Miriam E. Tucker

Bariatric surgery reduced the incidence of type 2 diabetes by 78% compared with usual care at 15 years in a prospective, case-matched study of more than 3,000 obese adults.

This significant risk reduction was seen with all types of bariatric surgery and regardless of baseline body mass index. And, it occurred despite the fact that the matching process unexpectedly resulted in the bariatric surgery group having a higher mean body weight and more severe risk factors at baseline than the controls.

The impact of bariatric surgery was even greater, with an 87% risk reduction, for those with impaired fasting glucose at baseline, said Dr. Lena M.S. Carlsson of the Sahlgrenska Academy at the University of Gothenburg, Sweden, and her associates (N. Engl. J. Med. 2012;367:695-704).

© Sean Locke/iStockphoto.com

"Our data indicate that bariatric surgery has a preventive effect on incident type 2 diabetes, particularly in participants with impaired fasting glucose. In contrast, baseline BMI did not influence the preventive effect of bariatric surgery on type 2 diabetes, implying that anthropometric data are not useful in the selection of candidates for bariatric surgery, whereas data on impaired fasting glucose may be helpful," the authors wrote.

The finding comes from the Swedish Obese Subjects (SOS) trial, which included 1,658 patients who chose to undergo bariatric surgery and 1,771 matched controls. All patients in both groups entered the study with the intention of losing weight. None had diabetes at baseline.

In the bariatric surgery group, the types of procedures were banding in 311, vertical banded gastroplasty in 1,140, and gastric bypass in 207. Patients in the control group received the customary treatment for obesity at their primary health care centers, which in Sweden ranges from advanced lifestyle modification – including recommendations regarding eating behavior, food selection, energy intake, and physical activity – to no treatment. About half (54%) of the controls reported receiving professional guidance in attempts to lose weight.

There were several significant differences between groups at baseline. The bariatric surgery group weighed an average of 6 kg more than did the controls, and had a greater mean BMI (42.4 vs. 40.2 kg/m²). They also had higher mean blood pressures and total cholesterol and triglyceride levels, and were more likely to smoke and to be less active.

After adjustment for follow-up of less than 15 years and for death, the 15-year participation rate was 54%. At 15 years, the bariatric surgery group had lost 31 kg after 1 year, but then regained weight, so the average loss at 10 and 15 years was about 20 kg. The control group never lost or gained more than 3 kg over the entire study period, regardless of whether they had professional help.

During the follow-up, type 2 diabetes developed in 110 of the bariatric surgery patients and in 392 controls, corresponding to incidence rates of 6.8 and 28.4 cases per 1,000 person-years, respectively (P less than .001). The unadjusted hazard ratio was 0.22, which dropped to 0.17 following multivariate adjustments. Aside from treatment group, other strong univariate predictors of diabetes outcome were baseline blood glucose and the presence or absence of impaired fasting glucose, Dr. Carlsson and her associates reported.

In a sensitivity analysis performed to account for the low participation rate, the impact of treatment on the incidence of type 2 diabetes was at least as strong after 2 years and 10 years of follow-up as after 15 years. All types of bariatric surgery were associated with a reduced incidence of diabetes, with no significant differences among them. There were also no differences by receipt of professional weight-loss assistance, or by BMI at baseline, the investigators noted.

A total of 3 patients (0.2%) died within 90 days of surgery, and 245 patients in the surgery group (15%) reported at least one complication. Of those, 46 (2.8%) were serious enough to require a reoperation.

The risk reduction seen among those with impaired fasting glucose was at least twice as large as the risk reduction achieved with lifestyle interventions in large, long-term trials of moderately obese people with prediabetes (Lancet 2006;368:1673-9, Lancet 2009;374:1677-86, and Lancet 2008;371:1783-9), the investigators noted.

The ongoing SOS study is supported by grants from the Swedish Research Council, the Swedish Foundation for Strategic Research to the Sahlgrenska Center for Cardiovascular and Metabolic Research, the Swedish federal government, the VINNOVA-VINNMER program, and the Wenner-Gren Foundations. The SOS study has previously been supported by grants to one of the authors from Hoffmann-La Roche, AstraZeneca, and other companies. Dr. Carlsson reported receiving consulting fees from AstraZeneca and owning stock in Sahltech. Other coinvestigators also had financial disclosures.

Bariatric surgery reduced the incidence of type 2 diabetes by 78% compared with usual care at 15 years in a prospective, case-matched study of more than 3,000 obese adults.

This significant risk reduction was seen with all types of bariatric surgery and regardless of baseline body mass index. And, it occurred despite the fact that the matching process unexpectedly resulted in the bariatric surgery group having a higher mean body weight and more severe risk factors at baseline than the controls.

The impact of bariatric surgery was even greater, with an 87% risk reduction, for those with impaired fasting glucose at baseline, said Dr. Lena M.S. Carlsson of the Sahlgrenska Academy at the University of Gothenburg, Sweden, and her associates (N. Engl. J. Med. 2012;367:695-704).

© Sean Locke/iStockphoto.com

"Our data indicate that bariatric surgery has a preventive effect on incident type 2 diabetes, particularly in participants with impaired fasting glucose. In contrast, baseline BMI did not influence the preventive effect of bariatric surgery on type 2 diabetes, implying that anthropometric data are not useful in the selection of candidates for bariatric surgery, whereas data on impaired fasting glucose may be helpful," the authors wrote.

The finding comes from the Swedish Obese Subjects (SOS) trial, which included 1,658 patients who chose to undergo bariatric surgery and 1,771 matched controls. All patients in both groups entered the study with the intention of losing weight. None had diabetes at baseline.

In the bariatric surgery group, the types of procedures were banding in 311, vertical banded gastroplasty in 1,140, and gastric bypass in 207. Patients in the control group received the customary treatment for obesity at their primary health care centers, which in Sweden ranges from advanced lifestyle modification – including recommendations regarding eating behavior, food selection, energy intake, and physical activity – to no treatment. About half (54%) of the controls reported receiving professional guidance in attempts to lose weight.

There were several significant differences between groups at baseline. The bariatric surgery group weighed an average of 6 kg more than did the controls, and had a greater mean BMI (42.4 vs. 40.2 kg/m²). They also had higher mean blood pressures and total cholesterol and triglyceride levels, and were more likely to smoke and to be less active.

After adjustment for follow-up of less than 15 years and for death, the 15-year participation rate was 54%. At 15 years, the bariatric surgery group had lost 31 kg after 1 year, but then regained weight, so the average loss at 10 and 15 years was about 20 kg. The control group never lost or gained more than 3 kg over the entire study period, regardless of whether they had professional help.

During the follow-up, type 2 diabetes developed in 110 of the bariatric surgery patients and in 392 controls, corresponding to incidence rates of 6.8 and 28.4 cases per 1,000 person-years, respectively (P less than .001). The unadjusted hazard ratio was 0.22, which dropped to 0.17 following multivariate adjustments. Aside from treatment group, other strong univariate predictors of diabetes outcome were baseline blood glucose and the presence or absence of impaired fasting glucose, Dr. Carlsson and her associates reported.

In a sensitivity analysis performed to account for the low participation rate, the impact of treatment on the incidence of type 2 diabetes was at least as strong after 2 years and 10 years of follow-up as after 15 years. All types of bariatric surgery were associated with a reduced incidence of diabetes, with no significant differences among them. There were also no differences by receipt of professional weight-loss assistance, or by BMI at baseline, the investigators noted.

A total of 3 patients (0.2%) died within 90 days of surgery, and 245 patients in the surgery group (15%) reported at least one complication. Of those, 46 (2.8%) were serious enough to require a reoperation.

The risk reduction seen among those with impaired fasting glucose was at least twice as large as the risk reduction achieved with lifestyle interventions in large, long-term trials of moderately obese people with prediabetes (Lancet 2006;368:1673-9, Lancet 2009;374:1677-86, and Lancet 2008;371:1783-9), the investigators noted.

The ongoing SOS study is supported by grants from the Swedish Research Council, the Swedish Foundation for Strategic Research to the Sahlgrenska Center for Cardiovascular and Metabolic Research, the Swedish federal government, the VINNOVA-VINNMER program, and the Wenner-Gren Foundations. The SOS study has previously been supported by grants to one of the authors from Hoffmann-La Roche, AstraZeneca, and other companies. Dr. Carlsson reported receiving consulting fees from AstraZeneca and owning stock in Sahltech. Other coinvestigators also had financial disclosures.

Bariatric surgery reduced the incidence of type 2 diabetes by 78% compared with usual care at 15 years in a prospective, case-matched study of more than 3,000 obese adults.

This significant risk reduction was seen with all types of bariatric surgery and regardless of baseline body mass index. And, it occurred despite the fact that the matching process unexpectedly resulted in the bariatric surgery group having a higher mean body weight and more severe risk factors at baseline than the controls.

The impact of bariatric surgery was even greater, with an 87% risk reduction, for those with impaired fasting glucose at baseline, said Dr. Lena M.S. Carlsson of the Sahlgrenska Academy at the University of Gothenburg, Sweden, and her associates (N. Engl. J. Med. 2012;367:695-704).

© Sean Locke/iStockphoto.com

"Our data indicate that bariatric surgery has a preventive effect on incident type 2 diabetes, particularly in participants with impaired fasting glucose. In contrast, baseline BMI did not influence the preventive effect of bariatric surgery on type 2 diabetes, implying that anthropometric data are not useful in the selection of candidates for bariatric surgery, whereas data on impaired fasting glucose may be helpful," the authors wrote.

The finding comes from the Swedish Obese Subjects (SOS) trial, which included 1,658 patients who chose to undergo bariatric surgery and 1,771 matched controls. All patients in both groups entered the study with the intention of losing weight. None had diabetes at baseline.

In the bariatric surgery group, the types of procedures were banding in 311, vertical banded gastroplasty in 1,140, and gastric bypass in 207. Patients in the control group received the customary treatment for obesity at their primary health care centers, which in Sweden ranges from advanced lifestyle modification – including recommendations regarding eating behavior, food selection, energy intake, and physical activity – to no treatment. About half (54%) of the controls reported receiving professional guidance in attempts to lose weight.

There were several significant differences between groups at baseline. The bariatric surgery group weighed an average of 6 kg more than did the controls, and had a greater mean BMI (42.4 vs. 40.2 kg/m²). They also had higher mean blood pressures and total cholesterol and triglyceride levels, and were more likely to smoke and to be less active.

After adjustment for follow-up of less than 15 years and for death, the 15-year participation rate was 54%. At 15 years, the bariatric surgery group had lost 31 kg after 1 year, but then regained weight, so the average loss at 10 and 15 years was about 20 kg. The control group never lost or gained more than 3 kg over the entire study period, regardless of whether they had professional help.

During the follow-up, type 2 diabetes developed in 110 of the bariatric surgery patients and in 392 controls, corresponding to incidence rates of 6.8 and 28.4 cases per 1,000 person-years, respectively (P less than .001). The unadjusted hazard ratio was 0.22, which dropped to 0.17 following multivariate adjustments. Aside from treatment group, other strong univariate predictors of diabetes outcome were baseline blood glucose and the presence or absence of impaired fasting glucose, Dr. Carlsson and her associates reported.

In a sensitivity analysis performed to account for the low participation rate, the impact of treatment on the incidence of type 2 diabetes was at least as strong after 2 years and 10 years of follow-up as after 15 years. All types of bariatric surgery were associated with a reduced incidence of diabetes, with no significant differences among them. There were also no differences by receipt of professional weight-loss assistance, or by BMI at baseline, the investigators noted.

A total of 3 patients (0.2%) died within 90 days of surgery, and 245 patients in the surgery group (15%) reported at least one complication. Of those, 46 (2.8%) were serious enough to require a reoperation.

The risk reduction seen among those with impaired fasting glucose was at least twice as large as the risk reduction achieved with lifestyle interventions in large, long-term trials of moderately obese people with prediabetes (Lancet 2006;368:1673-9, Lancet 2009;374:1677-86, and Lancet 2008;371:1783-9), the investigators noted.

The ongoing SOS study is supported by grants from the Swedish Research Council, the Swedish Foundation for Strategic Research to the Sahlgrenska Center for Cardiovascular and Metabolic Research, the Swedish federal government, the VINNOVA-VINNMER program, and the Wenner-Gren Foundations. The SOS study has previously been supported by grants to one of the authors from Hoffmann-La Roche, AstraZeneca, and other companies. Dr. Carlsson reported receiving consulting fees from AstraZeneca and owning stock in Sahltech. Other coinvestigators also had financial disclosures.

A group of experts has identified what they believe to be essential clinical components of an ideal severity grading scale for acne vulgaris.

Although more than 25 systems are in existence for acne grading, there is neither a gold standard nor a standardized system consistently used in research or clinical practice. "The reasons for this are multiple, including differing needs of the clinical versus research paradigms, the persistence of simpler tools with inadequate accuracy, the inefficiency of research methods such as lesion counting, and a previous lack of consensus building in this area," lead author Dr. Jerry Tan, a dermatologist at the University of Western Ontario in London, said in an interview.

The panel of 12 acne experts determined that an ideal scale should include the clinical components of primary acne lesions; their quantity, extent, and facial and extrafacial sites of involvement; and features of clinimetric properties, categorization, efficiency, and acceptance.

This consensus is considered a first step toward the development of a new acne severity grading scale. In the meantime, "this information can best be used by practicing dermatologists as an initial phase in further identifying and developing a standard for acne severity grading in the future," said Dr. Tan.

The panel arrived at this consensus via the "Delphi method," in which each member responded to a three-phase, online, anonymous survey. In the first Delphi round, they were asked open-ended questions about what components and features would be essential to the scale, and whether any current scales included the components the member deemed essential and the features deemed important (J. Am. Acad. Dermatol. 2012;67:187-93 [doi: 10.1016/j.jaad.2011.09.005]).

In the first round, the group identified primary acne lesions (evaluation of inflammatory or noninflammatory lesions together or separately), secondary lesions (such as scarring or pigmentary changes), quantity of lesions, extrafacial sites of involvement, extent of involvement, and patient experiences as being essential clinical components. Features deemed important included clinimetric properties (such as validity and reproducibility), efficiency/ease of use, categorization of severity (i.e., based on descriptive text and/or photographic examples), and acceptance (by physicians, patients, and other stakeholders).

In the next round, panel members were asked to grade each component and feature on a seven-point scale, and to provide subcategories for inclusion.

In the final consensus, the group agreed that the scale should include separate evaluation of inflammatory and noninflammatory primary lesions; determination of the quantity of lesions by counting and numerical range; grading of extrafacial sites including the chest, back, neck, and shoulders; and determination of extent of involvement using proportion descriptors such as "one third or less."

The panel also came to a consensus on excluding patient experiences, while a slight majority also opted for excluding secondary lesions. In addition, a consensus was achieved for inclusion of the clinimetric properties (validity, reproducibility, discriminatory capacity, and responsivity), efficiency, acceptability, and categorization of severity.

The agreement to exclude patient experiences was a bit of a surprise, according to Dr. Tan. The finding may reflect the focus of the group on expert-determined severity, as well as the availability of quality-of-life scales that are particular to patient experience with acne and are routinely used in conjunction with clinician-based global acne severity assessments in clinical trials.

The group also agreed that while several current acne severity grading scales contain some of these elements, none contain all. For example, the eight-point severity grade scale by Allen and Smith includes type and quantity of lesions and proportion of facial involvement, but it is limited to the face (Arch. Dermatol. 1982;118:23-5). The ECLA (Echelle de Cotation des Lésions d’Acné) scale comprises numerical ranges of primary acne lesions, and includes extrafacial sites, but it does not include proportion descriptors of anatomical sites, and the scale has not been validated (Ann. Derm. Venereol. 1999;126:136-41), they wrote.

"The next steps are to identify current systems which meet at least some of the identified clinical components and features from the Delphi process. This may then facilitate development of the ideal acne grading tool for future clinical practice and research," Dr. Tan said in the interview.

Dr. Tan is an advisory board member, speaker, consultant, and/or investigator for Bayer, Cipher, and other companies. All but two of the other panel members also reported conflicts of interest.

A group of experts has identified what they believe to be essential clinical components of an ideal severity grading scale for acne vulgaris.

Although more than 25 systems are in existence for acne grading, there is neither a gold standard nor a standardized system consistently used in research or clinical practice. "The reasons for this are multiple, including differing needs of the clinical versus research paradigms, the persistence of simpler tools with inadequate accuracy, the inefficiency of research methods such as lesion counting, and a previous lack of consensus building in this area," lead author Dr. Jerry Tan, a dermatologist at the University of Western Ontario in London, said in an interview.

The panel of 12 acne experts determined that an ideal scale should include the clinical components of primary acne lesions; their quantity, extent, and facial and extrafacial sites of involvement; and features of clinimetric properties, categorization, efficiency, and acceptance.

This consensus is considered a first step toward the development of a new acne severity grading scale. In the meantime, "this information can best be used by practicing dermatologists as an initial phase in further identifying and developing a standard for acne severity grading in the future," said Dr. Tan.

The panel arrived at this consensus via the "Delphi method," in which each member responded to a three-phase, online, anonymous survey. In the first Delphi round, they were asked open-ended questions about what components and features would be essential to the scale, and whether any current scales included the components the member deemed essential and the features deemed important (J. Am. Acad. Dermatol. 2012;67:187-93 [doi: 10.1016/j.jaad.2011.09.005]).

In the first round, the group identified primary acne lesions (evaluation of inflammatory or noninflammatory lesions together or separately), secondary lesions (such as scarring or pigmentary changes), quantity of lesions, extrafacial sites of involvement, extent of involvement, and patient experiences as being essential clinical components. Features deemed important included clinimetric properties (such as validity and reproducibility), efficiency/ease of use, categorization of severity (i.e., based on descriptive text and/or photographic examples), and acceptance (by physicians, patients, and other stakeholders).

In the next round, panel members were asked to grade each component and feature on a seven-point scale, and to provide subcategories for inclusion.

In the final consensus, the group agreed that the scale should include separate evaluation of inflammatory and noninflammatory primary lesions; determination of the quantity of lesions by counting and numerical range; grading of extrafacial sites including the chest, back, neck, and shoulders; and determination of extent of involvement using proportion descriptors such as "one third or less."

The panel also came to a consensus on excluding patient experiences, while a slight majority also opted for excluding secondary lesions. In addition, a consensus was achieved for inclusion of the clinimetric properties (validity, reproducibility, discriminatory capacity, and responsivity), efficiency, acceptability, and categorization of severity.

The agreement to exclude patient experiences was a bit of a surprise, according to Dr. Tan. The finding may reflect the focus of the group on expert-determined severity, as well as the availability of quality-of-life scales that are particular to patient experience with acne and are routinely used in conjunction with clinician-based global acne severity assessments in clinical trials.

The group also agreed that while several current acne severity grading scales contain some of these elements, none contain all. For example, the eight-point severity grade scale by Allen and Smith includes type and quantity of lesions and proportion of facial involvement, but it is limited to the face (Arch. Dermatol. 1982;118:23-5). The ECLA (Echelle de Cotation des Lésions d’Acné) scale comprises numerical ranges of primary acne lesions, and includes extrafacial sites, but it does not include proportion descriptors of anatomical sites, and the scale has not been validated (Ann. Derm. Venereol. 1999;126:136-41), they wrote.

"The next steps are to identify current systems which meet at least some of the identified clinical components and features from the Delphi process. This may then facilitate development of the ideal acne grading tool for future clinical practice and research," Dr. Tan said in the interview.

Dr. Tan is an advisory board member, speaker, consultant, and/or investigator for Bayer, Cipher, and other companies. All but two of the other panel members also reported conflicts of interest.

A group of experts has identified what they believe to be essential clinical components of an ideal severity grading scale for acne vulgaris.

Although more than 25 systems are in existence for acne grading, there is neither a gold standard nor a standardized system consistently used in research or clinical practice. "The reasons for this are multiple, including differing needs of the clinical versus research paradigms, the persistence of simpler tools with inadequate accuracy, the inefficiency of research methods such as lesion counting, and a previous lack of consensus building in this area," lead author Dr. Jerry Tan, a dermatologist at the University of Western Ontario in London, said in an interview.

The panel of 12 acne experts determined that an ideal scale should include the clinical components of primary acne lesions; their quantity, extent, and facial and extrafacial sites of involvement; and features of clinimetric properties, categorization, efficiency, and acceptance.

This consensus is considered a first step toward the development of a new acne severity grading scale. In the meantime, "this information can best be used by practicing dermatologists as an initial phase in further identifying and developing a standard for acne severity grading in the future," said Dr. Tan.

The panel arrived at this consensus via the "Delphi method," in which each member responded to a three-phase, online, anonymous survey. In the first Delphi round, they were asked open-ended questions about what components and features would be essential to the scale, and whether any current scales included the components the member deemed essential and the features deemed important (J. Am. Acad. Dermatol. 2012;67:187-93 [doi: 10.1016/j.jaad.2011.09.005]).

In the first round, the group identified primary acne lesions (evaluation of inflammatory or noninflammatory lesions together or separately), secondary lesions (such as scarring or pigmentary changes), quantity of lesions, extrafacial sites of involvement, extent of involvement, and patient experiences as being essential clinical components. Features deemed important included clinimetric properties (such as validity and reproducibility), efficiency/ease of use, categorization of severity (i.e., based on descriptive text and/or photographic examples), and acceptance (by physicians, patients, and other stakeholders).

In the next round, panel members were asked to grade each component and feature on a seven-point scale, and to provide subcategories for inclusion.

In the final consensus, the group agreed that the scale should include separate evaluation of inflammatory and noninflammatory primary lesions; determination of the quantity of lesions by counting and numerical range; grading of extrafacial sites including the chest, back, neck, and shoulders; and determination of extent of involvement using proportion descriptors such as "one third or less."

The panel also came to a consensus on excluding patient experiences, while a slight majority also opted for excluding secondary lesions. In addition, a consensus was achieved for inclusion of the clinimetric properties (validity, reproducibility, discriminatory capacity, and responsivity), efficiency, acceptability, and categorization of severity.

The agreement to exclude patient experiences was a bit of a surprise, according to Dr. Tan. The finding may reflect the focus of the group on expert-determined severity, as well as the availability of quality-of-life scales that are particular to patient experience with acne and are routinely used in conjunction with clinician-based global acne severity assessments in clinical trials.

The group also agreed that while several current acne severity grading scales contain some of these elements, none contain all. For example, the eight-point severity grade scale by Allen and Smith includes type and quantity of lesions and proportion of facial involvement, but it is limited to the face (Arch. Dermatol. 1982;118:23-5). The ECLA (Echelle de Cotation des Lésions d’Acné) scale comprises numerical ranges of primary acne lesions, and includes extrafacial sites, but it does not include proportion descriptors of anatomical sites, and the scale has not been validated (Ann. Derm. Venereol. 1999;126:136-41), they wrote.

"The next steps are to identify current systems which meet at least some of the identified clinical components and features from the Delphi process. This may then facilitate development of the ideal acne grading tool for future clinical practice and research," Dr. Tan said in the interview.

Dr. Tan is an advisory board member, speaker, consultant, and/or investigator for Bayer, Cipher, and other companies. All but two of the other panel members also reported conflicts of interest.

Use of biolimus-eluting stents with a biodegradable polymer resulted in a significantly lower major adverse cardiac event rate at 1 year than did use of bare-metal stents in patients with acute myocardial infarction who were undergoing primary percutaneous coronary intervention.

The finding comes from Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE AMI), a multicenter, randomized, assessor-blinded, superiority trial in patients presenting with STEMI who were undergoing primary PCI. The trial of more than 1,100 patients found that compared with the use of bare-metal stents, the use of biolimus-eluting stents with a biodegradable polymer was associated with a significant 4.4% absolute reduction and 51% relative reduction in the risk of major adverse cardiac events at 1 year. Use of the biolimus-eluting stents prevented 42 events per 1,000 patients at 1 year compared with bare-metal stents, said Dr. Lorenz Raber of Bern (Switzerland) University Hospital and his associates (JAMA 2012;308:777-87).

The final analysis included 575 patients with 629 infarct vessel lesions randomly assigned to biolimus-eluting stents (Bio-Matrix, Biosensors Europe SA) and 582 patients with 648 infarct-vessel lesions randomly assigned to otherwise identically designed bare-metal stents (Gazelle, Biosensors Europe SA). The patients had a mean age of 61 years, and 79% were men. The median time from symptom onset to balloon inflation was 234 minutes, and from hospital admission to balloon inflation, 44 minutes. There were no apparent differences in lesion complexity between the two groups.

At discharge, 43% of patients received prasugrel and 57% of patients received clopidogrel. In contrast with most previous trials of patients with STEMI, the use of dual antiplatelet therapy remained balanced in both treatment groups throughout the entire follow-up period up to 1 year, the investigators noted.

At 1 year, the primary end point of major adverse cardiac events (cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization) occurred in 4.3% of patients who received biolimus-eluting stents and 8.7% of patients given bare-metal stents, producing a hazard ratio of 0.49 (P = .004). For cardiac death alone, the percentages were 2.9% with biolimus-eluting stents and 3.5% for bare-metal stents (HR 0.81, P = .53).

The treatment effect in favor of patients receiving biolimus-eluting stents was attributable to significantly lower risks of target vessel–related reinfarction (0.5% vs 2.7% HR, 0.20, P =.01) and ischemia-driven target-lesion revascularization (1.6% vs 5.7%, HR 0.28). Differences between stent types with respect to the primary outcome emerged early and continued throughout the study period, Dr. Raber and his associates said.

The rates of definite stent thrombosis at 1 year did not differ significantly, at 0.9% in patients receiving biolimus-eluting stents and 2.1% in those receiving bare-metal stents. Furthermore, no differences were seen in all-cause and cardiac mortality between the groups at 1 year.

The biolimus-eluting stent used in this study is not approved by the Food and Drug Administration, but data showing that it was noninferior to the sirolimus-eluting Cypher stent (Lancet 2011;378:1940-8) provided the basis for a recommendation for its use in European guidelines on myocardial revascularization (Eur. Heart J. 2010;31:2501-5), they noted.

The COMFORTABLE AMI trial was investigator-initiated, managed by the Clinical Trials Unit, University of Bern (Switzerland), and supported by the Swiss National Science Foundation and an unrestricted research grant from Biosensors Europe SA, Morges, Switzerland. Dr. Raber is the recipient of a research fellowship funded by the Swiss National Science Foundation.

Use of biolimus-eluting stents with a biodegradable polymer resulted in a significantly lower major adverse cardiac event rate at 1 year than did use of bare-metal stents in patients with acute myocardial infarction who were undergoing primary percutaneous coronary intervention.

The finding comes from Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE AMI), a multicenter, randomized, assessor-blinded, superiority trial in patients presenting with STEMI who were undergoing primary PCI. The trial of more than 1,100 patients found that compared with the use of bare-metal stents, the use of biolimus-eluting stents with a biodegradable polymer was associated with a significant 4.4% absolute reduction and 51% relative reduction in the risk of major adverse cardiac events at 1 year. Use of the biolimus-eluting stents prevented 42 events per 1,000 patients at 1 year compared with bare-metal stents, said Dr. Lorenz Raber of Bern (Switzerland) University Hospital and his associates (JAMA 2012;308:777-87).

The final analysis included 575 patients with 629 infarct vessel lesions randomly assigned to biolimus-eluting stents (Bio-Matrix, Biosensors Europe SA) and 582 patients with 648 infarct-vessel lesions randomly assigned to otherwise identically designed bare-metal stents (Gazelle, Biosensors Europe SA). The patients had a mean age of 61 years, and 79% were men. The median time from symptom onset to balloon inflation was 234 minutes, and from hospital admission to balloon inflation, 44 minutes. There were no apparent differences in lesion complexity between the two groups.

At discharge, 43% of patients received prasugrel and 57% of patients received clopidogrel. In contrast with most previous trials of patients with STEMI, the use of dual antiplatelet therapy remained balanced in both treatment groups throughout the entire follow-up period up to 1 year, the investigators noted.

At 1 year, the primary end point of major adverse cardiac events (cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization) occurred in 4.3% of patients who received biolimus-eluting stents and 8.7% of patients given bare-metal stents, producing a hazard ratio of 0.49 (P = .004). For cardiac death alone, the percentages were 2.9% with biolimus-eluting stents and 3.5% for bare-metal stents (HR 0.81, P = .53).

The treatment effect in favor of patients receiving biolimus-eluting stents was attributable to significantly lower risks of target vessel–related reinfarction (0.5% vs 2.7% HR, 0.20, P =.01) and ischemia-driven target-lesion revascularization (1.6% vs 5.7%, HR 0.28). Differences between stent types with respect to the primary outcome emerged early and continued throughout the study period, Dr. Raber and his associates said.

The rates of definite stent thrombosis at 1 year did not differ significantly, at 0.9% in patients receiving biolimus-eluting stents and 2.1% in those receiving bare-metal stents. Furthermore, no differences were seen in all-cause and cardiac mortality between the groups at 1 year.

The biolimus-eluting stent used in this study is not approved by the Food and Drug Administration, but data showing that it was noninferior to the sirolimus-eluting Cypher stent (Lancet 2011;378:1940-8) provided the basis for a recommendation for its use in European guidelines on myocardial revascularization (Eur. Heart J. 2010;31:2501-5), they noted.

The COMFORTABLE AMI trial was investigator-initiated, managed by the Clinical Trials Unit, University of Bern (Switzerland), and supported by the Swiss National Science Foundation and an unrestricted research grant from Biosensors Europe SA, Morges, Switzerland. Dr. Raber is the recipient of a research fellowship funded by the Swiss National Science Foundation.

Use of biolimus-eluting stents with a biodegradable polymer resulted in a significantly lower major adverse cardiac event rate at 1 year than did use of bare-metal stents in patients with acute myocardial infarction who were undergoing primary percutaneous coronary intervention.

The finding comes from Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE AMI), a multicenter, randomized, assessor-blinded, superiority trial in patients presenting with STEMI who were undergoing primary PCI. The trial of more than 1,100 patients found that compared with the use of bare-metal stents, the use of biolimus-eluting stents with a biodegradable polymer was associated with a significant 4.4% absolute reduction and 51% relative reduction in the risk of major adverse cardiac events at 1 year. Use of the biolimus-eluting stents prevented 42 events per 1,000 patients at 1 year compared with bare-metal stents, said Dr. Lorenz Raber of Bern (Switzerland) University Hospital and his associates (JAMA 2012;308:777-87).

The final analysis included 575 patients with 629 infarct vessel lesions randomly assigned to biolimus-eluting stents (Bio-Matrix, Biosensors Europe SA) and 582 patients with 648 infarct-vessel lesions randomly assigned to otherwise identically designed bare-metal stents (Gazelle, Biosensors Europe SA). The patients had a mean age of 61 years, and 79% were men. The median time from symptom onset to balloon inflation was 234 minutes, and from hospital admission to balloon inflation, 44 minutes. There were no apparent differences in lesion complexity between the two groups.

At discharge, 43% of patients received prasugrel and 57% of patients received clopidogrel. In contrast with most previous trials of patients with STEMI, the use of dual antiplatelet therapy remained balanced in both treatment groups throughout the entire follow-up period up to 1 year, the investigators noted.

At 1 year, the primary end point of major adverse cardiac events (cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization) occurred in 4.3% of patients who received biolimus-eluting stents and 8.7% of patients given bare-metal stents, producing a hazard ratio of 0.49 (P = .004). For cardiac death alone, the percentages were 2.9% with biolimus-eluting stents and 3.5% for bare-metal stents (HR 0.81, P = .53).

The treatment effect in favor of patients receiving biolimus-eluting stents was attributable to significantly lower risks of target vessel–related reinfarction (0.5% vs 2.7% HR, 0.20, P =.01) and ischemia-driven target-lesion revascularization (1.6% vs 5.7%, HR 0.28). Differences between stent types with respect to the primary outcome emerged early and continued throughout the study period, Dr. Raber and his associates said.

The rates of definite stent thrombosis at 1 year did not differ significantly, at 0.9% in patients receiving biolimus-eluting stents and 2.1% in those receiving bare-metal stents. Furthermore, no differences were seen in all-cause and cardiac mortality between the groups at 1 year.

The biolimus-eluting stent used in this study is not approved by the Food and Drug Administration, but data showing that it was noninferior to the sirolimus-eluting Cypher stent (Lancet 2011;378:1940-8) provided the basis for a recommendation for its use in European guidelines on myocardial revascularization (Eur. Heart J. 2010;31:2501-5), they noted.

The COMFORTABLE AMI trial was investigator-initiated, managed by the Clinical Trials Unit, University of Bern (Switzerland), and supported by the Swiss National Science Foundation and an unrestricted research grant from Biosensors Europe SA, Morges, Switzerland. Dr. Raber is the recipient of a research fellowship funded by the Swiss National Science Foundation.

PHILADELPHIA – Glycemic variability appeared to be independently associated with increased length of stay and mortality in noncritically ill hospitalized patients, in a large retrospective study presented at the annual scientific sessions of the American Diabetes Association.

"Glycemic variability" refers to oscillations of blood glucose levels around the mean. Two people can have identical hemoglobin A_1c values, yet one may have far greater variability than the other and therefore be considered to have poorer control because of frequent bouts of hyper- and hypoglycemia, said Dr. Carlos E. Mendez, director of the diabetes management program at the Albany (N.Y.) Stratton VA Medical Center.

Previous studies done in critical care settings have demonstrated increased mortality in patients with high glycemic variability, independent of hypo- and hyperglycemia (Crit. Care Med. 2008;36:3008-13). Both in vitro and in vivo data suggest that "rather than hyperglycemia, glycemic variability has a more profound effect and greater production of reactive oxygen species and what we think is more reactive oxidative stress," Dr. Mendez said.

To examine this phenomenon in noncritically ill patients, he and his associates retrospectively reviewed glucose values from a total of 960 patients who were admitted to medical (81%) or surgical (19%) wards during 2008-2010 and for whom a minimum of two point-of-care blood glucose values per day had been ordered. A GSD (glucose standard deviation) value was calculated as a surrogate for glycemic variability.

The patients were typical of a VA population: They had a mean age of 69.8 years, and 95% were male. Their mean blood glucose was 181.3 mg/dL, with a mean GSD of 57.4 mg/dL. Average length of stay was 5.7 days. A mean of 4.8 glucose readings per day was performed for the group as a whole. Nearly a quarter (24%) had at least one hypoglycemic episode; about two-thirds were receiving insulin. The 90-day mortality was 11%. The majority (85%) had a diagnosis of diabetes.

Length of stay increased significantly with increasing GSD, from 3.3 days for the 166 patients with the least variability (0-30 mg/dL), to 6.5 days for the 245 patients with GSD of 61-90 mg/dL, to 7.4 days for the 39 who had glycemic variability greater than 120 mg/dL. Those increases translated to a mean 6% increase in length of stay for every 10-mg/dL increase in the GSD. The relationship remained significant for patients with and without diabetes, for medical and surgical patients, and for those who had and had not experienced hypoglycemia, Dr. Mendez said.

Mortality at 90 days also increased significantly with greater GSD, from 9% in those with the lowest variability, up to 28% for the patients with the highest variability. Here, there was a 9% increased risk of death for every 10 mg/dL of increased GSD. The mortality findings were significant for the patients with diabetes and for the medical ward patients, but didn’t reach significance for nondiabetic and surgical patients, probably because of low numbers, he said.

Prospective studies using continuous glucose monitoring would confirm these results and better elucidate factors that may influence glycemic variability in noncritically ill inpatients, he concluded.

Dr. Mendez disclosed no conflict of interest.

PHILADELPHIA – Glycemic variability appeared to be independently associated with increased length of stay and mortality in noncritically ill hospitalized patients, in a large retrospective study presented at the annual scientific sessions of the American Diabetes Association.

"Glycemic variability" refers to oscillations of blood glucose levels around the mean. Two people can have identical hemoglobin A_1c values, yet one may have far greater variability than the other and therefore be considered to have poorer control because of frequent bouts of hyper- and hypoglycemia, said Dr. Carlos E. Mendez, director of the diabetes management program at the Albany (N.Y.) Stratton VA Medical Center.

Previous studies done in critical care settings have demonstrated increased mortality in patients with high glycemic variability, independent of hypo- and hyperglycemia (Crit. Care Med. 2008;36:3008-13). Both in vitro and in vivo data suggest that "rather than hyperglycemia, glycemic variability has a more profound effect and greater production of reactive oxygen species and what we think is more reactive oxidative stress," Dr. Mendez said.

To examine this phenomenon in noncritically ill patients, he and his associates retrospectively reviewed glucose values from a total of 960 patients who were admitted to medical (81%) or surgical (19%) wards during 2008-2010 and for whom a minimum of two point-of-care blood glucose values per day had been ordered. A GSD (glucose standard deviation) value was calculated as a surrogate for glycemic variability.

The patients were typical of a VA population: They had a mean age of 69.8 years, and 95% were male. Their mean blood glucose was 181.3 mg/dL, with a mean GSD of 57.4 mg/dL. Average length of stay was 5.7 days. A mean of 4.8 glucose readings per day was performed for the group as a whole. Nearly a quarter (24%) had at least one hypoglycemic episode; about two-thirds were receiving insulin. The 90-day mortality was 11%. The majority (85%) had a diagnosis of diabetes.

Length of stay increased significantly with increasing GSD, from 3.3 days for the 166 patients with the least variability (0-30 mg/dL), to 6.5 days for the 245 patients with GSD of 61-90 mg/dL, to 7.4 days for the 39 who had glycemic variability greater than 120 mg/dL. Those increases translated to a mean 6% increase in length of stay for every 10-mg/dL increase in the GSD. The relationship remained significant for patients with and without diabetes, for medical and surgical patients, and for those who had and had not experienced hypoglycemia, Dr. Mendez said.

Mortality at 90 days also increased significantly with greater GSD, from 9% in those with the lowest variability, up to 28% for the patients with the highest variability. Here, there was a 9% increased risk of death for every 10 mg/dL of increased GSD. The mortality findings were significant for the patients with diabetes and for the medical ward patients, but didn’t reach significance for nondiabetic and surgical patients, probably because of low numbers, he said.

Prospective studies using continuous glucose monitoring would confirm these results and better elucidate factors that may influence glycemic variability in noncritically ill inpatients, he concluded.

Dr. Mendez disclosed no conflict of interest.

PHILADELPHIA – Glycemic variability appeared to be independently associated with increased length of stay and mortality in noncritically ill hospitalized patients, in a large retrospective study presented at the annual scientific sessions of the American Diabetes Association.

"Glycemic variability" refers to oscillations of blood glucose levels around the mean. Two people can have identical hemoglobin A_1c values, yet one may have far greater variability than the other and therefore be considered to have poorer control because of frequent bouts of hyper- and hypoglycemia, said Dr. Carlos E. Mendez, director of the diabetes management program at the Albany (N.Y.) Stratton VA Medical Center.

Previous studies done in critical care settings have demonstrated increased mortality in patients with high glycemic variability, independent of hypo- and hyperglycemia (Crit. Care Med. 2008;36:3008-13). Both in vitro and in vivo data suggest that "rather than hyperglycemia, glycemic variability has a more profound effect and greater production of reactive oxygen species and what we think is more reactive oxidative stress," Dr. Mendez said.

To examine this phenomenon in noncritically ill patients, he and his associates retrospectively reviewed glucose values from a total of 960 patients who were admitted to medical (81%) or surgical (19%) wards during 2008-2010 and for whom a minimum of two point-of-care blood glucose values per day had been ordered. A GSD (glucose standard deviation) value was calculated as a surrogate for glycemic variability.

The patients were typical of a VA population: They had a mean age of 69.8 years, and 95% were male. Their mean blood glucose was 181.3 mg/dL, with a mean GSD of 57.4 mg/dL. Average length of stay was 5.7 days. A mean of 4.8 glucose readings per day was performed for the group as a whole. Nearly a quarter (24%) had at least one hypoglycemic episode; about two-thirds were receiving insulin. The 90-day mortality was 11%. The majority (85%) had a diagnosis of diabetes.

Length of stay increased significantly with increasing GSD, from 3.3 days for the 166 patients with the least variability (0-30 mg/dL), to 6.5 days for the 245 patients with GSD of 61-90 mg/dL, to 7.4 days for the 39 who had glycemic variability greater than 120 mg/dL. Those increases translated to a mean 6% increase in length of stay for every 10-mg/dL increase in the GSD. The relationship remained significant for patients with and without diabetes, for medical and surgical patients, and for those who had and had not experienced hypoglycemia, Dr. Mendez said.

Mortality at 90 days also increased significantly with greater GSD, from 9% in those with the lowest variability, up to 28% for the patients with the highest variability. Here, there was a 9% increased risk of death for every 10 mg/dL of increased GSD. The mortality findings were significant for the patients with diabetes and for the medical ward patients, but didn’t reach significance for nondiabetic and surgical patients, probably because of low numbers, he said.

Prospective studies using continuous glucose monitoring would confirm these results and better elucidate factors that may influence glycemic variability in noncritically ill inpatients, he concluded.

Dr. Mendez disclosed no conflict of interest.

PHILADELPHIA – An investigational glucokinase activator lowered glucose levels without producing hypoglycemia in a 2-week, phase IIa study of 60 patients with type 2 diabetes.

The enzyme glucokinase (GK) is involved in glucose homeostasis via control of both pancreatic insulin secretion and glucose disposal in the liver. The compound GKM-001, under development by Advinus Therapeutics, differs from other investigational GK activators in that it specifically targets the liver and avoids the pancreas, thereby eliminating the risk for hypoglycemia, Rashmi H. Barbhaiya, Ph.D., said at the annual scientific sessions of the American Diabetes Association.

In a multiple ascending dose study, 60 patients were washed out of their prior medications, then randomized either to doses of 25, 50, 200, 600, or 1,000 mg or to placebo.

Compared with baseline, there were dose-dependent reductions in the 24-hour glucose area under the curve. At day 14, the percent reductions were 9% with 25 mg, 14% with 50 mg, 15% with 200 mg, 17% with 600 mg, and 20% with 1,000 mg, while the placebo group had a 2% increase. Significant reductions were also seen in fasting glucose levels, ranging from 23 to 46 mg/dL, reported Dr. Barbhaiya, CEO and managing director of Advinus, which is based in Bangalore, India.

No hypoglycemia was seen with any of the doses following 12 hours of overnight fasting and 2 hours of postdose fasting, he said.

Neither oral glucose tolerance tests nor dinnertime mixed-meal tolerance tests on days 1 and 14 showed any changes in C-peptide area under the curve, providing further evidence that GKM-001 is not interacting with the pancreas and that its glucose-lowering action is not due to increased insulin levels, he said.

There were also no changes in levels of plasma triglycerides, aspartate transaminase, or alanine aminotransferase.

The company will soon be initiating a phase IIb study of GKM-001 that will assess its impact on hemoglobin A_1c levels when used in combination with metformin, he said.

The study was funded by Advinus Therapeutics. Dr. Barbhaiya is a cofounder and a shareholder of the company.

PHILADELPHIA – An investigational glucokinase activator lowered glucose levels without producing hypoglycemia in a 2-week, phase IIa study of 60 patients with type 2 diabetes.

The enzyme glucokinase (GK) is involved in glucose homeostasis via control of both pancreatic insulin secretion and glucose disposal in the liver. The compound GKM-001, under development by Advinus Therapeutics, differs from other investigational GK activators in that it specifically targets the liver and avoids the pancreas, thereby eliminating the risk for hypoglycemia, Rashmi H. Barbhaiya, Ph.D., said at the annual scientific sessions of the American Diabetes Association.

In a multiple ascending dose study, 60 patients were washed out of their prior medications, then randomized either to doses of 25, 50, 200, 600, or 1,000 mg or to placebo.

Compared with baseline, there were dose-dependent reductions in the 24-hour glucose area under the curve. At day 14, the percent reductions were 9% with 25 mg, 14% with 50 mg, 15% with 200 mg, 17% with 600 mg, and 20% with 1,000 mg, while the placebo group had a 2% increase. Significant reductions were also seen in fasting glucose levels, ranging from 23 to 46 mg/dL, reported Dr. Barbhaiya, CEO and managing director of Advinus, which is based in Bangalore, India.

No hypoglycemia was seen with any of the doses following 12 hours of overnight fasting and 2 hours of postdose fasting, he said.

Neither oral glucose tolerance tests nor dinnertime mixed-meal tolerance tests on days 1 and 14 showed any changes in C-peptide area under the curve, providing further evidence that GKM-001 is not interacting with the pancreas and that its glucose-lowering action is not due to increased insulin levels, he said.

There were also no changes in levels of plasma triglycerides, aspartate transaminase, or alanine aminotransferase.

The company will soon be initiating a phase IIb study of GKM-001 that will assess its impact on hemoglobin A_1c levels when used in combination with metformin, he said.

The study was funded by Advinus Therapeutics. Dr. Barbhaiya is a cofounder and a shareholder of the company.

PHILADELPHIA – An investigational glucokinase activator lowered glucose levels without producing hypoglycemia in a 2-week, phase IIa study of 60 patients with type 2 diabetes.

The enzyme glucokinase (GK) is involved in glucose homeostasis via control of both pancreatic insulin secretion and glucose disposal in the liver. The compound GKM-001, under development by Advinus Therapeutics, differs from other investigational GK activators in that it specifically targets the liver and avoids the pancreas, thereby eliminating the risk for hypoglycemia, Rashmi H. Barbhaiya, Ph.D., said at the annual scientific sessions of the American Diabetes Association.

In a multiple ascending dose study, 60 patients were washed out of their prior medications, then randomized either to doses of 25, 50, 200, 600, or 1,000 mg or to placebo.

Compared with baseline, there were dose-dependent reductions in the 24-hour glucose area under the curve. At day 14, the percent reductions were 9% with 25 mg, 14% with 50 mg, 15% with 200 mg, 17% with 600 mg, and 20% with 1,000 mg, while the placebo group had a 2% increase. Significant reductions were also seen in fasting glucose levels, ranging from 23 to 46 mg/dL, reported Dr. Barbhaiya, CEO and managing director of Advinus, which is based in Bangalore, India.

No hypoglycemia was seen with any of the doses following 12 hours of overnight fasting and 2 hours of postdose fasting, he said.

Neither oral glucose tolerance tests nor dinnertime mixed-meal tolerance tests on days 1 and 14 showed any changes in C-peptide area under the curve, providing further evidence that GKM-001 is not interacting with the pancreas and that its glucose-lowering action is not due to increased insulin levels, he said.

There were also no changes in levels of plasma triglycerides, aspartate transaminase, or alanine aminotransferase.

The company will soon be initiating a phase IIb study of GKM-001 that will assess its impact on hemoglobin A_1c levels when used in combination with metformin, he said.

The study was funded by Advinus Therapeutics. Dr. Barbhaiya is a cofounder and a shareholder of the company.

PHILADELPHIA – Previous costimulation with abatacept for 24 months was associated with a continued slowing of the decline in beta-cell function 1 year after discontinuation in patients with recent-onset type 1 diabetes.

The findings suggest that abatacept might be useful in prevention studies in individuals at high risk of type 1 diabetes, or as one component in studies that use a combination of different strategies, said Dr. Tihamer Orban, principal investigator in the Type 1 Diabetes TrialNet, through which the study was conducted.

Abatacept, marketed by Bristol-Myers Squibb as Orencia, is a costimulation modulator that was approved to treat rheumatoid arthritis and juvenile idiopathic arthritis. The biologic blocks the process of T-lymphocyte activation that drives the autoimmune destruction of beta-cells leading to type 1 diabetes, according to Dr. Orban.

The current data constitute a follow-up to a randomized, double-masked trial that included 112 patients, aged 6-36 years (mean, 14 years), who had been diagnosed with type 1 diabetes within the previous 100 days. The administration of 27 intravenous infusions of abatacept over 2 years in 77 patients was associated with a 59% higher adjusted C-peptide AUC (area under the curve), compared with the 35 patients who received placebo infusions. The difference (0.378 nmol/L with abatacept vs. 0.238 nmol/L with placebo) was significant. Hemoglobin A_1c was also significantly lower in the abatacept patients, with no difference in insulin use (Lancet 2011;378:412-9).

However, despite continued administration of abatacept over 24 months, the decrease in beta-cell function with abatacept was parallel to that with placebo after 6 months of treatment, causing the investigators to speculate that T-cell activation lessens with time.

The study remained double-blinded at 36 months. At that point, the mean adjusted 2-hour C-peptide AUC was 0.215 nmol/L for the 64 abatacept patients in whom it was measured, compared with 0.135 nmol/L for the 29 remaining placebo patients. The difference was still significant, said Dr. Orban, who is also an investigator in the section on immunobiology at the Joslin Diabetes Center and an instructor in medicine at Harvard Medical School, both in Boston.

Still, the major effect appeared to be within the first year of the treatment phase, and the two groups remained relatively parallel thereafter. This suggests that the drug may only be actively blocking T-cell activation around the time of diagnosis, he noted.

HbA_1c was significantly lower in the abatacept-treated patients, with no difference in insulin use. In all, abatacept treatment resulted in an average 9.5 months’ delay of loss in beta-cell function, compared with placebo, Dr. Orban said.

"It seems that we may not need a full 2 years of treatment to achieve this effect. It’s very logical to try a shorter course of the drug and see if a similar effect can be achieved," Dr. Orban commented.

This study was sponsored by the Type 1 Diabetes TrialNet Study Group, a clinical trials network funded by the National Institutes of Health. Dr. Orban is founder and CEO of Orban Biotech LLC.

PHILADELPHIA – Previous costimulation with abatacept for 24 months was associated with a continued slowing of the decline in beta-cell function 1 year after discontinuation in patients with recent-onset type 1 diabetes.

The findings suggest that abatacept might be useful in prevention studies in individuals at high risk of type 1 diabetes, or as one component in studies that use a combination of different strategies, said Dr. Tihamer Orban, principal investigator in the Type 1 Diabetes TrialNet, through which the study was conducted.

Abatacept, marketed by Bristol-Myers Squibb as Orencia, is a costimulation modulator that was approved to treat rheumatoid arthritis and juvenile idiopathic arthritis. The biologic blocks the process of T-lymphocyte activation that drives the autoimmune destruction of beta-cells leading to type 1 diabetes, according to Dr. Orban.

The current data constitute a follow-up to a randomized, double-masked trial that included 112 patients, aged 6-36 years (mean, 14 years), who had been diagnosed with type 1 diabetes within the previous 100 days. The administration of 27 intravenous infusions of abatacept over 2 years in 77 patients was associated with a 59% higher adjusted C-peptide AUC (area under the curve), compared with the 35 patients who received placebo infusions. The difference (0.378 nmol/L with abatacept vs. 0.238 nmol/L with placebo) was significant. Hemoglobin A_1c was also significantly lower in the abatacept patients, with no difference in insulin use (Lancet 2011;378:412-9).

However, despite continued administration of abatacept over 24 months, the decrease in beta-cell function with abatacept was parallel to that with placebo after 6 months of treatment, causing the investigators to speculate that T-cell activation lessens with time.

The study remained double-blinded at 36 months. At that point, the mean adjusted 2-hour C-peptide AUC was 0.215 nmol/L for the 64 abatacept patients in whom it was measured, compared with 0.135 nmol/L for the 29 remaining placebo patients. The difference was still significant, said Dr. Orban, who is also an investigator in the section on immunobiology at the Joslin Diabetes Center and an instructor in medicine at Harvard Medical School, both in Boston.

Still, the major effect appeared to be within the first year of the treatment phase, and the two groups remained relatively parallel thereafter. This suggests that the drug may only be actively blocking T-cell activation around the time of diagnosis, he noted.

HbA_1c was significantly lower in the abatacept-treated patients, with no difference in insulin use. In all, abatacept treatment resulted in an average 9.5 months’ delay of loss in beta-cell function, compared with placebo, Dr. Orban said.

"It seems that we may not need a full 2 years of treatment to achieve this effect. It’s very logical to try a shorter course of the drug and see if a similar effect can be achieved," Dr. Orban commented.

This study was sponsored by the Type 1 Diabetes TrialNet Study Group, a clinical trials network funded by the National Institutes of Health. Dr. Orban is founder and CEO of Orban Biotech LLC.

PHILADELPHIA – Previous costimulation with abatacept for 24 months was associated with a continued slowing of the decline in beta-cell function 1 year after discontinuation in patients with recent-onset type 1 diabetes.

The findings suggest that abatacept might be useful in prevention studies in individuals at high risk of type 1 diabetes, or as one component in studies that use a combination of different strategies, said Dr. Tihamer Orban, principal investigator in the Type 1 Diabetes TrialNet, through which the study was conducted.

Abatacept, marketed by Bristol-Myers Squibb as Orencia, is a costimulation modulator that was approved to treat rheumatoid arthritis and juvenile idiopathic arthritis. The biologic blocks the process of T-lymphocyte activation that drives the autoimmune destruction of beta-cells leading to type 1 diabetes, according to Dr. Orban.

The current data constitute a follow-up to a randomized, double-masked trial that included 112 patients, aged 6-36 years (mean, 14 years), who had been diagnosed with type 1 diabetes within the previous 100 days. The administration of 27 intravenous infusions of abatacept over 2 years in 77 patients was associated with a 59% higher adjusted C-peptide AUC (area under the curve), compared with the 35 patients who received placebo infusions. The difference (0.378 nmol/L with abatacept vs. 0.238 nmol/L with placebo) was significant. Hemoglobin A_1c was also significantly lower in the abatacept patients, with no difference in insulin use (Lancet 2011;378:412-9).

However, despite continued administration of abatacept over 24 months, the decrease in beta-cell function with abatacept was parallel to that with placebo after 6 months of treatment, causing the investigators to speculate that T-cell activation lessens with time.

The study remained double-blinded at 36 months. At that point, the mean adjusted 2-hour C-peptide AUC was 0.215 nmol/L for the 64 abatacept patients in whom it was measured, compared with 0.135 nmol/L for the 29 remaining placebo patients. The difference was still significant, said Dr. Orban, who is also an investigator in the section on immunobiology at the Joslin Diabetes Center and an instructor in medicine at Harvard Medical School, both in Boston.

Still, the major effect appeared to be within the first year of the treatment phase, and the two groups remained relatively parallel thereafter. This suggests that the drug may only be actively blocking T-cell activation around the time of diagnosis, he noted.

HbA_1c was significantly lower in the abatacept-treated patients, with no difference in insulin use. In all, abatacept treatment resulted in an average 9.5 months’ delay of loss in beta-cell function, compared with placebo, Dr. Orban said.

"It seems that we may not need a full 2 years of treatment to achieve this effect. It’s very logical to try a shorter course of the drug and see if a similar effect can be achieved," Dr. Orban commented.

This study was sponsored by the Type 1 Diabetes TrialNet Study Group, a clinical trials network funded by the National Institutes of Health. Dr. Orban is founder and CEO of Orban Biotech LLC.

Children who snore persistently and loudly at age 2 and 3 years are more likely to have problem behaviors at age 3 years, compared with children who don’t snore or who only snore transiently.

Those findings come from a prospective analysis of 249 mother-child pairs who were part of the Cincinnati-based Health Outcomes and Measures of the Environment (HOME) Study, which enrolled the women at or before 19 weeks’ gestation. The results highlight the importance of routine screening for snoring in particular, because parents’ responses to more general sleep questions may not reflect this hallmark symptom of sleep-disordered breathing (SDB), said Dean W. Beebe, Ph.D., of Cincinnati Children’s Hospital Medical Center, and his associates (Pediatrics 2012 Aug. 13 [doi:10.1542/peds.2012-0045]).

© Mykola Velychko - Fotolia.com

The findings of this study, believed to be the first to examine the relationship between the persistence of snoring and behavioral functioning in preschool-aged children, also suggest that screening is particularly important for children from lower socioeconomic backgrounds who are at higher risk for persistent SDB and its associated morbidity. It is also important to document whether snoring persists, the investigators said.

Snoring was assessed when the children were aged 2 and 3 years with the validated Child Sleep Habits Questionnaire, which asked parents to report how often their child "snored loudly" during the previous week. Of the 249 children, 170 (68%) were "nonsnorers" whose parents reported that they "rarely" snored loudly over the previous week. Another 57 children (23%) were "transient snorers," who snored loudly two or more times per week at either age 2 or 3 years but not both, and 22 (9%) were "persistent snorers," who snored two or more times per week at ages 2 and 3 years.

Parents completed the validated preschool form of the Behavior Assessment System for Children, and a trained research associate administered the Bayley Scales of Infant Development. Prenatal exposure to tobacco was assessed through maternal serum cotinine measures during pregnancy, and childhood tobacco exposure was assessed through collected serum. The mothers were surveyed about breast feeding, and the children were examined at annual visits.

The three groups did not differ significantly with regard to gender, birth weight, or gestational age. In the unadjusted analysis, the persistent snorers tended toward a higher body mass index z score than did the transient snorers or the nonsnorers at both the 2-year and 3-year assessments. Persistent snorers had significantly higher prenatal and childhood cotinine levels than did either of the other two groups at both time points.

Persistent snorers were significantly more likely to be African American (55% versus 13.5% of the nonsnorers), and to have lower parental education and annual family income ($49,000 vs. $84,000). None of the children fed breast milk for more than 12 months developed persistent snoring, but nearly one-quarter of those who were never fed breast milk, or who received breast milk for less than 1 month, did so.

Persistent snorers had significantly worse overall behavioral functioning than did the nonsnorers and transient snorers. Overall Behavioral Symptoms Index (BSI) scores were 49.2 for the nonsnorers, 50.9 for the transient snorers, and 57.6 for the persistent snorers, with a P value of less than .001 for the persistent snorers versus the other two groups. The difference was particularly significant with regard to hyperactivity, depression, and attention.

"At risk" or worse overall behaviors, defined as a BSI index score of 60 or greater, were reported in 35% of persistent snorers, compared with 10% of nonsnorers and 12% of transient snorers. "Preschool behavior and emotional problems of this magnitude were once dismissed as trivial, but are now recognized as significant sources of functional impairment at the population level," Dr. Beebe and his associates noted.

These results are consistent with reports on older children, and remained significant after the researchers controlled for child gender, race, and socioeconomic status.

Definitive causal conclusions can’t be drawn from this study. However, the findings are consistent with previous data suggesting that SDB-mediated sleep disruption and intermittent hypoxia can result in elevated oxidative stress, systemic inflammation, and changes in neural and neurobehavioral functioning. An ongoing randomized trial is currently examining the effect of surgical treatment of SDB on cognitive and behavioral functioning (Sleep 2011;34:1509-17).

A simple screening tool called BEARS (Bedtime Issues, Excessive Daytime Sleepiness, Night Awakenings, Regularity and Duration of Sleep, Snoring) has shown utility for identifying sleep problems in the primary care setting (Sleep Med. 2005;6:63-9).

None of the authors have any conflicts of interest to declare.

Children who snore persistently and loudly at age 2 and 3 years are more likely to have problem behaviors at age 3 years, compared with children who don’t snore or who only snore transiently.

Those findings come from a prospective analysis of 249 mother-child pairs who were part of the Cincinnati-based Health Outcomes and Measures of the Environment (HOME) Study, which enrolled the women at or before 19 weeks’ gestation. The results highlight the importance of routine screening for snoring in particular, because parents’ responses to more general sleep questions may not reflect this hallmark symptom of sleep-disordered breathing (SDB), said Dean W. Beebe, Ph.D., of Cincinnati Children’s Hospital Medical Center, and his associates (Pediatrics 2012 Aug. 13 [doi:10.1542/peds.2012-0045]).

© Mykola Velychko - Fotolia.com

The findings of this study, believed to be the first to examine the relationship between the persistence of snoring and behavioral functioning in preschool-aged children, also suggest that screening is particularly important for children from lower socioeconomic backgrounds who are at higher risk for persistent SDB and its associated morbidity. It is also important to document whether snoring persists, the investigators said.

Snoring was assessed when the children were aged 2 and 3 years with the validated Child Sleep Habits Questionnaire, which asked parents to report how often their child "snored loudly" during the previous week. Of the 249 children, 170 (68%) were "nonsnorers" whose parents reported that they "rarely" snored loudly over the previous week. Another 57 children (23%) were "transient snorers," who snored loudly two or more times per week at either age 2 or 3 years but not both, and 22 (9%) were "persistent snorers," who snored two or more times per week at ages 2 and 3 years.

Parents completed the validated preschool form of the Behavior Assessment System for Children, and a trained research associate administered the Bayley Scales of Infant Development. Prenatal exposure to tobacco was assessed through maternal serum cotinine measures during pregnancy, and childhood tobacco exposure was assessed through collected serum. The mothers were surveyed about breast feeding, and the children were examined at annual visits.

The three groups did not differ significantly with regard to gender, birth weight, or gestational age. In the unadjusted analysis, the persistent snorers tended toward a higher body mass index z score than did the transient snorers or the nonsnorers at both the 2-year and 3-year assessments. Persistent snorers had significantly higher prenatal and childhood cotinine levels than did either of the other two groups at both time points.

Persistent snorers were significantly more likely to be African American (55% versus 13.5% of the nonsnorers), and to have lower parental education and annual family income ($49,000 vs. $84,000). None of the children fed breast milk for more than 12 months developed persistent snoring, but nearly one-quarter of those who were never fed breast milk, or who received breast milk for less than 1 month, did so.

Persistent snorers had significantly worse overall behavioral functioning than did the nonsnorers and transient snorers. Overall Behavioral Symptoms Index (BSI) scores were 49.2 for the nonsnorers, 50.9 for the transient snorers, and 57.6 for the persistent snorers, with a P value of less than .001 for the persistent snorers versus the other two groups. The difference was particularly significant with regard to hyperactivity, depression, and attention.

"At risk" or worse overall behaviors, defined as a BSI index score of 60 or greater, were reported in 35% of persistent snorers, compared with 10% of nonsnorers and 12% of transient snorers. "Preschool behavior and emotional problems of this magnitude were once dismissed as trivial, but are now recognized as significant sources of functional impairment at the population level," Dr. Beebe and his associates noted.

These results are consistent with reports on older children, and remained significant after the researchers controlled for child gender, race, and socioeconomic status.

Definitive causal conclusions can’t be drawn from this study. However, the findings are consistent with previous data suggesting that SDB-mediated sleep disruption and intermittent hypoxia can result in elevated oxidative stress, systemic inflammation, and changes in neural and neurobehavioral functioning. An ongoing randomized trial is currently examining the effect of surgical treatment of SDB on cognitive and behavioral functioning (Sleep 2011;34:1509-17).

A simple screening tool called BEARS (Bedtime Issues, Excessive Daytime Sleepiness, Night Awakenings, Regularity and Duration of Sleep, Snoring) has shown utility for identifying sleep problems in the primary care setting (Sleep Med. 2005;6:63-9).

None of the authors have any conflicts of interest to declare.

Children who snore persistently and loudly at age 2 and 3 years are more likely to have problem behaviors at age 3 years, compared with children who don’t snore or who only snore transiently.

Those findings come from a prospective analysis of 249 mother-child pairs who were part of the Cincinnati-based Health Outcomes and Measures of the Environment (HOME) Study, which enrolled the women at or before 19 weeks’ gestation. The results highlight the importance of routine screening for snoring in particular, because parents’ responses to more general sleep questions may not reflect this hallmark symptom of sleep-disordered breathing (SDB), said Dean W. Beebe, Ph.D., of Cincinnati Children’s Hospital Medical Center, and his associates (Pediatrics 2012 Aug. 13 [doi:10.1542/peds.2012-0045]).

© Mykola Velychko - Fotolia.com

The findings of this study, believed to be the first to examine the relationship between the persistence of snoring and behavioral functioning in preschool-aged children, also suggest that screening is particularly important for children from lower socioeconomic backgrounds who are at higher risk for persistent SDB and its associated morbidity. It is also important to document whether snoring persists, the investigators said.

Snoring was assessed when the children were aged 2 and 3 years with the validated Child Sleep Habits Questionnaire, which asked parents to report how often their child "snored loudly" during the previous week. Of the 249 children, 170 (68%) were "nonsnorers" whose parents reported that they "rarely" snored loudly over the previous week. Another 57 children (23%) were "transient snorers," who snored loudly two or more times per week at either age 2 or 3 years but not both, and 22 (9%) were "persistent snorers," who snored two or more times per week at ages 2 and 3 years.

Parents completed the validated preschool form of the Behavior Assessment System for Children, and a trained research associate administered the Bayley Scales of Infant Development. Prenatal exposure to tobacco was assessed through maternal serum cotinine measures during pregnancy, and childhood tobacco exposure was assessed through collected serum. The mothers were surveyed about breast feeding, and the children were examined at annual visits.

The three groups did not differ significantly with regard to gender, birth weight, or gestational age. In the unadjusted analysis, the persistent snorers tended toward a higher body mass index z score than did the transient snorers or the nonsnorers at both the 2-year and 3-year assessments. Persistent snorers had significantly higher prenatal and childhood cotinine levels than did either of the other two groups at both time points.

Persistent snorers were significantly more likely to be African American (55% versus 13.5% of the nonsnorers), and to have lower parental education and annual family income ($49,000 vs. $84,000). None of the children fed breast milk for more than 12 months developed persistent snoring, but nearly one-quarter of those who were never fed breast milk, or who received breast milk for less than 1 month, did so.

Persistent snorers had significantly worse overall behavioral functioning than did the nonsnorers and transient snorers. Overall Behavioral Symptoms Index (BSI) scores were 49.2 for the nonsnorers, 50.9 for the transient snorers, and 57.6 for the persistent snorers, with a P value of less than .001 for the persistent snorers versus the other two groups. The difference was particularly significant with regard to hyperactivity, depression, and attention.

"At risk" or worse overall behaviors, defined as a BSI index score of 60 or greater, were reported in 35% of persistent snorers, compared with 10% of nonsnorers and 12% of transient snorers. "Preschool behavior and emotional problems of this magnitude were once dismissed as trivial, but are now recognized as significant sources of functional impairment at the population level," Dr. Beebe and his associates noted.

These results are consistent with reports on older children, and remained significant after the researchers controlled for child gender, race, and socioeconomic status.

Definitive causal conclusions can’t be drawn from this study. However, the findings are consistent with previous data suggesting that SDB-mediated sleep disruption and intermittent hypoxia can result in elevated oxidative stress, systemic inflammation, and changes in neural and neurobehavioral functioning. An ongoing randomized trial is currently examining the effect of surgical treatment of SDB on cognitive and behavioral functioning (Sleep 2011;34:1509-17).

A simple screening tool called BEARS (Bedtime Issues, Excessive Daytime Sleepiness, Night Awakenings, Regularity and Duration of Sleep, Snoring) has shown utility for identifying sleep problems in the primary care setting (Sleep Med. 2005;6:63-9).

None of the authors have any conflicts of interest to declare.

The ability to detect the recently circulating influenza variant H3N2v was low in some commercially available rapid detection tests, according to an analysis conducted by the Centers for Disease Control and Prevention.

"The ability to detect H3N2v virus varied substantially among the tests. This evaluation emphasizes the fact that a negative [rapid influenza detection test (RIDT)] result should not be considered as conclusive evidence of lack of infection with influenza A (H3N2)v ... Results from RIDTs, both positive and negative, always should be interpreted in the broader context of the circulating influenza strains present in the area, level of clinical suspicion, severity of illness, and risk for complications in a patient with suspected infection," the CDC said Aug. 10 in an early online release from Morbidity and Mortality Weekly Report (2012;61:1-3).

CDC/ Dr. Michael Shaw; Doug Jordan, M.A.

The H3N2v viruses can be definitively identified only at qualified U.S. public health laboratories using a polymerase chain reaction–based influenza diagnostic panel that is not available as a point-of-care test for clinicians. Specimens that test positive for influenza A, H3, and pandemic influenza A markers and negative for H1 and pandemic H1 markers are called "presumptive positive for influenza A(H3N2)v virus," until confirmed as influenza A(H3N2)v, the CDC said.

The CDC analyzed seven Food and Drug Administration–cleared rapid influenza detection tests (RIDTs) for their ability to detect H3N2v viruses, of which 153 infections were reported from four states between July 12 and Aug. 9, 2012. Each of the seven RIDTs – the BinaxNOW, Directigen, FluAlert, QuickVue, Sofia, Xpect, and Veritor – was tested with seven different H3N2 viruses, according to their respective package instructions. Positive and negative controls contained in each RIDT were run before testing the viruses in the study to verify performance of each assay lot, with the exception of FluAlert, which does not provide controls.

Only four of the seven RIDTs (Directigen, Sofia, Veritor, and Xpect) detected all influenza A(H3N2)v viruses. BinaxNOW detected five of seven, and QuickVue detected three of seven. FluAlert detected only one of seven, the CDC said.

More data are needed on the clinical performance of all RIDTs in detecting H3N2v virus in various respiratory specimens, the CDC said.

Clinicians should minimize the occurrence of false RIDT results by strictly following the manufacturer’s instructions, collecting specimens soon after the onset of influenza-like illness – ideally within the first 72 hours – and confirming RIDT results by sending the specimen to a public health laboratory. Additional CDC guidance on interpretation of RIDTs for testing of patients with suspected H3N2v infection is available here.

No disclosure statement was listed.

The ability to detect the recently circulating influenza variant H3N2v was low in some commercially available rapid detection tests, according to an analysis conducted by the Centers for Disease Control and Prevention.

"The ability to detect H3N2v virus varied substantially among the tests. This evaluation emphasizes the fact that a negative [rapid influenza detection test (RIDT)] result should not be considered as conclusive evidence of lack of infection with influenza A (H3N2)v ... Results from RIDTs, both positive and negative, always should be interpreted in the broader context of the circulating influenza strains present in the area, level of clinical suspicion, severity of illness, and risk for complications in a patient with suspected infection," the CDC said Aug. 10 in an early online release from Morbidity and Mortality Weekly Report (2012;61:1-3).

CDC/ Dr. Michael Shaw; Doug Jordan, M.A.

The H3N2v viruses can be definitively identified only at qualified U.S. public health laboratories using a polymerase chain reaction–based influenza diagnostic panel that is not available as a point-of-care test for clinicians. Specimens that test positive for influenza A, H3, and pandemic influenza A markers and negative for H1 and pandemic H1 markers are called "presumptive positive for influenza A(H3N2)v virus," until confirmed as influenza A(H3N2)v, the CDC said.

The CDC analyzed seven Food and Drug Administration–cleared rapid influenza detection tests (RIDTs) for their ability to detect H3N2v viruses, of which 153 infections were reported from four states between July 12 and Aug. 9, 2012. Each of the seven RIDTs – the BinaxNOW, Directigen, FluAlert, QuickVue, Sofia, Xpect, and Veritor – was tested with seven different H3N2 viruses, according to their respective package instructions. Positive and negative controls contained in each RIDT were run before testing the viruses in the study to verify performance of each assay lot, with the exception of FluAlert, which does not provide controls.

Only four of the seven RIDTs (Directigen, Sofia, Veritor, and Xpect) detected all influenza A(H3N2)v viruses. BinaxNOW detected five of seven, and QuickVue detected three of seven. FluAlert detected only one of seven, the CDC said.

More data are needed on the clinical performance of all RIDTs in detecting H3N2v virus in various respiratory specimens, the CDC said.

Clinicians should minimize the occurrence of false RIDT results by strictly following the manufacturer’s instructions, collecting specimens soon after the onset of influenza-like illness – ideally within the first 72 hours – and confirming RIDT results by sending the specimen to a public health laboratory. Additional CDC guidance on interpretation of RIDTs for testing of patients with suspected H3N2v infection is available here.

No disclosure statement was listed.

The ability to detect the recently circulating influenza variant H3N2v was low in some commercially available rapid detection tests, according to an analysis conducted by the Centers for Disease Control and Prevention.

"The ability to detect H3N2v virus varied substantially among the tests. This evaluation emphasizes the fact that a negative [rapid influenza detection test (RIDT)] result should not be considered as conclusive evidence of lack of infection with influenza A (H3N2)v ... Results from RIDTs, both positive and negative, always should be interpreted in the broader context of the circulating influenza strains present in the area, level of clinical suspicion, severity of illness, and risk for complications in a patient with suspected infection," the CDC said Aug. 10 in an early online release from Morbidity and Mortality Weekly Report (2012;61:1-3).

CDC/ Dr. Michael Shaw; Doug Jordan, M.A.

The H3N2v viruses can be definitively identified only at qualified U.S. public health laboratories using a polymerase chain reaction–based influenza diagnostic panel that is not available as a point-of-care test for clinicians. Specimens that test positive for influenza A, H3, and pandemic influenza A markers and negative for H1 and pandemic H1 markers are called "presumptive positive for influenza A(H3N2)v virus," until confirmed as influenza A(H3N2)v, the CDC said.

The CDC analyzed seven Food and Drug Administration–cleared rapid influenza detection tests (RIDTs) for their ability to detect H3N2v viruses, of which 153 infections were reported from four states between July 12 and Aug. 9, 2012. Each of the seven RIDTs – the BinaxNOW, Directigen, FluAlert, QuickVue, Sofia, Xpect, and Veritor – was tested with seven different H3N2 viruses, according to their respective package instructions. Positive and negative controls contained in each RIDT were run before testing the viruses in the study to verify performance of each assay lot, with the exception of FluAlert, which does not provide controls.

Only four of the seven RIDTs (Directigen, Sofia, Veritor, and Xpect) detected all influenza A(H3N2)v viruses. BinaxNOW detected five of seven, and QuickVue detected three of seven. FluAlert detected only one of seven, the CDC said.

More data are needed on the clinical performance of all RIDTs in detecting H3N2v virus in various respiratory specimens, the CDC said.

Clinicians should minimize the occurrence of false RIDT results by strictly following the manufacturer’s instructions, collecting specimens soon after the onset of influenza-like illness – ideally within the first 72 hours – and confirming RIDT results by sending the specimen to a public health laboratory. Additional CDC guidance on interpretation of RIDTs for testing of patients with suspected H3N2v infection is available here.

No disclosure statement was listed.

New federal guidelines outline steps to prevent infection in HIV-negative individuals at high risk of acquiring HIV through heterosexual sex.

The Centers for Disease Control and Prevention issued the interim recommendations pending the debut of a more complete set of HIV prevention guidelines both for heterosexuals and men who have sex with men (MSM).

© Dr. A. Harrison; Dr. P. Feorino / CDC

The guidance comes on the heels of a new drug approval for pre-exposure prophylaxis (PrEP). In July, the Food and Drug Administration approved Truvada, the combination of tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC), for PrEP in HIV-negative men and women who are at high risk for HIV acquisition through sexual intercourse.

Previous CDC guidance in January 2011 addressed PrEP in MSM (MMWR 2011;60:65-8).

The latest CDC document specifically addresses the use of PrEP in individuals who are at risk via heterosexual sex (MMWR 2012;61:586-9). The recommendations include new data about PrEP among heterosexual men and women (N. Engl. J. Med. 2012;367:399-434), as well as new information about pregnancy and other safety issues.

Both interim documents will remain valid until the CDC and other public health agencies complete a comprehensive set of HIV prevention recommendations on PrEP in both MSM and heterosexually active adults at high risk for HIV acquisition, the CDC said.

There are several new recommendations for initiating PrEP in individuals who are at very high risk for acquisition of HIV via penile-vaginal sex with a known HIV-positive partner:

• Prior to initiation: Confirm that the person is HIV-negative immediately before initiating TDF/FTC. Determine if the HIV-infected partner is receiving antiretroviral therapy, and if not, assist with a patient’s transition to care. Screen for hepatitis B and other sexually transmitted infections (STIs) and treat any that are detected. Check creatinine clearance, confirming that the calculated value is 60 mL/min or greater.

Determine if women are planning to become pregnant, are currently pregnant, or are breastfeeding. Women should be advised that PrEP safety during pregnancy has not been fully assessed, but that no harm has been reported. PrEP should not be prescribed for women who are breastfeeding.

• Beginning the PrEP regimen: Prescribe one Truvada tablet daily, with no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV uninfected. For women, ensure that a pregnancy test is negative or, if pregnant, that the patient has been informed about PrEP use during pregnancy. Provide risk reduction and PrEP medication-adherence counseling and condoms.

• Follow-up during PrEP: Every 2-3 months, perform an HIV test and a pregnancy test for women, assess risk behaviors and STI symptoms, and test and treat if present. Counsel the individual regarding medication adherence, risk reduction, and condom use. Check serum creatinine and calculate creatinine clearance 3 months after initiation, then every 6 months while on PrEP medication. Test for bacterial STIs every 6 months, regardless of symptoms.

• Discontinuing PrEP: This may be necessary because of patient requests, safety concerns, or acquisition of HIV infection. If HIV status is unknown, a test should be performed. If a patient is HIV-positive, link the patient to HIV care. If active hepatitis B infection is diagnosed, consider continuing medication for that infection. If the individual is pregnant, communicate and coordinate with the prenatal-care provider about the patient’s PrEP use.

New federal guidelines outline steps to prevent infection in HIV-negative individuals at high risk of acquiring HIV through heterosexual sex.

The Centers for Disease Control and Prevention issued the interim recommendations pending the debut of a more complete set of HIV prevention guidelines both for heterosexuals and men who have sex with men (MSM).

© Dr. A. Harrison; Dr. P. Feorino / CDC

The guidance comes on the heels of a new drug approval for pre-exposure prophylaxis (PrEP). In July, the Food and Drug Administration approved Truvada, the combination of tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC), for PrEP in HIV-negative men and women who are at high risk for HIV acquisition through sexual intercourse.

Previous CDC guidance in January 2011 addressed PrEP in MSM (MMWR 2011;60:65-8).

The latest CDC document specifically addresses the use of PrEP in individuals who are at risk via heterosexual sex (MMWR 2012;61:586-9). The recommendations include new data about PrEP among heterosexual men and women (N. Engl. J. Med. 2012;367:399-434), as well as new information about pregnancy and other safety issues.

Both interim documents will remain valid until the CDC and other public health agencies complete a comprehensive set of HIV prevention recommendations on PrEP in both MSM and heterosexually active adults at high risk for HIV acquisition, the CDC said.

There are several new recommendations for initiating PrEP in individuals who are at very high risk for acquisition of HIV via penile-vaginal sex with a known HIV-positive partner:

• Prior to initiation: Confirm that the person is HIV-negative immediately before initiating TDF/FTC. Determine if the HIV-infected partner is receiving antiretroviral therapy, and if not, assist with a patient’s transition to care. Screen for hepatitis B and other sexually transmitted infections (STIs) and treat any that are detected. Check creatinine clearance, confirming that the calculated value is 60 mL/min or greater.

Determine if women are planning to become pregnant, are currently pregnant, or are breastfeeding. Women should be advised that PrEP safety during pregnancy has not been fully assessed, but that no harm has been reported. PrEP should not be prescribed for women who are breastfeeding.

• Beginning the PrEP regimen: Prescribe one Truvada tablet daily, with no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV uninfected. For women, ensure that a pregnancy test is negative or, if pregnant, that the patient has been informed about PrEP use during pregnancy. Provide risk reduction and PrEP medication-adherence counseling and condoms.

• Follow-up during PrEP: Every 2-3 months, perform an HIV test and a pregnancy test for women, assess risk behaviors and STI symptoms, and test and treat if present. Counsel the individual regarding medication adherence, risk reduction, and condom use. Check serum creatinine and calculate creatinine clearance 3 months after initiation, then every 6 months while on PrEP medication. Test for bacterial STIs every 6 months, regardless of symptoms.

• Discontinuing PrEP: This may be necessary because of patient requests, safety concerns, or acquisition of HIV infection. If HIV status is unknown, a test should be performed. If a patient is HIV-positive, link the patient to HIV care. If active hepatitis B infection is diagnosed, consider continuing medication for that infection. If the individual is pregnant, communicate and coordinate with the prenatal-care provider about the patient’s PrEP use.

New federal guidelines outline steps to prevent infection in HIV-negative individuals at high risk of acquiring HIV through heterosexual sex.

The Centers for Disease Control and Prevention issued the interim recommendations pending the debut of a more complete set of HIV prevention guidelines both for heterosexuals and men who have sex with men (MSM).

© Dr. A. Harrison; Dr. P. Feorino / CDC

The guidance comes on the heels of a new drug approval for pre-exposure prophylaxis (PrEP). In July, the Food and Drug Administration approved Truvada, the combination of tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC), for PrEP in HIV-negative men and women who are at high risk for HIV acquisition through sexual intercourse.

Previous CDC guidance in January 2011 addressed PrEP in MSM (MMWR 2011;60:65-8).

The latest CDC document specifically addresses the use of PrEP in individuals who are at risk via heterosexual sex (MMWR 2012;61:586-9). The recommendations include new data about PrEP among heterosexual men and women (N. Engl. J. Med. 2012;367:399-434), as well as new information about pregnancy and other safety issues.

Both interim documents will remain valid until the CDC and other public health agencies complete a comprehensive set of HIV prevention recommendations on PrEP in both MSM and heterosexually active adults at high risk for HIV acquisition, the CDC said.

There are several new recommendations for initiating PrEP in individuals who are at very high risk for acquisition of HIV via penile-vaginal sex with a known HIV-positive partner:

• Prior to initiation: Confirm that the person is HIV-negative immediately before initiating TDF/FTC. Determine if the HIV-infected partner is receiving antiretroviral therapy, and if not, assist with a patient’s transition to care. Screen for hepatitis B and other sexually transmitted infections (STIs) and treat any that are detected. Check creatinine clearance, confirming that the calculated value is 60 mL/min or greater.

Determine if women are planning to become pregnant, are currently pregnant, or are breastfeeding. Women should be advised that PrEP safety during pregnancy has not been fully assessed, but that no harm has been reported. PrEP should not be prescribed for women who are breastfeeding.

• Beginning the PrEP regimen: Prescribe one Truvada tablet daily, with no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV uninfected. For women, ensure that a pregnancy test is negative or, if pregnant, that the patient has been informed about PrEP use during pregnancy. Provide risk reduction and PrEP medication-adherence counseling and condoms.

• Follow-up during PrEP: Every 2-3 months, perform an HIV test and a pregnancy test for women, assess risk behaviors and STI symptoms, and test and treat if present. Counsel the individual regarding medication adherence, risk reduction, and condom use. Check serum creatinine and calculate creatinine clearance 3 months after initiation, then every 6 months while on PrEP medication. Test for bacterial STIs every 6 months, regardless of symptoms.

• Discontinuing PrEP: This may be necessary because of patient requests, safety concerns, or acquisition of HIV infection. If HIV status is unknown, a test should be performed. If a patient is HIV-positive, link the patient to HIV care. If active hepatitis B infection is diagnosed, consider continuing medication for that infection. If the individual is pregnant, communicate and coordinate with the prenatal-care provider about the patient’s PrEP use.