Madhu Rajaraman

Confusion about the strength of the antibacterial drug Zerbaxa could potentially lead to dosage errors, the Food and Drug Administration cautioned in a May 20 announcement.

The label for Zerbaxa was approved with a strength that reflects each individual active ingredient, although the product is dosed based on the sum of these ingredients, which has led to at least seven cases of medication error, the FDA said.

“In some cases, this led to administration of 50% more drug than was prescribed,” the agency said in its statement.

To prevent future confusion, the FDA has revised the labeling to show the sum of the two active ingredients, ceftolozane and tazobactam. The strength will now be listed as 1.5 g, equivalent to 1 g of ceftolozane and 0.5 g tazobactam. This labeling is consistent with other beta-lactam/beta-lactamase medications that list drug strength as the sum of the two active ingredients, the FDA said.

Zerbaxa is approved to treat complicated urinary tract infections and intra-abdominal infections in combination with metronidazole.

No adverse events were reported in the seven cases that were evaluated. Patients and providers can report serious side effects, adverse events, and medication dosage errors to the FDA’s MedWatch program.

[email protected]

Confusion about the strength of the antibacterial drug Zerbaxa could potentially lead to dosage errors, the Food and Drug Administration cautioned in a May 20 announcement.

The label for Zerbaxa was approved with a strength that reflects each individual active ingredient, although the product is dosed based on the sum of these ingredients, which has led to at least seven cases of medication error, the FDA said.

“In some cases, this led to administration of 50% more drug than was prescribed,” the agency said in its statement.

To prevent future confusion, the FDA has revised the labeling to show the sum of the two active ingredients, ceftolozane and tazobactam. The strength will now be listed as 1.5 g, equivalent to 1 g of ceftolozane and 0.5 g tazobactam. This labeling is consistent with other beta-lactam/beta-lactamase medications that list drug strength as the sum of the two active ingredients, the FDA said.

Zerbaxa is approved to treat complicated urinary tract infections and intra-abdominal infections in combination with metronidazole.

No adverse events were reported in the seven cases that were evaluated. Patients and providers can report serious side effects, adverse events, and medication dosage errors to the FDA’s MedWatch program.

[email protected]

Confusion about the strength of the antibacterial drug Zerbaxa could potentially lead to dosage errors, the Food and Drug Administration cautioned in a May 20 announcement.

The label for Zerbaxa was approved with a strength that reflects each individual active ingredient, although the product is dosed based on the sum of these ingredients, which has led to at least seven cases of medication error, the FDA said.

“In some cases, this led to administration of 50% more drug than was prescribed,” the agency said in its statement.

To prevent future confusion, the FDA has revised the labeling to show the sum of the two active ingredients, ceftolozane and tazobactam. The strength will now be listed as 1.5 g, equivalent to 1 g of ceftolozane and 0.5 g tazobactam. This labeling is consistent with other beta-lactam/beta-lactamase medications that list drug strength as the sum of the two active ingredients, the FDA said.

Zerbaxa is approved to treat complicated urinary tract infections and intra-abdominal infections in combination with metronidazole.

No adverse events were reported in the seven cases that were evaluated. Patients and providers can report serious side effects, adverse events, and medication dosage errors to the FDA’s MedWatch program.

[email protected]

Most women who receive the Tetanus-diphtheria-acellular pertussis (Tdap) vaccine do so after delivery, contrary to recommendations from the Advisory Committee on Immunizations Practices, which calls for vaccination during pregnancy.

Data from the Pregnancy Risk Assessment Monitoring System show that among 6,852 survey respondents in 16 states and New York City who had a live birth between September and December 2011, 20.8% did not know their vaccination status. Of the 5,499 who did know their status, more than half reported being vaccinated with Tdap (13.9% before pregnancy, 9.9% during pregnancy, and 30.5% after delivery).

The findings were published May 21 in Morbidity and Mortality Weekly Report (MMWR. 2015;64:522-6).

ACIP guidelines suggest the optimal time for vaccination is at 27-36 weeks’ gestation, according to the report.

Until 2011, it was recommended that women receive the vaccine either before pregnancy or postpartum. In June 2011, the ACIP changed its recommendation to one dose of the vaccine during pregnancy in women who had never received it before. ACIP further expanded this recommendation in 2012 to recommend vaccination during each pregnancy to provide maternal antibodies for each infant.

“Results from this analysis might reflect the early transition from a policy of vaccinating women postpartum to a policy of vaccinating them during pregnancy,” wrote Indu B. Ahluwalia, Ph.D., and coauthors from the CDC’s Division of Reproductive Health at the National Center for Chronic Disease Prevention and Health Promotion.

Physicians can also “assist pregnant women by providing specific information about where to obtain Tdap vaccination, or offering to provide the vaccination, and also to write a prescription in case it is needed,” the authors wrote.

Most women who receive the Tetanus-diphtheria-acellular pertussis (Tdap) vaccine do so after delivery, contrary to recommendations from the Advisory Committee on Immunizations Practices, which calls for vaccination during pregnancy.

Data from the Pregnancy Risk Assessment Monitoring System show that among 6,852 survey respondents in 16 states and New York City who had a live birth between September and December 2011, 20.8% did not know their vaccination status. Of the 5,499 who did know their status, more than half reported being vaccinated with Tdap (13.9% before pregnancy, 9.9% during pregnancy, and 30.5% after delivery).

The findings were published May 21 in Morbidity and Mortality Weekly Report (MMWR. 2015;64:522-6).

ACIP guidelines suggest the optimal time for vaccination is at 27-36 weeks’ gestation, according to the report.

Until 2011, it was recommended that women receive the vaccine either before pregnancy or postpartum. In June 2011, the ACIP changed its recommendation to one dose of the vaccine during pregnancy in women who had never received it before. ACIP further expanded this recommendation in 2012 to recommend vaccination during each pregnancy to provide maternal antibodies for each infant.

“Results from this analysis might reflect the early transition from a policy of vaccinating women postpartum to a policy of vaccinating them during pregnancy,” wrote Indu B. Ahluwalia, Ph.D., and coauthors from the CDC’s Division of Reproductive Health at the National Center for Chronic Disease Prevention and Health Promotion.

Physicians can also “assist pregnant women by providing specific information about where to obtain Tdap vaccination, or offering to provide the vaccination, and also to write a prescription in case it is needed,” the authors wrote.

Most women who receive the Tetanus-diphtheria-acellular pertussis (Tdap) vaccine do so after delivery, contrary to recommendations from the Advisory Committee on Immunizations Practices, which calls for vaccination during pregnancy.

Data from the Pregnancy Risk Assessment Monitoring System show that among 6,852 survey respondents in 16 states and New York City who had a live birth between September and December 2011, 20.8% did not know their vaccination status. Of the 5,499 who did know their status, more than half reported being vaccinated with Tdap (13.9% before pregnancy, 9.9% during pregnancy, and 30.5% after delivery).

The findings were published May 21 in Morbidity and Mortality Weekly Report (MMWR. 2015;64:522-6).

ACIP guidelines suggest the optimal time for vaccination is at 27-36 weeks’ gestation, according to the report.

Until 2011, it was recommended that women receive the vaccine either before pregnancy or postpartum. In June 2011, the ACIP changed its recommendation to one dose of the vaccine during pregnancy in women who had never received it before. ACIP further expanded this recommendation in 2012 to recommend vaccination during each pregnancy to provide maternal antibodies for each infant.

“Results from this analysis might reflect the early transition from a policy of vaccinating women postpartum to a policy of vaccinating them during pregnancy,” wrote Indu B. Ahluwalia, Ph.D., and coauthors from the CDC’s Division of Reproductive Health at the National Center for Chronic Disease Prevention and Health Promotion.

Physicians can also “assist pregnant women by providing specific information about where to obtain Tdap vaccination, or offering to provide the vaccination, and also to write a prescription in case it is needed,” the authors wrote.

The Food and Drug Administration has approved the long-acting atypical antipsychotic Invega Trinza (3-month paliperidone palmitate) to treat schizophrenia, Janssen Pharmaceuticals announced May 19.

Invega Trinza is the first schizophrenia drug to be injected just four times per year, in 3-month intervals, and was approved under FDA priority review, the company said in a statement.

Before starting treatment with Invega Trinza, patients must first be treated with Invega Sustenna (paliperidone palmitate) for at least 4 months.

In a phase III trial recently published in JAMA Psychiatry, time to relapse was significantly delayed in patients who received Invega Trinza, compared with those on placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P <.001). Of patients treated with Invega Trinza, 93% did not experience a significant return of schizophrenia symptoms.

“With this new treatment option, health care providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan,” Janssen said in the statement.

Invega Trinza may cause serious side effects, including increased risk of death in elderly patients with confusion, memory loss, or dementia-related psychosis. For more safety information, please visit http://www.janssenmd.com/pdf/invega-trinza/invega-trinza_pi.pdf.

The Food and Drug Administration has approved the long-acting atypical antipsychotic Invega Trinza (3-month paliperidone palmitate) to treat schizophrenia, Janssen Pharmaceuticals announced May 19.

Invega Trinza is the first schizophrenia drug to be injected just four times per year, in 3-month intervals, and was approved under FDA priority review, the company said in a statement.

Before starting treatment with Invega Trinza, patients must first be treated with Invega Sustenna (paliperidone palmitate) for at least 4 months.

In a phase III trial recently published in JAMA Psychiatry, time to relapse was significantly delayed in patients who received Invega Trinza, compared with those on placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P <.001). Of patients treated with Invega Trinza, 93% did not experience a significant return of schizophrenia symptoms.

“With this new treatment option, health care providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan,” Janssen said in the statement.

Invega Trinza may cause serious side effects, including increased risk of death in elderly patients with confusion, memory loss, or dementia-related psychosis. For more safety information, please visit http://www.janssenmd.com/pdf/invega-trinza/invega-trinza_pi.pdf.

The Food and Drug Administration has approved the long-acting atypical antipsychotic Invega Trinza (3-month paliperidone palmitate) to treat schizophrenia, Janssen Pharmaceuticals announced May 19.

Invega Trinza is the first schizophrenia drug to be injected just four times per year, in 3-month intervals, and was approved under FDA priority review, the company said in a statement.

Before starting treatment with Invega Trinza, patients must first be treated with Invega Sustenna (paliperidone palmitate) for at least 4 months.

In a phase III trial recently published in JAMA Psychiatry, time to relapse was significantly delayed in patients who received Invega Trinza, compared with those on placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P <.001). Of patients treated with Invega Trinza, 93% did not experience a significant return of schizophrenia symptoms.

“With this new treatment option, health care providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan,” Janssen said in the statement.

Invega Trinza may cause serious side effects, including increased risk of death in elderly patients with confusion, memory loss, or dementia-related psychosis. For more safety information, please visit http://www.janssenmd.com/pdf/invega-trinza/invega-trinza_pi.pdf.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors may lead to ketoacidosis, and patients taking these medications should seek immediate medical attention if they experience symptoms, the Food and Drug Administration warned in an announcement May 15.

Medications in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin, and are used to treat type 2 diabetes. Ketoacidosis occurs when the body produces high levels of ketones, and may include symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and fatigue, the FDA said in the statement.

“Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels,” the statement said.

The FDA’s Adverse Event Reporting System database contains 20 recorded cases of diabetic ketoacidosis, ketoacidosis, or ketosis in patients receiving treatment with SGLT2 inhibitors, reported between March 2013 and June 2014, all of which required hospitalization or emergency department visits. The agency has since continued to receive reports of additional cases, they said.

The FDA is evaluating whether changes are needed in the prescribing information for SGLT2 inhibitor drugs. Health care providers should report adverse side effects to the FDA MedWatch program.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors may lead to ketoacidosis, and patients taking these medications should seek immediate medical attention if they experience symptoms, the Food and Drug Administration warned in an announcement May 15.

Medications in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin, and are used to treat type 2 diabetes. Ketoacidosis occurs when the body produces high levels of ketones, and may include symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and fatigue, the FDA said in the statement.

“Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels,” the statement said.

The FDA’s Adverse Event Reporting System database contains 20 recorded cases of diabetic ketoacidosis, ketoacidosis, or ketosis in patients receiving treatment with SGLT2 inhibitors, reported between March 2013 and June 2014, all of which required hospitalization or emergency department visits. The agency has since continued to receive reports of additional cases, they said.

The FDA is evaluating whether changes are needed in the prescribing information for SGLT2 inhibitor drugs. Health care providers should report adverse side effects to the FDA MedWatch program.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors may lead to ketoacidosis, and patients taking these medications should seek immediate medical attention if they experience symptoms, the Food and Drug Administration warned in an announcement May 15.

Medications in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin, and are used to treat type 2 diabetes. Ketoacidosis occurs when the body produces high levels of ketones, and may include symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and fatigue, the FDA said in the statement.

“Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels,” the statement said.

The FDA’s Adverse Event Reporting System database contains 20 recorded cases of diabetic ketoacidosis, ketoacidosis, or ketosis in patients receiving treatment with SGLT2 inhibitors, reported between March 2013 and June 2014, all of which required hospitalization or emergency department visits. The agency has since continued to receive reports of additional cases, they said.

The FDA is evaluating whether changes are needed in the prescribing information for SGLT2 inhibitor drugs. Health care providers should report adverse side effects to the FDA MedWatch program.

Use of an expanded genetic score in conjunction with the Framingham risk score improved risk prediction for type 2 diabetes, according to findings recently published in the journal Diabetes.

In an analysis of seven cohorts of European patients, a 65-SNP (single nucleotide polymorphism) genetic score alone detected 19.9% of incident cases with a 10% false-positive rate, compared with the Framingham risk model, which detected 30.7% (95% confidence interval, 27.5-33.8) of cases.

When combined, the two measures detected 37.3% (95% CI, 33.9-40.6) of cases, reported Dr. Philippa J. Talmud of the Centre for Cardiovascular Genetics at the Institute of Cardiovascular Science, University College London, and her associates.

The addition of a 65-SNP gene score improved correct classification of patients into higher risk disease categories by 6.2%.

Of the 13,294 patients included in the study, 804 developed type 2 diabetes during the study period. Patients were classified as having type 2 diabetes according to self-report, medical record review, prescription of glucose-lowering drugs, or a recorded fasting glucose of 7 mmol/L or greater, the authors said.

Genotyping was performed using MetaboChip array, which includes nearly 200,000 SNP loci for cardiometabolic disease and their genetic variants.

Area under the curve values for genetic score, Framingham risk model, and combined score were 0.60 (95% CI, 0.58-0.62), 0.75 (95% CI, 0.73-0.77), and 0.76 (95% CI, 0.75-0.78), respectively. The combined risk score net reclassification improvement (NRI) was 8.1% (P = 3.31 × 10^–7), the investigators reported (Diabetes 2015;64:1830-40).

The findings suggest that common variants of small effects in combination may help improve risk prediction for type 2 diabetes, Dr. Talmud and her coauthors said.

“For a gene score to be effective, it should improve the reclassification of individuals with [type 2 diabetes] into a more accurate risk category over and above the phenotypic risk score. The 65 SNP–weighted gene score did this,” they said.

“In actual terms, at a 10% [false-positive rate], the combined phenotypic and genetic risk score led to the correct identification of an additional 53 (6.6%) of the 804 cases,” they added.

This slight improvement demonstrates that the addition of a gene score to a phenotyping risk model could be a “potentially clinically important improvement” in disease discrimination and classification, Dr. Talmud and her associates concluded.

The study authors reported several sources of funding, including the British Heart Foundation, the Stroke Association, the National Heart, Lung, and Blood Institute, and others.

Use of an expanded genetic score in conjunction with the Framingham risk score improved risk prediction for type 2 diabetes, according to findings recently published in the journal Diabetes.

In an analysis of seven cohorts of European patients, a 65-SNP (single nucleotide polymorphism) genetic score alone detected 19.9% of incident cases with a 10% false-positive rate, compared with the Framingham risk model, which detected 30.7% (95% confidence interval, 27.5-33.8) of cases.

When combined, the two measures detected 37.3% (95% CI, 33.9-40.6) of cases, reported Dr. Philippa J. Talmud of the Centre for Cardiovascular Genetics at the Institute of Cardiovascular Science, University College London, and her associates.

The addition of a 65-SNP gene score improved correct classification of patients into higher risk disease categories by 6.2%.

Of the 13,294 patients included in the study, 804 developed type 2 diabetes during the study period. Patients were classified as having type 2 diabetes according to self-report, medical record review, prescription of glucose-lowering drugs, or a recorded fasting glucose of 7 mmol/L or greater, the authors said.

Genotyping was performed using MetaboChip array, which includes nearly 200,000 SNP loci for cardiometabolic disease and their genetic variants.

Area under the curve values for genetic score, Framingham risk model, and combined score were 0.60 (95% CI, 0.58-0.62), 0.75 (95% CI, 0.73-0.77), and 0.76 (95% CI, 0.75-0.78), respectively. The combined risk score net reclassification improvement (NRI) was 8.1% (P = 3.31 × 10^–7), the investigators reported (Diabetes 2015;64:1830-40).

The findings suggest that common variants of small effects in combination may help improve risk prediction for type 2 diabetes, Dr. Talmud and her coauthors said.

“For a gene score to be effective, it should improve the reclassification of individuals with [type 2 diabetes] into a more accurate risk category over and above the phenotypic risk score. The 65 SNP–weighted gene score did this,” they said.

“In actual terms, at a 10% [false-positive rate], the combined phenotypic and genetic risk score led to the correct identification of an additional 53 (6.6%) of the 804 cases,” they added.

This slight improvement demonstrates that the addition of a gene score to a phenotyping risk model could be a “potentially clinically important improvement” in disease discrimination and classification, Dr. Talmud and her associates concluded.

The study authors reported several sources of funding, including the British Heart Foundation, the Stroke Association, the National Heart, Lung, and Blood Institute, and others.

Use of an expanded genetic score in conjunction with the Framingham risk score improved risk prediction for type 2 diabetes, according to findings recently published in the journal Diabetes.

In an analysis of seven cohorts of European patients, a 65-SNP (single nucleotide polymorphism) genetic score alone detected 19.9% of incident cases with a 10% false-positive rate, compared with the Framingham risk model, which detected 30.7% (95% confidence interval, 27.5-33.8) of cases.

When combined, the two measures detected 37.3% (95% CI, 33.9-40.6) of cases, reported Dr. Philippa J. Talmud of the Centre for Cardiovascular Genetics at the Institute of Cardiovascular Science, University College London, and her associates.

The addition of a 65-SNP gene score improved correct classification of patients into higher risk disease categories by 6.2%.

Of the 13,294 patients included in the study, 804 developed type 2 diabetes during the study period. Patients were classified as having type 2 diabetes according to self-report, medical record review, prescription of glucose-lowering drugs, or a recorded fasting glucose of 7 mmol/L or greater, the authors said.

Genotyping was performed using MetaboChip array, which includes nearly 200,000 SNP loci for cardiometabolic disease and their genetic variants.

Area under the curve values for genetic score, Framingham risk model, and combined score were 0.60 (95% CI, 0.58-0.62), 0.75 (95% CI, 0.73-0.77), and 0.76 (95% CI, 0.75-0.78), respectively. The combined risk score net reclassification improvement (NRI) was 8.1% (P = 3.31 × 10^–7), the investigators reported (Diabetes 2015;64:1830-40).

The findings suggest that common variants of small effects in combination may help improve risk prediction for type 2 diabetes, Dr. Talmud and her coauthors said.

“For a gene score to be effective, it should improve the reclassification of individuals with [type 2 diabetes] into a more accurate risk category over and above the phenotypic risk score. The 65 SNP–weighted gene score did this,” they said.

“In actual terms, at a 10% [false-positive rate], the combined phenotypic and genetic risk score led to the correct identification of an additional 53 (6.6%) of the 804 cases,” they added.

This slight improvement demonstrates that the addition of a gene score to a phenotyping risk model could be a “potentially clinically important improvement” in disease discrimination and classification, Dr. Talmud and her associates concluded.

The study authors reported several sources of funding, including the British Heart Foundation, the Stroke Association, the National Heart, Lung, and Blood Institute, and others.

Use of an expanded genetic score in conjunction with the Framingham risk score improved risk prediction for type 2 diabetes, according to findings recently published in the journal Diabetes.

In an analysis of seven cohorts of European patients, a 65-SNP (single nucleotide polymorphism) genetic score alone detected 19.9% of incident cases with a 10% false-positive rate, compared with the Framingham risk model, which detected 30.7% (95% confidence interval, 27.5-33.8) of cases.

When combined, the two measures detected 37.3% (95% CI, 33.9-40.6) of cases, reported Dr. Philippa J. Talmud of the Centre for Cardiovascular Genetics at the Institute of Cardiovascular Science, University College London, and her associates.

The addition of a 65-SNP gene score improved correct classification of patients into higher risk disease categories by 6.2%.

Of the 13,294 patients included in the study, 804 developed type 2 diabetes during the study period. Patients were classified as having type 2 diabetes according to self-report, medical record review, prescription of glucose-lowering drugs, or a recorded fasting glucose of 7 mmol/L or greater, the authors said.

Genotyping was performed using MetaboChip array, which includes nearly 200,000 SNP loci for cardiometabolic disease and their genetic variants.

Area under the curve values for genetic score, Framingham risk model, and combined score were 0.60 (95% CI, 0.58-0.62), 0.75 (95% CI, 0.73-0.77), and 0.76 (95% CI, 0.75-0.78), respectively. The combined risk score net reclassification improvement (NRI) was 8.1% (P = 3.31 × 10^–7), the investigators reported (Diabetes 2015;64:1830-40).

The findings suggest that common variants of small effects in combination may help improve risk prediction for type 2 diabetes, Dr. Talmud and her coauthors said.

“For a gene score to be effective, it should improve the reclassification of individuals with [type 2 diabetes] into a more accurate risk category over and above the phenotypic risk score. The 65 SNP–weighted gene score did this,” they said.

“In actual terms, at a 10% [false-positive rate], the combined phenotypic and genetic risk score led to the correct identification of an additional 53 (6.6%) of the 804 cases,” they added.

This slight improvement demonstrates that the addition of a gene score to a phenotyping risk model could be a “potentially clinically important improvement” in disease discrimination and classification, Dr. Talmud and her associates concluded.

The study authors reported several sources of funding, including the British Heart Foundation, the Stroke Association, the National Heart, Lung, and Blood Institute, and others.

[email protected]

Use of an expanded genetic score in conjunction with the Framingham risk score improved risk prediction for type 2 diabetes, according to findings recently published in the journal Diabetes.

In an analysis of seven cohorts of European patients, a 65-SNP (single nucleotide polymorphism) genetic score alone detected 19.9% of incident cases with a 10% false-positive rate, compared with the Framingham risk model, which detected 30.7% (95% confidence interval, 27.5-33.8) of cases.

When combined, the two measures detected 37.3% (95% CI, 33.9-40.6) of cases, reported Dr. Philippa J. Talmud of the Centre for Cardiovascular Genetics at the Institute of Cardiovascular Science, University College London, and her associates.

The addition of a 65-SNP gene score improved correct classification of patients into higher risk disease categories by 6.2%.

Of the 13,294 patients included in the study, 804 developed type 2 diabetes during the study period. Patients were classified as having type 2 diabetes according to self-report, medical record review, prescription of glucose-lowering drugs, or a recorded fasting glucose of 7 mmol/L or greater, the authors said.

Genotyping was performed using MetaboChip array, which includes nearly 200,000 SNP loci for cardiometabolic disease and their genetic variants.

Area under the curve values for genetic score, Framingham risk model, and combined score were 0.60 (95% CI, 0.58-0.62), 0.75 (95% CI, 0.73-0.77), and 0.76 (95% CI, 0.75-0.78), respectively. The combined risk score net reclassification improvement (NRI) was 8.1% (P = 3.31 × 10^–7), the investigators reported (Diabetes 2015;64:1830-40).

The findings suggest that common variants of small effects in combination may help improve risk prediction for type 2 diabetes, Dr. Talmud and her coauthors said.

“For a gene score to be effective, it should improve the reclassification of individuals with [type 2 diabetes] into a more accurate risk category over and above the phenotypic risk score. The 65 SNP–weighted gene score did this,” they said.

“In actual terms, at a 10% [false-positive rate], the combined phenotypic and genetic risk score led to the correct identification of an additional 53 (6.6%) of the 804 cases,” they added.

This slight improvement demonstrates that the addition of a gene score to a phenotyping risk model could be a “potentially clinically important improvement” in disease discrimination and classification, Dr. Talmud and her associates concluded.

The study authors reported several sources of funding, including the British Heart Foundation, the Stroke Association, the National Heart, Lung, and Blood Institute, and others.

[email protected]

Use of an expanded genetic score in conjunction with the Framingham risk score improved risk prediction for type 2 diabetes, according to findings recently published in the journal Diabetes.

In an analysis of seven cohorts of European patients, a 65-SNP (single nucleotide polymorphism) genetic score alone detected 19.9% of incident cases with a 10% false-positive rate, compared with the Framingham risk model, which detected 30.7% (95% confidence interval, 27.5-33.8) of cases.

When combined, the two measures detected 37.3% (95% CI, 33.9-40.6) of cases, reported Dr. Philippa J. Talmud of the Centre for Cardiovascular Genetics at the Institute of Cardiovascular Science, University College London, and her associates.

The addition of a 65-SNP gene score improved correct classification of patients into higher risk disease categories by 6.2%.

Of the 13,294 patients included in the study, 804 developed type 2 diabetes during the study period. Patients were classified as having type 2 diabetes according to self-report, medical record review, prescription of glucose-lowering drugs, or a recorded fasting glucose of 7 mmol/L or greater, the authors said.

Genotyping was performed using MetaboChip array, which includes nearly 200,000 SNP loci for cardiometabolic disease and their genetic variants.

Area under the curve values for genetic score, Framingham risk model, and combined score were 0.60 (95% CI, 0.58-0.62), 0.75 (95% CI, 0.73-0.77), and 0.76 (95% CI, 0.75-0.78), respectively. The combined risk score net reclassification improvement (NRI) was 8.1% (P = 3.31 × 10^–7), the investigators reported (Diabetes 2015;64:1830-40).

The findings suggest that common variants of small effects in combination may help improve risk prediction for type 2 diabetes, Dr. Talmud and her coauthors said.

“For a gene score to be effective, it should improve the reclassification of individuals with [type 2 diabetes] into a more accurate risk category over and above the phenotypic risk score. The 65 SNP–weighted gene score did this,” they said.

“In actual terms, at a 10% [false-positive rate], the combined phenotypic and genetic risk score led to the correct identification of an additional 53 (6.6%) of the 804 cases,” they added.

This slight improvement demonstrates that the addition of a gene score to a phenotyping risk model could be a “potentially clinically important improvement” in disease discrimination and classification, Dr. Talmud and her associates concluded.

The study authors reported several sources of funding, including the British Heart Foundation, the Stroke Association, the National Heart, Lung, and Blood Institute, and others.

[email protected]

Both helmet therapy and conservative therapy were effective in correcting most positional cranial deformation, based on a study of 4,378 infants diagnosed with either deformational plagiocephaly or deformational brachycephaly between 2004 and 2011.

In a nonrandomized study, 3,381 infants received conservative therapy, which consisted of repositioning with or without physical therapy, and 997 received helmet therapy. Of infants who received conservative therapy alone, 77% achieved complete correction. The other 534 infants were transitioned to helmet therapy after failure to respond to conservative therapy alone. Among these “crossover” patients, 96% achieved complete correction.

In infants who received helmet therapy alone, over 94% achieved complete correction, Dr. Jordan P. Steinberg and colleagues wrote in a study published in Plastic and Reconstructive Surgery.

©area73/thinkstockphotos.com

Compared with infants who received conservative treatment alone, crossover patients had greater deformity, with an increased cranial ratio (0.94 ± 0.35 versus 0.91 ± 0.23; P = .012) and diagonal difference (10.3 ± 4.1 versus 9.0 ± 3.8; P < .001) at the start of therapy (Plast. Reconstr. Surg. 2015;135:833-42).

Parents were more likely to comply with helmet therapy than with conservative therapy, 94% versus 87% respectively (P = .001). For the infants crossed over to helmet therapy, parent compliance was 84% with positional therapy and 96% with helmet therapy (P < .001).

Noncompliant parents had infants who were 2.4 times more likely to fail helmet therapy (P = .025) than were compliant parents, the authors reported.

Risk factors for failing conservative therapy were poor compliance (RR = 2.4; P = .009), older infant age (RR 1.76-2.08; P = .008), torticollis (RR 1.12-1.74; P = .002), developmental delay (RR 1.44; P = .042), and increased severity of cranial deformity, indicated by cranial ratio (RR 1.08-1.11; P = .044) and diagonal difference (RR 1.07-1.13; P = .027).

The presence of these factors may be a guide to initiating helmet therapy from the outset of treatment, rather than initially undertaking a course of conservative treatment, the researchers said. Delaying helmet therapy in favor of first-line conservative treatment for positional cranial deformation does not hinder complete correction, as long as parents are compliant with positional therapy and helmet therapy is begun in nonresponders while the infants’ brain growth is ongoing.

The greatest limitation of the study, they wrote, is that treatments were not randomized, so conclusions cannot be made about which therapy may be more effective.

Dr. Steinberg and his coauthors did not report any relevant financial disclosures.

[email protected]

Both helmet therapy and conservative therapy were effective in correcting most positional cranial deformation, based on a study of 4,378 infants diagnosed with either deformational plagiocephaly or deformational brachycephaly between 2004 and 2011.

In a nonrandomized study, 3,381 infants received conservative therapy, which consisted of repositioning with or without physical therapy, and 997 received helmet therapy. Of infants who received conservative therapy alone, 77% achieved complete correction. The other 534 infants were transitioned to helmet therapy after failure to respond to conservative therapy alone. Among these “crossover” patients, 96% achieved complete correction.

In infants who received helmet therapy alone, over 94% achieved complete correction, Dr. Jordan P. Steinberg and colleagues wrote in a study published in Plastic and Reconstructive Surgery.

©area73/thinkstockphotos.com

Compared with infants who received conservative treatment alone, crossover patients had greater deformity, with an increased cranial ratio (0.94 ± 0.35 versus 0.91 ± 0.23; P = .012) and diagonal difference (10.3 ± 4.1 versus 9.0 ± 3.8; P < .001) at the start of therapy (Plast. Reconstr. Surg. 2015;135:833-42).

Parents were more likely to comply with helmet therapy than with conservative therapy, 94% versus 87% respectively (P = .001). For the infants crossed over to helmet therapy, parent compliance was 84% with positional therapy and 96% with helmet therapy (P < .001).

Noncompliant parents had infants who were 2.4 times more likely to fail helmet therapy (P = .025) than were compliant parents, the authors reported.

Risk factors for failing conservative therapy were poor compliance (RR = 2.4; P = .009), older infant age (RR 1.76-2.08; P = .008), torticollis (RR 1.12-1.74; P = .002), developmental delay (RR 1.44; P = .042), and increased severity of cranial deformity, indicated by cranial ratio (RR 1.08-1.11; P = .044) and diagonal difference (RR 1.07-1.13; P = .027).

The presence of these factors may be a guide to initiating helmet therapy from the outset of treatment, rather than initially undertaking a course of conservative treatment, the researchers said. Delaying helmet therapy in favor of first-line conservative treatment for positional cranial deformation does not hinder complete correction, as long as parents are compliant with positional therapy and helmet therapy is begun in nonresponders while the infants’ brain growth is ongoing.

The greatest limitation of the study, they wrote, is that treatments were not randomized, so conclusions cannot be made about which therapy may be more effective.

Dr. Steinberg and his coauthors did not report any relevant financial disclosures.

[email protected]

Both helmet therapy and conservative therapy were effective in correcting most positional cranial deformation, based on a study of 4,378 infants diagnosed with either deformational plagiocephaly or deformational brachycephaly between 2004 and 2011.

In a nonrandomized study, 3,381 infants received conservative therapy, which consisted of repositioning with or without physical therapy, and 997 received helmet therapy. Of infants who received conservative therapy alone, 77% achieved complete correction. The other 534 infants were transitioned to helmet therapy after failure to respond to conservative therapy alone. Among these “crossover” patients, 96% achieved complete correction.

In infants who received helmet therapy alone, over 94% achieved complete correction, Dr. Jordan P. Steinberg and colleagues wrote in a study published in Plastic and Reconstructive Surgery.

©area73/thinkstockphotos.com

Compared with infants who received conservative treatment alone, crossover patients had greater deformity, with an increased cranial ratio (0.94 ± 0.35 versus 0.91 ± 0.23; P = .012) and diagonal difference (10.3 ± 4.1 versus 9.0 ± 3.8; P < .001) at the start of therapy (Plast. Reconstr. Surg. 2015;135:833-42).

Parents were more likely to comply with helmet therapy than with conservative therapy, 94% versus 87% respectively (P = .001). For the infants crossed over to helmet therapy, parent compliance was 84% with positional therapy and 96% with helmet therapy (P < .001).

Noncompliant parents had infants who were 2.4 times more likely to fail helmet therapy (P = .025) than were compliant parents, the authors reported.

Risk factors for failing conservative therapy were poor compliance (RR = 2.4; P = .009), older infant age (RR 1.76-2.08; P = .008), torticollis (RR 1.12-1.74; P = .002), developmental delay (RR 1.44; P = .042), and increased severity of cranial deformity, indicated by cranial ratio (RR 1.08-1.11; P = .044) and diagonal difference (RR 1.07-1.13; P = .027).

The presence of these factors may be a guide to initiating helmet therapy from the outset of treatment, rather than initially undertaking a course of conservative treatment, the researchers said. Delaying helmet therapy in favor of first-line conservative treatment for positional cranial deformation does not hinder complete correction, as long as parents are compliant with positional therapy and helmet therapy is begun in nonresponders while the infants’ brain growth is ongoing.

The greatest limitation of the study, they wrote, is that treatments were not randomized, so conclusions cannot be made about which therapy may be more effective.

Dr. Steinberg and his coauthors did not report any relevant financial disclosures.

[email protected]

The Department of Health & Human Services should do more to curb antipsychotic use in older adults with dementia, according to a recent report by the Government Accountability Office.

Antipsychotics are often prescribed off label to treat behavioral symptoms of dementia such as delusions, agitation, aggression, and personality changes. But the medications carry an increased risk of death and other adverse effects in older adults and should be used only when other options have been exhausted, said Sen. Ron Johnson (R-WIs.) and Sen. Susan M. Collins (R-Maine), who requested the report.

“Clinical guidelines consistently suggest the use of antipsychotic drugs for the treatment of the behavioral symptoms of dementia only when other, non-pharmacological attempts to ameliorate the behaviors have failed, and the individuals pose a threat to themselves or to others,” they said.

In 2012, Medicare Part D plans paid about $363 million for antipsychotics used by dementia patients aged 66 years and older.

About 33% of older adults with dementia who resided in a nursing home and were enrolled in Medicare Part D plans were prescribed antipsychotics, the authors said. Among those who did not reside in a nursing home, 14% were prescribed antipsychotics.

The investigation also found that 23% of short-stay [100 days or fewer] nursing home residents were prescribed antipsychotics, compared with 33% of long-stay residents. Sixty-six percent of the antipsychotic prescriptions for Medicare Part D patients were prescribed by internists and family medicine physicians, and 16% were written by psychiatrists or neurologists, the report said. Meanwhile 5% of the antipsychotics for these patients were prescribed by nurse practitioners and physician assistants, and the rest were prescribed by many specialties.

Although several HHS programs exist that aim to reduce antipsychotic use in aging populations, these efforts are limited to adults in nursing homes, who likely have greater disease severity, Sen. Johnson and Sen. Collins wrote.

“Similar efforts have not been directed toward caregivers of older adults living outside of nursing homes, such as those in assisted living facilities and private residences,” the authors said. “Targeting this segment of the population is equally important given that over 1.2 million Medicare Part D enrollees living outside of nursing homes were diagnosed with dementia in 2012 and Medicare Part D pays for antipsychotic drugs prescribed to these individuals,” they added.

By expanding its outreach and educational efforts, HHS might be able to reduce the unnecessary reliance on antipsychotics for treating the “behavioral symptoms of dementia for all older adults regardless of their residential setting,” the author wrote. HHS concurred with the report’s conclusions.

The Department of Health & Human Services should do more to curb antipsychotic use in older adults with dementia, according to a recent report by the Government Accountability Office.

Antipsychotics are often prescribed off label to treat behavioral symptoms of dementia such as delusions, agitation, aggression, and personality changes. But the medications carry an increased risk of death and other adverse effects in older adults and should be used only when other options have been exhausted, said Sen. Ron Johnson (R-WIs.) and Sen. Susan M. Collins (R-Maine), who requested the report.

“Clinical guidelines consistently suggest the use of antipsychotic drugs for the treatment of the behavioral symptoms of dementia only when other, non-pharmacological attempts to ameliorate the behaviors have failed, and the individuals pose a threat to themselves or to others,” they said.

In 2012, Medicare Part D plans paid about $363 million for antipsychotics used by dementia patients aged 66 years and older.

About 33% of older adults with dementia who resided in a nursing home and were enrolled in Medicare Part D plans were prescribed antipsychotics, the authors said. Among those who did not reside in a nursing home, 14% were prescribed antipsychotics.

The investigation also found that 23% of short-stay [100 days or fewer] nursing home residents were prescribed antipsychotics, compared with 33% of long-stay residents. Sixty-six percent of the antipsychotic prescriptions for Medicare Part D patients were prescribed by internists and family medicine physicians, and 16% were written by psychiatrists or neurologists, the report said. Meanwhile 5% of the antipsychotics for these patients were prescribed by nurse practitioners and physician assistants, and the rest were prescribed by many specialties.

Although several HHS programs exist that aim to reduce antipsychotic use in aging populations, these efforts are limited to adults in nursing homes, who likely have greater disease severity, Sen. Johnson and Sen. Collins wrote.

“Similar efforts have not been directed toward caregivers of older adults living outside of nursing homes, such as those in assisted living facilities and private residences,” the authors said. “Targeting this segment of the population is equally important given that over 1.2 million Medicare Part D enrollees living outside of nursing homes were diagnosed with dementia in 2012 and Medicare Part D pays for antipsychotic drugs prescribed to these individuals,” they added.

By expanding its outreach and educational efforts, HHS might be able to reduce the unnecessary reliance on antipsychotics for treating the “behavioral symptoms of dementia for all older adults regardless of their residential setting,” the author wrote. HHS concurred with the report’s conclusions.

The Department of Health & Human Services should do more to curb antipsychotic use in older adults with dementia, according to a recent report by the Government Accountability Office.

Antipsychotics are often prescribed off label to treat behavioral symptoms of dementia such as delusions, agitation, aggression, and personality changes. But the medications carry an increased risk of death and other adverse effects in older adults and should be used only when other options have been exhausted, said Sen. Ron Johnson (R-WIs.) and Sen. Susan M. Collins (R-Maine), who requested the report.

“Clinical guidelines consistently suggest the use of antipsychotic drugs for the treatment of the behavioral symptoms of dementia only when other, non-pharmacological attempts to ameliorate the behaviors have failed, and the individuals pose a threat to themselves or to others,” they said.

In 2012, Medicare Part D plans paid about $363 million for antipsychotics used by dementia patients aged 66 years and older.

About 33% of older adults with dementia who resided in a nursing home and were enrolled in Medicare Part D plans were prescribed antipsychotics, the authors said. Among those who did not reside in a nursing home, 14% were prescribed antipsychotics.

The investigation also found that 23% of short-stay [100 days or fewer] nursing home residents were prescribed antipsychotics, compared with 33% of long-stay residents. Sixty-six percent of the antipsychotic prescriptions for Medicare Part D patients were prescribed by internists and family medicine physicians, and 16% were written by psychiatrists or neurologists, the report said. Meanwhile 5% of the antipsychotics for these patients were prescribed by nurse practitioners and physician assistants, and the rest were prescribed by many specialties.

Although several HHS programs exist that aim to reduce antipsychotic use in aging populations, these efforts are limited to adults in nursing homes, who likely have greater disease severity, Sen. Johnson and Sen. Collins wrote.

“Similar efforts have not been directed toward caregivers of older adults living outside of nursing homes, such as those in assisted living facilities and private residences,” the authors said. “Targeting this segment of the population is equally important given that over 1.2 million Medicare Part D enrollees living outside of nursing homes were diagnosed with dementia in 2012 and Medicare Part D pays for antipsychotic drugs prescribed to these individuals,” they added.

By expanding its outreach and educational efforts, HHS might be able to reduce the unnecessary reliance on antipsychotics for treating the “behavioral symptoms of dementia for all older adults regardless of their residential setting,” the author wrote. HHS concurred with the report’s conclusions.

The Department of Health & Human Services should do more to curb antipsychotic use in older adults with dementia, according to a recent report by the Government Accountability Office.

Antipsychotics are often prescribed off label to treat behavioral symptoms of dementia such as delusions, agitation, aggression, and personality changes. But the medications carry an increased risk of death and other adverse effects in older adults and should be used only when other options have been exhausted, said Sen. Ron Johnson (R-WIs.) and Sen. Susan M. Collins (R-Maine), who requested the report.

“Clinical guidelines consistently suggest the use of antipsychotic drugs for the treatment of the behavioral symptoms of dementia only when other, non-pharmacological attempts to ameliorate the behaviors have failed, and the individuals pose a threat to themselves or to others,” they said.

In 2012, Medicare Part D plans paid about $363 million for antipsychotics used by dementia patients aged 66 years and older.

About 33% of older adults with dementia who resided in a nursing home and were enrolled in Medicare Part D plans were prescribed antipsychotics, the authors said. Among those who did not reside in a nursing home, 14% were prescribed antipsychotics.

The investigation also found that 23% of short-stay [100 days or fewer] nursing home residents were prescribed antipsychotics, compared with 33% of long-stay residents. Sixty-six percent of the antipsychotic prescriptions for Medicare Part D patients were prescribed by internists and family medicine physicians, and 16% were written by psychiatrists or neurologists, the report said. Meanwhile 5% of the antipsychotics for these patients were prescribed by nurse practitioners and physician assistants, and the rest were prescribed by many specialties.

Although several HHS programs exist that aim to reduce antipsychotic use in aging populations, these efforts are limited to adults in nursing homes, who likely have greater disease severity, Sen. Johnson and Sen. Collins wrote.

“Similar efforts have not been directed toward caregivers of older adults living outside of nursing homes, such as those in assisted living facilities and private residences,” the authors said. “Targeting this segment of the population is equally important given that over 1.2 million Medicare Part D enrollees living outside of nursing homes were diagnosed with dementia in 2012 and Medicare Part D pays for antipsychotic drugs prescribed to these individuals,” they added.

By expanding its outreach and educational efforts, HHS might be able to reduce the unnecessary reliance on antipsychotics for treating the “behavioral symptoms of dementia for all older adults regardless of their residential setting,” the author wrote. HHS concurred with the report’s conclusions.

[email protected]

The Department of Health & Human Services should do more to curb antipsychotic use in older adults with dementia, according to a recent report by the Government Accountability Office.

Antipsychotics are often prescribed off label to treat behavioral symptoms of dementia such as delusions, agitation, aggression, and personality changes. But the medications carry an increased risk of death and other adverse effects in older adults and should be used only when other options have been exhausted, said Sen. Ron Johnson (R-WIs.) and Sen. Susan M. Collins (R-Maine), who requested the report.

“Clinical guidelines consistently suggest the use of antipsychotic drugs for the treatment of the behavioral symptoms of dementia only when other, non-pharmacological attempts to ameliorate the behaviors have failed, and the individuals pose a threat to themselves or to others,” they said.

In 2012, Medicare Part D plans paid about $363 million for antipsychotics used by dementia patients aged 66 years and older.

About 33% of older adults with dementia who resided in a nursing home and were enrolled in Medicare Part D plans were prescribed antipsychotics, the authors said. Among those who did not reside in a nursing home, 14% were prescribed antipsychotics.

The investigation also found that 23% of short-stay [100 days or fewer] nursing home residents were prescribed antipsychotics, compared with 33% of long-stay residents. Sixty-six percent of the antipsychotic prescriptions for Medicare Part D patients were prescribed by internists and family medicine physicians, and 16% were written by psychiatrists or neurologists, the report said. Meanwhile 5% of the antipsychotics for these patients were prescribed by nurse practitioners and physician assistants, and the rest were prescribed by many specialties.

Although several HHS programs exist that aim to reduce antipsychotic use in aging populations, these efforts are limited to adults in nursing homes, who likely have greater disease severity, Sen. Johnson and Sen. Collins wrote.

“Similar efforts have not been directed toward caregivers of older adults living outside of nursing homes, such as those in assisted living facilities and private residences,” the authors said. “Targeting this segment of the population is equally important given that over 1.2 million Medicare Part D enrollees living outside of nursing homes were diagnosed with dementia in 2012 and Medicare Part D pays for antipsychotic drugs prescribed to these individuals,” they added.

By expanding its outreach and educational efforts, HHS might be able to reduce the unnecessary reliance on antipsychotics for treating the “behavioral symptoms of dementia for all older adults regardless of their residential setting,” the author wrote. HHS concurred with the report’s conclusions.

[email protected]

The Department of Health & Human Services should do more to curb antipsychotic use in older adults with dementia, according to a recent report by the Government Accountability Office.

Antipsychotics are often prescribed off label to treat behavioral symptoms of dementia such as delusions, agitation, aggression, and personality changes. But the medications carry an increased risk of death and other adverse effects in older adults and should be used only when other options have been exhausted, said Sen. Ron Johnson (R-WIs.) and Sen. Susan M. Collins (R-Maine), who requested the report.

“Clinical guidelines consistently suggest the use of antipsychotic drugs for the treatment of the behavioral symptoms of dementia only when other, non-pharmacological attempts to ameliorate the behaviors have failed, and the individuals pose a threat to themselves or to others,” they said.

In 2012, Medicare Part D plans paid about $363 million for antipsychotics used by dementia patients aged 66 years and older.

About 33% of older adults with dementia who resided in a nursing home and were enrolled in Medicare Part D plans were prescribed antipsychotics, the authors said. Among those who did not reside in a nursing home, 14% were prescribed antipsychotics.

The investigation also found that 23% of short-stay [100 days or fewer] nursing home residents were prescribed antipsychotics, compared with 33% of long-stay residents. Sixty-six percent of the antipsychotic prescriptions for Medicare Part D patients were prescribed by internists and family medicine physicians, and 16% were written by psychiatrists or neurologists, the report said. Meanwhile 5% of the antipsychotics for these patients were prescribed by nurse practitioners and physician assistants, and the rest were prescribed by many specialties.

Although several HHS programs exist that aim to reduce antipsychotic use in aging populations, these efforts are limited to adults in nursing homes, who likely have greater disease severity, Sen. Johnson and Sen. Collins wrote.

“Similar efforts have not been directed toward caregivers of older adults living outside of nursing homes, such as those in assisted living facilities and private residences,” the authors said. “Targeting this segment of the population is equally important given that over 1.2 million Medicare Part D enrollees living outside of nursing homes were diagnosed with dementia in 2012 and Medicare Part D pays for antipsychotic drugs prescribed to these individuals,” they added.

By expanding its outreach and educational efforts, HHS might be able to reduce the unnecessary reliance on antipsychotics for treating the “behavioral symptoms of dementia for all older adults regardless of their residential setting,” the author wrote. HHS concurred with the report’s conclusions.

[email protected]