimen (Diab. Res. Clin. Pract. 2008;82:197–202).

Before intervention, the frequency of hypoglycemia was assessed by measuring the interventions groups' glucose levels 4 times each day for 3 days. There were 31 episodes of hypoglycemia (mean blood glucose level of 72 mg/dL or lower), of which about half (17) were at night.

Frequency varied with the antidiabetic regimen: 40% of patients on oral drugs alone had at least one hypoglycemic event, as did 75% of those on injected insulin and 100% of those on combination regimens.

After the baseline glucose measurements, oral drugs were withdrawn, as was insulin in patients taking 20 U/day or less. Insulin was cut by half in those taking more than 20 U/day.

At 3 months, 24 patients (76%) had been successfully weaned from their medication. Hyperglycemia (plasma glucose of at least 16 mmol/L) occurred in four patients; their medications were restored. Two patients were withdrawn from the trial due to relatives' concern, and two died from causes unrelated to diabetes.

The study was funded by local and regional governmental grants.

The authors said they had no conflicts of interest.

Weaning or reducing diabetes medications in elderly nursing home residents is possible and may reduce the risk of hypoglycemic events that can cause cognitive impairment, cardiac arrhythmias, and even death, a small Swedish study has concluded.

Blood glucose remained stable in the intervention patients by 3 and 6 months. Glucose levels also decreased slightly in patients in a comparator group that continued antidiabetes medications during the study period, Dr. Peter Sjoblom of the Soderkoping (Sweden) Primary Health Care Center and colleagues reported.

They noted the effect of diabetes medication continuation, or withdrawal/reduction in 98 patients (mean age 84 years). Patients with hemoglobin A1c (HbA_1c) levels at 6% or higher at baseline (66) stayed on their medication, whereas those with HbA_1c levels below 6% (32) were placed in the intervention group. Of these, 10 took oral antidiabetic drugs, 17 needed insulin injections, and 5 were on a combination regimen (Diab. Res. Clin. Pract. 2008;82:197–202).

Before intervention, the frequency of hypoglycemia was assessed by measuring the interventions groups' glucose levels 4 times each day for 3 days. There were 31 episodes of hypoglycemia (mean blood glucose level of 72 mg/dL or lower), of which about half (17) were at night.

Frequency varied with the antidiabetic regimen: 40% of patients on oral drugs alone had at least one hypoglycemic event, as did 75% of those on injected insulin and 100% of those on combination regimens.

After the baseline glucose measurements, oral drugs were withdrawn, as was insulin in patients taking 20 U/day or less. Insulin was cut by half in those taking more than 20 U/day.

At 3 months, 24 patients (76%) had been successfully weaned from their medication. Hyperglycemia (plasma glucose of at least 16 mmol/L) occurred in four patients; their medications were restored. Two patients were withdrawn from the trial due to relatives' concern, and two died from causes unrelated to diabetes.

The study was funded by local and regional governmental grants.

The authors said they had no conflicts of interest.

Intensive glucose control isn't any more effective than standard therapy at reducing the rates of major cardiovascular events, death, or microvascular disease in patients with poorly controlled type 2 diabetes, a prospective study of nearly 1,800 such patients has indicated.

In fact, patients assigned to intensive therapy were significantly more likely to experience hypoglycemia, dyspnea, and other serious adverse events, the investigators wrote.

Given these findings, the authors recommended that preventive efforts focus on factors more directly tied to cardiovascular health. “For now, appropriate management of hypertension, dyslipidemia, and other cardiovascular risk factors appears to be the most effective approach to preventing cardiovascular morbidity and mortality” in these patients, wrote Dr. William Duckworth of the Phoenix Veterans Affairs Health Care Center and his colleagues (N. Engl. J. Med. 2008 Dec. 17 [doi:10.1056/NEJMoa0808431]).

The Veterans Affairs Diabetes Trial (VADT) examined the effect of intensive glucose control in 1,791 military veterans (mean age, 60 years) who had poorly controlled type 2 diabetes. Patients were randomized to either standard or intensive glucose control therapy. In both groups, obese patients (those with a body mass index of 27 kg/m

The primary outcome was the time from randomization to a first major cardiovascular event, heart failure, surgery for vascular disease, or amputation for ischemic gangrene.

At 3 months, median HbA1c had decreased in both groups; by 6 months, it had stabilized at 8% in the standard therapy group and 7% in the intensive therapy group.

After a median follow-up of 6 years, the investigators found that those in the intensive therapy group were 12% less likely than those in the standard care group to have had a cardiovascular event (not a significant difference). Nor were there significant differences in any of the individual cardiovascular end points, or in the rate of cardiovascular deaths.

Intensive therapy did not significantly affect any of the outcomes associated with microvascular disease. There were no significant between-group differences in amputation. And although the investigators found a slight reduction in diabetic retinopathy in the intensive therapy group, it was nonsignificant. Intensive therapy did not significantly improve renal function or slow its decline, and was associated with a nonsignificant increase in autonomic neuropathy.

Patients in the intensive therapy group had significantly more adverse events than did those in the standard therapy group. The most common was hypoglycemia (1,566 vs. 432 incidents per 100 patient-years). Significantly more patients in the intensive therapy group had at least one serious adverse event (24% vs. 18%). Among these, dyspnea was the most commonly reported.

There were 95 deaths from any cause in the standard therapy group, and 102 in the intensive therapy group, which was not a significant difference.

The results of VADT agree with those of two other large trials—ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease)—that examined the effect of intensive glucose control, the authors said. “Intensive glucose control did not reduce cardiovascular events [in these trials]. The ACCORD study was terminated at 3.5 years because of increased mortality in the intensive therapy group. The ADVANCE study showed a reduction in the progression of albuminuria, but there were no changes in the rates of severe nephropathy, retinopathy, or cardiovascular events.”

The American Association of Clinical Endocrinologists (AACE) presented its view of the VADT results on the AACE Web site (www.aace.com

The committee emphasized that “AACE… continue[s] to advocate good glycemic control for diabetic patients, recognizing that treatment targets and strategies have to be individualized.”

The study was sponsored by the Department of Veterans Affairs, the American Diabetes Association, and the National Eye Institute, with additional funding from various pharmaceutical companies. Dr. Duckworth and his coauthors reported numerous financial connections with those companies.

'Appropriate management of … risk factors appears to be the most effective approach.' DR. DUCKWORTH

Intensive glucose control isn't any more effective than standard therapy at reducing the rates of major cardiovascular events, death, or microvascular disease in patients with poorly controlled type 2 diabetes, a prospective study of nearly 1,800 such patients has indicated.

In fact, patients assigned to intensive therapy were significantly more likely to experience hypoglycemia, dyspnea, and other serious adverse events, the investigators wrote.

Given these findings, the authors recommended that preventive efforts focus on factors more directly tied to cardiovascular health. “For now, appropriate management of hypertension, dyslipidemia, and other cardiovascular risk factors appears to be the most effective approach to preventing cardiovascular morbidity and mortality” in these patients, wrote Dr. William Duckworth of the Phoenix Veterans Affairs Health Care Center and his colleagues (N. Engl. J. Med. 2008 Dec. 17 [doi:10.1056/NEJMoa0808431]).

The Veterans Affairs Diabetes Trial (VADT) examined the effect of intensive glucose control in 1,791 military veterans (mean age, 60 years) who had poorly controlled type 2 diabetes. Patients were randomized to either standard or intensive glucose control therapy. In both groups, obese patients (those with a body mass index of 27 kg/m

The primary outcome was the time from randomization to a first major cardiovascular event, heart failure, surgery for vascular disease, or amputation for ischemic gangrene.

At 3 months, median HbA1c had decreased in both groups; by 6 months, it had stabilized at 8% in the standard therapy group and 7% in the intensive therapy group.

After a median follow-up of 6 years, the investigators found that those in the intensive therapy group were 12% less likely than those in the standard care group to have had a cardiovascular event (not a significant difference). Nor were there significant differences in any of the individual cardiovascular end points, or in the rate of cardiovascular deaths.

Intensive therapy did not significantly affect any of the outcomes associated with microvascular disease. There were no significant between-group differences in amputation. And although the investigators found a slight reduction in diabetic retinopathy in the intensive therapy group, it was nonsignificant. Intensive therapy did not significantly improve renal function or slow its decline, and was associated with a nonsignificant increase in autonomic neuropathy.

Patients in the intensive therapy group had significantly more adverse events than did those in the standard therapy group. The most common was hypoglycemia (1,566 vs. 432 incidents per 100 patient-years). Significantly more patients in the intensive therapy group had at least one serious adverse event (24% vs. 18%). Among these, dyspnea was the most commonly reported.

There were 95 deaths from any cause in the standard therapy group, and 102 in the intensive therapy group, which was not a significant difference.

The results of VADT agree with those of two other large trials—ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease)—that examined the effect of intensive glucose control, the authors said. “Intensive glucose control did not reduce cardiovascular events [in these trials]. The ACCORD study was terminated at 3.5 years because of increased mortality in the intensive therapy group. The ADVANCE study showed a reduction in the progression of albuminuria, but there were no changes in the rates of severe nephropathy, retinopathy, or cardiovascular events.”

The American Association of Clinical Endocrinologists (AACE) presented its view of the VADT results on the AACE Web site (www.aace.com

The committee emphasized that “AACE… continue[s] to advocate good glycemic control for diabetic patients, recognizing that treatment targets and strategies have to be individualized.”

The study was sponsored by the Department of Veterans Affairs, the American Diabetes Association, and the National Eye Institute, with additional funding from various pharmaceutical companies. Dr. Duckworth and his coauthors reported numerous financial connections with those companies.

'Appropriate management of … risk factors appears to be the most effective approach.' DR. DUCKWORTH

Intensive glucose control isn't any more effective than standard therapy at reducing the rates of major cardiovascular events, death, or microvascular disease in patients with poorly controlled type 2 diabetes, a prospective study of nearly 1,800 such patients has indicated.

In fact, patients assigned to intensive therapy were significantly more likely to experience hypoglycemia, dyspnea, and other serious adverse events, the investigators wrote.

Given these findings, the authors recommended that preventive efforts focus on factors more directly tied to cardiovascular health. “For now, appropriate management of hypertension, dyslipidemia, and other cardiovascular risk factors appears to be the most effective approach to preventing cardiovascular morbidity and mortality” in these patients, wrote Dr. William Duckworth of the Phoenix Veterans Affairs Health Care Center and his colleagues (N. Engl. J. Med. 2008 Dec. 17 [doi:10.1056/NEJMoa0808431]).

The Veterans Affairs Diabetes Trial (VADT) examined the effect of intensive glucose control in 1,791 military veterans (mean age, 60 years) who had poorly controlled type 2 diabetes. Patients were randomized to either standard or intensive glucose control therapy. In both groups, obese patients (those with a body mass index of 27 kg/m

The primary outcome was the time from randomization to a first major cardiovascular event, heart failure, surgery for vascular disease, or amputation for ischemic gangrene.

At 3 months, median HbA1c had decreased in both groups; by 6 months, it had stabilized at 8% in the standard therapy group and 7% in the intensive therapy group.

After a median follow-up of 6 years, the investigators found that those in the intensive therapy group were 12% less likely than those in the standard care group to have had a cardiovascular event (not a significant difference). Nor were there significant differences in any of the individual cardiovascular end points, or in the rate of cardiovascular deaths.

Intensive therapy did not significantly affect any of the outcomes associated with microvascular disease. There were no significant between-group differences in amputation. And although the investigators found a slight reduction in diabetic retinopathy in the intensive therapy group, it was nonsignificant. Intensive therapy did not significantly improve renal function or slow its decline, and was associated with a nonsignificant increase in autonomic neuropathy.

Patients in the intensive therapy group had significantly more adverse events than did those in the standard therapy group. The most common was hypoglycemia (1,566 vs. 432 incidents per 100 patient-years). Significantly more patients in the intensive therapy group had at least one serious adverse event (24% vs. 18%). Among these, dyspnea was the most commonly reported.

There were 95 deaths from any cause in the standard therapy group, and 102 in the intensive therapy group, which was not a significant difference.

The results of VADT agree with those of two other large trials—ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease)—that examined the effect of intensive glucose control, the authors said. “Intensive glucose control did not reduce cardiovascular events [in these trials]. The ACCORD study was terminated at 3.5 years because of increased mortality in the intensive therapy group. The ADVANCE study showed a reduction in the progression of albuminuria, but there were no changes in the rates of severe nephropathy, retinopathy, or cardiovascular events.”

The American Association of Clinical Endocrinologists (AACE) presented its view of the VADT results on the AACE Web site (www.aace.com

The committee emphasized that “AACE… continue[s] to advocate good glycemic control for diabetic patients, recognizing that treatment targets and strategies have to be individualized.”

The study was sponsored by the Department of Veterans Affairs, the American Diabetes Association, and the National Eye Institute, with additional funding from various pharmaceutical companies. Dr. Duckworth and his coauthors reported numerous financial connections with those companies.

'Appropriate management of … risk factors appears to be the most effective approach.' DR. DUCKWORTH